DeviceClearance

Product code SCR— Ear, Nose, Throat

Hearing Aid Feature

Classification name
Air-Conduction Hearing Aid Software
Device class
Class 2
Regulation
21 CFR 874.3335
Advisory panel
Ear, Nose, Throat
Total cleared
5
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SCR under 21 CFR 874.3335, via openFDA

Market context for product code SCR

FDA has cleared 5 devices under product code SCR between 2024 and 2026, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SCR

Recent clearances under product code SCR

Data sourced from openFDA. This site is unofficial and independent of the FDA.