Envoy Medical Surpasses 6-Month Follow-Up Visit Milestone For Pivotal Clinical Trial Evaluating Investigational Fully Implanted Acclaim Cochlear Implant; Expects To Submit Final Clinical PMA Module By End Of Q2 2027

Company Believes It Is the First to Reach This Milestone in a U.S. Pivotal Trial of a Fully Implanted Cochlear Implant

Remains on Track to Reach 12-Month Visit Milestone by Early Q2 2027 and Submit Final Clinical PMA Module by End of Q2 2027

White Bear Lake, Minnesota--(Newsfile Corp. - October 20, 2026) - Envoy Medical® Inc. (NASDAQ:COCH) ("Envoy Medical" or the "Company"), a hearing health and neuroprosthetics company pioneering fully implanted hearing solutions, today announced that it has surpassed the six-month follow-up visit milestone for the Company's pivotal clinical trial evaluating the investigational fully implanted Acclaim® cochlear implant. This milestone signifies the halfway point in the trial's final stage of data collection as each participant is followed for a total of 12 months. To the Company's knowledge, Envoy Medical is the first company to achieve this milestone in a U.S. pivotal clinical trial of a fully implanted cochlear implant and remains the only company pursuing fully implanted cochlear implants ("FCIs") with its differentiated device design.

The Company remains on track to complete 12-month visits by early Q2 2027. Envoy Medical has submitted two of the four planned modules of its Modular Premarket Approval ("PMA") application to the U.S. Food and Drug Administration ("FDA") and expects to submit the final module, containing final clinical trial data, by the end of Q2 2027.