GN Hearing
Jabra Enhance Plus,demo,bge,us
2manufacturers in China registered for this device type
17catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Helen of Troy Macao Limited | Macau | Guangdong | Private-label distributor | 11 |
Record
| Listed by | GN Hearing A/S, Denmark |
|---|---|
| FDA product code | QDD |
| Device type | Self-Fitting Air-Conduction Hearing Aid, Prescription |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3325 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-04-04 |
| Record revised | 2025-09-30 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2023-11-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 22017300 | In distribution | |
| 21945791 | In distribution | |
| 22017200 | In distribution | |
| 22244090 | In distribution | |
| 22500400 | In distribution | |
| 22017100 | In distribution | |
| 22244191 | In distribution | |
| 21945590 | In distribution | |
| 21945591 | In distribution | |
| 22244190 | In distribution | |
| 21945790 | In distribution | |
| 22244091 | In distribution | |
| 22500300 | In distribution | |
| 22500500 | In distribution | |
| 22077691 | Withdrawn | |
| 22247191 | Withdrawn | |
| 22077690 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sony | WS Audiology USA, Inc. | 3 |
| Eargo RX | Eargo Inc | 2 |
| Lexie Hearing | Hearx SA | 2 |
| Lexie B1, Powered by Bose | Hearx SA | 1 |
| Lexie B2, Powered by Bose | Hearx SA | 1 |
| Braun | KAZ USA, Inc. | 1 |
| Bose Hear App | Bose Corporation | 1 |
| Bose SoundControl Hearing Aid | Bose Corporation | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213424 | 2022-01-19 |
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.