KLW · Class II · 21 CFR 874.3400

FDA Product Code KLW: Masker, Tinnitus

Leading manufacturers include Starkey Laboratories, Inc., Gn Resound A/S and Audifon-USA, Inc..

78
Total
78
Cleared
114d
Avg days
1977
Since
78 devices
25–48 of 78
Cleared Sep 12, 2013
AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S
K130417
Audifon-USA, Inc.
Ear, Nose, Throat · 205d
Cleared May 07, 2013
UNITRON TINNITUS MASKER FEATURE
K130494
Unitron Hearing
Ear, Nose, Throat · 70d
Cleared Feb 11, 2013
PHONAK TINNITUS BALANCE
K123450
Phonak, LLC
Ear, Nose, Throat · 94d
Cleared Oct 31, 2012
MULTIFLEX TINNITUS TECHNOLOGY
K122876
Starkey Laboratories
Ear, Nose, Throat · 42d
Cleared Dec 16, 2011
TINNITUS THERAPY SYSTEM ANM T30 CR
K112752
Anm Adaptive Neuromodulation GmbH
Ear, Nose, Throat · 86d
Cleared Aug 24, 2011
SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM
K111293
Soundcure, Inc.
Ear, Nose, Throat · 110d
Cleared May 05, 2011
IE-ZEN (IN CLEAR SERIES HEARING AID)
K110973
Widex USA
Ear, Nose, Throat · 29d
Cleared May 03, 2011
TINNITUS SOUND GENERATOR MODULE
K110932
Gn Resound A/S
Ear, Nose, Throat · 29d
Cleared Dec 22, 2010
EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE
K093715
Magnatone Hearing Aid Corp. Dba Persona Medical
Ear, Nose, Throat · 386d
Cleared Aug 12, 2009
SWITCH TRT
K091552
Audifon GmbH & Co. KG
Ear, Nose, Throat · 77d
Cleared Feb 19, 2009
JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT
K083488
Audifon-USA, Inc.
Ear, Nose, Throat · 86d
Cleared Jun 27, 2008
ZEN PROGRAM (MIND 440 HEARING AID)
K080955
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 85d
Cleared Mar 13, 2008
TINNITUS SOUND GENERATOR MODULE
K073636
Gn Resound A/S
Ear, Nose, Throat · 78d
Cleared Jul 13, 2007
CUSTOMIZED SOUND THERAPY (CST)
K070599
Tinnitus Otosound Products, LLC
Ear, Nose, Throat · 133d
Cleared Jun 29, 2007
THE INHIBITOR, MODEL 001
K070648
Melmedtronics, Inc.
Ear, Nose, Throat · 113d
Cleared Jun 30, 2006
TRANQUIL TRI-BTE
K061459
General Hearing Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared May 16, 2006
TINNITUS PHASE-OUT
K061111
Tinnitus Control, Inc.
Ear, Nose, Throat · 25d
Cleared Jan 28, 2005
NEUROMONICS TINNITUS TREATMENT
K043274
Neuromonics Pty, Ltd.
Ear, Nose, Throat · 63d
Cleared Jul 01, 2004
REFUGE SOUND GENERATOR
K041302
Micro-Ear Technology, Inc.
Ear, Nose, Throat · 48d
Cleared Sep 17, 2003
CRESCENT TINNITUS RETAINING SOUND GENERATOR
K030180
Starkey Laboratories, Inc.
Ear, Nose, Throat · 243d
Cleared Jul 24, 2003
TINNITUS RX
K031624
Tinnitus Control, Inc.
Ear, Nose, Throat · 62d
Cleared Apr 17, 2003
ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)
K030791
Tinnitech, Ltd.
Ear, Nose, Throat · 36d
Cleared Jul 13, 2002
ULTRAQUIET
K021202
Sound Technique System, LLC
Ear, Nose, Throat · 88d
Cleared May 21, 2002
TST - SUPPRESSOR MODEL #1000
K013827
Neurosim Limited
Ear, Nose, Throat · 183d