510(k) · Cleared
ClearedHearing assist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meta Platform Technologies, LLC · SCR Air-Conduction Hearing Aid Software
Cleared on Jul 13, 2026 as substantially equivalent to DEN230081 (Apple, Inc., 2024) after a 208-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Jul 13, 2026
- Review
- 208 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 deviceK254044 Hearing assistMeta Platform Technologies, LLC · 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) | K254044 | Hearing assist | Meta Platform Technologies, LLC | 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 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
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…Regulatory Class: Class II 3. Predicate Device Information Device Name: Apple Hearing Aid Feature (HAF) 510(k) Number: DEN230081 Manufacturer: Apple Inc. The predicate device has not been subject to a design related recall.… | 2024 |
| † | K243150 | Nuance Audio Hearing Aid Software | 2025 |
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?
Hearing assist is an over-the-counter (OTC), self-fitting software as a medical device (SaMD) hearing aid to be used with compatible wearable electronic products. Hearing assist is intended to compensate for perceived mild to moderate hearing loss for users 18 years of age and older. Hearing assist utilizes a self-fitting strategy and is adjusted by the user to meet their hearing needs without the assistance of a hearing healthcare professional.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K254044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254044: Hearing assist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254044
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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