Envoy Medical Hits Six-Month Milestone, Marks Halfway Point in Final Stage of Data Collection, and Highlights Differentiated Device Design
Envoy Medical surpassed the six-month follow-up milestone in its pivotal trial of the fully implanted Acclaim cochlear implant, the halfway point of the final 12-month data-collection stage. The company says it is the first to reach this milestone in a U.S. pivotal trial of a fully implanted cochlear implant and has submitted two of four planned PMA modules to the FDA, with the final module due by end of Q2 2027.
Key figures
- Drug Name
- Acclaim fully implanted cochlear implant (Acclaim CI)
- Phase Of Trial
- Pivotal clinical trial
- Followup milestone
- six-month visits complete; 12-month total follow-up per participant
- Expected fda decision
- end of 2027 or early 2028
- Pma modules submitted
- 2 of 4
- Final pma module submission
- end of Q2 2027
- Twelve month visits completion
- early Q2 2027
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