Envoy Medical Announces First Three Patients Enrolled in Final Stage of Acclaim(R) Cochlear Implant Pivotal Clinical Trial

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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/273051

SOURCE Envoy Medical, Inc.

Released November 4, 2025