Envoy Medical Submits Second Module of Modular Premarket Approval Application to FDA for Breakthrough Designated Acclaim(R) Cochlear Implant
Envoy Medical announced submission of the second of four planned modules of a Modular Premarket Approval (PMA) application to the U.S. Food and Drug Administration for the Acclaim cochlear implant, a device holding FDA Breakthrough Device Designation. The company says the second module focused on engineering information and that the final clinical module is expected by the end of Q2 2027.
What Envoy reported
Envoy Medical announced it submitted the second module of a Modular Premarket Approval application to the U.S. Food and Drug Administration for the Acclaim cochlear implant. The company said the second module included primarily engineering information and follows its first-module submission on June 30, 2026. Envoy described the PMA approach as modular and rolling, with multiple submissions allowing the FDA to review material while clinical data collection continues.
Sources: S1
Planned timeline and remaining materials
Envoy stated it expects to submit a total of four modules on a rolling basis, with the final module containing final clinical trial data and completing the PMA application. The company also said it expects to submit two additional modules, including the final clinical module, towards the end of the second quarter in 2027.
Sources: S1
Regulatory status of Acclaim
Envoy noted the fully implanted Acclaim cochlear implant received Breakthrough Device Designation from the FDA in 2019 and is under investigation in a U.S.-based pivotal clinical trial. The company emphasized the device is investigational and limited by United States law to investigational use.
Sources: S1
Why this may matter (inference)
A modular PMA process with multiple rolling submissions can allow the FDA to begin technical review of submitted sections before the submission of final clinical data, potentially creating opportunities for iterative feedback. For Envoy, completing the remaining modules is a stated milestone toward a finished PMA application.
Sources: S1
What remains uncertain
- All quantitative and timeline statements are company disclosures and subject to change; the press release contains forward-looking statements and does not guarantee regulatory outcomes.
- The Acclaim cochlear implant is described as investigational and limited by United States law to investigational use; submission of PMA modules is not equivalent to FDA approval.
- The company's stated timing for remaining module submissions and completion (towards the end of the second quarter in 2027) is an expectation, not a confirmed deadline, and may be affected by regulatory feedback or trial progress.