Envoy Medical (Envoy Medical (COCH)) is building a pretty compelling case for its fully implanted Acclaim cochlear implant. On Tuesday, the company reported 12-month results from the first 10 participants in Stage 1 of its pivotal clinical trial, and the numbers keep moving in the right direction.

At the 12-month mark, participants achieved a mean Consonant-Nucleus-Consonant (CNC) word recognition score of 53.2%, up from a pre-implantation baseline of 15.2%. That's a 38 percentage point improvement — and notably, it's a bigger jump than the 24 point gain seen at six months, when the group averaged 39.2%. So the improvement isn't just holding; it's accelerating.

The 12-month data is the primary efficacy endpoint for the Acclaim study, so these results are the ones the FDA will be looking at most closely.

Most Patients Are Responding Well

Nine of the 10 Stage 1 participants showed hearing improvements consistent with the overall trend. One participant was flagged as a potential non-responder, and Envoy Medical said it's reviewing the underlying cause. If you exclude that one outlier, the remaining nine participants recorded a mean CNC word recognition score of 59.1% at 12 months — a 42.2 percentage point improvement from baseline. That's a pretty dramatic gain.

On the safety side, the company reported no serious adverse events among the first 10 participants through their 12-month follow-up visits. That's exactly what you want to hear when you're building toward an FDA submission.

Stage 2 Is Fully Enrolled and Moving

The completion of the 12-month assessments marks the end of primary endpoint follow-up for Stage 1. After getting FDA authorization to expand the study, Envoy Medical moved into Stage 2, which is now fully enrolled. All participants have completed their one-month visits, and many have already reached their three- and six-month follow-up milestones.

The company is collecting additional study measures and plans to include them in its Premarket Approval (PMA) submission to the FDA. Envoy Medical expects all Stage 2 participants to complete their 12-month follow-up by early Q2 2027, with the PMA submission coming a few months after that.

As for the stock, Envoy Medical shares were down 3.24% in premarket trading Tuesday at $0.67. That's a small dip, but the real catalyst will be the FDA submission and eventual approval decision.