CUSTOM IN-THE-EAR AND CANAL HEARING AID

CUSTOM IN-THE-EAR AND CANAL HEARING AID is an FDA 510(k)-cleared medical device (K862754) manufactured by Cochlear Laboratories, Ltd.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 31, 1986. Regulation: 8.