CLEARTONE MODEL-1 & 2 HEARING AIDS

CLEARTONE MODEL-1 & 2 HEARING AIDS is an FDA 510(k)-cleared medical device (K780459) manufactured by Cleartone Custom 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 March 29, 1978. Regulation: 8.