Tinnitus Masker
510(k) K781798
Tinnitus Masker is a Class II device made by Starkey Laboratories, Inc., cleared under FDA 510(k) K781798 on 3 Nov 1978, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781798 | Date3 Nov 1978 | StatusActive |
Official records
- FDA 510(k) database K781798
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KLW
- Device class
- Class II
- Regulation
- 21 CFR Part 874.3400
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code KLW (Masker, Tinnitus).
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- PILLOW MASKER, C2007M, C2008M, CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5- by Tinnitus Treatment Centers, Inc.
- Philips 294525 by Sbo Hearing A/S
- TRANQUIL TRI-BTE by General Hearing Instruments, Inc.
- BEHIND-THE-EAR MASKING AMPLIFIER, 735S by Danavox, Inc.
- AUREX-3 by ADM TRONICS UNLTD, INC.
- MODEL#1550 MARSONA(R) TINNITUS MASKER by Marpac, Inc.
- HyperSound Tinnitus Module by Turtle Beach Corporation
- IE-ZEN (IN CLEAR SERIES HEARING AID) by Widex USA
- TINNITUS MASKERS MODEL S584 by Vican Instrument Co.