FDA WARNING_LETTER - Envoy - July 02, 2025

The FDA issued a Warning Letter to Envoy Medical Inc. on November 11, 2025, following an inspection of its Saint Paul, MN facility from June 24 to July 2, 2025. The inspection determined that the company"s Esteem II Implantable Hearing System is an adulterated device under the Federal Food, Drug, and Cosmetic Act, specifically due to non-conformity with the Quality System regulation (21 CFR Part 820).

Key violations included a failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints. The FDA cited instances where complaints, including those involving patient infection and sudden battery depletion, experienced significant delays in investigation, with some remaining incomplete for several months. The company"s complaint handling procedures were not uniformly and timely implemented.

Furthermore, Envoy Medical Inc. failed to adequately establish and maintain procedures for corrective and preventive action (CAPA). This was exemplified by inadequately implemented CAPAs concerning high particulate counts in ISO Class 8 Cleanrooms, with no Health Hazard Evaluation conducted to assess potential impacts on user safety or products manufactured under non-conforming conditions.

The company"s responses dated July 22, 2025, were deemed inadequate by the FDA, with proposed procedure changes not yet implemented and several investigations still open. Envoy Medical Inc. is required to promptly address these violations and implement effective corrective actions to ensure full compliance with regulatory requirements.