Envoy Medical Inc. (NASDAQ:COCH) on Tuesday said it surpassed the three-month milestone for all 56 patients enrolled in the company’s pivotal clinical trial evaluating the investigational fully implanted Acclaim cochlear implant.
Envoy Medical Completes Three-Month Milestone In Acclaim Trial
The update marks another important clinical trial milestone as the company continues to build momentum with the hearing industry.
"Envoy Medical continues to demonstrate its ability to execute," said Brent Lucas, CEO of Envoy Medical. "Each milestone achieved brings us one big step closer to our next major goal – submission of our PMA application to the FDA."
FDA Submission Timeline Remains On Track
The company is continuing to collect safety and other study measures as part of its ongoing pivotal trial, with full data to be included as part of its planned Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA).
Envoy Medical anticipates achieving its six-month visit milestone by late 2026 and its 12-month visit milestone for the entire study by April 2027.
Implant Targets Severe Hearing Loss
Acclaim Cochlear Implant is an investigational hearing device. Envoy Medical’s fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.
The Acclaim implant is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids.
Last week, Envoy Medical reported 12-month results from the first 10 participants in Stage 1 of its pivotal clinical trial evaluating the investigational fully implanted Acclaim cochlear implant, with hearing performance continuing to improve over previously reported six-month data.
The company said participants achieved a mean Consonant-Nucleus-Consonant word recognition score of 53.2% at the 12-month mark, compared with a pre-implantation baseline of 15.2%.
The 38.0 percentage point improvement exceeded the 24.0 percentage point gain reported after six months, when the cohort posted a mean score of 39.2%.
COCH Price Action: Envoy Medical shares were up 1.34% at $0.68 during premarket trading on Tuesday, according to Benzinga Pro data.
Photo by PeopleImages via Shutterstock
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