CUSTOM IN-THE-EAR HEARING AID

CUSTOM IN-THE-EAR HEARING AID is an FDA 510(k)-cleared medical device (K830960) manufactured by Finetone Hearing Instruments. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 29, 1983. Regulation: 8.