FDA product code SCR: Air-Conduction Hearing Aid Software
SCR is the FDA product code for air-conduction hearing aid software. It is a Class II device, regulated under 21 CFR 874.3335 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 4 510(k) submissions under SCR, 4 in the last five years, from 4 different applicants. The average 510(k) review took 151 days (median 142); 151 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Air-Conduction Hearing Aid Software |
| Device class | Class II |
| Regulation | 21 CFR 874.3335 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for SCR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 2 | 142 |
| 2026 | 2 | 160 |
Compare with all 510(k) review times · Search every SCR clearance
Top SCR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Samsung Electronics Co., Ltd. | 1 | 2026-07-31 |
| Meta Platform Technologies, LLC | 1 | 2026-07-13 |
| Tuned , Ltd. | 1 | 2025-09-26 |
| Luxottica Group S.P.A. | 1 | 2025-01-31 |
Most recent SCR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261187 | Samsung Electronics Co., Ltd. | Hearing Aid Feature | 2026-07-31 | 112 |
| K254044 | Meta Platform Technologies, LLC | Hearing assist | 2026-07-13 | 208 |
| K251208 | Tuned , Ltd. | Tuned Self-Fitting Mobile App | 2025-09-26 | 161 |
| K243150 | Luxottica Group S.P.A. | Nuance Audio Hearing Aid Software | 2025-01-31 | 123 |
Recalls for SCR devices
openFDA lists no recalls for product code SCR.
Frequently asked questions
What is FDA product code SCR?
SCR is the FDA product code for air-conduction hearing aid software. It is a Class II device, regulated under 21 CFR 874.3335 and reviewed by the Ear, Nose and Throat panel.
What device class is SCR?
Class II, regulation 21 CFR 874.3335. Typical premarket route: 510(k).
How long does a 510(k) take for product code SCR?
Across 4 cleared submissions the average was 151 days from receipt to decision (median 142).
Which companies have the most SCR clearances?
Samsung Electronics Co., Ltd. (1); Meta Platform Technologies, LLC (1); Tuned , Ltd. (1); Luxottica Group S.P.A. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SCR
- Run a recall and safety report across every SCR manufacturer
- Watch product code SCR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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