510(k) Report

Devices descending from K011366

7 later devices reach Custom Tci-Combi (Tinnitus Control Instrument Combination) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130937Wave 2G, SoulHansaton Akustik GmbH20140—
+1K080955Zen Program (Mind 440 Hearing Aid)Widex Hearing Aid Co., Inc.20085—
+2K110973IE-Zen (in Clear Series Hearing Aid)Widex USA20114—
+3K123450Phonak Tinnitus BalancePhonak, LLC20133—
+4K133308Tinnitus SoundsupportOticon A/S20142—
+5K151719REVE134Kw Ear Lab, Inc.20151—
+6K221168Tinnitogram Signal GeneratorGoldenear Company, Inc.20230—