# K254044: Hearing assist

- Pathway: 510(k) (Traditional)
- Applicant: Meta Platform Technologies, LLC
- Decided: Jul 13, 2026 after 208 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
Hearing assist is an over-the-counter (OTC), self-fitting software as a medical device (SaMD) hearing aid to be used with compatible wearable electronic products. Hearing assist is intended to compensate for perceived mild to moderate hearing loss for users 18 years of age and older. Hearing assist utilizes a self-fitting strategy and is adjusted by the user to meet their hearing needs without the assistance of a hearing healthcare professional.

Source page: https://510kreport.com/device/K254044
Methodology: https://510kreport.com/methodology