Envoy Medical completes activation of all 56 patients in pivotal Acclaim cochlear implant trial

Envoy Medical/Acclaim Cochlear Implant

All 56 patients enrolled in the Acclaim pivotal trial completed activation visits by April 22, 2026. Enrollment had been completed on March 11, 2026 with the 56th patient implantation. CEO Brent Lucas stated FDA PMA submission would follow 12-month follow-up completion, targeting approval by late 2027.

• Enrollment milestone completed March 11, 2026 with 56th patient implanted; all patients activated by April 22.
• Acclaim received FDA Breakthrough Device Designation in 2020, expediting regulatory review.
• Unlike traditional cochlear implants with external microphones, Acclaim is fully implanted with sensor-based sound capture.
• 12-month follow-up data collection underway to support FDA Premarket Approval application.