TRANSEAR BONE CONDUCTION HEARING AID

TRANSEAR BONE CONDUCTION HEARING AID is an FDA 510(k)-cleared medical device (K050653) manufactured by United Hearing Systems, 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 30, 2005. Regulation: 8.