SCR

5 FDA 510(k) clearances · Product code

FDA profile

Official device name

Air-Conduction Hearing Aid Software

Device class

Class II (moderate risk)

Regulation

21 CFR 874.3335

Medical specialty

Ear, Nose, Throat

FDA 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.

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