CRESCENT TINNITUS RETAINING SOUND GENERATOR

CRESCENT TINNITUS RETAINING SOUND GENERATOR is an FDA 510(k)-cleared medical device (K030180) 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 September 16, 2003. Regulation: 8.