510(k) · Cleared
ClearedHearing Aid Feature
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Samsung Electronics Co., Ltd. · SCR Air-Conduction Hearing Aid Software
Cleared on Jul 31, 2026 as substantially equivalent to DEN230081 (Apple, Inc., 2024) after a 112-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Jul 31, 2026
- Review
- 112 days
- Class
- Class II
- Product code
- SCR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230081 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230081 Hearing Aid Feature (HAF)Apple, Inc. · 2024
- This deviceK261187 Hearing Aid FeatureSamsung Electronics Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230081 | Hearing Aid Feature (HAF) | Apple, Inc. | 2024 | — |
| 0 (this device) | K261187 | Hearing Aid Feature | Samsung Electronics Co., Ltd. | 2026 | — |
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 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 K254044 Hearing assistscore 11.7 · 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 |
|---|---|---|---|
| * | DEN230081 | Hearing Aid Feature (HAF)Summary page 5…Hearing Aid Feature Classification: • SCR – air-conduction hearing aid software (21 CFR 874.3335) Predicate Device: • Hearing Aid Feature (DEN230081) Device Description The Samsung Hearing Aid Feature (HAF) is an over-the-counter, software as a medical device (SaMD) that in… | 2024 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate DEN230081.
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. 2026, 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 Samsung Hearing Aid is an over-the-counter (OTC) software-only, mobile medical application intended to amplify sound for users 18 years or older with perceived mild-to moderate hearing impairment.
The device operates on compatible Samsung Galaxy mobile and earbud wearable devices, both off-the-shelf commercial platforms. The user is intended to self-fit the device, including adjusting it to suit their own hearing needs, without assistance from a hearing healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261187: Hearing Aid Feature.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261187
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026