Envoy Medical receives FDA approval to initiate study for hearing device

Envoy Medical (COCH) announces that its Investigational Device Exemption, IDE, application for its pivotal study of the Acclaim Fully Implanted Cochlear Implant has been approved by the U.S. Food and Drug Administration, FDA. The Acclaim technology includes an implanted sensor designed to leverage the natural anatomy of the ear to capture sound, making it different from existing cochlear implants on the market. “Receiving FDA approval to initiate this pivotal study marks a significant milestone in our efforts to bring this breakthrough hearing device to more people with severe to profound hearing loss,” said Brent Lucas CEO of Envoy Medical. “Currently, it is estimated that roughly 95% of patients with significant hearing loss who could benefit from a cochlear implant have not received one. We believe the differences in our device’s design provide an opportunity to pursue this important therapy in a more discrete manner and offer candidates a welcomed new option that may get more patients to embrace the potential benefits of a cochlear implant.”