KLW · Class II · 21 CFR 874.3400

FDA Product Code KLW: Masker, Tinnitus

Leading manufacturers include Starkey Laboratories, Inc., GN Hearing A/S and Gn Resound A/S.

78
Total
78
Cleared
114d
Avg days
1977
Since
78 devices
49–72 of 78
Cleared Apr 05, 2002
HISONIC-TRD TINNITUS RELIEF DEVICE
K013253
Hearing Innovations, Inc.
Ear, Nose, Throat · 189d
Cleared Jun 07, 2001
CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
K011364
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 34d
Cleared Jun 01, 2001
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K011366
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 28d
Cleared Apr 26, 2001
TCI (TINNITUS CONTROL INSTRUMENT)
K003559
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 160d
Cleared May 07, 1999
TTCGHI-T AND TTCTN3-T-T
K982451
Tinnitus Treatment Centers, Inc.
Ear, Nose, Throat · 296d
Cleared Jan 25, 1999
PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5-
K982432
Tinnitus Treatment Centers, Inc.
Ear, Nose, Throat · 196d
Cleared Jan 21, 1999
TELEX TINNITUS-COMPANION
K984243
Telex Communications, Inc.
Ear, Nose, Throat · 55d
Cleared Aug 05, 1998
AUREX-3
K981704
Adm Tronics Unltd, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 20, 1998
DIGITAL TINNITUS MASKING SYSTEM
K974501
Petroff Audio Technologies
Ear, Nose, Throat · 53d
Cleared Dec 06, 1996
STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER
K964216
Starkey Laboratories, Inc.
Ear, Nose, Throat · 45d
Cleared Nov 26, 1996
STARKEY TM AIR CONDUCTION TINNITUS MASKER
K963838
Starkey Laboratories, Inc.
Ear, Nose, Throat · 63d
Cleared Nov 26, 1996
STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER
K963995
Starkey Laboratories, Inc.
Ear, Nose, Throat · 53d
Cleared Apr 29, 1980
MINUET MASKER
K800784
Beltone Electronics Corp.
Ear, Nose, Throat · 21d
Cleared Oct 26, 1979
MODEL TM5 BEHIND EAR TINNITUS MASKER
K791790
Starkey Laboratories, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 28, 1979
HEARING AID, MODEL MA-1
K791142
Starkey Laboratories, Inc.
Ear, Nose, Throat · 102d
Cleared Jul 03, 1979
MODEL MA3 BEHIND-THE-EAR MASKER/HEARING
K791071
Starkey Laboratories, Inc.
Ear, Nose, Throat · 21d
Cleared Nov 03, 1978
TINNITUS MASKER
K781798
Starkey Laboratories, Inc.
Ear, Nose, Throat · 11d
Cleared Apr 10, 1978
BEHIND-THE-EAR MASKING AMPLIFIER,735S
K780546
Danavox, Inc.
Ear, Nose, Throat · 5d