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Air-Conduction Hearing Aid Software

FDA product code SCR · 4 cleared devices

Class 2 Ear, Nose, Throat
Regulation
21 CFR 874.3335
Review panel
EN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-01-31 – 2026-07-31

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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