KLW · Class II · 21 CFR 874.3400

FDA Product Code KLW: Masker, Tinnitus

Leading manufacturers include GN Hearing A/S, Starkey Laboratories, Inc. and Aureliym GmbH.

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

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 →