SCR · Class II · 21 CFR 874.3335

FDA Product Code SCR: Air-conduction Hearing Aid Software

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.

Leading manufacturers include Apple, Inc., Luxottica Group S.P.A. and Tuned , Ltd..

5
Total
4
Cleared
177d
Avg days
2024
Since
Growing category - 4 submissions in the last 2 years vs 1 in the prior period
Review times improving: avg 151d recently vs 283d historically

FDA 510(k) Cleared Air-conduction Hearing Aid Software Devices (Product Code SCR)

5 devices
1–5 of 5
Cleared Jul 31, 2026
Hearing Aid Feature
K261187
Samsung Electronics Co., Ltd.
Ear, Nose, Throat · 112d
Cleared Jul 13, 2026
Hearing assist
K254044
Meta Platform Technologies, LLC
Ear, Nose, Throat · 208d
Cleared Sep 26, 2025
Tuned Self-Fitting Mobile App
K251208
Tuned , Ltd.
Ear, Nose, Throat · 161d
Cleared Jan 31, 2025
Nuance Audio Hearing Aid Software
K243150
Luxottica Group S.P.A.
Ear, Nose, Throat · 123d
Not Cleared Sep 12, 2024
Hearing Aid Feature (HAF)
DEN230081
Apple, Inc.
Ear, Nose, Throat · 283d

About Product Code SCR - Regulatory Context

510(k) Submission Activity

5 total 510(k) submissions under product code SCR since 2024, with 4 receiving FDA clearance (average review time: 177 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - SCR Product Code

Recent submissions under SCR have taken an average of 151 days to reach a decision - down from 283 days historically, suggesting improved FDA processing for this classification.

SCR devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →