FDA Panel To Consider Data Shift For Pediatric Cochlear Implants
This article was originally published in The Gray Sheet
Executive Summary
The Ear, Nose and Throat Devices Panel will convene for two days, April 30 and May 1, first to recommend risk-classification categories for five types of hearing devices and, on the second day, consider the potential of moving clinical requirements for cochlear implant modifications for kids to the postmarket phase.