Hearing Aid Feature
Device Facts
| Record ID | K261187 |
|---|---|
| Device Name | Hearing Aid Feature |
| Applicant | Samsung Electronics Co., Ltd. |
| Product Code | SCR · Ear, Nose, Throat |
| Decision Date | Jul 31, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3335 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Air-conduction hearing aid software is a device that is intended to be used with a compatible wearable hardware platform to compensate for impaired hearing. The software also allows for customization to the user's hearing needs. The Hearing Aid Feature (HAF) is a software-only mobile medical application intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment, utilizing a self-fitting strategy adjusted by the user without the assistance of a hearing healthcare professional.
Special Controls
In combination with the general controls of the FD&C Act, including 21 CFR 800.30 (over-thecounter hearing aids) and 21 CFR 801.422 (prescription hearing aids) as applicable, airconduction hearing aid software is subject to the following special controls:
