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..
FDA 510(k) Cleared Air-conduction Hearing Aid Software Devices (Product Code SCR)
About Product Code SCR - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code SCR since 2024, with 2 receiving FDA clearance (average review time: 189 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SCR devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →