Envoy Medical Successfully Reaches Three-Month Follow-Up Milestone in Clinical Trial of the Acclaim Fully Implanted Cochlear Implant
Envoy Medical (NASDAQ: COCH) has announced a significant milestone in its pivotal clinical trial for the Acclaim® fully implanted cochlear implant. The first stage patients have successfully reached their three-month follow-up with no serious adverse events (SAEs) or unanticipated device effects (UADEs) reported.
The Acclaim® device, designed to be the first-of-its-kind fully implanted cochlear implant, features Invisible Hearing® technology with no external components, natural ear sound capture, in-ear flexibility for consumer electronics use, extended battery life, and wireless update capabilities. The company remains on track for FDA approval submission in 2027.
Envoy Medical (NASDAQ: COCH) ha annunciato un traguardo importante nel suo trial clinico pilota per l'impianto cocleare completamente impiantabile Acclaim®. I pazienti della prima fase hanno raggiunto con successo il controllo a tre mesi senza che siano stati riportati eventi avversi gravi (SAE) o effetti inaspettati del dispositivo (UADE).
Il dispositivo Acclaim®, progettato per essere il primo impianto cocleare completamente impiantabile del suo genere, integra la tecnologia Invisible Hearing® senza componenti esterni, cattura naturale del suono auricolare, flessibilità per l'uso con dispositivi elettronici di consumo nell'orecchio, maggiore durata della batteria e capacità di aggiornamento wireless. L'azienda conferma di essere in linea con la presentazione della domanda di approvazione FDA prevista per il 2027.
Envoy Medical (NASDAQ: COCH) ha anunciado un hito importante en su ensayo clínico pivotal para el implante coclear completamente implantado Acclaim®. Los pacientes de la primera etapa han alcanzado con éxito el seguimiento a los tres meses sin registrarse eventos adversos graves (SAE) ni efectos inesperados del dispositivo (UADE).
El dispositivo Acclaim®, diseñado para ser el primer implante coclear completamente implantado de su tipo, incorpora la tecnología Invisible Hearing® sin componentes externos, captura natural del sonido del oído, flexibilidad para usar con dispositivos electrónicos de consumo in ear, mayor duración de batería y capacidad de actualización inalámbrica. La compañía mantiene el objetivo de presentar la solicitud de aprobación a la FDA en 2027.
Envoy Medical (NASDAQ: COCH)는 Acclaim® 완전 이식형 인공와우에 대한 주요 임상시험에서 중대한 이정표를 발표했습니다. 1단계 환자들이 3개월 추적 관찰을 성공적으로 마쳤으며 중대한 이상반응(SAE)이나 기기 예기치 않은 영향(UADE)은 보고되지 않았습니다.
Acclaim® 장치는 외부 부품이 없는 Invisible Hearing® 기술을 적용한 최초의 완전 이식형 인공와우로 설계되었으며, 자연스러운 귀 소리 포착, 이어 인(ear) 방식으로 소비자 전자제품 사용에 대한 유연성, 향상된 배터리 수명 및 무선 업데이트 기능을 특징으로 합니다. 회사는 2027년 FDA 승인 신청 계획을 예정대로 추진하고 있습니다.
Envoy Medical (NASDAQ: COCH) a annoncé une avancée importante dans son essai clinique pivotal pour l'implant cochléaire entièrement implanté Acclaim®. Les patients de la première phase ont atteint avec succès le suivi à trois mois, sans événements indésirables graves (SAE) ni effets imprévus liés au dispositif (UADE) signalés.
Le dispositif Acclaim®, conçu pour être le premier implant cochléaire entièrement implanté de ce type, intègre la technologie Invisible Hearing® sans composants externes, une capture naturelle du son auriculaire, une flexibilité in-ear pour l'utilisation avec des appareils électroniques grand public, une autonomie de batterie prolongée et des capacités de mise à jour sans fil. La société confirme être en bonne voie pour la soumission de la demande d'approbation FDA en 2027.
Envoy Medical (NASDAQ: COCH) hat einen bedeutenden Meilenstein in seiner entscheidenden klinischen Studie für das vollimplantierbare Cochlea-Implantat Acclaim® bekanntgegeben. Die Patienten der ersten Phase haben die Drei-Monats-Nachuntersuchung erfolgreich erreicht, ohne dass schwere unerwünschte Ereignisse (SAE) oder unerwartete Geräteeffekte (UADE) gemeldet wurden.
Das Acclaim®-Gerät, das als das erste seiner Art vollständig implantierbare Cochlea-Implantat entwickelt wurde, verfügt über die Invisible Hearing®-Technologie ohne externe Komponenten, natürliche Erfassung der Ohrgeräusche, In-Ear-Flexibilität für den Einsatz mit Unterhaltungselektronik, verlängerte Batterielaufzeit und drahtlose Update-Funktionen. Das Unternehmen bleibt auf Kurs für die Einreichung des FDA-Zulassungsantrags im Jahr 2027.
- No serious adverse events (SAEs) or unanticipated device effects reported in clinical trial
- Company remains on track for FDA approval submission timeline in 2027
- Breakthrough device status with unique features including fully implanted design
- Several days battery life on single charge, supporting all-day hearing capability
- Wireless firmware update capability without surgical intervention
- FDA approval timeline extends to 2027, indicating a lengthy path to market
- Product still in early clinical trial stages with long-term efficacy yet to be proven
Insights
Positive early safety data from Envoy's implantable cochlear device trial shows promise, supporting timeline toward 2027 FDA submission.
The three-month safety data from Envoy's pivotal trial represents a critical early milestone for their Acclaim® device. With no serious adverse events or unanticipated device effects reported, the company has cleared an important initial hurdle in demonstrating the safety profile of their fully implanted cochlear implant technology. While these are preliminary results from just the first stage of their pivotal trial, the clean safety profile helps de-risk the program's clinical development pathway.
The absence of early safety signals is particularly noteworthy for a first-of-its-kind implantable device that represents a significant advancement over traditional cochlear implants. Standard cochlear implants require external hardware, whereas Envoy's approach eliminates external components entirely. From a regulatory standpoint, this early safety data builds a foundation for the company's planned PMA submission targeted for 2027.
The device's differentiated features—including its ability to capture sound through the natural ear rather than external microphones, multi-day battery life, and capacity for wireless firmware updates without surgical intervention—address key barriers to cochlear implant adoption. The milestone achievement suggests the program remains on its clinical timeline, though investors should note that significant development and regulatory hurdles remain before potential commercialization.
No Serious Adverse Events or Unanticipated Device Effects Reported; Company Confirms Program Remains On Track
White Bear Lake, Minnesota--(Newsfile Corp. - September 3, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company focused on developing innovative, fully implanted technologies, today announced that the patients in the first stage of its pivotal clinical trial for the investigational Acclaim® fully implanted cochlear implant have successfully reached their three-month follow-up milestone. During this timeframe, no serious adverse events (SAEs) or unanticipated device effects (UADEs) were reported.
Envoy Medical's pivotal trial is designed to evaluate the safety and effectiveness of its Acclaim® fully implanted cochlear implant, an investigational first-of-its-kind device that aims to overcome adoption barriers associated with wearable external hardware in traditional hearing devices. With the pivotal trial progressing as planned, the Company believes it remains on track to achieve subsequent milestones and is targeting a submission for FDA approval in 2027. Successfully reaching this clinical trial milestone adds crucial data to the risk-benefit profile of Envoy Medical's breakthrough device and underscores the Company's progress toward its goal of redefining the standard of care for adults with significant hearing loss with hearing solutions that are fully implanted.
"We continue to be encouraged by the direction and momentum of our pivotal clinical trial," said Brent Lucas, Chief Executive Officer of Envoy Medical. "The absence of any serious adverse events or unanticipated device effects to date gives us an increasing level of confidence as we continue to progress through the clinical trial. We believe reaching this milestone helps support de-risking a fully implanted cochlear implant program and moves us one step closer to PMA submission and meeting our goal of being able to address unmet needs in the highly underpenetrated cochlear implant market."
Envoy Medical believes its investigational fully implanted cochlear implant, the Acclaim® device, is designed to be meaningfully different from any of its competitors' products. The Acclaim® is a breakthrough device that is designed to have the following attributes:
Invisible Hearing® — With no required externals worn on the ear, the Acclaim® device is designed to allow patients to address their significant hearing loss with discretion.
No Microphone — The Acclaim® device is designed to use the natural ear, not an external or sub-dermal microphone to capture sound.
In-Ear Flexibility — Due to the Acclaim® device using the ear to pick up sound (versus an off-the-ear, in-the-ear, or sub-dermal microphone), a patient can still choose to use their ear for an ear-based consumer electronic device (e.g., headphones) or other in-ear accessories. As Artificial Intelligence (AI) improves rapidly and consumer electronics evolve much faster than implanted medical devices, the in-ear flexibility allowed by the Acclaim® device's design may prove to be important to some users who want an option to use ear-worn consumer electronics.
Long Battery Life — Designed to last several days on one charge, the Acclaim® battery design supports a patient's ability to hear all day, every day without having to worry about daily charging.
Wireless Updates — The internal components of the Acclaim® device are designed to allow for certain firmware updates, supporting wireless device improvements without surgical intervention.
Mr. Lucas concluded, "While the Acclaim® cochlear implant remains in clinical trials, we believe it has potential to be exceptionally well received by adults with significant hearing loss. We see a future where fully implanted hearing devices become the standard of care, and Envoy Medical is uniquely positioned to be a leader in that transformation. As the only U.S.-based hearing health company solely focused on fully implanted hearing solutions, from the FDA-approved Esteem® active middle ear implant to the investigational, first-of-its-kind Acclaim® cochlear implant, we are committed to redefining what's possible in hearing health. We believe the future of hearing loss treatment is fully implanted."
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 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 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.
###
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/264902
FAQ
What are the key features of Envoy Medical's Acclaim cochlear implant?
When does Envoy Medical (COCH) expect FDA approval for the Acclaim cochlear implant?
What were the results of Envoy Medical's Acclaim clinical trial 3-month follow-up?
How is Envoy Medical's Acclaim different from traditional cochlear implants?
What is the battery life of the Envoy Medical Acclaim cochlear implant?
