Envoy Medical Advances Commercialization Planning for Breakthrough Hearing Device as FDA Clinical Trial Remains On Track

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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/267678

SOURCE Envoy Medical, Inc.

Released September 24, 2025