Retone
Catalogue number Smart 1604LE, listed by Xiamen Retone Hearing Technology Co., Ltd., China, under Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter. 52 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (33), Fujian (11), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Xiamen Newsound Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Shenzhen Zowee Smart Manufacturing Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Huizhou Jinghao Medical Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 5 |
| Austar Hearing Science & Technology (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 5 |
| Xiamen Retone Hearing Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 5 |
| Hangzhou Acosound Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 4 |
| Minami Medical Technology (Guangdong) Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 4 |
| Living Science Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Hong YU Kang Technology (Guangdong) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
Showing 12 of 52. All 52 manufacturers in China registered for Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
Record
| Listed by | Xiamen Retone Hearing Technology Co., Ltd., China |
|---|---|
| FDA product code | QUG |
| Device type | Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3305 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-01-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Smart 1604LE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tianle | Zhongshan Tianle Hearing Technology Co., Ltd. | 146 |
| GN Hearing | GN Hearing A/S | 82 |
| Tomore | Tomore Medical (Shenzhen) Co., Ltd. | 62 |
| Tomore | Tomore Healthcare (Dongguan) Co., Ltd. | 44 |
| Austar | Austar Hearing Science & Technology (Xiamen) Co., Ltd. men) Co., Ltd. | 42 |
| Lucid® | Hearing LAB Technology, LLC | 36 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | Blue Deer Medical Equipment (Guangdong) Co., Ltd. | 28 |
| Lucid Hearing® | Hearing LAB Technology, LLC | 25 |
| AcoSound | Hangzhou Acosound Technology Co., Ltd. | 18 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | Yeasound (Xiamen) Hearing Technology Co., Ltd. | 15 |
| Jiuyee, Smart Bluetooth Hearing Aid (RIC) | Hunan Jiuyee Medical Technology Co., Ltd. | 12 |
| Cearvol | Shenzhen Cannice Technology Co., Ltd. | 12 |
Showing 12 of 79. All products under Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
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.