Envoy Medical hearing implant gets FDA fast track
White Bear Lake–based Envoy Medical says the latest version of its fully implanted Acclaim hearing device has received FDA breakthrough device designation, placing it on a fast track and expanding clinical trials from 10 to 46 patients. The company, which earlier secured 2010 FDA approval for its Esteem implant, is targeting 2027 approval for the new system after roughly $250 million in cumulative investment.
📌 Key Facts
- FDA breakthrough device designation granted to Envoy Medical’s fully implanted hearing device (Acclaim).
- Clinical trial enrollment expanded from 10 to 46 patients.
- Company based in White Bear Lake; aiming for FDA approval in 2027 after ~$250M invested.