WIDEXLINK IN CLEAR SERIES HEARING AIDS

WIDEXLINK IN CLEAR SERIES HEARING AIDS is an FDA 510(k)-cleared medical device (DEN100025) manufactured by Office Research IN Clinical Amplifiction. 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 30, 2011. Regulation: 8.