Hearing Aid Feature (HAF)
Hearing Aid Feature AirPods Pro 2 or later Firmware (1.X)
1manufacturer
4catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Luxottica Tristar (Dong Guan) Optical Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Apple Inc., United States |
|---|---|
| FDA product code | SCR |
| Device type | Air-Conduction Hearing Aid Software |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3335 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | DEN230081 |
| Record published | 2024-10-21 |
| Record revised | 2025-09-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Feature version 1.X | In distribution | |
| Feature version 1.X | In distribution | |
| Feature version 1.X | In distribution | |
| Feature version 1.X | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| nuance audio | Luxottica Group SPA | 19 |
| Hearing Aid Feature 2.0 (HAF 2.0) | Apple Inc. | 4 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| DEN230081 | 2024-09-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.