510(k) · Cleared
ClearedNuance Audio Hearing Aid Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luxottica Group S.P.A. · SCR Air-Conduction Hearing Aid Software
Cleared on Jan 31, 2025 as substantially equivalent to DEN230081 (Apple, Inc., 2024) after a 123-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Jan 31, 2025
- Review
- 123 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 deviceK243150 Nuance Audio Hearing Aid SoftwareLuxottica Group S.P.A. · 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) | K243150 | Nuance Audio Hearing Aid Software | Luxottica Group S.P.A. | 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…ftware Regulation: 21 CFR §874.3335 Regulatory Class: II Product Code: SCR 2. PREDICATE DEVICE [PER 807.92(a)(3)] Predicate: Apple Hearing Aid Feature (HAF) DEN230081 This predicate has not been subject to a design-related recall. 3. DEVICE DESCRIPTION [PER 807.92(a)(4)] The Nuance Audio… | 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. 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 Nuance Audio Hearing Aid Software 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 software utilizes a preset 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243150: Nuance Audio Hearing Aid Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243150
Report an extraction error
Are you the manufacturer?
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