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Envoy Medical announced that the first three participants in its pivotal clinical trial for the Acclaim fully implanted cochlear implant have completed their 12-month follow-up evaluations. These were the earliest patients implanted in the trial, which began in early 2025. Reaching the 12-month mark is significant because the trial's primary endpoints are tied to 12-month outcome data.
Full enrollment of all 56 participants was completed in March 2026. All enrolled patients will need to complete 12-month follow-up visits before Envoy can compile data for a Pre-Market Approval submission to the FDA. The company previously stated it expects to file that application in the second quarter of 2027. The Acclaim is designed without any externally worn components; it captures sound through a piezoelectric sensor implanted in the middle ear. The device holds FDA Breakthrough Device Designation but remains investigational. Commercial availability depends on FDA review following submission.
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