The Acclaim CI was granted the breakthrough device designation by the FDA in 2019.
Envoy Medical received FDA approval for an investigational study of the Acclaim cochlear implant for adults with severe to profound sensorineural hearing loss. This allows them to collect initial clinical data before expanding to more patients. The Acclaim CI uses an implanted sensor to capture sound and will be tested at various US institutions. CEO Brent Lucas noted the approval as a significant milestone in making this device available to more patients.
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