Envoy Medical Submits First PMA Module to FDA; 12-Month Clinical Improvement Reported
COCH Envoy Medical Inc
$0.65 +0.03%
View chart & analysis → - 1Envoy Medical (COCH) has submitted the first module of its modular PMA for the fully implantable Acclaim cochlear implant to the FDA.
- 2In the first-stage cohort of 10 patients, the 12-month CNC word recognition score improved by 38.0 percentage points, from 15.2% pre-implant to 53.2%.
- 3The remaining modules will be submitted sequentially, with the final module targeted for the second quarter of 2027, and primary efficacy will be evaluated using the 12-month data.
Source Newsfile Corp. +1 · View original ↗
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