Envoy Medical Corporation – FDA 483, Jul 2, 2025

Envoy Medical Corporation, a manufacturer of Class III implantable hearing systems in Saint Paul, MN, was cited for significant deficiencies in its quality system. Observations included inadequate control of nonconforming products, unvalidated critical processes, insufficient process monitoring, delayed complaint investigations, and inadequate risk analysis and equipment calibration. These issues indicate a systemic breakdown in ensuring product quality and patient safety.