MODEL TM2-BEHIND-THE-EAR TINNITUS

MODEL TM2-BEHIND-THE-EAR TINNITUS is an FDA 510(k)-cleared medical device (K792214) manufactured by Starkey Laboratories, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 26, 1979. Regulation: 8.