Data / Medical devices / Air-Conduction Hearing Aid Software
Air-Conduction Hearing Aid Software (SCR): 5 FDA-registered makers in 5 countries
5 establishments in 5 countries are registered with the FDA to make Air-Conduction Hearing Aid Software (product code SCR, Class 2, 21 CFR 874.3335). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on July 31, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- SCR
- Device class
- 2
- Regulation
- 874.3335
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| United States | 1 |
| Italy | 1 |
| South Korea | 1 |
| Israel | 1 |
| China | 1 |
Makers of Air-Conduction Hearing Aid Software
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Apple Inc. | Cupertino, CA, United States | Manufacturer | 1 | September 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Luxottica Group S.P.A | Milan Milano, Italy | Manufacturer | 1 | January 31, 2025 | 0 | 0 | 0 | api.fda.gov |
| Samsung Electronics Co., Ltd. Mobile eXperience Business | Suwon-si Gyeonggi, South Korea | Manufacturer | 1 | July 31, 2026 | 0 | 0 | 0 | api.fda.gov |
| Tuned Ltd | Gan Yoshiya Central, Israel | Manufacturer | 1 | September 26, 2025 | 0 | 0 | 0 | api.fda.gov |
| Luxottica Tristar (dong Guan) Optical Co., Ltd. | DONG GUAN CITY Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.