Acclaim cochlear implant — NDA/BLA submission
Q2 2027
The Company expects to submit a total of four modules, with the final module containing final clinical trial data targeted for submission in the second quarter of 2027.Source filing
COCH biotech catalysts & pipeline
ENVOY MEDICAL INC · Data as of 2026-10-25
Upcoming catalysts
Acclaim cochlear implant — Regulatory decision
H2 2027
As a result, we currently anticipate obtaining the FDA's decision on our PMA application at some point within the second half of 2027 assuming that no panel review is requested.Source filing
Acclaim cochlear implant — Regulatory decision
H1 2028
If a panel review is requested, the FDA's decision could extend to the first half of 2028.Source filing