Envoy Medical Submits Second Module of Modular Premarket Approval Application to FDA for Breakthrough Designated Acclaim(R) Cochlear Implant
Envoy Medical submitted the second of four planned modules of its Modular PMA application to the FDA for the Breakthrough Device-designated Acclaim cochlear implant. The second module contained primarily engineering information and follows the first module submitted June 30, 2026; the final module with clinical trial data is targeted for the end of Q2 2027.
Key figures
- Drug Name
- Acclaim Cochlear Implant
- Phase Of Trial
- pivotal clinical trial
- First module date
- June 30, 2026
- Modules submitted
- 2 of 4
- Final module target
- Q2 2027
- Breakthrough designation year
- 2019
AI analysis
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