COCHW

We have not been profitable historically and may not be able to achieve profitability in the future. ● We have generated limited revenue from product sales and may never be profitable. ● If the Acclaim CI contains design or manufacturing defects, our business and financial results could be harmed. ● We may need to raise substantial additional funding, which may not be available on acceptable terms, or at all.
Failure to obtain or maintain coverage and adequate reimbursement for our product candidates could limit our ability to market those products and decrease our ability to generate revenue. v ● We operate in a very competitive business environment, and if we are unable to compete successfully against our existing or potential competitors, our business, financial condition and results of operations may be adversely affected. ● We expect to derive most of our revenues from sales of the Acclaim CI.
Our inability to successfully commercialize this product, or any subsequent decline in demand for this product, could severely harm our ability to generate revenues. ● If healthcare professionals do not recommend the Acclaim CI to their patients, the Acclaim CI may not achieve market acceptance and we may not become profitable. ● We will be dependent upon contract manufacturing organizations and material suppliers, making us vulnerable to supply shortages and problems, increased costs and quality or compliance issues, any of which could harm our business. ● Our business plan relies on certain assumptions about the market for our product; however, the size and expected growth of our addressable market has not been established with precision and may be smaller than we estimate, and even if the addressable market is as large as we estimate, we may not be able to capture market share. ● We depend on third parties to manage our pre-clinical studies and clinical trials, perform related data collection and analysis, and to enroll patients for our clinical trials, and, as a result, we may face costs and delays that are beyond our control. ● We are highly dependent on key members of our executive management team.
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.
Overview We are a hearing health company focused on providing innovative medical technologies across the hearing loss spectrum.
We believe leveraging the ear’s natural anatomy, rather than external or sub-dermal artificial microphone, is the ideal way for people to hear.
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.
Some devices were implanted in the early 2000s during clinical trials, providing us with over two decades of experience with its implantable sensor technology.
As a result, we have developed the investigational Acclaim CI.
We now believe we have the possibility to disrupt the cochlear implant market currently dominated by three main incumbents.
Cochlear implants use electronic signals to directly stimulate the auditory nerve via the cochlea.
Unlike partially implanted devices, the Acclaim CI uses the ear to capture sound via a piezoelectric sensor that is implanted in the middle ear.
CAUTION: Investigational Device — Limited by Federal Law to Investigational Use.
Acclaim CI — A Breakthrough Device The Acclaim CI received the Breakthrough Device Designation from the U.S.
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.
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.
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.
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.
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. ● No need for backup or secondary processors.
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.
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 expect that patients will experience mild to moderate discomfort after the procedure and benefit from several days of rest after surgery.
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.
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.
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.
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.
Moderate to profound hearing loss is often defined as 70-90 dB of hearing loss.
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.
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).
Auditory osseointegrated implants (i.e. bone conduction implants) are used for conductive or certain types of mixed hearing loss.
Acclaim CI’s Market Opportunity The Acclaim CI is designed to address sensorineural hearing loss that is not adequately addressed by hearing aids.
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.
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.
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.
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.
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.
Oticon Medical (“Demant”) was set to become the fourth global cochlear implant player, but Cochlear Ltd purchased the cochlear implant business portion of Oticon Medical from Demant.
(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.
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.

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Gone since FY2024

We have not been profitable historically and may not be able to achieve profitability in the future. ● We have generated limited revenue from product sales and may never be profitable. ● If the Acclaim CI contains design or manufacturing defects, our business and financial results could be harmed. ● 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 or maintain coverage and adequate reimbursement for our product candidates could limit our ability to market those products and decrease our ability to generate revenue. ● We operate in a very competitive business environment, and if we are unable to compete successfully against our existing or potential competitors, our business, financial condition and results of operations may be adversely affected. ● We expect to derive most of our revenues from sales of the Acclaim CI.
Our inability to successfully commercialize this product, or any subsequent decline in demand for this product, could severely harm our ability to generate revenues. v ● If healthcare professionals do not recommend the Acclaim CI to their patients, the Acclaim CI may not achieve market acceptance and we may not become profitable. ● We will be dependent upon contract manufacturing organizations and material suppliers, making us vulnerable to supply shortages and problems, increased costs and quality or compliance issues, any of which could harm our business. ● Our business plan relies on certain assumptions about the market for our product; however, the size and expected growth of our addressable market has not been established with precision and may be smaller than we estimate, and even if the addressable market is as large as we estimate, we may not be able to capture market share. ● We depend on third parties to manage our pre-clinical studies and clinical trials, perform related data collection and analysis, and to enroll patients for our clinical trials, and, as a result, we may face costs and delays that are beyond our control. ● We are highly dependent on key members of our executive management team.
Business Overview We are a hearing health company focused on providing innovative medical technologies across the hearing loss spectrum.
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.
The ear itself is an ideal way to capture sound from our environment.
Our first product, the Esteem Fully Implanted Active Middle Ear Implant (“Esteem FI-AMEI”), received FDA approval in 2010.
The Esteem FI-AMEI remains the only FDA approved fully implanted active hearing device on the market.
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.
Some devices were implanted in the early 2000s during clinical trials, providing us with nearly two decades of experience with its implantable sensor technology.
As a result, we have developed the investigational fully implanted Acclaim CI.
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.
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.
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.
Cochlear implants use electronic signals to stimulate the auditory nerve.
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.
CAUTION: Investigational Device – Limited by Federal (or United States) Law to Investigational Use.
Acclaim CI - A Breakthrough Device The fully implanted Acclaim CI received the Breakthrough Device Designation from the U.S.
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.
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.
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.
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.
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. ● 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. ● No need for backup or secondary processors.
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.
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.
We expect that patients may experience mild to moderate discomfort after the procedure.
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.
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.
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.
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.
Severe hearing loss is often defined as 70-90 dB of hearing loss.
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.
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.
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.
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.
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.
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.
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.

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