Second of Four Planned Modules Moves Rolling FDA Review Forward

Advances Toward Targeted Completion of the Final Clinical Module Submission in Q2 2027

White Bear Lake, Minnesota--(Newsfile Corp. - October 12, 2026) - Envoy Medical® Inc. (NASDAQ:COCH) ("Envoy Medical" or the "Company"), a hearing health and neuroprosthetics company pioneering fully implanted hearing solutions, today announced the submission of the second module of its Modular Premarket Approval ("PMA") application to the U.S. Food and Drug Administration ("FDA") for the Acclaim® cochlear implant, which has received FDA Breakthrough Device Designation.

The second module, which included primarily engineering information, follows the Company's submission of the first module on June 30, 2026. Envoy Medical expects to submit a total of four modules on a rolling basis, with the final module containing final clinical trial data and completing the PMA application.