Envoy Medical Announces First Three Patients Enrolled in Final Stage of Acclaim(R) Cochlear Implant Pivotal Clinical Trial
Envoy Medical (NASDAQ: COCH) announced on November 4, 2025 that the first three patients have been enrolled and implanted in the final stage of the pivotal U.S. trial for the fully implanted Acclaim cochlear implant. Those initial surgeries were performed at two of seven U.S. investigational sites.
The final stage will implant 46 patients in total; 43 spots remain. The Acclaim device, engineered to operate without external wearable components, received FDA Breakthrough Device Designation in 2019 and remains under investigation. Management said faster enrollment supports progress toward FDA submission and potential commercialization.
Envoy Medical (NASDAQ: COCH) ha annunciato il 4 novembre 2025 che i primi tre pazienti sono stati arruolati e impiantati nella fase finale del trial statunitense chiave per l'impianto cocleare completamente impiantato Acclaim. Le prime chirurgie sono state eseguite in due di sette siti investigativi negli Stati Uniti.
La fase finale impianterà 46 pazienti in totale; restano 43 posti. Il dispositivo Acclaim, progettato per funzionare senza componenti esterni indossabili, ha ricevuto l'FDA Breakthrough Device Designation nel 2019 e rimane in fase di indagine. Il management ha detto che un'accelerazione dell'arruolamento sostiene i progressi verso la presentazione all'FDA e una potenziale commercializzazione.
Envoy Medical (NASDAQ: COCH) anunció el 4 de noviembre de 2025 que ya se han inscrito e implantado los primeros tres pacientes en la etapa final del ensayo pivotal en Estados Unidos para el implante coclear completamente implantado Acclaim. Esas cirugías iniciales se realizaron en dos de los siete centros de investigación en Estados Unidos.
La etapa final implantará 46 pacientes en total; quedan 43 plazas. El dispositivo Acclaim, diseñado para operar sin componentes externos portátiles, recibió en 2019 la Designación de Dispositivo Innovador de la FDA y sigue en investigación. La dirección dijo que un reclutamiento más rápido apoya el progreso hacia la presentación ante la FDA y la posible comercialización.
Envoy Medical (NASDAQ: COCH)는 2025년 11월 4일에 미국의 핵심 임상시험 최종 단계에서 완전히 이식된 Acclaim 인공 와우 이식기를 위해 처음으로 세 명의 환자가 등록되고 이식되었음을 발표했습니다. 초기 수술은 미국의 7개 연구 사이트 중 두 곳에서 수행되었습니다.
최종 단계에서는 총 46명의 환자를 이식하게 되며; 남은 자리는 43개입니다. 외부 웨어러블 없이 작동하도록 설계된 Acclaim 기기는 2019년 FDA Breakthrough Device Designation를 받았고 여전히 연구 중입니다. 경영진은 더 빠른 등록이 FDA 제출 및 잠재적 상용화를 향한 진행을 뒷받침한다고 말했습니다.
Envoy Medical (NASDAQ: COCH) a annoncé le 4 novembre 2025 que les trois premiers patients ont été recrutés et implantés dans la phase finale de l’essai pivot américain pour l’implant cochléaire entièrement implanté Acclaim. Ces premières chirurgies ont été réalisées dans deux des sept sites d’investigation américains.
La phase finale implantera 46 patients au total; il reste 43 places. Le dispositif Acclaim, conçu pour fonctionner sans composants externes portables, a reçu en 2019 la designation FDA Breakthrough Device et reste à l’étude. La direction a déclaré qu’un recrutement plus rapide soutient les progrès vers la soumission à la FDA et une éventuelle commercialisation.
Envoy Medical (NASDAQ: COCH) gab am 4. November 2025 bekannt, dass die ersten drei Patienten eingeschrieben und in die Endphase der wegweisenden US-Studie für den vollständig implantierbaren Acclaim-Hörimplantat implantiert wurden. Diese ersten Eingriffe wurden an zwei von sieben US-Forschungsstandorten durchgeführt.
Die Endphase wird insgesamt 46 Patienten implantieren; 43 Plätze bleiben frei. Das Acclaim-Gerät, entwickelt, um ohne externe tragbare Komponenten zu arbeiten, erhielt 2019 die FDA Breakthrough Device Designation und befindet sich weiterhin in der Untersuchung. Das Management sagte, dass ein schnelleres Recruiting den Fortschritt in Richtung FDA-Einreichung und potenzielle Vermarktung unterstützt.
Envoy Medical (NASDAQ: COCH) أعلن عن 4 نوفمبر 2025 أن أول ثلاثة مرضى تم تسجيلهم وزرعهم في المرحلة النهائية من التجربة المحورية الأمريكية لجهاز زراعة القوقعة القابل للزراعة بالكامل Acclaim. تم إجراء هذه الجراحات الأولية في اثنين من seven مواقع البحث الأميركية.
Stage النهائي سيزرع 46 مريضاً إجمالاً؛ لا يزال هناك 43 مقعداً. تم تصميم جهاز Acclaim ليعمل بدون مكونات خارجية قابلة للارتداء، وحصل على ت designation FDA Breakthrough Device في 2019 ولا يزال قيد الدراسة. قال الإدارة إن التوسع الأسرع في التسجيل يدعم التقدم نحو تقديم FDA وإمكانية التسويق المحتمل.
- 3 of 46 final-stage implants completed
- 46-patient final-stage trial target confirmed
- 7 U.S. investigational sites participating
- FDA Breakthrough Device Designation (2019)
- Device remains investigational and is not yet FDA approved
- 43 final-stage enrollments remain to complete pivotal trial
- Commercialization depends on successful trial results and FDA submission
Insights
First three enrollments in the pivotal final stage and 46-patient target speed FDA pathway toward commercialization.
Envoy Medical advanced to the final stage of its pivotal trial with the first three patients enrolled on
The business mechanism is clear: efficient enrollment maintains trial timeline and supports next steps the company cited, including FDA submission and commercialization. The device holds an FDA Breakthrough Device Designation from 2019, which the company notes as part of its regulatory pathway.
Key dependencies and risks remain factual and explicit: continued enrollment velocity, completion of the full 46-patient final stage, and subsequent regulatory review. Statements in the release link faster enrollment to capital conservation and program pacing, but those are company-provided outcomes and should be viewed as management claims.
Watch enrollment progress, the number of completed implants out of 46, and any announced FDA submission milestones as near-term checkpoints. Expect updates in the coming months as sites complete more surgeries and screen additional candidates.
Rapid patient enrollment underscores strong market interest and reinforces commercialization opportunity for fully implanted cochlear implants
White Bear Lake, Minnesota--(Newsfile Corp. - November 4, 2025) - Envoy Medical, Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced that the first three patients have been enrolled in the final stage of the Company's pivotal clinical trial of the full implanted Acclaim® cochlear implant. These initial surgeries in this final stage were performed by Dr. Abraham Jacob at the Center for Neurosciences Ear and Hearing Center in Tucson, Arizona and Dr. Jack Shohet at Shohet Ear Associates in Seal Beach, California, two of the seven investigational sites in the United States.
The Acclaim® cochlear implant is an investigational, first-of-its-kind device engineered to operate without external wearable components. Unlike conventional cochlear implants, it uses a novel sensor to capture sound leveraging the ear's natural anatomy, removing the need for an external microphone or sound processor. This fully implanted design also supports patient choice to use standard in-ear devices such as earbuds or headphones, facilitating additional flexibility and differentiation from traditional cochlear implants.
"We are seeing strong interest in Envoy Medical's fully implanted cochlear device," said Dr. Jack Shohet. "Patients are eager to participate in this study, which is not always the case with studies. People with significant hearing loss have wanted a fully implanted cochlear device for decades — it is thrilling to be part of this moment in hearing health innovation."
"After successfully implanting three of the ten patients in the first stage and following their initial progress, our site was excited to move forward with more surgeries in the final stage," said Dr. Abraham Jacob. "We have patients from all over contacting us asking to get the fully implanted device. We expect enrollment to move quickly and see this as a strong indication for significant demand once this product is commercially available."
"This milestone brings us another step closer to our goal of making the future of hearing fully implanted," said Brent Lucas, CEO of Envoy Medical. "Faster enrollment accelerates our path to key milestones, including FDA submission and eventual commercialization of the Acclaim cochlear implant. It also validates strong product market fit, helps conserve capital, and keeps our clinical program on pace. We're moving with smart, deliberate urgency because patients are ready, and they shouldn't have to wait any longer for a fully implanted option."
A total of 46 patients will be implanted in the final stage of the trial; with today's news, 43 spots remain. Seven clinical trial sites are participating, and several additional surgeries are already scheduled with many more potential participants actively progressing through the screening process. Enrollment is proceeding efficiently. The strong interest underscores the momentum behind Envoy Medical's mission and the untapped demand for a fully implanted cochlear implant.
The Acclaim cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S.-based pivotal clinical trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal.
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 operations; the ability to obtain and maintain compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the amount of capital required to complete the FDA pivotal trial; the Acclaim CI being the first to market fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of the Acclaim CI; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI's PMA submission to the FDA; 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; the ability to engage 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.
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
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/273051
FAQ
What did Envoy Medical (COCH) announce on November 4, 2025 about the Acclaim trial?
How many patients will be implanted in the final stage of the Acclaim trial (COCH)?
Which clinical sites performed the initial Acclaim surgeries reported by Envoy Medical (COCH)?
Does the Acclaim cochlear implant have any special regulatory designation?
What does the November 4, 2025 enrollment milestone mean for COCH's timeline to market?
Is the Acclaim cochlear implant fully implanted and different from conventional cochlear implants?
