STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER

STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER is an FDA 510(k)-cleared medical device (K964216) manufactured by Starkey Laboratories, 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 December 5, 1996. Regulation: 8.