De Novo · Granted
GrantedBose Hearing Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bose Corporation · QDD Self-Fitting Air-Conduction Hearing Aid, Prescription
Granted on Oct 5, 2018 as a new device type through De Novo after a 147-day review. 16 later devices descend from it.
- Decided
- Oct 5, 2018
- Review
- 147 days
- Class
- Class II
- Product code
- QDD
- Recalls
- None
16 later devices descend from it, 5 citing it directly.
- This deviceDEN180026 Bose Hearing AidBose Corporation · 2018
- Descendant · cites it directly · 8 of its ownK211008 Bose SoundControl Hearing AidsBose Corporation · 2021
- Descendant · 2 generations on · 2 of its ownK212609 BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy Company · 2022
- Descendant · cites it directly · 1 of its ownK221064 Nuheara IQbuds 2 PRO Hearing AidNuheara Limited · 2022
- Descendant · cites it directly · 1 of its ownK220403 Vibe SF Self-Fitting Hearing AidWsaud A/S · 2022
- Descendant · cites it directly · 1 of its ownK213424 Jabra Enhance PlusGN Hearing A/S · 2022
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K211008Bose SoundControl Hearing AidsBose Corporation · 2021 · cites it directly8descendants
- K212609BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy Company · 2022 · 2 generations on2descendants
- K221064Nuheara IQbuds 2 PRO Hearing AidNuheara Limited · 2022 · cites it directly1descendant
- K220403Vibe SF Self-Fitting Hearing AidWsaud A/S · 2022 · cites it directly1descendant
- K213424Jabra Enhance PlusGN Hearing A/S · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180026 | Bose Hearing Aid | Bose Corporation | 2018 | — |
| +1 | K211008 | Bose SoundControl Hearing Aids | Bose Corporation | 2021 | — |
| +2 | K212609 | BHA100 Series Braun Clear Hearing Aid | Kaz USA, Inc., A Helen of Troy Company | 2022 | — |
| +1 | K221064 | Nuheara IQbuds 2 PRO Hearing Aid | Nuheara Limited | 2022 | — |
| +1 | K220403 | Vibe SF Self-Fitting Hearing Aid | Wsaud A/S | 2022 | — |
| +1 | K213424 | Jabra Enhance Plus | GN Hearing A/S | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (16)
See all 165 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?
- Of its descendants, K211008 (Bose Corporation, 2021) has gone furthest, with 8 descendants of its own.
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. 2018, 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 Bose Hearing Aid 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. No pre-programming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180026 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180026: Bose Hearing Aid.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180026
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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