510(k) · Cleared
ClearedBose SoundControl Hearing Aids
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
Cleared on May 5, 2021 as substantially equivalent to DEN180026 (Bose Corporation, 2018) after a 30-day review. Its family tree reaches back 1 generation to 2018. 8 later devices descend from it.
- Decided
- May 5, 2021
- Review
- 30 days
- Class
- Class II
- Product code
- QDD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180026 (2018). 8 later devices descend from it, 6 citing it directly.
- Root · 1 generation backDEN180026 Bose Hearing AidBose Corporation · 2018
- This deviceK211008 Bose SoundControl Hearing AidsBose Corporation · 2021
- Descendant · cites it directly · 2 of its ownK212609 BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy Company · 2022
- Descendant · cites it directly · 0 of its ownK233747 Concha Sol Hearing Aids (CL-1001)Concha Labs · 2024
- Descendant · cites it directly · 0 of its ownK231550 Sontro® OTC Hearing Aids (AI)Soundwave Hearing, LLC · 2023
- Descendant · cites it directly · 0 of its ownK221052 Self-Fitting hearing aidsHuizhou Jinghao Medical Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK223848 Intrisound™ Tuned Lumen® 155 Hearing AidsTuned, Ltd. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K212609BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy Company · 2022 · cites it directly2descendants
- K233747Concha Sol Hearing Aids (CL-1001)Concha Labs · 2024 · cites it directly0descendants
- K231550Sontro® OTC Hearing Aids (AI)Soundwave Hearing, LLC · 2023 · cites it directly0descendants
- K221052Self-Fitting hearing aidsHuizhou Jinghao Medical Technology Co., Ltd. · 2023 · cites it directly0descendants
- K223848Intrisound™ Tuned Lumen® 155 Hearing AidsTuned, Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180026 | Bose Hearing Aid | Bose Corporation | 2018 | — |
| 0 (this device) | 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 | — |
| +1 | K233747 | Concha Sol Hearing Aids (CL-1001) | Concha Labs | 2024 | — |
| +1 | K231550 | Sontro® OTC Hearing Aids (AI) | Soundwave Hearing, LLC | 2023 | — |
| +1 | K221052 | Self-Fitting hearing aids | Huizhou Jinghao Medical Technology Co., Ltd. | 2023 | — |
| +2 | K223848 | Intrisound™ Tuned Lumen® 155 Hearing Aids | Tuned, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 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 K212609 BHA100 Series Braun Clear Hearing Aidscore 8.9 · 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 |
|---|---|---|---|
| * | DEN180026 | Bose Hearing AidSummary page 5…ir-Conduction Hearing Aid Regulation Number: 874.3325 Product Code: QDD Classification: Class II Panel: Ear, Nose, and Throat Devices Predicate Device: Bose Hearing Aid (DEN180026) Submitter/510(k) Holder: Bose Corporation Submission Date: April 1, 2021 Device Description: Per 21 CFR 874.3325 a self-… | 2018 |
What descends from it? (8)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212609 | BHA100 Series Braun Clear Hearing Aid | 2022 | 2 |
| K233747 | Concha Sol Hearing Aids (CL-1001) | 2024 | 0 |
| K231550 | Sontro® OTC Hearing Aids (AI) | 2023 | 0 |
| K221052 | Self-Fitting hearing aids | 2023 | 0 |
| K230538 | All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid | 2023 | 0 |
| K221698 | Eargo 5 , Eargo 6 | 2022 | 0 |
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?
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. 2021, 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 SoundControl™ Hearing Aids 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/K211008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211008: Bose SoundControl Hearing Aids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211008
Report an extraction error
Are you the manufacturer?
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