Envoy Medical (NASDAQ:COCH) has announced that the FDA has approved its Investigational Device Exemption application for the pivotal study of its Acclaim fully implanted cochlear implant.
The company asserts that the Acclaim technology differs from other hearing implants on the market because it features an implanted sensor designed to use the natural anatomy of the ear to capture sound.
“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,” he added.
