De Novo · Granted
GrantedHearing Aid Feature (HAF)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apple, Inc. · SCR Air-Conduction Hearing Aid Software
Granted on Sep 12, 2024 as a new device type through De Novo after a 283-day review. 4 later devices descend from it.
- Decided
- Sep 12, 2024
- Review
- 283 days
- Class
- Class II
- Product code
- SCR
- Recalls
- None
4 later devices descend from it, 4 citing it directly.
- This deviceDEN230081 Hearing Aid Feature (HAF)Apple, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK261187 Hearing Aid FeatureSamsung Electronics Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK254044 Hearing assistMeta Platform Technologies, LLC · 2026
- Descendant · cites it directly · 0 of its ownK251208 Tuned Self-Fitting Mobile AppTuned, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK243150 Nuance Audio Hearing Aid SoftwareLuxottica Group S.P.A. · 2025
Most influential descendants
Showing 4 of 4 · See all- K261187Hearing Aid FeatureSamsung Electronics Co., Ltd. · 2026 · cites it directly0descendants
- K254044Hearing assistMeta Platform Technologies, LLC · 2026 · cites it directly0descendants
- K251208Tuned Self-Fitting Mobile AppTuned, Ltd. · 2025 · cites it directly0descendants
- K243150Nuance Audio Hearing Aid SoftwareLuxottica Group S.P.A. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN230081 | Hearing Aid Feature (HAF) | Apple, Inc. | 2024 | — |
| +1 | K261187 | Hearing Aid Feature | Samsung Electronics Co., Ltd. | 2026 | — |
| +1 | K254044 | Hearing assist | Meta Platform Technologies, LLC | 2026 | — |
| +1 | K251208 | Tuned Self-Fitting Mobile App | Tuned, Ltd. | 2025 | — |
| +1 | K243150 | Nuance Audio Hearing Aid Software | Luxottica Group S.P.A. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 2 | 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 SCR? 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 SCR device
- #1 K261187 Hearing Aid Featurescore 11.8 · 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? (4)
4 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, K261187 (Samsung Electronics Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All SCR devicesSCR Air-Conduction Hearing Aid Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SCR
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SCR
Too few SCR 510(k)s in any year since 2007 to give a median.
Recalls per year · SCR
No recall names SCR since 2007.
Adverse event reports per year · SCR
4in 2025
MAUDE reports naming product code SCR, 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 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 4 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Hearing Aid Feature is a software-only mobile medical application that is intended to be used with compatible wearable electronic products. The feature is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The Hearing Aid Feature utilizes a self-fitting strategy and is adjusted by the user to meet their hearing needs without the assistance of a hearing healthcare professional. The device is intended for Over-the-Counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230081 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230081: Hearing Aid Feature (HAF).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230081
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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