# K243150: Nuance Audio Hearing Aid Software

- Pathway: 510(k) (Traditional)
- Applicant: Luxottica Group S.P.A.
- Decided: Jan 31, 2025 after 123 days
- Product code: SCR (Air-Conduction Hearing Aid Software)
- Device class: 2
- Regulation: 21 CFR 874.3335
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230081 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230081: Hearing Aid Feature (HAF), Apple, Inc. (2024) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K243150
Methodology: https://510kreport.com/methodology