510(k) Report

Devices descending from K003558

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260614Tinnitus TherapySivantos GmbH20260—
+1K130937Wave 2G, SoulHansaton Akustik GmbH20140—
+1K123450Phonak Tinnitus BalancePhonak, LLC20133—
+1K091552Switch TRTAudifon GmbH & Co. KG20093—
+1K073636Tinnitus Sound Generator ModuleGn Resound A/S200822—
+2K132965Solace Sound GeneratorsAmplisound Hearing Products & Services20140—
+2K133308Tinnitus SoundsupportOticon A/S20142—
+2K130514Audifon Arriva Cic, IS, IS+, M, S, S+, X TRT, Audifon Vico, Audifon Prado, Audifon Elia…Audifon-USA, Inc.20131—
+2K130417Audifon Sueno Cic, Audifon Sueno S, Audifon Sueno T Cic, Audifon Sueno T SAudifon-USA, Inc.20130—
+2K111293Soundcure Serenade Tinnitus Treatment SystemSoundcure, Inc.20116—
+2K110932Tinnitus Sound Generator ModuleGn Resound A/S201113—
+2K093715Evok 900 Series Hearing Aid/Tinnitus Masker Option DeviceMagnatone Hearing Aid Corp. Dba Persona Medical20100—
+3K171243audifon Tinnitus-ModuleAudiofon USA, Inc.20170—
+3K163094TinniLogic Mobile Tinnitus Management DeviceJiangsu Betterlife Medical Co., Ltd.20170—
+3K161562Sound Options Tinnitus TreatmentSound Options Tinnitus Treatments, Inc.20161—
+3K161331HyperSound Tinnitus ModuleTurtle Beach Corporation20160—
+3K151719REVE134Kw Ear Lab, Inc.20151—
+3K150171Tinnitus Sound Generator ModuleGn Resound A/S20153—
+3K150065SoundCure Serenade Tinnitus Treatment SystemSoundcure, Inc.20152—
+3K140845Levo Tinnitus Masking Software DeviceOtoharmonics Corp20141—
+3K130494Unitron Tinnitus Masker FeatureUnitron Hearing20131—
+3K122876Multiflex Tinnitus TechnologyStarkey Laboratories20121—
+4K233435Peace N Quiet (0.7.0)Pnq Health20240—
+4K221168Tinnitogram Signal GeneratorGoldenear Company, Inc.20230—
+4K201370Multiflex Tinnitus TechnologyStarkey Laboratories, Inc.20200—
+4K181586Tinnitus Sound Generator ModuleGN Hearing A/S20182—
+4K150014SerenitySanuthera, Inc.20150—
+5K180495Tinnitus Sound Generator ModuleGN Hearing A/S20181—
+6K193303Tinnitus Sound Generator ModuleGN Hearing A/S20200—