TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)

TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) is an FDA 510(k)-cleared medical device (K003558) 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 April 23, 2001. Regulation: 8.