Baha 5 Super Power Sound Processor

Baha 5 Super Power Sound Processor is an FDA 510(k)-cleared medical device (K153245) 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 March 1, 2016. Regulation: 8.