SOUNDBITE HEARING SYSTEM BY SONITUS

SOUNDBITE HEARING SYSTEM BY SONITUS is an FDA 510(k)-cleared medical device (K100649) manufactured by Sonitus Medical, 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 January 13, 2011. Regulation: 8.