Envoy Medical Submits Second FDA Application Module for Acclaim Cochlear Implant
Envoy Medical, Inc. (NASDAQ:COCH) has submitted the second module of its four-part Premarket Approval application to the U.S. Food and Drug Administration for the Acclaim fully implanted cochlear implant. This second submission focuses primarily on engineering data and follows the submission of the first module on June 30, 2026.
The Acclaim device, which received FDA Breakthrough Device Designation in 2019, uses an internal sensor rather than an external microphone to capture sound using the natural anatomy of the ear. The modular submission process allows the FDA to evaluate technical sections sequentially while clinical data collection continues under an ongoing pivotal clinical trial in the United States.
Envoy Medical plans to submit two more modules on a rolling basis. The fourth and final module, which will feature final clinical trial data, is expected to be submitted toward the end of the second quarter of 2027 to complete the approval application.
Key points
- Envoy Medical submitted the second engineering module of its FDA Premarket Approval application for the Acclaim cochlear implant.
- The company submitted the first module on June 30, 2026, and is using a rolling four-module review process.
- The Acclaim device is a fully implanted cochlear implant that earned FDA Breakthrough Device Designation in 2019.
- Envoy Medical expects to submit the final clinical data module toward the end of the second quarter of 2027.
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What did Envoy Medical submit to the FDA?
Envoy Medical submitted the second module of its four-part Premarket Approval application for its Acclaim fully implanted cochlear implant. The second module contains primarily engineering information.
When will Envoy Medical complete its FDA application for Acclaim?
Envoy Medical expects to submit the fourth and final module containing clinical trial data toward the end of the second quarter of 2027.
What makes the Acclaim cochlear implant unique?
The Acclaim is a fully implanted device that uses a sensor leveraging the natural anatomy of the ear to capture sound rather than an external microphone.