45 of 56 Patients Implanted; Enrollment Completion Anticipated by End of March
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.
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.
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.
"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."
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."
The investigational Acclaim® fully implanted cochlear implant is designed to leverage the natural ear, rather than an external microphone, to capture sound using Envoy Medical's proprietary implanted piezoelectric sensor technology. Unlike traditional cochlear implants, the Acclaim® device is designed without required externally worn components on or in the ear, representing a differentiated approach in the cochlear implant market.
About Envoy Medical, Inc.
Envoy 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.
About the Fully Implanted Acclaim® Cochlear Implant
We believe the fully implanted Acclaim Cochlear Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound. The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician. The Acclaim Cochlear Implant received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.
CAUTION: The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by Federal (or United States) law to investigational use.
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