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Envoy Medical, Inc.

Envoy Medical, Inc.COCH财报

Nasdaq · 医疗保健 · 骨科、假肢及手术器械与用品

Envoy Medical, Inc. is a medical technology firm specializing in developing and commercializing advanced implantable hearing solutions for sensorineural hearing loss patients. Its core products include fully implanted middle ear hearing devices, with primary markets across North America and Europe, serving users who gain limited benefit from conventional external hearing aids.

What changed in Envoy Medical, Inc.'s 10-K — 2024 vs 2025

Top changes in Envoy Medical, Inc.'s 2025 10-K

671 paragraphs added · 432 removed · 91 edited across 9 sections

Item 1. Business

Business — how the company describes what it does

72 edited+138 added−13 removed53 unchanged
This capability may support audibility of alarms, sirens, telephones, and other people for an added sense of security while they sleep. ● Hearing in and around water. Patients using the Acclaim CI will not need to worry about removing their device when showering, at the beach, or swimming laps.
This capability will support audibility of alarms, sirens, telephones, and other people for an added sense of security while they sleep. ● Hearing in and around water. Patients using the Acclaim CI will not need to worry about removing their device when showering, at the beach, or swimming laps.
Currently, industry sources, including a 2018 paper published in the journal Trends in Hearing, 11 and our own market research estimate that less than 10% of adults who meet the indications for cochlear implant candidacy are implanted, leaving more than 90% of the current adult market as untapped potential for new technologies.
Currently, industry sources, including a 2018 paper published in the journal Trends in Hearing, 10 and our own market research estimate that less than 10% of adults who meet the indications for cochlear implant candidacy are implanted, leaving more than 90% of the current adult market as untapped potential for new technologies.
Traditionally, all cochlear implants were partially implanted with an external component. We believe the fully implanted Acclaim CI will be the first-of-a-kind cochlear implant with no external component worn on the ear or required for daily hearing and that leverages the ear to pick up sound (i.e., versus a microphone).
Traditionally, all cochlear implants were partially implanted with an external component. We believe the Acclaim CI will be the first-of-a-kind cochlear implant with no external component worn on the ear or required for daily hearing and that leverages the ear to pick up sound (i.e., versus a microphone).
Candidacy was expanded to include children and people with different levels or types of hearing loss. Over the last few years, the trends of the cochlear implant industry have mirrored that of the hearing aid industry, with less emphasis on hardware design and more placed on appearance and usability.
Candidacy was expanded to include children and people with different levels or types of hearing loss. 8 Over the last few years, the trends of the cochlear implant industry have mirrored that of the hearing aid industry, with less emphasis on hardware design and more placed on appearance and usability.
While there is no active litigation involving any of our patents or other intellectual property rights and we have not received any notices of patent infringement, we may be required to enforce or defend our intellectual property rights against third parties in the future. See
While there is no active litigation involving any of our patents or other intellectual property rights and we have not received any notices of patent infringement, we may be required to enforce or defend our intellectual property rights against third parties in the future.
The signal from the external component is transferred to the internal coil where it is delivered to the electrode array, which is implanted in the cochlea, to electrically stimulate the cochlea. The Acclaim CI is fully implanted and does not have the need for any external component to be worn on the ear.
The signal from the external component is transferred to the internal coil where it is delivered to the electrode array, which is implanted in the cochlea, to electrically stimulate the cochlea. 1 The Acclaim CI is fully implanted and does not have the need for any external component to be worn on the ear.
Regulatory delays would also put us further behind our established competitors in the market and may allow additional competitors into the market with products that have competitive advantages over ours. 9 Moreover, if FDA approval is delayed beyond our current plan or if delay is based on safety or efficacy concerns that require product redesign, we will be required to raise significant additional capital to continue our operations.
Regulatory delays would also put us further behind our established competitors in the market and may allow additional competitors into the market with products that have competitive advantages over ours. 11 Moreover, if FDA approval is delayed beyond our current plan or if delay is based on safety or efficacy concerns that require product redesign, we will be required to raise significant additional capital to continue our operations.
A four to eight week waiting period is required before the Acclaim CI can be activated to allow the middle ear to heal and fluid from surgery to dissipate.
A four-week waiting period is required before the Acclaim CI can be activated to allow the middle ear to heal and fluid from surgery to dissipate.
If FDA approval is materially delayed for any reason, it is possible that competitors will offer products with similar features before we are able to market the Acclaim CI. 4 Market Overview Overview of Hearing Loss According to the National Center for Health Statistics, hearing loss impacts about 15% of the adult population in the United States. 3 Among older adults, nearly 25% of people aged 65 to 74 have disabling hearing loss, and 50% of those aged 75 and older have disabling hearing loss, according to the National Institute on Deafness and Other Communications Disorders. 4 Organizations such as the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have recognized significant hearing loss as one of the most common disabilities impacting people around the world. 5 The WHO estimates economic impact of untreated or undertreated hearing loss is approximately $750 billion each year. 6 In common parlance, the terms “hearing loss,” “hard of hearing,” or “deafness” are often used to describe a variety of types, levels, and causes of hearing loss that are treated differently clinically.
If FDA approval is materially delayed for any reason, it is possible that competitors will offer products with similar features before we are able to market the Acclaim CI. 4 Market Overview Overview of Hearing Loss According to the National Center for Health Statistics, hearing loss impacts about 15% of the adult population in the United States. 2 Among older adults, nearly 25% of people aged 65 to 74 have disabling hearing loss, and 50% of those aged 75 and older have disabling hearing loss, according to the National Institute on Deafness and Other Communications Disorders. 3 Organizations such as the Centers for Disease Control and Prevention (“CDC”) and the World Health Organization (“WHO”) have recognized significant hearing loss as one of the most common disabilities impacting people around the world. 4 The WHO estimates economic impact of untreated or undertreated hearing loss is approximately $750 billion each year. 5 In common parlance, the terms “hearing loss,” “hard of hearing,” or “deafness” are often used to describe a variety of types, levels, and causes of hearing loss that are treated differently clinically.
However, this strategy will require significant investments in the development of our management team, corporate infrastructure, and manufacturing capabilities, as well as expansion of our sales, distribution, and training network. We do not anticipate offering the Acclaim CI at every cochlear implant center. 10 The other key professional group is audiologists.
However, this strategy will require significant investments in the development of our management team, corporate infrastructure, and manufacturing capabilities, as well as expansion of our sales, distribution, and training network. We do not anticipate offering the Acclaim CI at every cochlear implant center in the country. The other key professional group is audiologists.
According to data published in the Journal of the American Medical Association, sensorineural hearing loss is the most common form of hearing loss, representing approximately 90% of all hearing loss. 7 Conductive hearing loss is due to mechanical or structural problems with a part of the hearing system, generally a result of congenital issues with or damage to the ear canal, ear drum, or ossicular chain.
According to data published in the Journal of the American Medical Association, sensorineural hearing loss is the most common form of hearing loss, representing approximately 90% of all hearing loss. 6 Conductive hearing loss is due to mechanical or structural problems with a part of the hearing system, generally a result of congenital issues with or damage to the ear canal, ear drum, or ossicular chain.
These 30 sites are expected to be spread throughout the country and focus on quality of surgical care and capacity to serve a sufficient number of qualified patients. Following the initial 30 sites, we intend to add additional sites every year until there are roughly 120-150 sites actively implanting the Acclaim CI.
These 30 sites are expected to be spread throughout the country and focus on quality of surgical care and capacity to serve a sufficient number of qualified patients. Following the initial 30 sites, we intend to add an additional 30 sites every year until there are roughly 150 sites actively implanting the Acclaim CI.
In late 2015, we made the decision to shift our focus from the Esteem FI-AMEI to a new product that would leverage our sensor technology and incorporate it into a cochlear implant. As a result, we have developed the investigational fully implanted Acclaim CI.
In late 2015, we made the decision to shift our focus from the Esteem FI-AMEI to a new product that would leverage our sensor technology and incorporate it into a cochlear implant. As a result, we have developed the investigational Acclaim CI.
There is also reason to believe that increasing compliance and use of cochlear implants, reducing time to adoption for candidates, and helping to support safety and security by providing the ability for true all-day hearing may improve the net healthcare outcome for society over time.
There is also reason to believe that increasing compliance and use of cochlear implants, reducing time to adoption for candidates, and increasing safety and security by providing the ability for true all-day hearing may improve the net healthcare outcome for society over time.
We believe that the fully implanted nature of the Acclaim CI may facilitate an increase in daily usage over other types of cochlear implants because the device can be used 24-hours a day. ● Hearing at night. Unlike other types of available cochlear implants, the Acclaim CI can be used at night.
We believe that the fully implanted nature of the Acclaim CI will facilitate an increase in daily usage over other types of cochlear implants because the device can be used 24-hours a day. ● Hearing at night. Unlike other types of available cochlear implants, the Acclaim CI can be used at night.
The objective of this pivotal clinical study is to demonstrate the safety and efficacy of the fully implanted Acclaim cochlear implant for the treatment of severe to profound sensorineural hearing loss and is designed as a prospective, multicenter, non-randomized, open label clinical trial to evaluate the safety and efficacy of the Acclaim CI.
The objective of this pivotal clinical study is to demonstrate the safety and efficacy of the Acclaim cochlear implant for the treatment of severe to profound sensorineural hearing loss and is designed as a prospective, multicenter, non-randomized, open label clinical trial to evaluate the safety and efficacy of the Acclaim CI.
There is existing coding, coverage, and payment for cochlear implants. 11 Source: Holder JT, et al., Current Profile of Adults Presenting for Preoperative Cochlear Implant Evaluation ; TRENDS IN HEARING (2018). 8 Unlike the Esteem FI-AMEI, which was classified as a hearing aid by CMS and therefore statutorily excluded from being a coverable benefit under Medicare and Medicaid, the Acclaim CI is expected to be eligible for Medicare and Medicaid coverage as a cochlear implant.
There is existing coding, coverage, and payment for cochlear implants. 10 Source: Holder JT, et al., Current Profile of Adults Presenting for Preoperative Cochlear Implant Evaluation ; Trends in Hearing (2018). 9 Unlike the Esteem FI-AMEI, which was classified as a hearing aid by CMS and therefore statutorily excluded from being a coverable benefit under Medicare and Medicaid, the Acclaim CI is expected to be eligible for Medicare and Medicaid coverage as a cochlear implant.
An article published in the journal Acta Otorhinolaryngol Italica in June 2016 suggests that untreated or undertreated hearing loss correlates with earlier loss of cognitive function and poorer cardiovascular health. 2 While some solutions for hearing loss already exist (e.g., hearing aids, traditional cochlear implants) these have inherent limitations in being fully or partially external, which may limit patients in initial time to adoption, hours of use during the day (inherent compliance restrictions), lifestyle, or quality of life.
An article published in the journal Acta Otorhinolaryngol Italica in June 2016 suggests that untreated or undertreated moderate to profound hearing loss correlates with earlier loss of cognitive function and poorer cardiovascular health. 1 While some solutions for hearing loss already exist (e.g., hearing aids, traditional cochlear implants) these have inherent limitations in being fully or partially external, which limit patients in initial time to adoption, hours of use during the day (inherent compliance restrictions), lifestyle, and quality of life.
It is common for hearing loss to progress – continue to get worse – over the course of an individual’s life, so it is possible that a patient may have one or more hearing devices during the course of their lives. Personal Sound Amplification Devices (PSAPs) are small electronic devices used to make sounds louder but with little sophistication.
It is common for hearing loss to progress (i.e. continue to get worse) over the course of an individual’s life, so it is possible that a patient may have one or more hearing devices during the course of their lives. Personal Sound Amplification Devices (“PSAPs”) are small electronic devices used to make sounds louder but with little sophistication.
ITEM 1. Business Overview We are a hearing health company focused on providing innovative medical technologies across the hearing loss spectrum. Our technologies are designed to shift the paradigm within the hearing industry and bring both providers and patients the hearing devices they desire.
Overview We are a hearing health company focused on providing innovative medical technologies across the hearing loss spectrum. Our technologies are designed to shift the paradigm within the hearing industry and bring both providers and patients the hearing devices they desire.
Absent a change in reimbursement policy, there only will be nominal revenue from replacement of the sound processor / battery assembly (the “Battery”) for existing patients who need a new Battery. Intellectual Property We rely on a combination of patent, copyright, trademark and trade secret laws and confidentiality and invention assignment agreements to protect our intellectual property rights.
Absent a change in reimbursement policy, there only will be nominal revenue from replacement of sound processors for existing patients who need a new battery. Intellectual Property We rely on a combination of patent, copyright, trademark and trade secret laws and confidentiality and invention assignment agreements to protect our intellectual property rights.
There is no guarantee that we will meet any of the safety, efficacy, secondary, or exploratory endpoints or that the clinical study will proceed to the second stage or enroll all patients. Once the pivotal study is completed, the data will be analyzed and sent to the FDA with the PMA submission.
There is no guarantee that we will meet any of the safety, efficacy, secondary, or exploratory endpoints or enroll all patients. Once the pivotal study is completed, the data will be analyzed and sent to the FDA with the PMA submission.
It is not only important for the market to know our strategy for supporting patients for life, but it is the right thing to do for the patients. New implantations of the Esteem FI-AMEI are not expected to be more than a few per year until, and if, the reimbursement policy changes.
It is not only important for the market to know we support our patients for life, but it is the right thing to do for the patients. 13 New implantations of the Esteem FI-AMEI are not expected to be more than a few per year until, and if, the reimbursement policy changes.
Product Evolution and Next Generation Products The focus of research and development over the next several years will be to improve upon the existing product design of the Acclaim CI to aid the process of obtaining FDA approval. Quality and reliability will be a primary focus of the team in the initial years of market release.
Product Evolution and Next Generation Products The focus of research and development over the next several years will be to improve upon the existing product design of the Acclaim CI. Quality and reliability will be a primary focus of the team in the initial years of market release.
We currently anticipate obtaining FDA approval in late 2027 or early 2028, although the process of obtaining FDA approval is uncertain, and we may not obtain approval on that timeline or at all. A large component of our PMA will be a successful pivotal clinical study.
We currently anticipate obtaining FDA approval in late 2027 or early 2028, although the process of obtaining FDA approval is uncertain, and we may not obtain approval on that timeline or at all. A large component of our PMA will be a successful pivotal clinical study. We received approval for our IDE on October 31, 2024.
We believe there is a significant population of adults in the United States who are cochlear implant candidates but choose not to get the therapy because of the external component required for daily hearing.
We believe there is a significant population of adults in the United States who are cochlear implant candidates but choose not to get traditional, partially-implanted cochlear implants because of the external component required for daily hearing.
Moderate hearing loss is often defined as 40-70 dB of hearing loss and begins to show up with people reporting the ability to “hear but not understand” speech. More words are missed in conversations, and it is harder to hear in certain environments. Severe hearing loss is often defined as 70-90 dB of hearing loss.
As hearing loss progresses, the impact on the individual becomes more noticeable. Moderate hearing loss is often defined as 40-70 dB of hearing loss and begins to show up with people reporting the ability to “hear but not understand” speech. More words are missed in conversations, and it is harder to hear in certain environments.
However, we will be unable to train, educate, and develop these relationships until we are able to obtain FDA approval for the Acclaim CI. Commercial Activities Outside of the United States We anticipate pursuing the Conformité Européenne mark (“ CE Mark ”) in the European Union shortly after FDA approval.
However, we will be unable to commercialize until we are able to obtain FDA approval for the Acclaim CI. 12 Commercial Activities Outside of the United States We anticipate pursuing the Conformité Européenne mark (“ CE Mark ”) in the European Union shortly after FDA approval.
The Acclaim CI is implanted by a surgeon through a procedure that we believe will average around two and a half to three hours under general anesthesia. We expect that patients may experience mild to moderate discomfort after the procedure.
The Acclaim CI is implanted by a surgeon through a procedure that we believe will average around two and a half to three hours under general anesthesia. We expect that patients will experience mild to moderate discomfort after the procedure and benefit from several days of rest after surgery.
The sensor absorbs the mechanical energy from ossicular chain and turns it into a signal that can be processed, improved, and increased for a patient’s particular hearing needs. Our first product, the Esteem Fully Implanted Active Middle Ear Implant (“Esteem FI-AMEI”), received FDA approval in 2010.
The sensor absorbs the mechanical energy from ossicular chain and turns it into a signal that can be processed, improved, and increased for a patient’s particular hearing needs. Our first product, the Esteem FI-AMEI, received FDA approval in 2010. The Esteem FI-AMEI remains the only FDA approved fully implanted active hearing implant on the market.
Most people who are considered clinically “deaf” would have severe to profound hearing loss. 3 Source: National Health Interview Survey ; Center For Disease Control And Prevention: National Center For Health Statistics (2022), finding that as of 2022 15.5% of US adults reported some level of difficulty hearing. 4 Source: Quick Statistics About Hearing; National Institute Of Health ; National Institute On Deafness And Other Communications Disorders ( https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing ), summarizing statistics on hearing loss, including that 25% of people aged 65 to 74 have disabling hearing loss, and 50% of those aged 75 and older have disabling hearing loss. 5 Source: Preventing Noise-Induced Hearing Loss ; Center For Disease Control And Prevention (2022); and Deafness and Hearing Loss , World Health Organization (2023), each providing an overview of the prevalence of hearing loss. 6 Source: Global Costs of Unaddressed Hearing Loss and Cost-Effectiveness of Intervention ; World Health Organization (2017), providing an overview of the global costs of hearing loss, including components of cost and the monetary values attributable to such elements as costs typically incurred by health-care systems and patients, respectively, and reaching the conclusion that the cost of untreated or undertreated hearing loss is approximately $750 billion each year. 7 Source: Yueh B, et al.; Screening and Management of Adult Hearing Loss in Primary Care: Scientific Review ; Journal Of The American Medical Association (2003), providing an epidemiology of types of hearing loss and identifying sensorineural hearing loss as the cause of 90% of hearing loss. 8 Source: Yueh B, et al.; Screening and Management of Adult Hearing Loss in Primary Care: Scientific Review ; Journal Of The American Medical Association (2003), providing an epidemiology of hearing loss, including the allocation of hearing loss between sensorineural hearing loss and other types. 5 Overview of Hearing Devices There are several different types of hearing devices to address hearing loss.
Conductive hearing loss represents approximately 10% of all hearing loss, according to data published in the Journal of the American Medical Association. 7 Finally, mixed hearing loss has some combination of both sensorineural and conductive components. 2 Source: National Health Interview Survey ; Center For Disease Control And Prevention: National Center For Health Statistics (2022), finding that as of 2022 15.5% of US adults reported some level of difficulty hearing. 3 Source: Quick Statistics About Hearing; National Institute Of Health ; National Institute On Deafness And Other Communications Disorders ( https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing ), summarizing statistics on hearing loss, including that 25% of people aged 65 to 74 have disabling hearing loss, and 50% of those aged 75 and older have disabling hearing loss. 4 Source: Preventing Noise-Induced Hearing Loss ; Center For Disease Control And Prevention (2022); and Deafness and Hearing Loss , World Health Organization (2023), each providing an overview of the prevalence of hearing loss. 5 Source: Global Costs of Unaddressed Hearing Loss and Cost-Effectiveness of Intervention ; World Health Organization (2017), providing an overview of the global costs of hearing loss, including components of cost and the monetary values attributable to such elements as costs typically incurred by health-care systems and patients, respectively, and reaching the conclusion that the cost of untreated or undertreated hearing loss is approximately $750 billion each year. 6 Source: Yueh B, et al.; Screening and Management of Adult Hearing Loss in Primary Care: Scientific Review ; Journal Of The American Medical Association (2003), providing an epidemiology of types of hearing loss and identifying sensorineural hearing loss as the cause of 90% of hearing loss. 7 Source: Yueh B, et al.; Screening and Management of Adult Hearing Loss in Primary Care: Scientific Review ; Journal Of The American Medical Association (2003), providing an epidemiology of hearing loss, including the allocation of hearing loss between sensorineural hearing loss and other types. 5 In addition to the three main types of hearing loss, there are generally five levels of hearing loss severity: normal, mild, moderate, severe, and profound.
The ear itself is an ideal way to capture sound from our environment. To leverage the natural ear’s benefits, an implanted sensor was created to pick up incoming sound energy from the ossicular chain (i.e., the three tiny hearing bones that connect the eardrum to the cochlea).
To leverage the natural ear’s benefits, an implanted sensor was created to pick up incoming sound energy from the ossicular chain (i.e., the three tiny hearing bones that connect the eardrum to the cochlea).
Other cochlear implants require near-daily battery replacement or battery charging. In addition to the logistical hassle of worrying about keeping the batteries charged, this can be challenging for patients who have issues with dexterity or neuropathy, as the batteries and components are small and can be hard to handle.
In addition to the logistical hassle of worrying about keeping the batteries charged, this can be challenging for patients who have issues with dexterity or neuropathy, as the batteries and components are small and can be hard to handle.
(ASX: COH) is the leading cochlear implant device manufacturer with approximately 60% of global market share and a market capitalization of approximately $12 billion (US Dollars) as of December 31, 2024.
(ASX: COH) is the leading cochlear implant device manufacturer with approximately 65% of global market share and a market capitalization of approximately $12 billion USD as of December 31, 2025.
We believe this is one of the main reasons why industry sources, such as a 2018 paper published in the journal Trends in Hearing, and our own market research estimate 5-8% penetration rate for cochlear implants in the adult population. 9 9 Sources: Holder JT, et al., Current Profile of Adults Presenting for Preoperative Cochlear Implant Evaluation ; Trends In Hearing (2018), providing an analysis of implantation rates of cochlear implants among adults receiving preoperative screening, including a determination that “the market penetration for cochlear implantation was just 7.7% in the adult population of individuals with severe-to-profound sensory hearing loss.” We have also commissioned market research by S2N Health, which analyzed available literature and estimates from other market participants to reach the 5 - 8% penetration rate, based in part on an expansion of candidacy criteria since the publication of the Holder article.
Moreover, it is reasonable to believe that Acclaim CI will demand a higher average selling price than existing partially implanted cochlear implants. 8 Sources: Holder JT, et al., Current Profile of Adults Presenting for Preoperative Cochlear Implant Evaluation ; Trends In Hearing (2018), providing an analysis of implantation rates of cochlear implants among adults receiving preoperative screening, including a determination that “the market penetration for cochlear implantation was just 7.7% in the adult population of individuals with severe-to-profound sensory hearing loss.” We have also commissioned market research by S2N Health, which analyzed available literature and estimates from other market participants to reach the 5 – 8% penetration rate, based in part on an expansion of candidacy criteria since the publication of the Holder article.
Despite the commercial challenges of the Esteem FI-AMEI, roughly 1,000 devices were implanted globally. Some devices were implanted in the early 2000s during clinical trials, providing us with nearly two decades of experience with its implantable sensor technology. Throughout our experience, our sensor technology proved a viable alternative to external or implanted microphones.
Some devices were implanted in the early 2000s during clinical trials, providing us with over two decades of experience with its implantable sensor technology. Throughout our experience, our sensor technology proved a viable alternative to external or implanted microphones.
FDA-approved since 2010, the Esteem FI-AMEI suffered from a lack of reimbursement due to categorization as a hearing aid. We believe that this categorization is inaccurate as, unlike a hearing aid which is essentially an externally worn microphone and speaker simply making sounds louder, the Esteem FI-AMEI is fully implanted and replaces the function of the middle ear.
We believe that this categorization is inaccurate as, unlike a hearing aid which is essentially an externally worn microphone and speaker simply making sounds louder, the Esteem FI-AMEI is fully implanted and replaces the function of the middle ear to directly stimulate the cochlear via the stapes.
These bills seek to clarify that fully implanted active middle ear hearing devices (FI-AMEIs) are prosthetics and not subject to the current Medicare hearing aid coverage exclusion.
The bill seeks to clarify that fully implanted active middle ear hearing devices (“FI-AMEIs”) are prosthetics and not subject to the current Medicare hearing aid coverage exclusion.
If these bills are successful in clarifying that FI-AMEIs are eligible for coverage and a change does happen to reimbursement policy for fully implanted active middle ear implants, the Esteem FI-AMEI is an existing FDA approved product ready to capitalize on such a change. 11 Existing Esteem FI-AMEI patients and professionals who work with those patients will continue to be supported.
If the bill is successful clarifying that FI-AMEIs are eligible for coverage and then a change does happen to reimbursement policy for fully implanted active middle ear implants, the Esteem FI-AMEI is an existing FDA approved product ready to capitalize on such a change.
The study is essentially designed to elicit patient and professional feedback regarding their experience using the device and inform any necessary design changes prior to beginning the pivotal clinical study. We believe that the initial results of the EFS were promising. A few device shortcomings have been identified and are in process of being addressed or appropriately mitigated.
The study is essentially designed to elicit patient and professional feedback regarding their experience using the device and inform any necessary design changes prior to beginning the pivotal clinical study. We believe that the initial results of the EFS were primarily promising.
Because the Acclaim CI is currently our only product candidate that we believe can be commercialized, we would be unable to continue operations if it were determined that we could not obtain FDA approval for the Acclaim CI. Early Feasibility Study The Acclaim CI has undergone extensive benchtop and laboratory testing throughout the design and development process.
Because the Acclaim CI is currently our only product candidate that we believe can be commercialized, we would be unable to continue operations if it were determined that we could not obtain FDA approval for the Acclaim CI.
As of March 10, 2025, we had rights to 35 issued U.S. patents, which are estimated to expire between 2025 and 2043 assuming all required fees are paid, 13 pending U.S. patent applications, 33 issued foreign patents and 32 pending foreign and international patent applications.
As of March 2, 2026, we had rights to 40 issued U.S. patents, which are estimated to expire between 2028 and 2043 assuming all required fees are paid, 9 pending U.S. patent applications, 48 issued foreign patents and 26 pending foreign and international patent applications.
Current Estimates of Cochlear Implant Utilization in the United States , Otol Neurotol (June 2022). 6 Based on published literature and industry sources (prior to candidacy expansion for cochlear implant candidates), including the American Journal of Public Health, we believe there are approximately 6.6 million Americans age 12 or older with severe to profound hearing loss in at least one ear. 10 Incorporating estimates for clinical indications (including limited benefit from hearing aids), we believe there are approximately 2.8 million adults in the United States who could qualify for a cochlear implant.
We believe this is one of the main reasons why industry sources, such as a 2018 paper published in the journal Trends in Hearing, and our own market research estimate 5-8% penetration rate for cochlear implants in the adult population. 8 Based on published literature and industry sources (prior to candidacy expansion for cochlear implant candidates), including the American Journal of Public Health, we believe there are approximately 6.6 million Americans age 12 or older with severe to profound hearing loss in at least one ear. 9 Incorporating estimates for clinical indications (including limited benefit from hearing aids), we believe there are approximately 2.8 million adults in the United States who could qualify for a cochlear implant.
The Esteem FI-AMEI remains the only FDA approved fully implanted active hearing device on the market. The Esteem FI-AMEI failed to gain commercial traction, primarily because the Centers for Medicaid and Medicare Services (“CMS”) classified it as a hearing aid and therefore not eligible for coverage.
The Esteem FI-AMEI failed to gain commercial traction, primarily because the Centers for Medicaid and Medicare Services (“ CMS ”) classified it as a hearing aid and therefore not eligible for coverage.
Unlike partially implanted devices, the fully implanted Acclaim CI uses the ear to capture sound via a piezoelectric sensor that is implanted in the middle ear. The sound processor and power source are also implanted. 2 CAUTION: Investigational Device – Limited by Federal (or United States) Law to Investigational Use.
Unlike partially implanted devices, the Acclaim CI uses the ear to capture sound via a piezoelectric sensor that is implanted in the middle ear. The sound processor and power source are also implanted.
The Acclaim CI processor is implanted and therefore not susceptible to damage, discomfort or issues associated with moisture, germs, dirt, or other external causes of loss or physical damage due to having an externally worn processor. ● Use of equipment and accessories.
In addition, lost or damaged components can be expensive to replace, with the cost of replacement often not covered by insurance. The Acclaim CI processor is implanted and therefore not susceptible to issues associated with moisture, germs, dirt, or other external causes of loss or physical damage due to having an externally worn processor. ● Flexibility with equipment or accessories.
Our Product Cochlear Implants - Fully Implanted vs. Partially Implanted The cochlea converts vibrations from the ossicular chain into nerve signals that are transmitted through the auditory nerve for processing by the brain. Cochlear implants use electronic signals to stimulate the auditory nerve.
We now believe we have the possibility to disrupt the cochlear implant market currently dominated by three main incumbents. Our Product Cochlear Implants — Fully Implanted vs. Partially Implanted The cochlea converts vibrations from the ossicular chain into nerve signals that are transmitted through the auditory nerve for processing by the brain.
Partially implanted cochlear implants have two main components: a large external component that sits on or behind the patient’s ear and a surgically implanted internal component. The external component contains a microphone, sound processer, and batteries. A magnetic coil on the external component lines up with an internal magnetic coil in the internal component.
Cochlear implants use electronic signals to directly stimulate the auditory nerve via the cochlea. Partially implanted cochlear implants have two main components: a large external component that sits on or behind the patient’s ear and a surgically implanted internal component. The external component contains a microphone, sound processer, and batteries.
However, we will be unable to expand into international markets if we are unable to obtain these regulatory approvals. Market Competition There are currently three major cochlear implant manufacturers - Cochlear Ltd., Advanced Bionics (Sonova), and Med-El. There are a few other minor regional players, such as Nurotron in China, which appears to be focused on developing countries. Cochlear Ltd.
However, we will be unable to expand into international markets if we are unable to obtain these regulatory approvals. Market Competition There are currently three major cochlear implant manufacturers — Cochlear Ltd., Advanced Bionics (“Sonova”), and Med-El.
In addition, current providers also have substantially greater financial and operational resources, which may give them an advantage in capitalizing on new technology and responding to other changes to the marketplace. 10 Source: Goman, AM and Frank RL, Prevalence of Hearing Loss by Severity in the United States , AMERICAN JOURNAL OF PUBLIC HEALTH (Oct 2016), estimating that 6.6 million (2.5%) of Americans aged 12 years or older have severe to profound hearing loss in at least one ear, with three quarters of these individuals being older than 60 years.
Current Estimates of Cochlear Implant Utilization in the United States , Otol Neurotol (June 2022). 9 Source: Goman, AM and Frank RL, Prevalence of Hearing Loss by Severity in the United States , American Journal of Public Health (Oct 2016), estimating that 6.6 million (2.5%) of Americans aged 12 years or older have severe to profound hearing loss in at least one ear, with three quarters of these individuals being older than 60 years.
Animal testing was done to demonstrate the reliability of the Acclaim CI’s rechargeable battery and charging safety algorithm. In the third quarter of 2022, we received an IDE to undergo a small Early Feasibility Study (“ EFS ”) at Mayo Clinic in Rochester, Minnesota. The principal investigator is Dr. Colin Driscoll, a respected veteran in the global cochlear implant industry.
In the third quarter of 2022, we received an Investigational Device Designation (“IDE”) approved by the FDA to undergo a small Early Feasibility Study (“ EFS ”) at Mayo Clinic in Rochester, Minnesota. The principal investigator is Dr. Colin Driscoll, a respected veteran in the global cochlear implant industry.
The patient will not need to preemptively remove the device prior to engaging in these types of activities, thus retaining audibility of the surrounding environment. 2 Source: Fortunato S, et al.; A Review of New Insights on the Association Between Hearing Loss and Cognitive Decline in Ageing ; A cta Otorhinolaryngologica Italica (Jun 2016), finding that increasing evidence has linked age related hearing loss to more rapid progression of cognitive decline and incidental dementia and that many aspects of daily living of elderly people have been associated to hearing abilities, showing that hearing loss affects the quality of life, social relationships, motor skills, psychological aspects and function and morphology in specific brain areas. 3 ● Lowered battery maintenance.
The Acclaim CI battery is expected to last for several days between charges and will not require the patient to use or handle small components like current cochlear implant systems do. 1 Source: Fortunato S, et al.; A Review of New Insights on the Association Between Hearing Loss and Cognitive Decline in Ageing; ACTA OTORHINOLARYNGOLOGICA ITALICA (Jun 2016), finding that increasing evidence has linked age related hearing loss to more rapid progression of cognitive decline and incidental dementia and that many aspects of daily living of elderly people have been associated to hearing abilities, showing that hearing loss affects the quality of life, social relationships, motor skills, psychological aspects and function and morphology in specific brain areas. 3 ● No need for backup or secondary processors.
This combination helps to mitigate the noise and provide patients with a signal to noise ratio that allows them to use and enjoy the performance of the device. It was an unanticipated discovery during the EFS that a hearing aid on top of the Acclaim CI could provide patients with additional improvement.
It was an unanticipated discovery during the EFS that a hearing aid on top of the Acclaim CI could provide patients with additional improvement.
As cochlear implants become more accepted as a therapy for individuals with moderate to profound sensorineural hearing loss, manufacturers will pay attention to ways of making patients interested in their device over a similarly performing competing device. Another major trend within the industry is a loosening of the clinical candidacy requirements.
We believe that the trend over the next decade will be a continuation of the focus on usability, connectivity, lifestyle, and miniaturization. As cochlear implants become more accepted as a therapy for individuals with moderate to profound sensorineural hearing loss, manufacturers will pay attention to ways of making patients interested in their device over a similarly performing competing device.
As a result, more patients are eligible for cochlear implants than ever before. Finally, industry participants have made material investments to inform more adult candidates about cochlear implants to increase usage.
Both Med El (in 2019) and Cochlear (in 2021) achieved FDA approval for treatment of those with SSD and asymmetric hearing loss. As a result, more patients are eligible for cochlear implants than ever before. Finally, industry participants have made material investments to inform more adult candidates about cochlear implants to increase usage.
We are intrigued by the possibility of offering a fully implanted cochlear implant that could also allow for the use of a hearing aid or other ear accessory (e.g., ear buds) because the Acclaim CI leverages the ear to pick up sound.
We are intrigued by the possibility of offering a fully implanted cochlear implant that could also allow for the use of a hearing aid or other ear accessory (e.g., ear buds) because the Acclaim CI leverages the ear to pick up sound. 10 Timeline to Commercialization of Acclaim CI In the United States, before we can market a new Class III medical device, which the Acclaim CI is, we must first receive FDA approval via the Premarket Approval (“PMA”) approval process.
We do not plan to market the Acclaim CI to patients under age 18. 7 If we are able to obtain regulatory approval of the Acclaim CI, we believe physicians and patients may be receptive to it being a fully implanted cochlear implant.
If we are able to obtain regulatory approval of the Acclaim CI, we believe physicians and patients will be receptive to its competitive advantage as a fully implanted cochlear implant.
Mild hearing loss is often defined as 20-40 dB of hearing loss with some people reporting difficulty hearing soft spoken people. Most people with mild hearing loss do not address their hearing loss. As hearing loss progresses, the impact on the individual becomes more noticeable.
Normal hearing is often defined as 0-20 decibels (“dB”) of hearing loss and even with a slight loss most people do not notice any impact. Mild hearing loss is often defined as 20-40 dB of hearing loss with some people reporting difficulty hearing soft spoken people. Most people with mild hearing loss do not address their hearing loss.
In addition to people with “better” hearing levels being considered for cochlear implants (e.g., people with moderate hearing in the lower frequencies) there has also been a movement to implant people with “single sided deafness” (“ SSD ”). Both Med El (in 2019) and Cochlear (in 2021) achieved FDA approval for treatment of those with SSD and asymmetric hearing loss.
Another major trend within the industry is the loosening of the clinical candidacy requirements. In addition to people with “better” hearing levels being considered for cochlear implants (e.g., people with moderate hearing in the lower frequencies) there has also been a movement to implant people with “single sided deafness” (“ SSD ”).
Auditory osseointegrated implants (bone conduction implants) are used for conductive or certain types of mixed hearing loss. They are not used for sensorineural hearing loss. They address a patient’s conductive hearing loss by transferring sound information through the patient’s skull via vibration.
Auditory osseointegrated implants (i.e. bone conduction implants) are used for conductive or certain types of mixed hearing loss. They are not used for sensorineural hearing loss.
Acclaim CI - A Breakthrough Device The fully implanted Acclaim CI received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.
CAUTION: Investigational Device — Limited by Federal Law to Investigational Use. 2 Acclaim CI — A Breakthrough Device The Acclaim CI received the Breakthrough Device Designation from the U.S. Food and Drug Administration (“FDA”) in 2019.
People with severe hearing loss are unable to hear most speech and miss large portions of conversations without assistance. People with severe hearing loss may find that even with hearing aids they are not getting enough benefit to hear and understand most of the words in a conversation.
People with severe hearing loss may find that even with hearing aids they are not getting enough benefit to hear and understand most of the words in a conversation. Profound hearing loss is often defined as 90 dB or more of hearing loss. People with profound hearing loss cannot hear speech or loud sounds such as sirens or horns.
Moreover, it is reasonable to believe that Acclaim CI will demand a higher average selling price than existing partially implanted cochlear implants. We also believe there are substantial total market and annual market opportunities outside the United States. Currently, our analysis estimates that approximately 50% of the hearing device market is international.
We do not plan to market the Acclaim CI to patients under age 18. 7 We also believe there are substantial total market and annual market opportunities outside the United States. Currently, our analysis estimates that approximately 50% of the hearing device market is international.
The backup processor provides the patient with a sense of security because they know if their primary processor is lost or damaged, they will be left without hearing for a period of time while they wait for a replacement. In addition, lost or damaged components can be expensive to replace, with the cost of replacement often not covered by insurance.
Many patients who have partially implanted cochlear implants with external hardware desire or need a backup processor. The backup processor provides the patient with a sense of security because they know if their primary processor is lost or damaged, they will be left without hearing for a period of time while they wait for a replacement.
Although efforts to change that categorization have been unsuccessful to date, two bipartisan Congressional bills, both titled the Hearing Device Coverage Clarification Act were introduced in the House and the Senate in the 118 th Congress. It is anticipated, although not guaranteed, that the bills will be reintroduced into the 119 th Congress.
Although efforts to change that categorization have been unsuccessful to date, a bipartisan Congressional bill, titled the Hearing Device Coverage Clarification Act was introduced in both the House of Representatives and in the Senate.
At an average total price (i.e., device and surgery) of over $25,000, very few individuals were willing or able to pay out-of-pocket for the Esteem FI-AMEI. We believe hearing aid classification is improper for the Esteem FI-AMEI and we continue to work towards having the Esteem FI-AMEI properly classified as a Fully Implanted Active Middle Ear Implant.
We believe hearing aid classification is improper for the Esteem FI-AMEI and we continue to work towards having the Esteem FI-AMEI properly classified as a Fully Implanted Active Middle Ear Implant. Despite the commercial challenges of the Esteem FI-AMEI, roughly 1,000 devices were implanted globally.
Acclaim CI’s Market Opportunity The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. We anticipate that the Acclaim CI will only be indicated for adults who have been deemed adequate candidates by a qualified physician.
As part of the clinical trial, the Acclaim CI will only be intended for adults with severe-to-profound sensorineural hearing loss who have been deemed adequate candidates by a qualified physician.
In order to begin a pivotal clinical study, you must have an Investigational Device Designation (“IDE”) approved by the FDA. We received approval for our IDE on October 31, 2024. However, FDA approved our IDE based on a staged clinical study that will require approval from the FDA to move from the first stage to the second stage.
However, FDA approved our IDE based on a staged clinical study that required approval from the FDA to move from the first stage to the second stage. We received approval to expand the study to the second and final stage on October 3, 2025.
We will also focus on the growing need for robust software and user interfaces for both the patient and the professional. It is possible that we will expand our portfolio to include a variety of cochlear electrode arrays similar to other cochlear implant companies.
We will also focus on the growing need for robust software and user interfaces for both the patient and the professional. Esteem FI-AMEI — a potentially viable product with reimbursement The Esteem FI-AMEI is a unique technology that could serve a niche segment of the hearing market.
We are dedicated to pushing beyond the status quo to provide patients with improved access, usability, independence, and quality of life. We were founded in 1995 to create a fully implanted hearing device that leveraged the natural ear - not an artificial microphone - to pick up sound.
We are dedicated to pushing beyond the status quo to provide patients with improved access, usability, independence, and quality of life. We believe leveraging the ear’s natural anatomy, rather than external or sub-dermal artificial microphone, is the ideal way for people to hear.
Profound hearing loss is often defined as 90 dB or more of hearing loss. People with profound hearing loss cannot hear speech or loud sounds such as sirens or horns.
Moderate to profound hearing loss is often defined as 70-90 dB of hearing loss. People with severe hearing loss are unable to hear most speech and miss large portions of conversations without assistance.
The current providers also have existing relationships with patients who have used their devices.
The current providers also have existing relationships with patients who have used their devices. In addition, current providers also have substantially greater financial and operational resources, which may give them an advantage in capitalizing on new technology and responding to other changes to the marketplace.
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We now believe we have the possibility to disrupt the cochlear implant market currently dominated by a small number of incumbents. Business Combination In September 2023, we completed the Business Combination pursuant to the Business Combination Agreement between Anzu and Legacy Envoy.
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ITEM 1. Business Unless otherwise noted or the context otherwise requires, all references in this section to “Envoy Medical,” “we,” “us” or “our” refer to Envoy Medical, Inc. following the Business Combination, other than certain historical information which refers to the business of Legacy Envoy prior to the consummation of the Business Combination.
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As contemplated by the Business Combination Agreement: (a) each share of Legacy Envoy Preferred Stock issued and outstanding immediately prior to the Closing was converted into shares of Legacy Envoy Common Stock; (b) each share of Merger Sub Common Stock issued and outstanding immediately prior to the Closing was converted into and exchanged for one share of Legacy Envoy Common Stock; (c) each outstanding option to purchase shares of Legacy Envoy Common Stock outstanding as of immediately prior to the Closing was cancelled in exchange for nominal consideration; (d) each outstanding warrant to purchase shares of Legacy Envoy Common Stock outstanding as of immediately prior to the Closing automatically, depending on the applicable exercise price, was cancelled or exercised on a net exercise basis and converted into shares of Legacy Envoy Common Stock in accordance with its terms; (e) each outstanding Legacy Envoy convertible promissory note was automatically converted into shares of Legacy Envoy Common Stock in accordance with its terms; (f) each share of Legacy Envoy Common Stock issued and outstanding immediately prior to the Closing was cancelled and converted into the right to receive a number of shares of our Class A Common Stock equal to the Exchange Ratio; (g) the Sponsor forfeited 5,510,000 shares of Anzu Class B Common Stock and all 12,500,000 private warrants pursuant to the Sponsor Support Agreement; (h) the Sponsor exchanged 2,500,000 shares of Anzu Class B Common Stock for 2,500,000 shares of our Series A Preferred Stock; (i) an aggregate of 2,615,000 shares of Anzu Class B Common Stock held by the Sponsor and Anzu’s former independent directors automatically converted into our Class A Common Stock; (j) the Sponsor transferred an aggregate of 490,000 shares of our Class A Common Stock to the Legacy Forward Purchasers and the Extension Support Parties pursuant to the Side Letter Agreements and Extension Support Agreements, respectively; and (k) the Company issued an aggregate of 8,512 shares of Class A Common Stock to the Meteora FPA Parties pursuant to the Forward Purchase Agreement. 1 As of the open of trading on October 2, 2023, the Class A Common Stock and Public Warrants of the Company, formerly those of Anzu, began trading on Nasdaq as “COCH” and “COCHW,” respectively.
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A magnetic coil on the external component lines up with an internal magnetic coil in the internal component.
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The Acclaim CI battery is expected to last for several days between charges and will not require the patient to use or handle small components like current cochlear implant systems do. ● No need for backup or secondary processors. Many patients who have partially implanted cochlear implants with external hardware desire or need a backup processor.
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The patient will not need to preemptively remove the device prior to engaging in these types of activities, thus retaining audibility of the surrounding environment. ● Lowered battery maintenance. Other cochlear implants require near-daily battery replacement or battery charging.
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Conductive hearing loss represents approximately 10% of all hearing loss, according to data published in the Journal of the American Medical Association. 8 Finally, mixed hearing loss has some combination of both sensorineural and conductive components.
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Most people who are considered clinically “deaf” would have severe to profound hearing loss. Overview of Hearing Devices There are several different types of hearing devices to address hearing loss.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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In addition, we have limited experience and have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the medical device industry. To date, we have not generated any revenue from the sale of the Acclaim CI. See
In addition, we have limited experience and have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the medical device industry. To date, we have not generated any revenue from the sale of the Acclaim CI.
Risk Factors Risks Relating to Our Business and Operations We are an early-stage company with a history of losses. We have not been profitable historically and may not be able to achieve profitability in the future. We are a development-stage medical device company with a limited operating history.
Risks Relating to Our Business and Operations We are an early-stage company with a history of losses. We have not been profitable historically and may not be able to achieve profitability in the future. We are a development-stage medical device company with a limited operating history.
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Item 1A. Risk Factors - Risks Relating to our Intellectual Property for additional information regarding these and other risks related to our intellectual property portfolio and their potential effect on us. Material Patents As of March 10, 2025, our material patents, their jurisdiction, patent number, and expiration date are listed in the tables below: Jurisdiction Patent No.
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ITEM 1A. Risk Factors An investment in our securities involves substantial risks. In addition to other information in this Annual Report on Form 10-K, you should carefully consider the risks described in this Report, as well as other information and data set forth in this Report, before making an investment decision with respect to our securities.
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Expiration Date Title U.S. 7297101 01/17/2026 Method and apparatus for minimally invasive placement of sensing and driver assemblies to improve hearing loss U.S. 9782600 05/17/2033 Self-regulating transcutaneous energy transfer U.S. 7524278 08/15/2025 Hearing aid system and transducer with hermetically sealed housing U.S. 9497555 01/30/2035 Implantable middle ear transducer having improved frequency response U.S. 10129660 10/27/2028 Implantable middle ear transducer having improved frequency response U.S. 9036824 12/30/2033 Transducer impedance measurement for hearing aid U.S. 9521493 05/03/2032 Transducer impedance measurement for hearing aid U.S. 9682226 12/06/2033 Electronic lead connection and related devices U.S. 10549090 10/20/2037 Communication system and methods for fully implantable modular cochlear implant system U.S. 10646709 04/09/2038 Fully implantable modular cochlear implant system U.S. 10569079 09/04/2037 Communication system and methods for fully implantable modular cochlear implant system U.S. 10743812 03/25/2035 Implantable middle ear diagnostic transducer U.S. 11260220 02/28/2040 Implantable cochlear system with integrated components and lead characterization U.S. 11266831 06/13/2040 Implantable cochlear system with integrated components and lead characterization U.S. 9525949 03/16/2034 Implantable middle ear transducer having diagnostic detection sensor 12 Jurisdiction Patent No.
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The occurrence of any of such risks could materially and adversely affect our business, prospects, financial condition and results of operations, which could cause you to lose all or a part of your investment in our securities. Some statements in this Report constitute forward-looking statements.
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Expiration Date Title U.S. 11051116 10/11/2032 Implantable middle ear transducer having diagnostic detection sensor U.S. 11471689 04/14/2041 Cochlear implant stimulation calibration U.S. 11564046 07/17/2041 Programming of cochlear implant accessories U.S. 9313590 03/13/2033 Hearing aid amplifier having feed forward bias control based on signal amplitude and frequency for reduced power consumption U.S. 9635478 03/09/2034 Coulomb counter and battery management for hearing aid U.S. 11672970 02/21/2040 Implantable cochlear system with integrated components and lead characterization U.S. 11697019 12/02/2040 Combination hearing aid and cochlear implant system U.S. 11711658 10/11/2032 Implantable middle ear transducer having diagnostic detection sensor EP 3500337 08/17/2037 Implantable modular cochlear implant system with communication system and network DE 3500337 08/17/2037 Implantable modular cochlear implant system with communication system and network DK 3500337 08/17/2037 Implantable modular cochlear implant system with communication system and network AT 3500337 08/17/2037 Implantable modular cochlear implant system with communication system and network GB 3500337 08/17/2037 Implantable modular cochlear implant system with communication system and network BE 3500337 08/17/2037 Implantable modular cochlear implant system with communication system and network FR 3500337 08/17/2037 Implantable modular cochlear implant system with communication system and network IT 3500337 08/17/2037 Implantable modular cochlear implant system with communication system and network SE 3500337 08/17/2037 Implantable modular cochlear implant system with communication system and network MX 421017 2/21/20240 Implantable cochlear system with integrated components and lead characterization EP 3927420 2/21/2040 Implantable cochlear system with integrated components and lead characterization UP 3927420 2/21/2040 Implantable cochlear system with integrated components and lead characterization GB 3927420 2/21/2040 Implantable cochlear system with integrated components and lead characterization U.S. 11633591 8/3/2041 Combination implant system with removable earplug sensor and implanted battery U.S. 11806531 4/11/2041 Implantable cochlear system with inner ear sensor U.S. 11839765 1/23/2042 Cochlear implant system with integrated signal analysis functionality U.S. 11865339 6/22/2042 Cochlear implant system with electrode impedance diagnostics EP 3858425 08/17/2037 Implantable Modular Cochlear Implant System with Communication System and Network GB 3858425 08/17/2037 Implantable Modular Cochlear Implant System with Communication System and Network UP 3858425 08/17/2037 Implantable Modular Cochlear Implant System with Communication System and Network U.S. 12090318 02/21/2040 Implantable Cochlear System with Integrated Components and Lead Characterization U.S. 12233256 10/09/2040 Implantable Cochlear System with Integrated Components and Lead Characterization 13 Jurisdiction Patent No.
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See “ Cautionary Note Regarding Forward-Looking Statements .” Risks Relating to Our Class A Common Stock The market price of our Class A Common Stock has been and may continue to be extremely volatile, which could cause purchasers of our securities to incur substantial losses.
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Expiration Date Title HK HK40066136 02/21/2040 Implantable Cochlear System with Integrated Components and Lead Characterization JP 7598401 02/21/2040 Implantable Cochlear System with Integrated Components and Lead Characterization JP 7597846 02/21/2040 Implantable Cochlear System with Integrated Components and Lead Characterization JP 7598327 02/21/2040 Implantable Cochlear System with Integrated Components and Lead Characterization U.S. 12081061 02/07/2043 Recharge System For Implantable Battery U.S. 12214195 12/02/2040 Implantable Cochlear System with Inner Ear Sensor EP 4204071 08/27/2041 Programming Of Cochlear Implant Accessories GB 4204071 08/27/2041 Programming Of Cochlear Implant Accessories HK HK40097814 08/27/2041 Programming Of Cochlear Implant Accessories UP 4204071 08/27/2041 Programming Of Cochlear Implant Accessories U.S. 12151102 12/02/2040 Combination Hearing Aid and Cochlear Implant System EP 4255554 11/24/2041 Combination Hearing Aid and Cochlear Implant System GB 4255554 11/24/2041 Combination Hearing Aid and Cochlear Implant System UP 4255554 11/24/2041 Combination Hearing Aid and Cochlear Implant System EP 4255555 11/24/2041 Cochlear Implant Stimulation Calibration GB 4255555 11/24/2041 Cochlear Implant Stimulation Calibration UP 4255555 11/24/2041 Cochlear Implant Stimulation Calibration EP 4319866 04/01/2042 Cochlear Implant System with Electrode Impedance Diagnostics GB 4319866 04/01/2042 Cochlear Implant System with Electrode Impedance Diagnostics UP 4319866 04/01/2042 Cochlear Implant System with Electrode Impedance Diagnostics Trademarks As of February 28, 2025, we had trademark registrations, covering “Acclaim”, “Envoy”, “Envoy Medical”, “EnvoyCEM”, “Esteem”, “Invisible Hearing”, and “MEDCEM.” Our U.S. trademarks have registration dates between 2002 and 2021 and have upcoming renewal dates between 2027 and 2033.
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The market price and trading volume of our shares of Class A Common Stock has recently experienced, and may continue to experience, extreme volatility, which could cause purchasers of our Class A Common Stock to incur substantial losses.
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All of our trademarks are in current use, and we expect that they will remain in use for the foreseeable future. We also have pending trademark applications covering “Nature’s Microphone” and “Naturemic” with application dates in 2024 for use in 2025.
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Since the closing of the Business Combination, our Class A Common Stock has traded as low as $0.36 and as high as $11.46. In addition, the volume of trading of our Class A Common Stock has been inconsistent.
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We also rely, in part, upon unpatented trade secrets, know-how and continuing technological innovation, and may in the future rely upon licensing opportunities, to develop and maintain our competitive position. We protect our proprietary rights through a variety of methods, including confidentiality and assignment agreements with suppliers, employees, consultants and others who may have access to our proprietary information.
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We believe that the volatility and our current market prices reflect market and trading dynamics unrelated to our underlying business, or macro or industry fundamentals, and we do not know how long these dynamics will last.
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Manufacturing and Supply We currently do all final manufacturing at our facility in White Bear Lake, Minnesota. We rely on a limited number of technicians and have some critical equipment that would be difficult to replace in a timely manner. In order to scale quickly, we will need to expand our manufacturing capacity and add additional shifts.
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Under the circumstances, investors in our Class A Common Stock are subject to the risk of losing all or a substantial portion of their investment.
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We rely on third-party suppliers to manufacture some of our critical sub-assemblies. Outsourcing sub-assemblies manufacturing reduces our need for additional capital investment. We select our suppliers carefully and require they adhere to all applicable regulations. We monitor our suppliers and always inspect all components received.
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The market volatility and trading patterns we have experienced create several risks for investors, including the following: ● the market price of our Class A Common Stock has experienced and may continue to experience rapid and substantial increases or decreases unrelated to our operating performance or prospects, or macro or industry fundamentals, and substantial increases may be significantly inconsistent with the risks and uncertainties that we continue to face; ● factors in the public trading market for our Class A Common Stock may include the sentiment of retail investors, the direct access by retail investors to broadly available trading platforms, the amount and status of short interest in our securities, access to margin debt, trading in options and other derivatives on our Class A Common Stock and any related hedging and other trading factors; ● if the market price of our Class A Common Stock declines, you may be unable to resell your shares at or above the price at which you acquired them. 28 The trading price of our Class A Common Stock depends on many factors, including those described in this “ Risk Factors ” section, many of which are beyond our control and may not be related to our operating performance.
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Our quality assurance process monitors and maintains supplier performance through qualification and periodic supplier reviews and audits. Certain components used in our products are supplied by single-source suppliers, but we believe that we are able to plan supply in a manner that would minimize the effect of losing any of our existing suppliers.
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Any of the factors listed below could have a material adverse effect on investment in our Class A Common Stock, and our Class A Common Stock may trade at prices significantly below the price paid for them. In such circumstances, the trading prices of our Class A Common Stock may not recover and may experience a further decline.
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Our suppliers manufacture the components they produce for us and test our components and devices to our specifications. We intend to maintain sufficient levels of inventory to enable us to continue our operations while we qualify additional potential suppliers in the event that one or more of our single-source suppliers were to encounter a delay in supply or end supply.
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Factors affecting the trading price of our Class A Common Stock may includes: ● changes in the market’s expectations regarding our ability to obtain FDA approval for the Acclaim CI, and the time and capital required to reach an FDA decision; ● changes in the market’s expectations about our operating results; ● the public’s reaction to our press releases, our other public announcements and our filings with the SEC; ● speculation in the press or investment community; ● actual or anticipated developments in our business or our competitors’ businesses or the competitive landscape generally; ● our failure to meet the expectation of securities analysts or investors in a particular period; ● changes in financial estimates and recommendations by securities analysts concerning us or the market in general; ● publications of research reports by securities analysts about us, our competitors, or the industry we operate in; ● changes in laws and regulations affecting our business; ● commencement of, or involvement in, litigation involving us; ● changes in our capital structure, such as future issuances of securities or the incurrence of additional debt; ● the volume of Class A Common Stock available for public sale; ● any major change in the Board or management; ● sales of substantial amounts of Class A Common Stock by directors, officers or significant stockholders or the perception that such sales could occur; ● general economic and political conditions such as recessions, interest rates, fuel prices, trade wars, pandemics, currency fluctuations and acts of war or terrorism; and ● other risk factors listed under this “ Risk Factors ” section. 29 Currently, our Class A Common Stock is listed on Nasdaq.
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Due to our current limited production numbers, we order components and sub-assemblies on a purchase order basis and do not have supply agreements with any of our suppliers. 14 Government Regulation The FDA’s policies may change and additional government laws and regulations may be enacted that could prevent, limit, or delay regulatory approval of our product candidates, that could limit the marketability of our product candidates, or that could impose additional regulatory obligations on us.
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However, limited liquidity in the market may limit the ability to sell shares of our Class A Common Stock at a favorable price. Currently, our Class A Common Stock is listed on The Nasdaq Capital Market. However, trading in our Class A Common Stock has been variable, with periods of limited trading volume.
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For example, the current administration may implement new or revised laws, regulatory requirements, and associated compliance obligations, as well as postponed or frozen regulatory requirements. Changes in medical practice and standard of care may also impact the marketability of our product candidates.
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If we do not maintain our increased trading volume, investors may not be able to re-sell their securities or may be required to take a lower price to liquidate their investment as sales reduce the trading price of our Class A Common Stock.
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If we are slow or unable to adapt to changes in existing requirements, standards of care, or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and be subject to regulatory enforcement action.
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We cannot predict the extent to which investor interest in us will lead allow us to maintain a consistent, active, and liquid trading market.
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Our products and our operations are subject to extensive regulation by the FDA and other federal and state authorities in the U.S., as well as comparable authorities in the European Economic Area (“ EEA ”) and other countries in which we may sell our products.
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The trading price of and demand for our Class A Common Stock will depend on a number of conditions, including the development of a market following, including by analysts and other investment professionals, the businesses, operations, results, and prospects of the Company, general market and economic conditions, governmental actions, regulatory considerations, legal proceedings, and developments or other factors.
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In the U.S., our products are subject to regulation as medical devices under the Federal Food, Drug, and Cosmetic Act (“ FDCA ”) as implemented and enforced by the FDA.
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These and other factors may impair the development of a liquid market and the ability of investors to sell shares at an attractive price.
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The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, storage, installation, servicing, recordkeeping, premarket clearance or approval, import, export, adverse event reporting, advertising, promotion, marketing and distribution, and import and export of medical devices to ensure that medical devices distributed domestically are safe and effective for their intended uses and otherwise meet the requirements of the FDCA.
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These factors also could cause the market price and demand for the common stock to fluctuate substantially, which may limit or prevent investors from readily selling their shares and may otherwise negatively affect the price and liquidity of the common stock. Many of these factors and conditions are beyond the control of the Company or the stockholders.
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In addition to U.S. regulations, we are subject to a variety of regulations in the EEA governing clinical trials and the commercial sales and distribution of our products.
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The exercise of our outstanding Warrants would result in substantial increase in the number of shares eligible for future resale in the public market and result in dilution to our stockholders.
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Even if we obtain the required FDA clearance or approval for a product in the United States, we will be required to obtain authorization before commencing clinical studies and to obtain marketing authorization or approval of our products under the comparable regulatory authorities of countries outside of the U.S. before we can commence clinical studies or commercialize our products in those countries.
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As of December 31, 2025, we had the following warrants to purchase our Class A Common stock: (i) 14,166,666 outstanding Public Warrants to purchase 14,166,666 shares of Class A Common Stock at an exercise price of $11.50 per share, (ii) 1,135,499 outstanding Shortfall Warrants to purchase 1,135,499 shares of Class A Common Stock at an exercise price of $1.50 per share, (iii) 3,500,000 outstanding GAT Warrants to purchase 3,500,000 shares of Class A Common Stock at exercise prices ranging from $1.24 per share to $3.04 per share, (iv) 5,725,206 outstanding September 2025 Warrants to purchase 5,725,206 shares of Class A Common Stock at an exercise price of $1.31 per share, (v) 9,022,572 outstanding October 2025 Warrants to purchase 9,022,572 shares of Class A Common Stock at an exercise price of $1.33 per share and (vi) 368,694 outstanding Placement Agent Warrants to purchase 368,694 shares of Class A Common Stock at exercises prices of $1.6375 and $1.6625 per share.
Removed
The approval process varies from country to country and the time may be longer or shorter than that required for FDA clearance or approval. FDA Premarket Clearance and Approval Requirements Unless an exemption applies, each medical device commercially distributed in the U.S. requires either FDA clearance of a 510(k) premarket notification or PMA.
Added
In addition, in the February 2026 Offering we issued 120,000,000 Series A Warrants to purchase 120,000,000 shares of Class A Common Stock at an exercise price of $0.40 per share and 27,053,850 Pre-Funded Warrants to purchase 27,053,850 shares of Class A Common Stock at a price of $0.0001 per share.
Removed
Under the FDCA, medical devices are classified into one of three classes, Class I, Class II, or Class III, depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure its safety and effectiveness.
Added
To the extent any of these warrants are exercised, the interest of the shares of Class A Common Stock outstanding prior to such warrant exercise will be diluted on a pro rata basis based on the number of additional shares of Class A Common Stock issued upon exercise.
Removed
Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of the FDA’s Quality System Regulations (“QSR”), facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials.
Added
Although the Company will receive additional capital upon exercise of these warrants (other than Pre-Funded Warrants for which the exercise price is nominal), we expect that the warrants would only be exercised when the exercise price is less than the current market value of our Class A Common Stock.
Removed
Class II devices are subject to the FDA’s General Controls, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device.
Added
While we will pay dividends on shares of Series A Preferred Stock pursuant to the Certificate of Designation, we do not intend to pay dividends on shares of Class A Common Stock for the foreseeable future.
Removed
While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device.
Added
Except with respect to dividends on shares of Series A Preferred Stock pursuant to the terms of the Certificate of Designation, we currently intend to retain all available funds and any future earnings to fund the development and growth of our business.
Removed
The FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance.
Added
As a result, while we will pay dividends on shares of Series A Preferred Stock, we do not anticipate declaring or paying any cash dividends on shares of Class A Common Stock in the foreseeable future.
Removed
Under the 510(k) process, the manufacturer must submit to the FDA a premarket notification demonstrating that the device is “substantially equivalent” to either a device that was legally marketed prior to May 28, 1976, the date upon which the Medical Device Amendments of 1976 were enacted, or another legally marketed device that was cleared through the 510(k) process. 15 Devices deemed by the FDA to pose the greatest risks, such as life-sustaining, life-supporting or some implantable devices, or devices that have a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed in Class III, requiring approval of a PMA.
Added
Any decision to declare and pay dividends in the future will be made at the discretion of the Board of Directors of the Company and will depend on, among other things, the dividend rights of the Series A Preferred Stock pursuant to the Certificate of Designation, our business prospects, results of operations, financial condition, cash requirements and availability, certain restrictions related to our indebtedness, industry trends and other factors that the Board may deem relevant.
Removed
Some pre-amendment devices are unclassified but are subject to the FDA’s premarket notification and clearance process in order to be commercially distributed. The Acclaim CI will be regulated as a Class III device and will require approval of a PMA prior to commercialization.
Added
Any such decision will also be subject to compliance with contractual restrictions and covenants in the agreements governing our current and future indebtedness. In addition, we may incur additional indebtedness, the terms of which may further restrict or prevent us from paying dividends on shares of Class A Common Stock.
Removed
PMA Approval Pathway Class III devices require PMA approval before they can be marketed although some pre-amendment Class III devices for which the FDA has not yet required a PMA are cleared through the 510(k) process. The PMA process is more demanding than the 510(k) premarket notification process.
Added
As a result, you may have to sell some or all of your shares of Class A Common Stock after price appreciation in order to generate cash flow from your investment, which you may not be able to do.
Removed
In a PMA process, the manufacturer must demonstrate that the device is safe and effective, and the PMA must be supported by extensive data, including data from preclinical studies and human clinical trials.
Added
Our inability or decision not to pay dividends, particularly when others in our industry have elected to do so, could also adversely affect the market price of shares of Class A Common Stock. 30 If analysts do not publish research about our business or if they publish inaccurate or unfavorable research, our stock price and trading volume could decline.
Removed
The PMA must also contain a full description of the device and its components, a full description of the methods, facilities and controls used for manufacturing, and proposed labeling. Following receipt of a PMA, the FDA determines whether the application is sufficiently complete to permit a substantive review.
Added
The trading market for our Class A Common Stock will depend in part on the research and reports that analysts publish about our business. We do not have any control over these analysts.
Removed
If the FDA accepts the application for review, it has 180 days under the FDCA to complete its review of a PMA, although in practice, the FDA’s review often takes significantly longer, and can take up to several years.
Added
If one or more of the analysts who cover us downgrade our Class A Common Stock or publish inaccurate or unfavorable research about our business, the price of our Class A Common Stock would likely decline.
Removed
An advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device. The FDA may or may not accept the panel’s recommendation.
Added
If few analysts cover us, demand for our Class A Common Stock could decrease and our Class A Common Stock price and trading volume may decline. Similar results may occur if one or more of these analysts stop covering us in the future or fail to publish reports on us regularly.
Removed
In addition, the FDA will generally conduct a preapproval inspection of the applicant or its third-party manufacturers’ or suppliers’ manufacturing facility or facilities to ensure compliance with the QSR.
Added
You may experience future dilution as a result of future equity offerings.
Removed
The FDA will approve the new device for commercial distribution if it determines that the data and information in the PMA constitute valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its intended use(s).
Added
In order to raise additional capital, we may, in the future, offer additional shares of our Class A Common Stock or other securities convertible into or exchangeable for our Class A Common Stock at prices that may not be the same as the price per share paid by any investor.
Removed
The FDA may approve a PMA with post-approval conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported the PMA or requirements to conduct additional clinical studies post-approval.
Added
We may sell shares or other securities in any other offering at a price per share that is less than the price per share paid by any investor, and investors purchasing shares or other securities in the future could have rights superior to you.
Removed
The FDA may condition a PMA approval on some form of post-market surveillance when deemed necessary to protect the public health or to provide additional safety and efficacy data for the device in a larger population or for a longer period of use.
Added
The price per share at which we sell additional shares of our Class A Common Stock, or securities convertible or exchangeable into common stock, in future transactions may be higher or lower than the price per share paid by any investor. We may be subject to securities litigation, which is expensive and could divert management attention.
Removed
In such cases, the manufacturer might be required to follow certain patient groups for a number of years and to make periodic reports to the FDA on the clinical status of those patients. Failure to comply with the conditions of approval can result in material adverse enforcement action, including withdrawal of the approval.
Added
The market price of our Class A Common Stock may continue to be volatile and, in the past, companies that have experienced volatility in the market price of their stock have been subject to securities class action litigation. We may be the target of this type of litigation in the future.
Removed
Certain changes to an approved device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the design performance specifications, which affect the safety or effectiveness of the device, require submission of a PMA supplement.
Added
Securities litigation against us could result in substantial costs and divert management’s attention from other business concerns, which could seriously harm our business. We are and may become involved in legal proceedings, and no assurance can be provided as to the outcome of these matters.
Removed
PMA supplements often require submission of the same type of information as a PMA, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA and may not require as extensive clinical data or the convening of an advisory panel.
Added
From time to time, we are involved in various legal proceedings, lawsuits, and other claims relating to matters incidental to our business. For example, we are currently a defendant in a lawsuit in the Court of Chancery of the State of Delaware involving a stockholder’s redemption request in connection with our special meeting of stockholders held on September 27, 2023.
Removed
Certain other changes to an approved device require the submission of a new PMA, such as when the design change causes a different intended use, mode of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be developed, and the data that were submitted with the original PMA are not applicable for the change in demonstrating a reasonable assurance of safety and effectiveness.
Added
An unfavorable resolution of any litigation may have a material adverse effect on our business, results of operations and financial condition. Additionally, litigation may result in substantial costs and expenses and significantly divert the attention of management. 31 Our failure to meet Nasdaq’s continued listing requirements could result in a delisting of our Class A Common Stock from Nasdaq.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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The audit committee of the board of directors intends to provide oversight of our cybersecurity risk as part of its periodic review of enterprise risk management. Additionally, the board of directors intends to review our enterprise risk management processes and will be notified by management between management updates regarding significant new cybersecurity threats or incidents. 51
Additionally, the board of directors intends to review our enterprise risk management processes and will be notified by management between management updates regarding significant new cybersecurity threats or incidents.
For more information about the cybersecurity risks we face, see the risk factor entitled “ Failure of a key information technology system, process or site could have an adverse effect on our business ” in the section titled “Risk Factors” in Part 1, Item 1A of this Annual Report.
For more information about the cybersecurity risks we face, see the risk factor entitled “ Failure of a key information technology system, process or site could have an adverse effect on our business ” in the section titled “Risk Factors” in Part 1, Item 1A of this Annual Report. 54 Governance Our third-party vendor, alongside our senior management leads the operational oversight of the company-wide cybersecurity strategy, policy, standards and processes.
Governance Our third-party vendor, alongside our senior management leads the operational oversight of the company-wide cybersecurity strategy, policy, standards and processes. As a smaller-reporting Company we do not have an employee who has significant and demonstrated professional IT management experience and possesses the requisite education, skills and experience expected to perform such a duty.
As a smaller-reporting Company we do not have an employee who has significant and demonstrated professional IT management experience and possesses the requisite education, skills and experience expected to perform such a duty. The audit committee of the board of directors intends to provide oversight of our cybersecurity risk as part of its periodic review of enterprise risk management.

Item 2. Properties

Properties — owned and leased real estate

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We also lease 1,100 square feet of office space in Ausbach, Germany pursuant to a lease that automatically renews each year for a successive one year period, unless the we notify the landlord six (6) months prior to the annual renewal. This lease renewed automatically on January 1, 2024 and again on January 1, 2025.
We also lease 1,100 square feet of office space in Ausbach, Germany pursuant to a lease that automatically renews each year for a successive one year period, unless we notify the landlord 6 months prior to the annual renewal. This lease renewed automatically on January 1, 2025 and again on January 1, 2026.
ITEM 2. Properties Our principal office is located at 4875 White Bear Lake, Minnesota, where we lease approximately 11,540 square feet of office space. We lease this space under a lease that terminates on December 31, 2030. We believe that our existing facility is sufficient to meet our needs for the foreseeable future.
ITEM 2. Properties Our principal office is located at 4875 White Bear Parkway, White Bear Lake, Minnesota, where we lease approximately 13,500 square feet of office space. We lease this space under a lease that terminates on December 31, 2030. We believe that our existing facility is sufficient to meet our needs for the foreseeable future.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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On November 14, 2023, the Company, Whitney Haring-Smith (the former chief executive officer and a former director of the Company), Daniel Hirsch (the former chief financial officer of the Company), and Anzu SPAC GP I LLC were named as defendants in a complaint filed by Atlas Merchant Capital SPAC Fund I LP (“Atlas”) in the Delaware Court of Chancery.
On November 14, 2023, the Company, Whitney Haring-Smith (the former chief executive officer and a former director of the Company), Daniel Hirsch (the former chief financial officer of the Company), and Anzu SPAC GP I LLC were named as defendants in a complaint filed by Atlas Merchant Capital SPAC Fund I LP (“ Atlas ”) in the Delaware Court of Chancery.
Atlas alleges that it was not allowed to redeem its shares of the Company’s Common Stock and that Defendants acted to prevent Atlas’s attempt to redeem its shares. Defendants assert that Atlas did not comply with the requirements for redeeming shares set forth in the Company’s organizational documents.
Atlas alleges that it was not allowed to redeem its shares of the Anzu class A common stock and that Defendants acted to prevent Atlas’s attempt to redeem its shares. Defendants assert that Atlas did not comply with the requirements for redeeming shares set forth in the Company’s organizational documents.
Mine Safety Disclosures Not applicable. 52 PART II
Mine Safety Disclosures Not applicable. 55 PART II

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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ITEM 4. Mine Safety Disclosures 52 PART II ITEM 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 53 ITEM 6. [Reserved] 53 ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 54 ITEM 7A. Quantitative and Qualitative Disclosures About Market Risk 66 ITEM 8.
ITEM 4. Mine Safety Disclosures 55 PART II ITEM 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 56 ITEM 6. [Reserved] 56 ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 57 ITEM 7A. Quantitative and Qualitative Disclosures About Market Risk 73 ITEM 8.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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As of March 10, 2025, there were 397 holders of record of Class A Common Stock and one holder of record of Public Warrants.
As of March 19, 2026, there were 272 holders of record of Class A Common Stock and one holder of record of Public Warrants.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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We anticipate that our expenses will increase substantially if and as we: ● continue the research and development of the Acclaim CI, including through clinical trials; ● seek additional regulatory and marketing approvals in jurisdictions outside the United States; ● establish a sales, marketing, and distribution infrastructure to commercialize our product candidate; ● rely on our third-party suppliers and manufacturers to obtain adequate supply of materials and components for our products; ● seek to identify, assess, acquire, license, and/or develop other product candidates and subsequent generations of our current product candidate; ● seek to maintain, protect, and expand our intellectual property portfolio; ● seek to identify, hire, and retain skilled personnel; ● create additional infrastructure to support our operations as a public company and our product candidate development and planned future commercialization efforts; and ● experience any delays or encounter issues with respect to any of the above, including, but not limited to, failed studies, complex results, safety issues or other regulatory challenges that require longer follow-up of existing studies or additional supportive studies in order to pursue marketing approval. 27 The amount of any future operating losses will depend, in part, on the rate of our future expenditures and our ability to obtain funding through equity or debt financings, strategic collaborations, or grants.
We anticipate that our expenses will increase significantly in connection with our ongoing activities, if and as we: ● continue our research and development efforts for the Acclaim CI product candidate, including through clinical trials; ● seek additional regulatory and marketing approvals in jurisdictions outside the United States; 58 ● establish a sales, marketing and distribution infrastructure to commercialize our product candidate; ● rely on our third-party suppliers and manufacturers to obtain adequate supply of materials and components for our products; ● seek to identify, assess, acquire, license, and/or develop other product candidates and subsequent generations of our current product candidate; ● seek to maintain, protect, and expand our intellectual property portfolio; ● seek to identify, hire, and retain additional skilled personnel; ● create additional infrastructure to support our operations as a public company and our product candidate development and planned future commercialization efforts; and ● experience any delays or encounter issues with respect to any of the above, including, but not limited to, failed studies, complex results, safety issues or other regulatory challenges that require longer follow-up of existing studies or additional supportive studies in order to pursue marketing approval.
To the extent that we raise additional capital through the issuance of equity or otherwise, including through additional preferred stock or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder.
If we do raise additional capital through public or private equity or convertible debt offerings, the ownership interest of our existing stockholders may be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights.
We will incur significant expenses related to clinical trials to obtain approval of the FDA to market the Acclaim CI. If we obtain FDA marketing approval for the Acclaim CI we will likely incur significant sales, marketing, and outsourced manufacturing expenses, as well as continued research and development expenses.
We do not expect to generate any product sales from the Acclaim CI unless and until we successfully complete development and obtain regulatory approval for our product candidate. If we obtain regulatory approval for the Acclaim CI, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution.
Raising additional capital would cause dilution to our existing stockholders, which may adversely affect the rights of existing stockholders. We may seek additional capital through a combination of private and public equity offerings, debt financings and collaborations, and strategic and licensing arrangements.
See Note 1, “Nature of the Business and Basis of Presentation”, of the accompanying consolidated financial statements included elsewhere in this Report. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements.
We expect that we will need to raise substantial additional funding, which may not be available on acceptable terms, or at all. Failure to obtain funding on acceptable terms and on a timely basis may require us to curtail, delay or discontinue our product development efforts or other operations.
We have based our estimates as to how long we expect we will be able to fund our operations on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect, in which case we would be required to obtain additional financing sooner than currently projected, which may not be available to us on acceptable terms, or at all.
Removed
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations for additional information. We have incurred losses in each year since our inception, including net losses of approximately $20.8 million and $29.9 million for the years ended December 31, 2024 and 2023, respectively.
Added
ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations The following analysis of our financial condition and results of operations should be read in conjunction with the consolidated financial statements and the notes included elsewhere in this Report, and other filings with the SEC.
Removed
As of December 31, 2024 and 2023, we had an accumulated deficit of approximately $284.7 million and $257.3 million, respectively. Substantially all of our operating losses in such years resulted from costs incurred in connection with the development of the Acclaim CI and from general and administrative costs associated with our operations.
Added
Unless otherwise indicated or the context otherwise requires, references in this section to the “Company,” “Envoy Medical,” “we,” “us,” “our” and other similar terms refer (i) prior to the Closing Date, to Envoy Medical Corporation and (ii) after the Closing Date, to Envoy Medical, Inc.
Removed
Furthermore, now that the Business Combination has been completed, we expect to incur additional costs associated with operating as a public company. As a result, we expect to continue to incur significant and increasing operating losses for the foreseeable future.
Added
The following discussion contains forward-looking statements based upon Envoy Medical’s current expectations that involve risks, uncertainties, and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under the section of this Report titled “Risk Factors” and/or elsewhere in this Report.
Removed
Because of the numerous risks and uncertainties associated with developing a medical device, we are unable to predict the extent of any future losses or when we will become profitable, if at all.
Added
Our historical results are not necessarily indicative of the results that may be expected for any period in the future. All dollar amounts are expressed in thousands of United States dollars (“$”), unless otherwise indicated. Overview We are a hearing health company focused on providing innovative medical technologies across the hearing loss spectrum.
Removed
We expect to continue to incur significant losses until we receive the necessary regulatory approvals to commercialize the Acclaim CI in the United States, which we may not be successful in achieving.
Added
Our technologies are designed to shift the paradigm within the hearing industry and bring both providers and patients the hearing devices they desire. We are dedicated to pushing beyond the status quo to provide patients with improved access, usability, independence, and quality of life.
Removed
Even if we obtain regulatory approvals to market the Acclaim CI or any future product candidates, our future revenue will depend upon the size of any markets in which our products and product candidates receive approval and our ability to achieve sufficient market acceptance, pricing and reimbursement from third-party payors for our products and product candidates.
Added
We believe leveraging the ear’s natural anatomy, rather than the external or sub-dermal artificial microphone, is the ideal way for people to hear. In recent years, we have focused almost exclusively on developing the fully implanted Acclaim® cochlear implant (the “Acclaim CI”), our lead product candidate. We believe that the Acclaim CI is a first-of-its-kind cochlear implant.
Removed
Further, the operating losses that we incur may fluctuate significantly from quarter-to-quarter and year to year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance. Other unanticipated costs may also arise.
Added
Our fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound. The Acclaim CI is designed to address sensorineural hearing loss that is not adequately addressed by hearing aids.
Removed
If we continue to generate operating losses, there will be an adverse effect on our results of operations, financial condition, and the market price of our Class A Common Stock. We have generated limited revenue from product sales and may never be profitable.
Added
As part of the clinical trial, the Acclaim CI is intended for adults with severe-to-profound sensorineural hearing loss who have been deemed adequate candidates by a qualified physician. The Acclaim CI received the Breakthrough Device Designation from the United States Food and Drug Administration (the “FDA”) in 2019.
Removed
While we have historically obtained revenue from our legacy Esteem FI-AMEI product, such revenue has been limited, and we have not generated any revenue from sales of the Acclaim CI.
Added
Our first product, the Esteem ® Fully Implanted Active Middle Ear Implant (“Esteem FI-AMEI”), received FDA approval in 2010. The Esteem FI-AMEI is a fully implanted active middle ear hearing device and remains the only FDA approved fully implanted active hearing implant in the U.S. market.
Removed
Our ability to generate revenue and achieve profitability mainly depends on our ability to obtain FDA approval for the Acclaim CI and, if we obtain such approval, to successfully scale up production and market the device. We do not know when, or if, we will generate any such revenue.
Added
Unfortunately, the Esteem FI-AMEI failed to gain commercial traction, primarily due to a lack of reimbursement or insurance coverage from third-party payors. Despite the commercial challenges, approximately 1,000 Esteem FI-AMEI devices were implanted. Some devices were implanted in the early 2000s during clinical trials, providing Envoy Medical with over two decades of experience with our implantable sensor technology.
Removed
Our ability to generate future revenue from product sales will depend heavily on our success in many areas, including but not limited to: ● completing research and development of the Acclaim CI in a timely and successful manner; ● completing our pivotal clinical study in the United States successfully; ● obtaining FDA approval for the Acclaim CI; ● maintaining and enhancing a commercially viable, sustainable, scalable, reproducible and transferable manufacturing process for the Acclaim CI that is compliant with current good manufacturing practices, (“ cGMP ”); ● establishing and maintaining supply and, if applicable, manufacturing relationships with third parties that can provide, in both amount and quality, adequate products to support development and the market demand for the Acclaim CI, if and when it is approved; ● identifying, assessing, acquiring and/or developing new product candidates; ● launching and commercializing any product candidates for which we obtain regulatory and marketing approval, either directly by establishing a sales force, marketing and distribution infrastructure, and/or with collaborators or distributors in the United States, Europe and other potential markets that we will target; ● accurately identifying demand for the Acclaim CI and any future product candidates; ● exposing and educating physicians and other medical professionals with respect to the use of our products; ● obtaining market acceptance of the Acclaim CI and any future product candidates from the medical community and third-party payors; ● ensuring our product candidates are approved for reimbursement from governmental agencies, health care providers and insurers in jurisdictions where they have been approved for marketing; ● addressing any competing technological and market developments that impact the Acclaim CI and any future product candidates or their prospective usage by medical professionals; ● negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter and performing our obligations under such arrangements; 28 ● maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, patent applications, trade secrets and know-how; ● avoiding and defending against third-party interference or infringement claims; and ● attracting, hiring and retaining qualified personnel.
Added
Throughout our experience, our sensor technology proved a viable alternative and robust option to external or implanted microphones. 57 In late 2015, we made the decision to shift our focus from the Esteem FI-AMEI to a new product that would leverage our sensor technology and incorporate it into a cochlear implant.
Removed
We anticipate incurring significant incremental costs associated with commercializing the Acclaim CI. Our expenses could increase beyond expectations if we are required by the FDA, or other domestic or foreign regulatory agencies, to change our product design or manufacturing processes or to perform studies in addition to those that we currently anticipate.
Added
As a result, we now have the Acclaim CI, a fully implanted cochlear implant. We believe that Acclaim CI gives us the opportunity to disrupt the existing cochlear implant market. The cochlear implant market is one that already has established market acceptance and reimbursement pathways.
Removed
Even if we are successful in obtaining regulatory approvals to market the Acclaim CI, our revenue earned from such product candidate will be dependent in part upon the size of the markets in the territories for which we gain regulatory approval for such product candidate, the accepted price for such product candidate, our ability to obtain reimbursement for such product candidate at any price, and the expenses associated with manufacturing and marketing such product candidate for such markets.
Added
In the United States, before we can market a new Class III medical device, like the Acclaim CI, we must first receive FDA approval via the premarket application approval process. The Investigational Device Exemption (“IDE”) to begin a pivotal clinical study on the Acclaim CI was granted by the FDA in October of 2024.
Removed
Therefore, we may not generate significant revenue from the sale of the Acclaim CI, even if we obtain FDA approval.
Added
Seven investigational sites were selected prior to the end of 2024. The IDE was approved as a “staged” clinical trial. The first stage allowed for enrollment of 10 study participants prior to the Company having to formally request FDA approval to expand enrollment to the full subject cohort of 56 patients.
Removed
Further, if we are not able to generate significant revenue from the sale of our approved products, we may be forced to curtail or cease our operations, in which case our investors may lose the full amount of their investment in us.
Added
The Company collected and submitted preliminary clinical data after the three-month follow up visit that adequately characterized device effectiveness of the first 10 study participants to justify study expansion into the second and final stage. Envoy Medical’s expansion request to the FDA was formally approved by the FDA on October 3, 2025.
Removed
Due to the numerous risks and uncertainties involved in product development, it is difficult to predict the timing or amount of increased expenses, or when, or if, we will be able to achieve or maintain profitability. If the Acclaim CI contains design or manufacturing defects, our business and financial results could be harmed.
Added
We completed enrollment of all 56 patients on March 10,2 2025. Each implanted study participant will be followed through their 12-month visit. After all 56 patients have been through their 12-month visits, the data will be collected and analyzed in accordance with the clinical study protocol and statistical analysis plan.
Removed
To date, we have completed initial patient implants of the Acclaim CI as part of our early feasibility study, and we received approval from the FDA to begin our pivotal trial, which we began in the first quarter of 2025.
Added
Upon finalization of the results, Envoy Medical intends to submit a Premarket Approval (“PMA”) application to the FDA. The FDA will have 180 days to review the PMA application unless a panel review is requested. If a panel review is requested, it may add several months of additional review time to the PMA application.
Removed
As the Acclaim CI has no history of commercial operation, we have a limited frame of reference from which to evaluate its long-term performance. There can be no assurance that we will be able to detect and fix any defects in the Acclaim CI in time to maintain our FDA trial schedule.
Added
As a result, Envoy Medical currently anticipates obtaining the FDA’s decision on our PMA application at some point within the second half of 2027 assuming that no panel review is requested. If a panel review is requested, the FDA’s decision could extend to the first half of 2028.
Removed
Once we have commenced with implantation in additional patients, we may discover latent defects in design, manufacture or construction that may cause our systems not to perform as expected or to cause side effects. The Acclaim CI also requires software to operate, which may need to be modified and updated over time.
Added
The FDA approval process is uncertain and there can be no guarantees of whether the Acclaim CI will ever successfully receive FDA approval. In addition, we cannot predict the effects that changes to federal regulatory staffing, funding, and policies and procedures will have on the timeline and ultimate FDA approval decision.
Removed
There can be no assurance that we will be able to detect and fix any defects in the hardware or software of the Acclaim CI on the timescale necessary to maintain our clinical trial schedule, or at all.
Added
As a result, we cannot guarantee that we will receive FDA approval on a specific timeline, or at all. We had a net loss of $23,756 and $20,795 for the years ended December 31, 2025 and 2024, respectively, and had an accumulated deficit of $313,396 and $284,734 as of December 31, 2025 and, 2024, respectively.
Removed
Further, such defects may not become apparent until our systems are implanted in patients and may cause adverse effects that cause harm to patients and require redesign of the Acclaim CI, which may result in great expense, harm to our reputation, and harm to our results of operations, financial condition, and the trading price of the Class A Common Stock.
Added
We have funded our operations to date primarily through the issuance of equity securities and debt. We expect to continue to incur net losses for the foreseeable future, and expect our research and development expenses, sales and marketing expenses, general and administrative expenses, and capital expenditures will continue to increase.
Removed
The expenses we were obligated to pay in relation to the Business Combination were substantial. As result, we will require substantial additional capital to commercialize the Acclaim CI. In addition, our operating plans may change as a result of many factors that may currently be unknown to us, and we may need to seek additional funds sooner than planned.
Added
In particular, we expect our expenses to increase as we continue our development of the Acclaim CI and seek the necessary regulatory approvals for our product candidate, as well as hire additional personnel, pay fees to outside consultants, attorneys and accountants, and incur other increased costs associated with being a public company.
Removed
Our future funding requirements will depend on many factors, including but not limited to: ● the progress, results and costs of our planned studies and pivotal clinical trials; ● the cost, timing and outcomes of regulatory review of the Acclaim CI; ● the scope, progress, results and costs of product development, testing, manufacturing, preclinical development and, if applicable, clinical trials for any other product candidates that we may develop or otherwise obtain in the future; 29 ● the costs of manufacturing the Acclaim CI, including costs related to engaging third-party manufacturers therefor; ● the cost of our future activities, including establishing sales, marketing and distribution capabilities for any product or product candidates in any particular geography where we receive marketing approval for such product candidates; ● the terms and timing of any collaborative, licensing and other arrangements that we may establish; ● the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; and ● the level of revenue, if any, received from commercial sales of any product candidates for which we receive marketing approval.
Added
In addition, if and when we seek and obtain regulatory approval to commercialize the Acclaim CI in the United States, we will also incur increased expenses in connection with commercialization and marketing of such product.
Removed
Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize the Acclaim CI. In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all.
Added
Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials, if any, and our expenditures on other research and development activities.
Removed
Moreover, the terms of any financing may adversely affect the holdings or the rights of holders of our securities and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the value of our securities to decline.
Added
We expect that our financial performance may fluctuate significantly from quarter-to-quarter and year-to-year due to the development status of our Acclaim CI product and our efforts to obtain regulatory approval and commercialize the Acclaim CI product. The Acclaim CI has not yet been approved for sale.
Removed
The incurrence of indebtedness could result in increased fixed payment obligations, and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.
Added
As a result, until such time, if ever, that we can generate substantial product revenue, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including collaborations, licenses or similar arrangements.
Removed
If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue our research and development program or the development or commercialization, if any, of the Acclaim CI or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially and adversely affect our business, financial condition, results of operations and value of our securities.
Added
However, we may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities.
Removed
Future sales of our Class A Common Stock or of securities convertible into our Class A Common Stock, or the perception that such sales may occur, could cause immediate dilution and adversely affect the value of our Class A Common Stock. Failure of a key information technology system, process or site could have an adverse effect on our business.
Added
If we are unable to raise capital, we will need to delay, reduce, or terminate planned activities to reduce costs. 59 Recent Developments Enrollment of Clinical Trial On March 10, 2026, we completed enrollment of our clinical trial for the Acclaim CI.
Removed
We rely extensively on information technology systems to conduct our business. These systems affect, among other things, ordering and managing materials from suppliers, summarizing and reporting results of operations, complying with regulatory, legal or tax requirements, data security, and other processes necessary to manage our business.
Added
With the successful implantation of the 56th and final patient, we are the first cochlear implant company to achieve full enrollment of a U.S. clinical trial to evaluate a fully implanted cochlear implant seeking FDA approval. With enrollment completed, the study will now progress through scheduled follow-up visits and data collection in accordance with the trial protocol.
Removed
Our information technology systems and those of our third-party service providers, vendors, strategic partners and other contractors or consultants are vulnerable to damage or interruption from computer viruses and malware (e.g., ransomware), natural disasters, terrorism, war, telecommunication and electrical failures, hacking, cyberattacks, phishing attacks and other social engineering schemes, malicious code, employee theft or misuse, human error, fraud, denial or degradation of service attacks, sophisticated nation-state and nation-state-supported actors or unauthorized access or use by persons inside our organization, or persons with access to systems inside our organization.
Added
Once 12-month follow up data has been collected for all patients, the data will then be analyzed and submitted to the FDA as part of a PMA application seeking FDA approval. Subject to FDA review and approval, commercialization in the United States would follow.
Removed
The risk of a security breach or disruption, particularly through cyberattacks or cyber intrusion, including by computer hackers, foreign governments and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased and evolved.
Added
Nasdaq Market Value of Listed Securities Requirement On February 25, 2025, we received a deficiency notification letter (the “Notification Letter”) from The Nasdaq Stock Market (“Nasdaq”) stating that we were not in compliance with Nasdaq Listing Rule 5550(b)(2) (the “Rule”) because the market value of the Company’s listed securities did not meet the minimum of $35,000 (the “MVLS Requirement”) for the period for 31 consecutive business days between January 7, 2025 and February 24, 2025.
Removed
As a result of the COVID-19 pandemic, we and our third-party service providers and partners may also face increased cybersecurity risks due to our reliance on internet technology and the number of our employees who are working remotely, which may create additional opportunities for cybercriminals to exploit vulnerabilities.
Added
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we had a grace period of 180 calendar days to regain compliance with Nasdaq Listing Rule 5550(b)(2) and would return to compliance if the market value of our listed securities exceeds $35,000 for ten consecutive business days.
Removed
Although we have implemented cybersecurity protections to safeguard our data, including our patient and subject data, we can provide no assurances that these protections will prevent all cybersecurity breaches. We primarily use common off-the-shelf software systems, such as Microsoft 365, which receive frequent security updates from the software providers.
Added
On August 26, 2025, we received a determination letter from Nasdaq notifying us that we had not regained compliance with the MVLS Requirement within the 180-day cure period.
Removed
We also utilize a third-party vendor to maintain our IT system networks, and as a result of limited internal IT resources, we are only able to perform limited due diligence on our third-party IT vendors.
Added
The determination letter informed the Company that it can request a hearing regarding Nasdaq’s determination with a Hearings Panel (the “Panel”) to discuss how we believe we will regain compliance and why the Company believes the Panel should grant an extension. The Company timely requested a hearing, which occurred on October 2, 2025.
Removed
We receive periodic security monitoring from our cybersecurity insurance provider. 30 However, because the techniques used to obtain unauthorized access to, or to sabotage, systems change frequently and often are not recognized until launched against a target, we may be unable to anticipate these techniques or implement adequate preventative measures.
Added
On October 23, 2025, the Panel notified us that it has granted the Company’s request for an exception to demonstrate compliance with the MVLS Requirement for continued listing through February 23, 2026.
Removed
We may experience security breaches that may remain undetected for an extended period. Even if identified, we may be unable to adequately investigate or remediate incidents or breaches due to attackers increasingly using tools and techniques that are designed to circumvent controls, to avoid detection, and to remove or obfuscate forensic evidence.
Added
On February 23, 2026, we received a letter confirming that the Company has evidenced compliance with Nasdaq Listing Rule 5550(b)(2) in compliance with the Panel’s letter dated October 23, 2025. In addition, pursuant to Nasdaq Listing Rule 5815(d)(4)(B), we are subject to a monitoring period of one year from February 12, 2026.
Removed
Our third-party service providers and partners are also subject to these heightened risks.
Added
February 2026 Offering On February 12, 2026, we completed a public offering (the “February 2026 Offering”) of an aggregate of (i) 47,946,150 shares of our Class A common stock, par value $0.0001 per share (“Class A Common Stock”), (ii) 27,053,850 pre-funded warrants (the “Issued Pre-Funded Warrants”) to purchase 27,053,850 shares of Class A Common Stock, (iii) 45,000,000 Series A-1 Warrants to purchase 45,000,000 shares of Class A Common Stock and/or pre-funded warrants (the “Series A-1 Warrants”), and (iv) 75,000,000 Series A-2 Warrants to purchase 75,000,000 shares of Class A Common Stock and/or Issued Pre-Funded Warrants (the “Series A-2 Warrants” and, together with the Series A-1 Warrants, the “Series A Warrants”).
Removed
If our systems are damaged or cease to function properly due to any number of causes, ranging from catastrophic events to power outages to security breaches, and our business continuity plans do not effectively compensate on a timely basis, we may experience interruptions in our operations, which could have an adverse effect on our business.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, a high rate of inflation in the future may have an adverse effect on our ability to maintain and increase our gross margin and decrease our selling and marketing and operating expenses as a percentage of our revenue if the selling prices of our products do not increase as much as or more than these increased costs. 66
Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, a high rate of inflation in the future may have an adverse effect on our ability to maintain and increase our gross margin and decrease our selling and marketing and operating expenses as a percentage of our revenue if the selling prices of our products do not increase as much as or more than these increased costs. 73
There were no customers that accounted for 10% or more of sales for the years ended December 31, 2024 and 2023. Inflation Risk Inflationary factors, such as increases in our cost of goods sold and selling and operating expenses, may adversely affect our operating results.
There were no customers that accounted for 10% or more of sales for the years ended December 31, 2025 and 2024. Inflation Risk Inflationary factors, such as increases in our cost of goods sold and selling and operating expenses, may adversely affect our operating results.

Other COCH 10-K year-over-year comparisons