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Envoy Medical Nears Completion of Enrollment in Pivotal Clinical Trial of Fully Implanted Acclaim(R) Cochlear Implant
45 of 56 Patients Implanted; Enrollment Completion Anticipated by End of MarchWhite Bear Lake, Minnesota--(Newsfile Corp. - February 17, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced continued progress in enrollment for its pivotal clinical trial of the investigational fully implanted Acclaim® cochlear implant.To date, 45 patients have been successfully implanted and are...
About this update from Envoy Medical, Inc.
[{"type":"text","content":"45 of 56 Patients Implanted; Enrollment Completion Anticipated by End of March","length":78,"tagName":"p","attribs":{"class":"nfSubHeading"},"className":""},{"type":"text","content":"White Bear Lake, Minnesota--(Newsfile Corp. - February 17, 2026) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical" or the "Company"), a hearing health company pioneering fully implanted hearing solutions, today announced continued progress in enrollment for its pivotal clinical trial of the investigational fully implanted Acclaim® cochlear implant.","length":374,"tagName":"p"},{"type":"text","content":"To date, 45 patients have been successfully implanted and are officially enrolled in the study. The trial calls for a total of 56 implanted participants. In other words, Envoy Medical has completed over 80% of targeted enrollment. The Company expects this pivotal clinical trial to complete full enrollment by the end of March 2026.","length":332,"tagName":"p"},{"type":"text","content":"Based on current enrollment trends and follow-up timelines, Envoy Medical believes the trial remains on track for completion and potential Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA) in the second quarter of 2027.","length":252,"tagName":"p"},{"type":"text","content":""We are extremely encouraged by the steady progress we've seen since receiving FDA approval to expand our pivotal study," said Brent Lucas, Chief Executive Officer of Envoy Medical. "Reaching 45 implanted patients and being approximately one month away from full enrollment is an exciting milestone for our entire organization. The journey to get to this point has been long, but we are now moving quickly and with great confidence."","length":457,"tagName":"p"},{"type":"text","content":"Lucas added, "We remain encouraged by what we are hearing from the trial and look forward to sharing more as results are formally analyzed and published. We expect to provide an update at an industry meeting in May as we continue advancing toward our goal of redefining the standard of care with a fully implanted cochlear implant."","length":342,"tagName":"p"},{"type":"text","content":"The investigational Acclaim® fully implanted cochlear implant is designed to leverage the natural ear, rather than an external microphone, to capture ...