510(k) · Cleared
ClearedBHA100 Series Braun Clear Hearing Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kaz USA, Inc., A Helen of Troy Company · QDD Self-Fitting Air-Conduction Hearing Aid, Prescription
Cleared on Jan 5, 2022 as substantially equivalent to K211008 (Bose Corporation, 2021) after a 141-day review. Its family tree reaches back 2 generations to 2018. 2 later devices descend from it.
- Decided
- Jan 5, 2022
- Review
- 141 days
- Class
- Class II
- Product code
- QDD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180026 (2018). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN180026 Bose Hearing AidBose Corporation · 2018
- 1 generation backK211008 Bose SoundControl Hearing AidsBose Corporation · 2021
- This deviceK212609 BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy Company · 2022
- Descendant · cites it directly · 0 of its ownK223848 Intrisound™ Tuned Lumen® 155 Hearing AidsTuned, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK223137 Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie ApplicationHearx SA (Pty), Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN180026 | Bose Hearing Aid | Bose Corporation | 2018 | — |
| −1 | K211008 | Bose SoundControl Hearing Aids | Bose Corporation | 2021 | — |
| 0 (this device) | K212609 | BHA100 Series Braun Clear Hearing Aid | Kaz USA, Inc., A Helen of Troy Company | 2022 | — |
| +1 | K223848 | Intrisound™ Tuned Lumen® 155 Hearing Aids | Tuned, Ltd. | 2023 | — |
| +1 | K223137 | Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application | Hearx SA (Pty), Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 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 QDD? 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 QDD device
- #1 K211008 Bose SoundControl Hearing Aidsscore 19.3 · 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 |
|---|---|---|---|
| * | K211008 | Bose SoundControl Hearing AidsSummary page 4…Fitting Air-Conduction Hearing Aid Regulatory Class: Class II Product Code: QDD 510(k) number: K212609 III. PREDICATE DEVICE Bose SoundControl™ Hearing Aids – 510(k) # K211008 IV. REFERENCE DEVICE iHearTest – 510(k) # K151025 V. DEVICE DESCRIPTION The BHA100 Series Braun® Clear™ Hearing Aid is a… | 2021 |
| † | K151025 | iHearTest | 2015 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K223848 (Tuned, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K211008.
How does its category compare?
All QDD devicesQDD Self-Fitting Air-Conduction Hearing Aid, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QDD
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QDD
162in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QDD
No recall names QDD since 2007.
Adverse event reports per year · QDD
2in 2024
MAUDE reports naming product code QDD, 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 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 4 | 162 | 0 | 1 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BHA100 Series Braun® Clear™ Hearing Aid 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. It is adjusted by the user to meet the user's hearing needs. The device is intended for direct-to-consumer sale and use without the assistance of a hearing health care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212609: BHA100 Series Braun Clear Hearing Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212609
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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