TRANQUIL TRI-BTE

TRANQUIL TRI-BTE is an FDA 510(k)-cleared medical device (K061459) manufactured by General Hearing Instruments, 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 June 29, 2006. Regulation: 8.