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Envoy Medical Reaches Critical Milestone in Pivotal Clinical Trial of Fully Implanted Acclaim(R) Cochlear Implant
All 56 Enrolled Subjects Have Been Through Their Activation Visit Firming Up Study Timeline White Bear Lake, Minnesota--(Newsfile Corp. - April 22, 2026) -
About this update from Envoy Medical, Inc.
[{"type":"text","content":"All 56 Enrolled Subjects Have Been Through Their Activation Visit Firming Up Study Timeline\nWhite Bear Lake, Minnesota--(Newsfile Corp. - April 22, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) (\"Envoy Medical\" or the \"Company\"), a hearing health company pioneering fully implanted hearing solutions, today announced that all 56 patients implanted and enrolled in its pivotal clinical trial evaluating the fully implanted Acclaim® cochlear implant have been through their \"Activation Visits,\" when a patient's device is initially turned on for the first time.\n\"The conclusion of our trial studying the first-of-its-kind fully implanted Acclaim® cochlear implant is now within sight,\" said Brent Lucas, Chief Executive Officer of Envoy Medical. \"We believe the future of hearing solutions for those with severe to profound hearing loss will be fully implanted devices, and we are excited to be on the leading edge of that revolution.\"\nNow that all 56 patients are through their Activation Visit, the remaining follow-up visits and trial-related events can be scheduled providing increased confidence in timing of upcoming milestones. Upon completion of 12-month follow-up for all patients, the Company expects to analyze the data and submit results to the U.S. Food and Drug Administration (FDA) as part of a Premarket Approval (PMA) application.\nThe Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S. based pivotal clinical trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal.\nTo be added to the Envoy Medical email distribution list, please email [email protected] with COCH in the subject line.\nAbout Envoy Medical, Inc.\nEnvoy Medical (NASDAQ: COCH) is a hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind, fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.\nAbout the Fully Implanted Acclaim® Cochlear Im...