Envoy Medical Nears Full Enrollment in Pivotal Acclaim Cochlear Implant Trial

Reuters
Feb 17
Envoy Medical Nears Full Enrollment in Pivotal Acclaim Cochlear Implant Trial

Envoy Medical Inc. has announced continued progress in enrollment for its pivotal clinical trial of the fully implanted Acclaim® cochlear implant. To date, 45 out of a planned 56 patients have been implanted and enrolled, with full enrollment expected by the end of March 2026. The company anticipates completing the trial and potentially submitting for Premarket Approval (PMA) to the U.S. FDA in the second quarter of 2027. Envoy Medical expects to provide an update on the trial at an industry meeting in May 2026. Results from the study have not yet been formally presented.

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