Acclaim cochlear implant — Topline data
Q2 2027
We expect all Stage 2 participants to complete their 12-month data collection by early Q2 2027, with a PMA submission to the FDA planned to follow a few months thereafter.Source filing
COCH biotech catalysts & pipeline
ENVOY MEDICAL INC · Data as of 2026-09-08
Upcoming catalysts
Acclaim cochlear implant — PDUFA
H2 2027
As a result, Envoy Medical currently anticipates 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
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