Envoy Medical Issues Letter to Shareholders and Provides Update on Recent Accomplishments
Envoy Medical (NASDAQ: COCH), a hearing health company, has announced significant achievements in Q3 2025. The company has completely eliminated over $32 million in debt, strengthening its balance sheet and capital structure. Envoy has expanded its global patent portfolio with 7 new patents across the U.S., Australia, and Hong Kong, now holding approximately 38 U.S. and 40 foreign patents.
The company reported positive progress in its pivotal clinical trial for the Acclaim® fully implanted cochlear implant, with all 10 initial patients completing three-month follow-ups without serious adverse events. Additionally, five new Category III CPT codes for totally-implantable active middle ear implants, including their FDA-approved Esteem® device, took effect on July 1, 2025, potentially improving reimbursement opportunities.
Envoy Medical (NASDAQ: COCH), azienda nel settore della salute uditiva, ha annunciato importanti risultati nel terzo trimestre 2025. L'azienda ha eliminato completamente oltre 32 milioni di dollari di debito, rafforzando il proprio bilancio e la struttura patrimoniale. Envoy ha ampliato il proprio portafoglio di brevetti a livello globale con 7 nuovi brevetti negli Stati Uniti, in Australia e a Hong Kong, arrivando a detenere circa 38 brevetti statunitensi e 40 brevetti esteri.
La società ha segnalato progressi positivi nello studio clinico pivotale per l'Acclaim® impianto cocleare completamente impiantabile, con tutti i 10 pazienti iniziali che hanno completato i controlli a tre mesi senza eventi avversi gravi. Inoltre, dal 1° luglio 2025 sono entrati in vigore cinque nuovi codici CPT di Categoria III per impianti attivi dell'orecchio medio totalmente impiantabili, compreso il loro dispositivo approvato dalla FDA Esteem®, potenzialmente migliorando le opportunità di rimborso.
Envoy Medical (NASDAQ: COCH), una empresa de salud auditiva, ha anunciado logros importantes en el tercer trimestre de 2025. La compañía ha eliminado por completo más de 32 millones de dólares en deuda, fortaleciendo su balance y su estructura de capital. Envoy ha ampliado su cartera mundial de patentes con 7 nuevas patentes en EE. UU., Australia y Hong Kong, teniendo ahora aproximadamente 38 patentes en EE. UU. y 40 patentas extranjeras.
La compañía informó avances positivos en su ensayo clínico pivotal para el implante coclear totalmente implantable Acclaim®, con los 10 pacientes iniciales completando los seguimientos a tres meses sin eventos adversos graves. Además, el 1 de julio de 2025 entraron en vigor cinco nuevos códigos CPT de Categoría III para implantes activos totalmente implantables del oído medio, incluido su dispositivo aprobado por la FDA, Esteem®, lo que podría mejorar las oportunidades de reembolso.
Envoy Medical (NASDAQ: COCH), 청각 건강 기업으로서 2025년 3분기에 중요한 성과를 발표했습니다. 회사는 3,200만 달러 이상의 부채를 전액 상환하여 재무상태와 자본구조를 강화했습니다. Envoy는 미국, 호주 및 홍콩에서 7건의 신규 특허를 추가해 글로벌 특허 포트폴리오를 확장했으며, 현재 약 38건의 미국 특허와 40건의 해외 특허를 보유하고 있습니다.
회사는 완전 이식형 인공와우 Acclaim®의 주요 임상시험에서 긍정적인 진전을 보고했으며, 초기 10명의 환자 모두 3개월 추적 관찰을 무사히 마치고 심각한 이상 사례는 없었습니다. 또한, 2025년 7월 1일부터 FDA 승인 장치인 Esteem®을 포함한 완전 이식형 중이(中耳) 활성 임플란트에 대해 신규 Category III CPT 코드 5건이 시행되어 보험 환급 가능성이 개선될 수 있습니다.
Envoy Medical (NASDAQ: COCH), entreprise spécialisée dans la santé auditive, a annoncé des réalisations significatives au troisième trimestre 2025. La société a entièrement éliminé plus de 32 millions de dollars de dette, renforçant ainsi son bilan et sa structure financière. Envoy a élargi son portefeuille mondial de brevets avec 7 nouveaux brevets aux États-Unis, en Australie et à Hong Kong, détenant désormais environ 38 brevets américains et 40 brevets étrangers.
La société a rapporté des progrès positifs dans son essai clinique pivot pour l'implant cochléaire totalement implantable Acclaim®, les 10 premiers patients ayant tous terminé le suivi à trois mois sans événements indésirables graves. De plus, cinq nouveaux codes CPT de catégorie III pour les implants actifs totalement implantables de l'oreille moyenne, y compris leur dispositif approuvé par la FDA Esteem®, sont entrés en vigueur le 1er juillet 2025, ce qui pourrait améliorer les possibilités de remboursement.
Envoy Medical (NASDAQ: COCH), ein Unternehmen im Bereich Hörgesundheit, hat bedeutende Erfolge im dritten Quartal 2025 bekanntgegeben. Das Unternehmen hat über 32 Millionen US-Dollar an Verbindlichkeiten vollständig getilgt, wodurch Bilanz und Kapitalstruktur gestärkt wurden. Envoy hat sein globales Patentportfolio um 7 neue Patente in den USA, Australien und Hongkong erweitert und verfügt nun über rund 38 US- und 40 ausländische Patente.
Das Unternehmen meldete positive Fortschritte in seiner wegweisenden klinischen Studie für das vollständig implantierbare Cochlea-Implantat Acclaim®, wobei alle 10 anfänglichen Patienten die Dreimonatsnachuntersuchungen ohne schwerwiegende unerwünschte Ereignisse abgeschlossen haben. Zusätzlich traten zum 1. Juli 2025 fünf neue Category-III-CPT-Codes für komplett implantierbare aktive Mittelohrimplantate, einschließlich ihres von der FDA zugelassenen Geräts Esteem®, in Kraft, was die Erstattungsmöglichkeiten verbessern könnte.
- None.
- PMA application for Acclaim® device not expected until 2027
- Category III CPT codes are temporary and do not guarantee insurance coverage or reimbursement
Insights
Envoy eliminated $32M debt, expanded patents, advanced clinical trials for fully implanted hearing devices, positioning for stronger commercial growth.
Envoy Medical's Q3 2025 shareholder letter reveals substantial financial improvement through the elimination of
The company has expanded its intellectual property portfolio with seven new patents across the US, Australia, and Hong Kong. Their patent estate now includes approximately 38 US and 40 foreign patents, all protecting their position in fully implanted hearing solutions. These patents cover critical technological areas including cochlear implant systems, programming methods, and diagnostic capabilities.
Clinically, Envoy reported positive momentum in their pivotal trial for the investigational Acclaim® cochlear implant. All 10 patients in the first stage have completed three-month follow-ups with no serious adverse events reported. The company remains on track for their planned FDA Premarket Approval submission in 2027.
A potentially significant commercial development is the implementation of five new Category III CPT codes for totally-implantable active middle ear implants, which took effect July 1, 2025. These codes could enhance reimbursement potential for their FDA-approved Esteem® device, potentially expanding market access.
The company is positioning its technology within the broader public health context, citing recent research connecting hearing loss to increased dementia risk. This strategy aligns their fully implanted "Invisible Hearing®" technology with both quality-of-life improvements and potential cognitive health benefits, potentially expanding their addressable market beyond traditional hearing aid users.
Highlights include Expanded Global Patent Portfolio, Complete Debt Elimination Strengthening Balance Sheet, and Further Momentum of Pivotal Clinical Trial
White Bear Lake, Minnesota--(Newsfile Corp. - September 10, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company focused on developing innovative, fully implanted technologies, today issued a letter to shareholders commenting on recent accomplishments and other operational updates from Chief Executive Officer, Brent Lucas.
Dear Shareholders:
The third quarter of 2025 has been one of tremendous progress and momentum for Envoy Medical. As "America's Hearing Implant Company," we are proud to be redefining what is possible in hearing health by leading a paradigm shift from within the United States to a future where fully implanted devices become the standard of care.
This quarter was full of many positive developments that continue to strengthen our position and draw positive attention across the hearing industry—we further expanded our global patent portfolio, significantly strengthened our balance sheet by completely eliminating over
Here is a deeper look at the last three months:
Favorable Debt Elimination Significantly Strengthens Balance Sheet
Envoy Medical successfully extinguished more than
It is hard to underestimate what a meaningfully valuable moment this is for Envoy Medical. Our newly strengthened financial foundation now allows us to move forward with additional confidence as we continue investing in clinical trials, regulatory milestones, growing a global patent portfolio, and preparing to scale up for commercialization.
Expanding Our Global Patent Portfolio
Envoy Medical maintains an impressive global patent portfolio with roughly 38 granted US patents and 40 foreign granted patents - all focused on protecting our leadership in fully implanted hearing solutions. We continue to invest in strengthening our patent and intellectual property position. We recently secured seven new patents across the U.S., Australia, and Hong Kong, which includes the following:
The U.S. patent issued on August 19, 2025, is titled "Fully Implantable Modular Cochlear Implant System" and relates to cochlear implant systems having a signal processor and an implantable battery and/or communication module having a signal generator that generates digital signals for communicating to the signal processor.
The United States Patent and Trademark Office is set to grant U.S. Patent No. 12,418,758 to Envoy Medical Corporation on September 16, 2025. The title is "Programming of Cochlear Implant Accessories." This patent will relate to systems and methods for easily communicating with, charging, and pairing multiple cochlear implant accessory devices.
The Hong Kong Patent issued on May 16, 2025 is titled "Cochlear Implant Stimulation Calibration" and it relates to calibrating current flow in a cochlear implant system. A switching network is controlled to place a source element of a cochlear implant system in communication with a testing circuit. An amount of electrical current provided to the testing circuit is determined and the output of the source element is adjusted based on the determined amount of electrical current.
The Australian Patent Office granted Australian Patent No. 2022227536 to Envoy Medical Corporation on July 24, 2025. The title is "Cochlear Implant System with Integrated Signal Analysis Functionality." This patent relates to using an external device to designate a signal within a fully implantable cochlear implant system for analysis and to receive a representative signal from the cochlear implant system.
On August 7, 2025, the Australian Patent office issued a patent to Envoy Medical for an "Implantable Cochlear System with Integrated Components and Lead Characterization," strengthening our ability to advance device reliability by improving how conductors within a cochlear implant system are tested and characterized.
On July 31, 2025, another Australian patent was granted titled "Programming of Cochlear Implant Accessories," covering systems and methods for seamlessly pairing and communicating with accessory devices. These additions to our intellectual property estate highlight Envoy Medical's focus on both improving device performance and enhancing patient usability.
On July 17, the company received a patent from the Australian patent office titled "Cochlear Implant System with Electrode Impedance Diagnostics." This patent relates to electrode impedance diagnostics in cochlear implant systems. A cochlear implant system determines an impedance associated with a current path from a source element to a return electrode and determines one or more stimulation parameters for the source element based on the impedance.
We will continue to focus on meaningful innovation and pushing the envelope. We are excited to push innovation and force healthy competition.
Invisible Hearing® technology
In addition to patent protection, we continue to strengthen and protect our registered trademarks as well. We recently solidified our sole ownership of the "Invisible Hearing" trademark in Australia, adding to our already registered marks in the United States, United Kingdom, and Europe.
We believe the aspiration of Invisible Hearing® resonates with many people who suffer from hearing loss, but do not want to be forced to use a highly visible external device on or around the ear. We further believe many hearing loss patients want the ability to be discrete about their hearing loss and want an option to disclose their hearing disability on their own terms.
We are proud to bring fully implanted solutions with Invisible Hearing® technology to empower patients with the choice and flexibility in their hearing loss solution rather than just telling these patients that they need to just accept that all hearing devices require wearable externals. We think patients and their loved ones want to hear that fully implanted hearing devices using Invisible Hearing® technology are actual possibilities, and we are here for it.
Clinical Momentum: Acclaim® Cochlear Implant
Our pivotal clinical trial for the investigational fully implanted investigational Acclaim® cochlear implant continues to progress as planned. All 10 patients enrolled in the first stage of the trial have reached their three-month follow-up visits with no serious adverse events or unanticipated device effects reported. We believe the trial remains on track to achieve subsequent milestones in the short and long term. We are currently maintaining our target submission of our Premarket Approval (PMA) application to the FDA in 2027.
As we continue to achieve these trial milestones, we are adding important information to the risk-benefit profile of our investigational Acclaim® device that will support our eventual FDA submission.
We see a future where adult cochlear implant candidates are given a choice where they can adequately address their hearing loss without the need to have a bulky, external component attached to the side of their head via magnet. We think that future will be well received, and we are excited to be a key change agent in that process.
CPT Codes Unlock New Opportunities
On July 1, 2025, five new Category III CPT codes for totally-implantable active middle ear implants, including our FDA-approved Esteem® device, officially took effect.* This milestone enhances the potential for meaningful reimbursement for patients, which would, in turn, expand patient access and create a more favorable commercial environment for the Esteem® device.
We believe positive changes to reimbursement for the Esteem® device would drive broader adoption of this one-of-a-kind device and provide a substantial business opportunity for Envoy Medical. The potential value creation that could come from meaningful reimbursement for the Esteem® is significant.
Public Health Impact
Untreated hearing loss is increasingly recognized not just as a sensory issue but as a major modifiable risk factor for dementia. A July 2025 study published in JAMA Neurology confirmed that hearing loss is significantly associated with greater dementia risk, reinforcing the importance of timely intervention (JAMA Neurology, 2025). Additional large-scale studies have shown that this risk is substantially reduced when individuals use hearing devices.
This growing body of evidence strengthens our conviction that Envoy Medical's fully implanted solutions—designed to offer reliable, 24/7 hearing without external wearable hardware—can play a transformative role not only in restoring hearing but also in supporting long-term brain health and wellbeing. We believe this dual impact elevates our mission, expands our relevance in public health, and enhances the long-term value we are striving to build for shareholders.
Looking Ahead
We believe that the future for Envoy Medical is extremely bright. With a significantly strengthened balance sheet, an expanded intellectual property portfolio, clinical trial momentum for our investigational fully implanted Acclaim® cochlear implant, and a step closer to favorable reimbursement for our FDA-Approved Esteem® fully implanted active middle ear implant, Envoy Medical is entering the final quarter of 2025 with exceptional progress and an ever-increasing level of confidence.
We remain committed to redefining what is possible in hearing health, providing patients with innovative solutions, and delivering long-term value to our shareholders.
Thank You,
Brent Lucas
Chief Executive Officer
Envoy Medical, Inc.
For more information about Envoy Medical's innovation pipeline and intellectual property portfolio, visit www.envoymedical.com.
To be added to the Envoy Medical email distribution list, please email Envoy@kcsa.com with COCH in the subject line.
*Category III CPT codes are temporary codes for emerging technologies, services, and procedures. The inclusion of a descriptor and its associated code number in the CPT code set does not represent endorsement by the American Medical Association of any particular diagnostic or therapeutic procedure/service. Inclusion or exclusion of a procedure/service does not imply any health insurance coverage or reimbursement policy.
About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.
About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's 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 severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.
The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.
CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.
About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted** hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.
**Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.
Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.
Additional Information and Where to Find It
Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.
Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operational improvements and capital investments; the ability to obtain additional patents and develop future products or product improvements, the Acclaim CI being the first to market fully implanted cochlear implant, the timing and results of approvals, site documents, logistics, activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI, and the participation or any changes in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timeline for the pivotal trial and the timeline for PMA submission and potential FDA approval of the Acclaim CI; the availability and timing of reimbursement for the Esteem® device; the impact of CPT codes for active middle ear hearing devices, changes in reimbursement for the Esteem FI-AMEI device or other changes in reimbursement policies or coverage decisions, changes in the hearing health market, and further development of the Esteem FI-AMEI device; the size of Envoy Medical's addressable market, operational performance, future market conditions or economic performance and developments in the capital and credit markets and any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index; Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on March 31, 2025, and in other reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical.
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Investor Contact:
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: Envoy@kcsa.com
Media Contact:
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.com
SOURCE: Envoy Medical, Inc.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/265720
FAQ
What major debt reduction did Envoy Medical (NASDAQ: COCH) announce in Q3 2025?
How many patents does Envoy Medical currently hold for hearing solutions?
What is the status of Envoy Medical's Acclaim® cochlear implant clinical trial?
What recent reimbursement developments occurred for Envoy Medical's Esteem® device?
How many new patents did Envoy Medical secure in their latest announcement?
