COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT

COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT is an FDA 510(k)-cleared medical device (K131240) manufactured by Cochlear Americas. 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 November 6, 2013. Regulation: 8.