Soundtec Direct System
This article was originally published in The Gray Sheet
Executive Summary
Ear canal sound processor for the middle ear implantable hearing device gains FDA go-ahead. The magnet-based component can be implanted in less than 30 minutes in an outpatient procedure. The ear canal processor is intended to be cosmetically more pleasing than the behind-the-ear processor that was available when the Direct System gained PMA approval in September 2001 (1"The Gray Sheet" Oct. 1, 2001, p. 20)...