SCRClass II

Air-Conduction Hearing Aid Software

21 CFR 874.3335 / Ear, Nose, Throat

SCR is the FDA product code for Air-Conduction Hearing Aid Software, a class II device type, regulated under 21 CFR 874.3335. FDA's definition for this code reads: "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 §...". As of 2026-09-10, FDA records hold 5 510(k) clearances under this code, the most recent dated 2026-07-31, and no recalls.

Classification record

Product code: SCR
Device name: Air-Conduction Hearing Aid Software
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.
Regulation: 21 CFR 874.3335
Device class: Class II
Review panel: Ear, Nose, Throat
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 5
Ingested recalls: 0

Clearances, product code SCR

By decision year

5 clearances under product code SCR with a decision year between 2024 and 2026, 2025 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code SCR by decision year
Year	Clearances
2024	1
2025	2
2026	2

Applicants with the most clearances

Product code SCR

Applicants holding the most 510(k) clearances under product code SCR
Applicant	Clearances
Apple Inc.	1
Luxottica Group S.p.A.	1
Meta Platform Technologies, LLC	1
Samsung Electronics Co., Ltd.	1
Tuned, Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code SCR

Recent recalls

Product code SCR

FDA records show no recalls under product code SCR.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)