TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION

TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION is an FDA 510(k)-cleared medical device (K963915) manufactured by Telex Communications, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 7, 1996. Regulation: 8.