SCR · Air-Conduction Hearing Aid Software
Ear, Nose, Throat · 21 CFR 874.3335 · Class 2
Overview
| Product Code | SCR |
|---|---|
| Device Name | Air-Conduction Hearing Aid Software |
| Regulation | 21 CFR 874.3335 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
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.
Classification Rationale
Class II (special controls). The device is subject to the general controls of the FD&C Act, including 21 CFR 800.30 (over-the-counter hearing aids) and 21 CFR 801.422 (prescription hearing aids) as applicable, and the identified special controls.
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:
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251208 | Tuned Self-Fitting Mobile App | Tuned , Ltd. | Sep 26, 2025 | SESE |
| K243150 | Nuance Audio Hearing Aid Software | Luxottica Group S.P.A. | Jan 31, 2025 | SESE |
| DEN230081 | Hearing Aid Feature (HAF) | Apple, Inc. | Sep 12, 2024 | DENG |
Top Applicants
- Tuned , Ltd. — 1 clearance
- Luxottica Group S.P.A. — 1 clearance
- Apple, Inc. — 1 clearance
