VOICEMODE, ITE, AIR-CONDUCTION HEARING AID

VOICEMODE, ITE, AIR-CONDUCTION HEARING AID is an FDA 510(k)-cleared medical device (K930541) manufactured by Personal Sound Technologies, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 2, 1993. Regulation: 8.