CUSTOMIZED SOUND THERAPY (CST)

CUSTOMIZED SOUND THERAPY (CST) is an FDA 510(k)-cleared medical device (K070599) manufactured by Tinnitus Otosound Products, LLC. 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 July 12, 2007. Regulation: 8.