Envoy Medical files first PMA module with FDA for cochlear implant
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Envoy Medical Submits First Module of Modular Premarket Approval Application to the U.S. Food and Drug Administration for Breakthrough-Designated Device
June 30, 2026 8:32 AM EDTModular 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... More
