510(k) · Cleared
ClearedLexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hearx SA (Pty), Ltd. · QUH Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Cleared on Mar 14, 2023 as substantially equivalent to K212609 (Kaz USA, Inc., A Helen of Troy Company, 2022) after a 161-day review. Its family tree reaches back 3 generations to 2018.
- Decided
- Mar 14, 2023
- Review
- 161 days
- Class
- Class II
- Product code
- QUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN180026 (2018). No later device cites it as a predicate yet.
- Root · 3 generations backDEN180026 Bose Hearing AidBose Corporation · 2018
- 2 generations backK211008 Bose SoundControl Hearing AidsBose Corporation · 2021
- 1 generation backK212609 BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy Company · 2022
- This deviceK223137 Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie ApplicationHearx SA (Pty), Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN180026 | Bose Hearing Aid | Bose Corporation | 2018 | — |
| −2 | K211008 | Bose SoundControl Hearing Aids | Bose Corporation | 2021 | — |
| −1 | K212609 | BHA100 Series Braun Clear Hearing Aid | Kaz USA, Inc., A Helen of Troy Company | 2022 | — |
| 0 (this device) | K223137 | Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application | Hearx SA (Pty), Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K212609 | BHA100 Series Braun Clear Hearing AidSummary page 5…r (21 CFR 874.3325) Regulation Class: Class II Product Code: QUH Assigned K-number: K223137 3. PREDICATE DEVICE Braun® Clear™ Hearing Aid BHA100 Series (K212609) This predicate device has not been subject to a design-related recall. 4. DEVICE DESCRIPTION Per 21 CFR 874.3325 a self-… | 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 5 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K212609.
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. 2023, 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 Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is a self-fitting air-conduction hearing aid,
intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment.
The device is adjusted by the user to meet the user's hearing needs. The device is intended for use without the assistance
of a hearing care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223137: Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223137
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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