Panels › Ear, Nose, Throat › Product code KLW · Class 2
Masker, Tinnitus
Regulation 874.3400
2510(k)s in 12 months (78 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KLW
| Company | 510(k)s | Recalls |
|---|---|---|
| Starkey Laboratories | 10 | 0 |
| Audifon GmbH & Co. KG | 4 | 0 |
| GN Hearing A/S | 3 | 0 |
| Gn Resound A/S | 3 | 0 |
| Siemens Hearing Instruments, Inc. | 3 | 0 |
| Audiotrone | 2 | 0 |
| Marpac, Inc. | 2 | 0 |
| Soundcure, Inc. | 2 | 0 |
| Tinnitus Control, Inc. | 2 | 0 |
| Tinnitus Treatment Centers, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 7, 2001 | K011364 | CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) Siemens Hearing Instruments, Inc. | KLW |
| Jun 1, 2001 | K011366 | CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) Siemens Hearing Instruments, Inc. | KLW |
| Apr 26, 2001 | K003559 | TCI (TINNITUS CONTROL INSTRUMENT) Siemens Hearing Instruments, Inc. | KLW |
| May 7, 1999 | K982451 | TTCGHI-T AND TTCTN3-T-T Tinnitus Treatment Centers, Inc. | KLW |
| Jan 25, 1999 | K982432 | PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5- Tinnitus Treatment Centers, Inc. | KLW |
| Jan 21, 1999 | K984243 | TELEX TINNITUS-COMPANION Telex Communications, Inc. | KLW |
| Aug 5, 1998 | K981704 | AUREX-3 Adm Tronics Unltd, Inc. | KLW |
| Jan 20, 1998 | K974501 | DIGITAL TINNITUS MASKING SYSTEM Petroff Audio Technologies | KLW |
| Dec 6, 1996 | K964216 | STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER Starkey Laboratories, Inc. | KLW |
| Nov 26, 1996 | K963995 | STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER Starkey Laboratories, Inc. | KLW |
| Nov 26, 1996 | K963838 | STARKEY TM AIR CONDUCTION TINNITUS MASKER Starkey Laboratories, Inc. | KLW |
| Oct 31, 1994 | K941834 | AUDITORY CASSETTE Ltmlt, Inc. | KLW |
| Jul 6, 1994 | K940567 | MODEL#1550 MARSONA(R) TINNITUS MASKER Marpac, Inc. | KLW |
| Jun 14, 1993 | K924991 | MICRO MASKER Associated Hearing Instruments | KLW |
| Nov 2, 1992 | K922572 | 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR Microbio-Medics, Inc. | KLW |
| Dec 31, 1980 | K802750 | NUVOX BEDSIDE TINNITUS MASKER Hal-Hen Co., Inc. | KLW |
| Oct 10, 1980 | K802234 | BEDSIDE TINNITUS MASKER #1500 Marpac, Inc. | KLW |
| May 8, 1980 | K800702 | TA-641 TINNITUS INSTRUMENT Audiotrone | KLW |
| Apr 29, 1980 | K800784 | MINUET MASKER; JUBILEE MASKER Beltone Electronics Corp. | KLW |
| Apr 10, 1980 | K800701 | T-570 TINNITUS MASKER Audiotrone | KLW |
| Oct 26, 1979 | K791790 | MODEL TM5 BEHIND EAR TINNITUS MASKER Starkey Laboratories, Inc. | KLW |
| Sep 28, 1979 | K791142 | HEARING AID, MODEL MA-1 Starkey Laboratories, Inc. | KLW |
| Jul 3, 1979 | K791071 | MODEL MA3 BEHIND-THE-EAR MASKER/HEARING Starkey Laboratories, Inc. | KLW |
| Feb 12, 1979 | K790190 | TINNITUS MASKERS MODEL S584 Vican Instrument Co. | KLW |
| Nov 3, 1978 | K781798 | TINNITUS MASKER Starkey Laboratories, Inc. | KLW |
| Apr 10, 1978 | K780546 | BEHIND-THE-EAR MASKING AMPLIFIER,735S Danavox, Inc. | KLW |
| Jan 3, 1978 | K771769 | TINNITUS MASKERS, MODELS S564&S574 Vicon Instrument Co. | KLW |
| Jun 28, 1977 | K770938 | TINNITUS AID, MODEL S244 Vicon Instrument Co. | KLW |
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