Nuance Audio
19 catalogue numbers from AW5002748, listed by Luxottica Group SPA, Italy, under Air-Conduction Hearing Aid Software. 1 manufacturer in China is registered for this product code.
1manufacturer
19catalogue numbers in this listing
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 | Luxottica Group SPA, Italy |
|---|---|
| FDA product code | SCR |
| Device type | Air-Conduction Hearing Aid Software |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3335 |
| Establishment | Private-label distributor, Manufacturer, Exporter |
| 510(k) | K243150 |
| Record published | 2025-09-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-02-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AW5002748 | In distribution | |
| AW5002448 | In distribution | |
| AW5002948 | In distribution | |
| AW5004556 | In distribution | |
| AW5004956 | In distribution | |
| AW5004656 | In distribution | |
| WAW000001 | In distribution | |
| AW5004356 | In distribution | |
| AW5004456 | In distribution | |
| AW5001954 | In distribution | |
| AW5004756 | In distribution | |
| AW5002648 | In distribution | |
| AW5001554 | In distribution | |
| AW5001754 | In distribution | |
| AW5001454 | In distribution | |
| AW5002548 | In distribution | |
| AW5002348 | In distribution | |
| AW5001354 | Withdrawn | |
| AW5001654 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hearing Aid Feature 2.0 (HAF 2.0) | Apple Inc. | 4 |
| Hearing Aid Feature (HAF) | Apple Inc. | 4 |
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.