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Envoy Medical Announces It Is Scaling Its Commercialization Planning For The Company's Breakthrough Investigational Acclaim Fully Implanted Cochlear Implant As Pivotal Trial Progresses

Author: Benzinga Newsdesk | September 24, 2025 07:03am

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.

Posted In: COCH

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