510(k) · Cleared
ClearedNuheara IQbuds 2 PRO Hearing Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuheara Limited · QUH Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Cleared on Oct 30, 2022 as substantially equivalent to DEN180026 (Bose Corporation, 2018) after a 202-day review. Its family tree reaches back 1 generation to 2018. 1 later device descends from it.
- Decided
- Oct 30, 2022
- Review
- 202 days
- Class
- Class II
- Product code
- QUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180026 (2018). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K223911Lumen 155-SFIntricon Corporation · 2023 · cites it directly0descendants
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) | K221064 | Nuheara IQbuds 2 PRO Hearing Aid | Nuheara Limited | 2022 | — |
| +1 | K223911 | Lumen 155-SF | Intricon Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 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 |
|---|---|---|---|
| * | DEN180026 | Bose Hearing AidSummary page 5…Name: Self-fitting Hearing Aid Regulation: 21 CFR §874.3325 Regulatory Class: II Product Code: QUH 3. PREDICATE DEVICE [PER 807.92(a)(3)] Predicate: Bose Hearing Aid – DEN180026 Reference: BHA100 Series Braun® Clear™ Hearing Aid - K212609 4. DEVICE DESCRIPTION [PER 807.92(a)(4)] The Nuheara IQbuds 2 PRO… | 2018 |
| † | K212609 | BHA100 Series Braun Clear Hearing Aid | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223911 | Lumen 155-SF | 2023 | 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 QUH devicesQUH Self-Fitting Air-Conduction Hearing Aid, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 IQbuds 2 PRO 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. No pre-programming or hearing test is necessary. The device is intended for over the counter
sale and use without the assistance of a hearing care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221064 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221064: Nuheara IQbuds 2 PRO Hearing Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221064
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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