# K251208: Tuned Self-Fitting Mobile App

- Pathway: 510(k) (Traditional)
- Applicant: Tuned, Ltd.
- Decided: Sep 26, 2025 after 161 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 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.

Source page: https://510kreport.com/device/K251208
Methodology: https://510kreport.com/methodology