510(k) · Cleared
ClearedTuned Self-Fitting Mobile App
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tuned, Ltd. · SCR Air-Conduction Hearing Aid Software
Cleared on Sep 26, 2025 as substantially equivalent to DEN230081 (Apple, Inc., 2024) after a 161-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Sep 26, 2025
- Review
- 161 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 deviceK251208 Tuned Self-Fitting Mobile AppTuned, Ltd. · 2025
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) | K251208 | Tuned Self-Fitting Mobile App | Tuned, Ltd. | 2025 | — |
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…gulation No: 21 CFR §874.3335 Class: 2 Review Panel: Ear Nose & Throat 3. PREDICATE DEVICE Apple Hearing Aid Feature (HAF) granted under DEN230081. 4. REFERENCE DEVICE Intrisound™ Tuned Lumen® 155 Hearing Aids cleared under K223848. 5. DEVICE DESCRIPTION The Tuned Self-Fitt… | 2024 |
| † | K223848 | Intrisound™ Tuned Lumen® 155 Hearing Aids | 2023 |
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. 2025, 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 Tuned Self-Fitting Mobile App is a software-only mobile medical application that is intended to be used with compatible wireless air-conduction hearing aids. The feature is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The Tuned Self-Fitting Mobile App 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/K251208 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251208: Tuned Self-Fitting Mobile App.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251208
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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