510(k) · Cleared
ClearedLumen 155-SF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intricon Corporation · QDD Self-Fitting Air-Conduction Hearing Aid, Prescription
Cleared on Oct 17, 2023 as substantially equivalent to K221064 (Nuheara Limited, 2022) after a 292-day review. Its family tree reaches back 2 generations to 2018.
- Decided
- Oct 17, 2023
- Review
- 292 days
- Class
- Class II
- Product code
- QDD
- 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 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 |
|---|---|---|---|
| * | K221064 | Nuheara IQbuds 2 PRO Hearing AidSummary page 4…Panel: Ear, Nose and Throat Devices 3. PREDICATE AND REFERENCE DEVICES Predicate Device: Nuheara IQbuds™ 2 PRO (K221064) Reference Devices: Bose Sound Control (K211008) Bose De Novo (DEN180026) The predicate… | 2022 |
| † | K211008 | Bose SoundControl Hearing Aids | 2021 |
| † | DEN180026 | Bose Hearing Aid | 2018 |
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 4.1 years on median.
- None of the 2 ancestors has a recall.
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. 2023, 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 Lumen® 155-SF self-fitting, wireless air conduction hearing aids are intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user's hearing needs. The device is intended for over-the-counter sales without the assistance of a hearing health care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223911: Lumen 155-SF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223911
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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