Austar
42 catalogue numbers from FH312-B, listed by Austar Hearing Science & Technology (Xiamen) Co., Ltd. men) Co., Ltd., 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 | Austar Hearing Science & Technology (Xiamen) Co., Ltd. men) Co., Ltd. |
|---|---|
| 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 |
| Premarket notification | Exempt |
| Record published | 2024-01-16 |
| Record revised | 2023-12-05 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Over the counter | Yes |
| Label carries | expiry date, serial number |
| Distribution end date | 2025-12-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FH312-B | In distribution | |
| FHW120-W | In distribution | |
| FH211-B | Withdrawn | |
| FH212-B | Withdrawn | |
| FHE412-B | Withdrawn | |
| FH208-B | Withdrawn | |
| FHE403-B | Withdrawn | |
| FH305-B | Withdrawn | |
| FH307-B | Withdrawn | |
| FH206-B | Withdrawn | |
| ATOM X | Withdrawn | |
| FHE407-B | Withdrawn | |
| FHE408-B | Withdrawn | |
| FHE411-B | Withdrawn | |
| FHE410-B | Withdrawn | |
| FHE511-B | Withdrawn | |
| FHE509-B | Withdrawn | |
| FH303-B | Withdrawn | |
| FHE404-B | Withdrawn | |
| FH308-B | Withdrawn | |
| FHE508B | Withdrawn | |
| FH204-B | Withdrawn | |
| FHE505-B | Withdrawn | |
| FH306-B | Withdrawn | |
| FH210-B | Withdrawn | |
| FHE512-B | Withdrawn | |
| FH203-B | Withdrawn | |
| FH310-B | Withdrawn | |
| FH304-B | Withdrawn | |
| FHE406-B | Withdrawn | |
| FHE510-B | Withdrawn | |
| FHE409-B | Withdrawn | |
| FH205-B | Withdrawn | |
| FHE503-B | Withdrawn | |
| FHE506-B | Withdrawn | |
| FH209-B | Withdrawn | |
| FHE507-B | Withdrawn | |
| FH311-B | Withdrawn | |
| FHE405-B | Withdrawn | |
| FH207-B | Withdrawn | |
| FHE504-B | Withdrawn | |
| FH309-B | Withdrawn |
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 |
| 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 |
| NoviMed Hearing | Novidan, Inc. | 8 |
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.