Soundtec Direct System
This article was originally published in The Gray Sheet
Executive Summary
Implantable hearing device PMA approved by FDA Sept. 7 for use in adults who have a moderate-to-severe sensorineural hearing loss and who desire an alternative to an acoustic hearing aid. Postapproval reports must include: clinically significant changes in residual hearing to the implant ear; alleged complications due to ossicular erosion; and device extrusions. The Oklahoma City firm's device consists of a speech/sound processor worn in or behind the ear and a tiny rare-earth magnet implanted in the middle ear in a procedure taking 25 minutes that be performed under local anesthetic