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Envoy Medical finished enrollment for its clinical trial of the Acclaim cochlear implant, a fully implanted device with no externally worn components. The 56th and final participant was implanted on March 11, 2026. The Acclaim captures sound through a piezoelectric sensor implanted in the middle ear. Envoy holds FDA Breakthrough Device Designation for the device. The company expects to submit a Pre-Market Approval application to the FDA in the second quarter of 2027, after completing 12-month follow-up assessments for all participants. Completion of enrollment is not FDA approval and does not indicate commercial availability.
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