LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE

LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE is an FDA 510(k)-cleared medical device (K921656) manufactured by Siemens Hearing Instruments, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 7, 1992. Regulation: 8.