GN Hearing
Jabra Enhance Plus,demo,dgr,us
4manufacturers in China registered for this device type
13catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (2), Fujian (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Luxshare Electronic Technology (Kunshan) Ltd. | Kunshan | Jiangsu | Contract manufacturer | 1 |
| Maintek Computer (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Huizhou Jinghao Medical Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | GN Hearing A/S, Denmark |
|---|---|
| FDA product code | QUH |
| Device type | Self-Fitting Air-Conduction Hearing Aid, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3325 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-03-21 |
| Record revised | 2023-11-03 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 22067690 | In distribution | |
| 22248490 | In distribution | |
| 22067391 | In distribution | |
| 22067490 | In distribution | |
| 21879090 | In distribution | |
| 21398591 | In distribution | |
| 21879091 | In distribution | |
| 22067491 | In distribution | |
| 22067390 | In distribution | |
| 22248491 | In distribution | |
| 21398590 | In distribution | |
| 22247190 | In distribution | |
| 22067691 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Eargo SE | Eargo Inc | 16 |
| Soundwave Hearing | Soundwave Hearing, LLC | 14 |
| Sontro Self-Fitting OTC Hearing Aids | Soundwave Hearing, LLC | 12 |
| Eargo 5 | Eargo Inc | 12 |
| Eargo 8 | Eargo Inc | 11 |
| Lexie Hearing | Hearx SA | 11 |
| Sony | WS Audiology USA, Inc. | 5 |
| Eargo 6 | Eargo Inc | 3 |
| Eargo 7 | Eargo Inc | 3 |
| Sonova Brand (multiple brand) | Sonova AG | 3 |
| Audialnet | Huizhou Jinghao Medical Technology Co., Ltd. | 2 |
| hear.com | WS Audiology USA, Inc. | 2 |
Showing 12 of 28. All products under Self-Fitting Air-Conduction Hearing Aid, Over The Counter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254108 | 2026-06-25 |
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.