BHA100 Series Braun Clear Hearing Aid

BHA100 Series Braun Clear Hearing Aid is an FDA 510(k)-cleared medical device (K212609) manufactured by Kaz USA, Inc., A Helen of Troy Company. 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 4, 2022. Regulation: 8.