MODIFIED HEARING AID (IN-THE-EAR)

MODIFIED HEARING AID (IN-THE-EAR) is an FDA 510(k)-cleared medical device (K902487) manufactured by Audio Hearing Aid Service. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 8, 1990. Regulation: 8.