# K261187: Hearing Aid Feature

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Electronics Co., Ltd.
- Decided: Jul 31, 2026 after 112 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 Samsung Hearing Aid is an over-the-counter (OTC) software-only, mobile medical application intended to amplify sound for users 18 years or older with perceived mild-to moderate hearing impairment. The device operates on compatible Samsung Galaxy mobile and earbud wearable devices, both off-the-shelf commercial platforms. The user is intended to self-fit the device, including adjusting it to suit their own hearing needs, without assistance from a hearing healthcare professional.

Source page: https://510kreport.com/device/K261187
Methodology: https://510kreport.com/methodology