510(k) · Cleared
ClearedJump S+ TRT, Jump Cic TRT, Jump S TRT, Jump C TRT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Audifon-USA, Inc. · KLW Masker, Tinnitus
Cleared on Feb 19, 2009 as substantially equivalent to K974751 (General Hearing Instruments, Inc., 1998) after an 86-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Feb 19, 2009
- Review
- 86 days
- Class
- Class II
- Product code
- KLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974751 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK974751 Tranquil Tri-OE, Tranquil Tri-Coe, Tranquil Tri-CicGeneral Hearing Instruments, Inc. · 1998
- This deviceK083488 Jump S+ TRT, Jump Cic TRT, Jump S TRT, Jump C TRTAudifon-USA, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974751 | Tranquil Tri-OE, Tranquil Tri-Coe, Tranquil Tri-Cic | General Hearing Instruments, Inc. | 1998 | — |
| 0 (this device) | K083488 | Jump S+ TRT, Jump Cic TRT, Jump S TRT, Jump C TRT | Audifon-USA, Inc. | 2009 | — |
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? (1)
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 |
|---|---|---|---|
| * | K974751 | Tranquil Tri-OE, Tranquil Tri-Coe, Tranquil Tri-CicSummary page 1…or cymba application. 13. Comparison Information to Predicate Device The jump C TRT is substantially equivalent to the General Hearing Instruments Tranquil Tri OE (K974751). Both products are analog noisier with no amplification. The jump C TRT differs in the housing for cymba application and in an a… | 1998 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K974751.
How does its category compare?
All KLW devicesKLW Masker, Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 jump S TRT is addressed to the adult population with a chronological persistent ringing in the ears (Tinnitus), who do not need or desire amplification. It may be used for masking tinnitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and…
Read the full statement (304 words)
The jump S TRT is addressed to the adult population with a chronological persistent ringing in the ears (Tinnitus), who do not need or desire amplification. It may be used for masking tinnitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and intensity and is applied on the ear.
The jump CIC TRT is addressed to the adult population with a chronological persistent ringing in the ears (Tinnitus), who do not need or desire amplification. It may be used for masking tinnitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and intensity and is applied on the ear.
The jump C TRT is addressed to the adult population with a chronological persistent ringing in the ears (Tinnitus), who do not need or desire amplification. It may be used for masking tinnitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and intensity and is applied on the ear.
The jump S+ TRT is addressed to the adult population with a chronological persistent ringing in the ears (Tinnitus), who do not need or desire amplification. It may be used for masking tinnitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and intensity and is applied on the ear.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083488: Jump S+ TRT, Jump Cic TRT, Jump S TRT, Jump C TRT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083488
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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