Soundtec
This article was originally published in The Gray Sheet
Executive Summary
Oklahoma City firm's PMA for Direct System implantable hearing device will not undergo review by FDA's Ear, Nose and Throat Devices Panel because information submitted in PMA "substantially duplicates" data previously reviewed, according to the agency. Procedure in which a tiny magnet is placed between the incus and stapes bones, takes 25 minutes to complete, firm says