$COCHJul 21, 2026, 1:17 PMAI processed
Envoy (COCH) says all 56 patients reached 3‐month visit in pivotal Acclaim cochlear implant trial
AI Summary
Envoy Medical (COCH) reported that all 56 patients enrolled in its pivotal trial of the investigational fully implanted Acclaim cochlear implant have completed their three‐month visits. The company is continuing to collect safety and other study measures for inclusion in a planned PMA submission and expects six‐month visits by late 2026 and full 12‐month follow‐up by April 2027, but did not disclose any safety or efficacy results.
Positives
- All 56 enrolled pivotal‑trial patients completed their 3‑month visit milestone
- Company continues collecting safety and study measures to support planned PMA submission
- Company provided projected timelines: six‑month visits by late 2026 and 12‑month completion by April 2027
Negatives
- No safety or efficacy data were disclosed with the milestone announcement
- Acclaim remains an investigational device and Envoy has not yet submitted a PMA
- Current data are early (3‑month) and from a modest sample size (56 patients)