ITE, ITC, OE(OPEN), HS(HALF SHELL) HEARING AID

ITE, ITC, OE(OPEN), HS(HALF SHELL) HEARING AID is an FDA 510(k)-cleared medical device (K922392) manufactured by A-1 Hearing Aid Lab. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 9, 1992. Regulation: 8.