Envoy Medical Inc. (Envoy Medical (COCH)) just cleared another hurdle in its quest to bring a fully implanted cochlear implant to market. On Tuesday, the company announced that all 56 patients enrolled in its pivotal clinical trial for the Acclaim cochlear implant have completed their three-month follow-up visits.

“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.”

The Acclaim implant is designed for people with severe to profound sensorineural hearing loss that hearing aids can't adequately address. Unlike traditional cochlear implants that use an external microphone, the Acclaim uses a sensor that leverages the natural anatomy of the ear to capture sound. That means the entire device is implanted, with nothing visible on the outside.

The company is still collecting safety and other data from the trial, which will be included in its Premarket Approval (PMA) submission to the FDA. Envoy Medical expects to hit the six-month visit milestone for all patients by late 2026, and the 12-month milestone by April 2027.

Last week, the company reported encouraging 12-month results from the first 10 participants in Stage 1 of the trial. Those patients 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%. That’s a 38 percentage point improvement, which more than doubled the 24 percentage point gain seen at six months (when the cohort scored 39.2%).

Envoy Medical shares were up 1.34% at $0.68 in premarket trading on Tuesday.