# DEN230081: Hearing Aid Feature (HAF)

- Pathway: De Novo (Direct)
- Applicant: Apple, Inc.
- Decided: Sep 12, 2024 after 283 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
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K261187: Hearing Aid Feature (2026), 0 descendants of its own
- K254044: Hearing assist (2026), 0 descendants of its own
- K251208: Tuned Self-Fitting Mobile App (2025), 0 descendants of its own
- K243150: Nuance Audio Hearing Aid Software (2025), 0 descendants of its own

## Indications for use
The Hearing Aid Feature 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 Hearing Aid Feature 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/DEN230081
Methodology: https://510kreport.com/methodology