SCR — Air-Conduction Hearing Aid Software Class II
FDA product code SCR covers "Air-Conduction Hearing Aid Software", a Class II medical device regulated under 21 CFR 874.3335. Submissions are reviewed by the Ear, Nose, Throat panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SCR
- Device Class
- Class II
- Regulation Number
- 874.3335
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254044 | meta platform technologies | Hearing assist | July 13, 2026 |
| K251208 | tuned | Tuned Self-Fitting Mobile App | September 26, 2025 |
| K243150 | luxottica group | Nuance Audio Hearing Aid Software | January 31, 2025 |
| DEN230081 | apple | Hearing Aid Feature (HAF) | September 12, 2024 |