510(k) · Cleared
ClearedWSA Self-Fitting Hearing Aid Gen 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wsaud A/S · QUH Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Cleared on Feb 9, 2024 as substantially equivalent to K220403 (Wsaud A/S, 2022) after a 109-day review. Its family tree reaches back 2 generations to 2018.
- Decided
- Feb 9, 2024
- Review
- 109 days
- Class
- Class II
- Product code
- QUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180026 (2018). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 QUH? 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 QUH device
- #1 K254108 Jabra Enhance Select Self-fit (Jabra Enhance…score 11.9 · 2 generations · 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 |
|---|---|---|---|
| * | K220403 | Vibe SF Self-Fitting Hearing AidSummary page 4…id, Over The Counter) Device Classification: Class II 3. Predicate Device: WSAUD A/S’s Vibe SF Self-Fitting Hearing Aid (K220403) 4. Device Description The WSA Self-Fitting Hearing Aid Gen 2 (“SF Gen 2”) is a self-fitting air conduction hearing aid th… | 2022 |
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 6 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All QUH devicesQUH Self-Fitting Air-Conduction Hearing Aid, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QUH
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QUH
161in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QUH
No recall names QUH since 2007.
Adverse event reports per year · QUH
7in 2025
MAUDE reports naming product code QUH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 5 | 161 | 0 | 3 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The WSA Self-Fitting Hearing Aid Gen 2 is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user's hearing needs through software tools. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
The SF-App is intended to support self-fitting and fine-tuning of the hearing aid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233464 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233464: WSA Self-Fitting Hearing Aid Gen 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233464
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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