Envoy Medical Inc. (NASDAQ:COCH) on Tuesday 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 (CNC) 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%.
The 12-month data will serve as the primary efficacy endpoint for the Acclaim pivotal clinical study.
Majority Of Patients Showed Positive Response
Nine of the 10 Stage 1 participants demonstrated hearing improvements consistent with the overall trend, while one participant was identified as a potential non-responder. Envoy Medical said it is reviewing the underlying cause of that outcome.
Excluding the potential non-responder, the remaining nine participants recorded a mean CNC word recognition score of 59.1% at 12 months, representing a 42.2 percentage point improvement from baseline.
On the safety front, the company reported no serious adverse events, as defined by the study protocol, among the first 10 participants through their 12-month follow-up visits.
Envoy Medical Says Stage 2 Enrollment Complete
The completion of the 12-month assessments marks the end of primary endpoint follow-up for Stage 1 of Envoy Medical’s two-stage pivotal trial.
Following FDA authorization to expand the study, the company moved into Stage 2, which is now fully enrolled. All participants have completed their one-month visits, while many have also reached their three- and six-month follow-up milestones.
The company is collecting additional study measures and will include them in its planned FDA Premarket Approval submission.
Envoy Medical expects all Stage 2 participants to complete their 12-month follow-up by the early second quarter of 2027, with a Premarket Approval submission planned several months later.
COCH Price Action: Envoy Medical shares were down 3.24% at $0.67 during premarket trading on Tuesday, according to Benzinga Pro data.
Photo by PeopleImages via Shutterstock