7/103 sources · 3 publishersUpdated Oct 12, 12:56 UTC
Envoy Medical submits second module of FDA PMA for Acclaim cochlear implant
Envoy Medical Inc. filed the second of four planned modules for its Modular Premarket Approval (PMA) application for the Acclaim fully implanted cochlear implant. The module, which contains primarily engineering information, follows the first submission on June 30, 2026. The company said the final clinical‑data module is expected by the end of the second quarter of 2027.
Why it matters
The filing moves the rolling FDA review halfway forward, reducing regulatory risk for the investigational device. Completion of the final module in Q2 2027 would allow the FDA to complete its review, potentially enabling market entry thereafter.
Key facts
- 1Envoy Medical submitted the second module of its PMA application on October 12, 2026. stocktitan.net
- 2The second module primarily contains engineering information. stocktitan.net
- 3The first module was submitted on June 30, 2026. stocktitan.net
- 4Envoy plans to submit a total of four modules, with the final clinical‑data module targeted for the end of Q2 2027. stocktitan.net
- 5The Acclaim cochlear implant received FDA Breakthrough Device Designation in 2019. stocktitan.net
- 6Brent Lucas, CEO of Envoy Medical, said the second module submission is an important milestone. stocktitan.net
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.