510(k) · Cleared
ClearedHisonic-TRD Tinnitus Relief Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hearing Innovations, Inc. · KLW Masker, Tinnitus
Cleared on Apr 5, 2002 as substantially equivalent to K963838 (Starkey Laboratories, Inc., 1996) and 3 other predicates after a 189-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Apr 5, 2002
- Review
- 189 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K940667 (1994). 5 ancestors in all, the oldest K791790 (1979). 1 later device descends from it, 1 citing it directly.
- 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 deviceK013253 Hisonic-TRD Tinnitus Relief DeviceHearing Innovations, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK070648 The Inhibitor, Model 001Melmedtronics, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K070648The Inhibitor, Model 001Melmedtronics, Inc. · 2007 · cites it directly0descendants
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) | K013253 | Hisonic-TRD Tinnitus Relief Device | Hearing Innovations, Inc. | 2002 | — |
| +1 | K070648 | The Inhibitor, Model 001 | Melmedtronics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K963838 | Starkey TM Air Conduction Tinnitus MaskerSummary page 2…ction Tinnitus Relief Device Classification l‘é'ame Tinhitt!lsi Masker \\\DC - 71717/630 - #919190 ¥1 | 1 : ! : OHOIBOO/HHGOJVGJ ‘ Predicate Devices K9638381 Starkey TM Air Conduction Tinnitus Masker, Starkey Labs K791790 Starkey TM-5 Behind Ear Tinnitus Masker, Starkey Labs K981704 Au… | 1996 |
| * | K791790 | Model TM5 Behind Ear Tinnitus MaskerSummary page 2…Masker \\\DC - 71717/630 - #919190 ¥1 | 1 : ! : OHOIBOO/HHGOJVGJ ‘ Predicate Devices K9638381 Starkey TM Air Conduction Tinnitus Masker, Starkey Labs K791790 Starkey TM-5 Behind Ear Tinnitus Masker, Starkey Labs K981704 Aurex-3 Tinnitus Masker, ADM-Tronics Unlimited, Inc. K951678 HiSon… | 1979 |
| * | K981704 | AUREX-3Summary page 2…OJVGJ ‘ Predicate Devices K9638381 Starkey TM Air Conduction Tinnitus Masker, Starkey Labs K791790 Starkey TM-5 Behind Ear Tinnitus Masker, Starkey Labs K981704 Aurex-3 Tinnitus Masker, ADM-Tronics Unlimited, Inc. K951678 HiSonic Hearing Instrument, Hearing Innovations Incorporated Inten… | 1998 |
| * | K951678 | HI Sonic 2000 Digital Hearing InstrumentSummary page 2…Air Conduction Tinnitus Masker, Starkey Labs K791790 Starkey TM-5 Behind Ear Tinnitus Masker, Starkey Labs K981704 Aurex-3 Tinnitus Masker, ADM-Tronics Unlimited, Inc. K951678 HiSonic Hearing Instrument, Hearing Innovations Incorporated Intended Use The HiSonic-TRD tinnitus masker is a wearable behind-… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070648 | The Inhibitor, Model 001 | 2007 | 0 |
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 8 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K070648 (Melmedtronics, Inc., 2007) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K963838.
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?
The HiSonic-TRD tinnitus masker is a wearable behind-the-ear style ultrasonic, bone conducted broadband noise and/or sweep frequency stimuli noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and is also suitable for tinnitus masking therapy. The HiSonic-TRD 1s intended to be used by those individuals who experience tinnitus, and do not need or desire amplification. The intended…
Read the full statement (118 words)
The HiSonic-TRD tinnitus masker is a wearable behind-the-ear style ultrasonic, bone conducted broadband noise and/or sweep frequency stimuli noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and is also suitable for tinnitus masking therapy. The HiSonic-TRD 1s intended to be used by those individuals who experience tinnitus, and do not need or desire amplification. The intended use of the HiSonic-TRD includes it’s fitting by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis of tinnitus and subsequent rehabilitation therapies. The target population is the adult population over 18 years of age. This product is not intended for use in children under the age of 18.
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/K013253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013253: Hisonic-TRD Tinnitus Relief Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013253
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026