Envoy Medical Advances Commercialization Planning for Breakthrough Hearing Device as FDA Clinical Trial Remains On Track
Envoy Medical (NASDAQ: COCH) is advancing commercialization plans for its breakthrough Acclaim® fully implanted cochlear implant while its FDA pivotal trial progresses successfully. The trial has reached significant milestones with all patients completing three-month follow-ups with no serious adverse events, and six-month follow-ups now underway.
The company plans to establish 30-40 clinical sites upon FDA approval, focusing on excellence and strong foundation building. The Acclaim device, which received FDA Breakthrough Device Designation in 2019, is targeting PMA submission in 2027. Envoy Medical aims to tap into an underserved market segment of individuals who haven't adopted traditional hearing loss treatments.
L'azienda prevede di istituire 30-40 centri clinici al momento dell'approvazione FDA, concentrandosi sull'eccellenza e sulla costruzione di una base solida. Il dispositivo Acclaim, che ha ricevuto la Designazione FDA Breakthrough Device nel 2019, punta a una presentazione PMA nel 2027. Envoy Medical mira ad accedere a una quota di mercato underserved di individui che non hanno adottato i trattamenti tradizionali per la perdita dell’udito.
La empresa planea establecer 30-40 sitios clínicos tras la aprobación de la FDA, enfocándose en la excelencia y la construcción de una base sólida. El dispositivo Acclaim, que recibió la Designación de Dispositivo Innovador de la FDA en 2019, apunta a la presentación PMA en 2027. Envoy Medical busca aprovechar un segmento de mercado desatendido de personas que no han adoptado tratamientos tradicionales para la pérdida de audición.
FDA 승인 시 30-40개의 임상 기관을 설립하는 것을 계획하고 있으며, 우수성에 집중하고 탄탄한 기반을 구축하는 데 초점을 둡니다. Acclaim 기기는 2019년 FDA Breakthrough Device 지정을 받았으며, 2027년 PMA 제출을 목표로 하고 있습니다. Envoy Medical은 전통적인 난청 치료를 채택하지 않은 미충족 시장 부문에 진입하는 것을 목표로 합니다.
L’entreprise prévoit d’établir 30-40 sites cliniques après l’approbation par la FDA, en se concentrant sur l’excellence et la construction d’une base solide. L’appareil Acclaim, qui a reçu en 2019 la désignation d’appareil révolutionnaire par la FDA, vise une soumission PMA en 2027. Envoy Medical cherche à exploiter un segment de marché mal desservi des personnes qui n’ont pas adopté les traitements traditionnels de la perte auditive.
Das Unternehmen plant, nach der FDA-Zulassung 30-40 klinische Standorte einzurichten, mit Fokus auf Exzellenz und dem Aufbau einer starken Grundlage. Das Acclaim-Gerät, das 2019 die FDA Breakthrough Device Designation erhielt, zielt auf eine PMA-Einreichung im Jahr 2027 ab. Envoy Medical will einen unterversorgten Marktabschnitt ansprechen, der aus Personen besteht, die traditionelle Hörverlust-Behandlungen nicht angenommen haben.
تخطط الشركة لتأسيس 30-40 مركزاً سريرياً بعد موافقة FDA، مع التركيز على التميز وبناء قاعدة قوية. الجهاز Acclaim، الذي حصل في 2019 على تصنيف جهاز تجاوزي من FDA، يستهدف تقديم PMA في 2027. تسعى Envoy Medical إلى الدخول في شريحة سوقية غير مخدومة من الأفراد الذين لم يعتمدوا العلاجات التقليدية لفقدان السمع.
公司计划在 FDA 批准后设立< b>30-40 个临床点，专注于卓越和扎实的基础建设。Acclaim 设备在 2019 年获得< b>FDA 破除性设备指定，目标在 2027 年提交 PMA。Envoy Medical 旨在进入尚未被传统听力损失治疗覆盖的 underserved 市场。
- All patients successfully completed three-month follow-ups with no serious adverse events
- FDA Breakthrough Device Designation status received in 2019
- Clinical trial expansion to seven U.S. sites pending FDA approval
- Strategic preparation for commercial launch with 30-40 planned clinical sites
- PMA submission not expected until 2027
- Commercial launch timeline dependent on successful trial completion and regulatory approval
Insights
Envoy's cochlear implant trial progressing well; commercialization planning accelerates while FDA approval remains years away.
Envoy Medical's pivotal clinical trial for its fully implanted Acclaim® cochlear implant is showing positive early progress. All patients in the first stage have successfully completed three-month follow-ups with no serious adverse events or unanticipated device effects reported - a critical milestone for any implantable medical device trial. Six-month follow-ups are now underway and will continue over the next two months.
The company is preparing to expand the trial to seven U.S. sites pending FDA approval of their expansion request, signaling confidence in the preliminary results. However, investors should note the timeline context - Envoy expects to submit for premarket approval (PMA) in 2027, indicating we're still early in the regulatory process with several years before potential commercialization.
Despite this extended timeline, Envoy is accelerating commercialization planning, targeting 30-40 initial clinical sites post-approval. This strategy of prioritizing depth over breadth is prudent for an innovative implantable device, as it allows for quality control and proper training during initial rollout. The company's focus on building infrastructure now suggests confidence in eventual approval, though regulatory hurdles remain.
The Acclaim device received FDA Breakthrough Device Designation in 2019, potentially expediting review processes, but cochlear implant approvals typically require substantial safety and efficacy data given their invasive nature and long-term implantation. The strategy to target patients who haven't adopted traditional hearing solutions indicates Envoy sees an opportunity to expand the total addressable market beyond current cochlear implant users.
The Company Begins Strategic Preparations To Support Anticipated Demand And Optimization Of The Acclaim® Fully Implanted Cochlear Implant Opportunity
Six-month follow-up visits are now underway and will continue over the next two months
White Bear Lake, Minnesota--(Newsfile Corp. - September 24, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company focused on developing innovative, fully implanted hearing solutions, today announced it is scaling its commercialization planning for the company's breakthrough investigational Acclaim® fully implanted hearing device, as its pivotal clinical trial continues to build momentum. The Company's proactive approach reflects its conviction that fully implanted cochlear implants have an opportunity to unlock a significant market opportunity. By accelerating efforts to train and engage in a network of clinical centers, Envoy Medical aims to achieve sufficient capacity to meet anticipated demand once the Acclaim device receives regulatory approval.
Envoy Medical's pivotal trial is progressing well, with all patients in the first stage having successfully completed their three-month follow-up milestones with no serious adverse events or unanticipated device effects reported. Six-month follow-up visits have begun with additional follow-up visits being completed over the next two months. The Company is now preparing for the next enrollment phase of the trial, which will be conducted at seven U.S. sites, to commence upon FDA approval of the Company's expansion request.
"We believe our fully implanted Acclaim® cochlear implant, now advancing through pivotal trials, has the potential to unlock a significant, underserved segment of the hearing loss market - individuals who have not pursued or adopted traditional treatment options. The early interest we're seeing is encouraging, and we are now focused on laying the groundwork to meet that anticipated demand," said Brent Lucas, Chief Executive Officer of Envoy Medical,
The Company's commercialization strategy will focus on identifying, training, and solidifying 30-40 sites should FDA regulatory approval be received. Envoy Medical plans to emphasize depth over breadth, prioritizing excellence and building a strong foundation. Assuming typical volumes at similar sites and a healthy price point, the Company believes there would be a relatively quick path to significant top-line growth.
Those interested in becoming potential surgical or audiological sites should contact customerservice@envoymedical.com.
Envoy Medical plans to provide additional updates on its FDA pivotal clinical trial and other topics over the next several months.
The investigational Acclaim® cochlear implant received Breakthrough Device Designation from the U.S. Food and Drug Administration in 2019. Envoy Medical anticipates submitting for premarket approval (PMA) in 2027, pending successful completion of its pivotal trial milestones.
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.
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 future outcome of its FDA pivotal trial; the ability to add surgical sites, and the effect of adding such sites; the effects on Envoy Medical's financial performance of FDA approval of its Acclaim CI device; 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 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/267678
FAQ
What is the current status of Envoy Medical's Acclaim cochlear implant clinical trial?
When does Envoy Medical (NASDAQ:COCH) expect FDA approval for the Acclaim device?
How many clinical sites does Envoy Medical plan to establish for the Acclaim cochlear implant?
What makes Envoy Medical's Acclaim cochlear implant different from traditional options?
How can medical facilities become Acclaim cochlear implant surgical or audiological sites?
