NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE

NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE is an FDA 510(k)-cleared medical device (K897154) manufactured by Nicolet Instrument Corp.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 29, 1990. Regulation: 8.