21 CFR 874.3335 — Air-Conduction Hearing Aid Software
Ear, Nose, Throat (EN) · Part 874 Subpart D—Prosthetic Devices · § 874.3335
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| SCR | Air-Conduction Hearing Aid Software | 2 | 3 | SaMD |
Special Controls
SCR — Air-Conduction Hearing Aid Software
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:
De Novo Order DEN230081
