StoryRegulatory
Envoy Medical submits second of four modules of its FDA premarket approval application for the Acclaim cochlear implant
Envoy Medical sent the FDA the second of four modules in its modular premarket approval application for the Acclaim cochlear implant, which received Breakthrough Device designation in 2019. The company says this module mainly contained engineering information, and that the FDA can review modules while clinical data is still being collected.
- Module 1 was submitted June 30, 2026, and module 2 on October 12, 2026, so half of the application is with the FDA.
- The Acclaim device is investigational and is being studied in a U.S. pivotal clinical trial.
- Each module gives Envoy a chance to get FDA feedback and answer questions before the final submission.
- Modules 3 and 4 are expected toward the end of the second quarter of 2027; the final one carries clinical trial data.
- CEO Brent Lucas said the company continues to steadily march along its defined regulatory pathway.