In Brief: Cochlear Corp. Nucleus 22 Channel
This article was originally published in The Gray Sheet
Executive Summary
Cochlear Corp. Nucleus 22 Channel: Cochlear implant system is approved by FDA for adults with severe-to- profound postlinguistic, sensioneural hearing loss and severely impaired speech recognition abilities. In April, the agency's Ear, Nose and Throat Devices Advisory Panel unanimously recommended approval of a PMA supplement to cover the broader indication, contingent upon certain labeling changes ("The Gray Sheet" April 24, p. 28). Cochlear says all outstanding issues raised by the panel have been addressed and the FDA approval contains no postmarket requirements