Device Panel Suggests Conditions for Approval of Hearing Implant

The Ear, Nose and Throat Device Advisory Panel has voted 15–0 to recommend conditional approval of Envoy Medical’s Esteem-Hearing implant for people with severe hearing loss despite CDRH’s concerns about adverse events such as partial facial palsy and taste disturbances that lasted longer than a year. Recommended conditions include labeling to indicate the possible side effects, a postapproval study and training for surgeons. If approved, the device would be the first of its kind as it is fully implantable.
Devices & Diagnostics Letter