SEARS MODEL LI9097 IN-THE-EAR HEARING INSTRUMENT

SEARS MODEL LI9097 IN-THE-EAR HEARING INSTRUMENT is an FDA 510(k)-cleared medical device (K901387) manufactured by Miracle-Ear, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 15, 1990. Regulation: 8.