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FDA Panel To Consider Data Shift For Pediatric Cochlear Implants

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.

The prospects of shifting clinical data requirements from premarket to postmarket to support cochlear implant modifications for pediatric patients will discussed at an upcoming FDA Ear, Nose and Throat Devices Panel meeting.

The panel will meet April 30 and May 1 first to recommend risk-classification categories for five types of hearing devices and, on the second day, consider the data shift for...

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