TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC

TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC is an FDA 510(k)-cleared medical device (K913495) manufactured by Telex Communications, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 31, 1991. Regulation: 8.