Envoy Medical reaches six-month follow-up milestone in pivotal cochlear implant trial
COCH•Envoy Medical reached the six-month follow-up milestone in its pivotal trial of the fully implanted Acclaim cochlear implant. Twelve-month visits are on track to finish by early Q2 2027, with final clinical results expected by the end of Q2 2027 and a potential FDA decision in late 2027 or early 2028.
1. Trial milestone
Envoy Medical said six-month follow-up in its pivotal trial of the fully implanted Acclaim cochlear implant has reached the halfway point for data collection. Twelve-month follow-up visits remain on track for completion by early Q2 2027.
2. FDA application timeline
The company expects to include final clinical results in the last module of its FDA premarket approval application by the end of Q2 2027. Two of four planned modules have been submitted, and a potential FDA decision is expected in late 2027 or early 2028.
