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Envoy Medical announced the first clinical data presentations from its pivotal trial of the Acclaim fully implanted cochlear implant. Interim data from an initial cohort showed improvements in speech recognition scores and quality-of-life measures. Among the four participants who reported tinnitus before surgery, tinnitus scores also decreased. The Acclaim captures sound through a sensor implanted in the middle ear and has no externally worn components.
This is a company-reported data release, not yet peer-reviewed. The Acclaim remains investigational. Envoy Medical expects to file a Pre-Market Approval application with the FDA in the second quarter of 2027. Additional presentations from the trial are scheduled at upcoming clinical conferences.
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