510(k) · Cleared
ClearedPillow Masker, C2007M, C2008M,CE2000, Wonder Ear, Mini Wonder Ear, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5-
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tinnitus Treatment Centers, Inc. · KLW Masker, Tinnitus
Cleared on Jan 25, 1999 as substantially equivalent to K964216 (Starkey Laboratories, Inc., 1996) and 3 other predicates after a 196-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jan 25, 1999
- Review
- 196 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K940667 (1994). 5 ancestors in all, the oldest K791790 (1979). No later device cites it as a predicate yet.
- Root · 2 generations backK940667 Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing AidStarkey Laboratories, Inc. · 1994
- 1 generation backK963838 Starkey TM Air Conduction Tinnitus MaskerStarkey Laboratories, Inc. · 1996
- This deviceK982432 Pillow Masker, C2007M, C2008M,CE2000, Wonder Ear, Mini Wonder Ear…Tinnitus Treatment Centers, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940667 | Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing Aid | Starkey Laboratories, Inc. | 1994 | — |
| −1 | K963838 | Starkey TM Air Conduction Tinnitus Masker | Starkey Laboratories, Inc. | 1996 | — |
| 0 (this device) | K982432 | Pillow Masker, C2007M, C2008M,CE2000, Wonder Ear, Mini Wonder Ear, PT-2SM… | Tinnitus Treatment Centers, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KLW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KLW device
- #1 K260413 Levo Gen 2 Tinnitus Therapy Systemscore 11.8 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964216 | Starkey TM-3, TM-5 High Frequency Tinnitus MaskerSummary page 1…n Number: None Assigned Classification: Class III, Tier 2 Panel: . Ear, Nose and Throat 874.3400 Product Code: 77KLW Performance Standards: Substanfial Equivalence to: K964216 (Starkey TM-3, TM-5 High Frequency Masker) K974501 (Digital Tinnitus Masking System) K963838 (Starkey TM Air Conduction Tinnitus… | 1996 |
| * | K974501 | Digital Tinnitus Masking SystemSummary page 1…Tier 2 Panel: . Ear, Nose and Throat 874.3400 Product Code: 77KLW Performance Standards: Substanfial Equivalence to: K964216 (Starkey TM-3, TM-5 High Frequency Masker) K974501 (Digital Tinnitus Masking System) K963838 (Starkey TM Air Conduction Tinnitus Masker) K791790 (Starkey TM-5 Behind Ear Tinnitus… | 1998 |
| * | K963838 | Starkey TM Air Conduction Tinnitus MaskerSummary page 1…400 Product Code: 77KLW Performance Standards: Substanfial Equivalence to: K964216 (Starkey TM-3, TM-5 High Frequency Masker) K974501 (Digital Tinnitus Masking System) K963838 (Starkey TM Air Conduction Tinnitus Masker) K791790 (Starkey TM-5 Behind Ear Tinnitus Masker) K9774751 (General Hearing Inst. Tr… | 1996 |
| * | K791790 | Model TM5 Behind Ear Tinnitus MaskerSummary page 1…tanfial Equivalence to: K964216 (Starkey TM-3, TM-5 High Frequency Masker) K974501 (Digital Tinnitus Masking System) K963838 (Starkey TM Air Conduction Tinnitus Masker) K791790 (Starkey TM-5 Behind Ear Tinnitus Masker) K9774751 (General Hearing Inst. Tranquil Tinnitus Masker) Description of Devices: Th… | 1979 |
| Kept off the family tree | K977475 | General Hearing Inst. Tranquil Tinnitus Masker Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…High Frequency Masker) K974501 (Digital Tinnitus Masking System) K963838 (Starkey TM Air Conduction Tinnitus Masker) K791790 (Starkey TM-5 Behind Ear Tinnitus Masker) K9774751 (General Hearing Inst. Tranquil Tinnitus Masker) Description of Devices: The tinnitus maskers are broad-band white noise signa… |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K964216.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KLW
261in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLW
No recall names KLW since 2007.
Adverse event reports per year · KLW
4in 2015
MAUDE reports naming product code KLW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 4 | 58 | 0 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 4 | 150 | 0 | 0 |
| 2014 | 4 | 164 | 0 | 0 |
| 2015 | 4 | 107 | 0 | 4 |
| 2016 | 3 | 114 | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 3 | 261 | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
These combination tinnitus masker and hearing aid devices can be used by people who not only have tinnitus but who also have a hearing impairment. These devices will comply with 21 CFR 801.420 and 801.421 and will include additional labeling for hearing aids. The noise is a broad-band white noise signal that can be housed in a variety of In-The-Ear or Behind-The-Ear (hearing aid type) shells. The noise can be used as an adjunct to assist individuals with…
Read the full statement (186 words)
These combination tinnitus masker and hearing aid devices can be used by people who not only have tinnitus but who also have a hearing impairment. These devices will comply with 21 CFR 801.420 and 801.421 and will include additional labeling for hearing aids.
The noise is a broad-band white noise signal that can be housed in a variety of In-The-Ear or Behind-The-Ear (hearing aid type) shells. The noise can be used as an adjunct to assist individuals with tinnitus to learn to refocus their attention away from their tinnitus and towards an alternate sound such as the noise generated from the tinnitus devices. The level of the noise should be adjusted by the individual to a level below their tinnitus so that both the noise and the tinnitus can be heard simultaneously. However, if the individual wishes to completely “mask-out” the tinnitus then the noise could be adjusted so that the noise is louder than the tinnitus. These same tinnitus masking devices can also be used by individuals who desire to mask out ambient environmental noise (e.g. office noise, outside noise, music, and other obtrusive noises).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982432 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982432: Pillow Masker, C2007M, C2008M,CE2000, Wonder Ear, Mini Wonder Ear, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5-.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982432
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026