Envoy Medical Submits First Module Of Modular Premarket Approval Application To FDA For Breakthrough Device-Designated Product; Co Plans Fou

Modular Regulatory Strategy Creates Defined Milestone Cadence, Enables Earlier FDA Engagement, and Supports Targeted Final Clinical Module Submission Planned for Q2 2027 White Bear Lake, Minnesota--(Newsfile Corp. - June 30, 2026) - Envoy Medical ® Inc. (NASDAQ: COCH ) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced the submission of the first module of its Modular Premarket Approval ("PMA") application to the U.S. Food and Drug Administration ("FDA") for its FDA Breakthrough Device-designated product. The submission marks the first regulatory milestone in the Company's planned modular PMA strategy. Unlike a traditional PMA, which is submitted as a single comprehensive application, the modular PMA pathway allows the Company to submit completed sections to the FDA for review as they become available, rather...