Envoy Medical Completes Activation for 56 Acclaim Implant Patients, Eyes FDA PMA
Envoy Medical has completed initial activation visits for all 56 participants in its pivotal trial of the fully implanted Acclaim cochlear implant, solidifying the study timeline. The company will conduct 12-month follow-ups before analyzing data and submitting a PMA application to the FDA.
1. Activation Visits Completed
Envoy Medical has activated the fully implanted Acclaim cochlear implant in all 56 enrolled subjects, concluding the initial phase of its pivotal trial and confirming the study's activation timeline.
2. Upcoming Follow-Up Schedule
The company will schedule the remaining follow-up visits over the next 12 months to monitor patient outcomes, capture performance metrics and ensure comprehensive data collection.
3. PMA Submission Timeline
After all participants complete their 12-month follow-up, Envoy Medical plans to analyze efficacy and safety data and file a Premarket Approval application with the FDA for the Acclaim device.
4. Device Innovation and Designation
The Acclaim cochlear implant leverages an implanted sensor using the ear's natural anatomy and holds FDA Breakthrough Device Designation, marking it as the first fully implanted solution for severe to profound sensorineural hearing loss.