PHILIPS MODEL S46-O BTE HEARING AID

PHILIPS MODEL S46-O BTE HEARING AID is an FDA 510(k)-cleared medical device (K910744) manufactured by Philips Hearing Instruments Co.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 27, 1991. Regulation: 8.