WHITE BEAR LAKE, MINNESOTA — Envoy Medical Inc. (NASDAQ: COCH) announced that all 56 patients enrolled in its pivotal clinical trial of the investigational Acclaim ® cochlear implant have completed their three-month follow-up visits....
✦ Clinical Takeaway ✦
No actionable change — this is a trial enrollment milestone announcement with no efficacy or safety outcomes reported yet.
✦ Why It Matters ✦
Completion of three-month follow-ups for all pivotal-trial participants moves the Acclaim fully implanted cochlear implant closer to a potential FDA submission, which could eventually expand treatment options for patients with severe-to-profound hearing loss.
✦ Key Points ✦
- 01All 56 patients in the Acclaim pivotal trial have completed their 3-month follow-up visits.
- 02The Acclaim is Envoy Medical's cochlear implant candidate seeking regulatory approval.
- 03Reaching this milestone is a procedural step toward an FDA submission — no outcome data were disclosed.
- 04No efficacy, safety, or audiological performance results were shared in this announcement.
- 05The trial is pivotal, meaning results are intended to support a premarket approval (PMA) application.
✦ Claims & Evidence ✦
ClaimEvidenceSupport
All 56 patients in the Acclaim pivotal cochlear implant trial have completed their three-month follow-up visits.
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