Envoy Medical Inc. (NASDAQ: COCH) submitted the second module of its Modular Premarket Approval application to the U.S. Food and Drug Administration for its Acclaim cochlear implant, the company announced Oct. 12, 2026.

The second module, which contained primarily engineering information, follows the first module submitted on June 30, 2026. Envoy Medical plans to submit a total of four modules on a rolling basis, with the final module expected to include clinical trial data. The company targets completion of the final module submission by the end of the second quarter of 2027.

The rolling submission structure allows the FDA to review completed sections while clinical data collection continues. Each submitted module may also generate agency feedback ahead of the final submission.

"The submission of our second module is an important milestone that demonstrates measurable progress," said Brent Lucas, Chief Executive Officer of Envoy Medical. "With two of the four modules submitted, we continue to steadily march along our defined regulatory pathway."

The Acclaim cochlear implant received FDA Breakthrough Device Designation in 2019 and is currently under investigation in a U.S.-based pivotal clinical trial. The device is described as fully implanted and designed to address severe to profound sensorineural hearing loss in adults. It remains an investigational device, limited by federal law to investigational use.

Envoy Medical is based in White Bear Lake, Minnesota, and also markets the Esteem fully implanted active middle ear implant, which has been commercially available in the U.S. since 2010.