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Envoy Medical Announces First Patients Successfully Reaching 12-Month Endpoint in Pivotal Clinical Trial for Fully Implanted Cochlear Implant
Company Remains on Schedule for PMA Submission to FDA White Bear Lake, Minnesota--(Newsfile Corp. - April 1, 2026) - Envoy Medical®, Inc. (NASDAQ: COCH)
About this update from Envoy Medical, Inc.
[{"type":"text","content":"Company Remains on Schedule for PMA Submission to FDA\nWhite Bear Lake, Minnesota--(Newsfile Corp. - April 1, 2026) - Envoy Medical®, Inc. (NASDAQ: COCH) (\"Envoy Medical\"), a hearing health company pioneering fully implanted hearing solutions, announced that the first three patients implanted in its pivotal clinical trial for the fully implanted Acclaim® cochlear implant have successfully completed their 12-month endpoint visit, marking a key milestone in the study's progress.\nThe first three pivotal trial patients implanted at the start of 2025 are now the first to reach the 12-month follow-up evaluation point. The primary endpoints for the trial are tied to 12-month data. Achieving this critical milestone on schedule underscores the Company's continued execution as it steadily marches towards commercialization.\n\"We are thrilled to highlight the first wave of trial participants successfully reaching and completing their 12-month endpoint,\" said Brent Lucas, CEO of Envoy Medical. \"We believe our first-of-its-kind breakthrough technology has the potential to change the perception around how severe to profound hearing loss is treated and potentially increase adoption rates. Now that the trial has been fully enrolled and we are beginning to collect 12-month data, the future of hearing implants may be closer than you realize.\"\nAfter all trial participants complete their 12-month evaluations, Envoy Medical plans to submit its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA).\nThe Acclaim® cochlear implant is an investigational, first-of-its-kind fully implanted device designed to address severe to profound sensorineural hearing loss without externally worn components. With Envoy Medical's proprietary sensor technology, the Acclaim® device design leverages the ear's natural anatomy to capture sound to support a smooth and discreet hearing experience.\nEnvoy Medical believes fully implanted hearing technology offers the potential to significantly expand adoption among patients unwilling or unable to use traditional hearing devices that rely on external hardware. Per the NIH, only six percent of eligible individuals receive cochlear implants, highlighting a substantial unmet need in the market.\nThe Company continues to build on its leadership in fully implanted hearing solutions, including it...