KLW · Class II · 21 CFR 874.3400

FDA Product Code KLW: Masker, Tinnitus

Leading manufacturers include Starkey Laboratories, Inc., Siemens Hearing Instruments, Inc. and GN Hearing A/S.

77
Total
77
Cleared
113d
Avg days
1977
Since
Declining activity - 1 submissions in the last 2 years vs 4 in the prior period
Consistent review times: 105d avg (recent)

FDA 510(k) Cleared Masker, Tinnitus Devices (Product Code KLW)

77 devices
1–24 of 77
Cleared Feb 27, 2024
Peace N Quiet (0.7.0)
K233435
Pnq Health
Ear, Nose, Throat · 137d
Cleared Jun 30, 2023
Tinearity G1 (6103)
K223694
Duearity AB
Ear, Nose, Throat · 203d
Cleared Feb 01, 2023
Tinnitogram Signal Generator
K221168
Goldenear Company, Inc.
Ear, Nose, Throat · 285d
Cleared Jan 04, 2023
SilentCloud
K221125
Aureliym GmbH
Ear, Nose, Throat · 261d
Cleared Jun 19, 2020
Multiflex Tinnitus Technology
K201370
Starkey Laboratories, Inc.
Ear, Nose, Throat · 28d
Cleared Feb 20, 2020
Tinnitus Sound Generator Module
K193303
GN Hearing A/S
Ear, Nose, Throat · 83d
Cleared Nov 30, 2018
Tinnitus Sound Generator Module
K180495
GN Hearing A/S
Ear, Nose, Throat · 277d
Cleared Jul 13, 2018
Tinnitus Sound Generator Module
K181586
GN Hearing A/S
Ear, Nose, Throat · 28d
Cleared Jun 27, 2008
ZEN PROGRAM (MIND 440 HEARING AID)
K080955
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 85d
Cleared Sep 17, 2003
CRESCENT TINNITUS RETAINING SOUND GENERATOR
K030180
Starkey Laboratories, Inc.
Ear, Nose, Throat · 243d
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 Jan 21, 1999
TELEX TINNITUS-COMPANION
K984243
Telex Communications, Inc.
Ear, Nose, Throat · 55d
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

About Product Code KLW - Regulatory Context

510(k) Submission Activity

77 total 510(k) submissions under product code KLW since 1977, with 77 receiving FDA clearance (average review time: 113 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - KLW Product Code

FDA review times for KLW submissions have been consistent, averaging 105 days recently vs 113 days historically.

KLW devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →