SCR

Air-Conduction Hearing Aid Software

Product code

SCR

Device name

Air-Conduction Hearing Aid Software

Device class

Class 2

21 CFR

21 CFR 874.3335

Medical specialty

Ear, Nose, Throat

Marketing pathway

510(K)

510(k) clearances (last 3 years)

5

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification definition

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. Devices in this classification are also subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. This classification does not include software that is used with hardware as part of a hearing-aid device system classified in other regulations, e.g., § 874.3300, § 874.3305, or § 874.3325.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2026-07-31.

3 summaries are archived here for direct download.