Product code SCR

Device name
Air-Conduction Hearing Aid Software
Medical specialty
Ear, Nose, Throat
Device class
2
Regulation number
874.3335
Review panel
EN
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset