Medline
OTC, Hearing AID, Behind EAR, WT
57manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (33), Fujian (9), Zhejiang (4). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xiamen Newsound Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| 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 |
| Xiamen Melosound Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 4 |
| Zhongshan Great-Ears Electronic Technology Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 3 |
| Eran Technology (Shenzhen)Co., Limited | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Rayson Technology (Huizhou) Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 2 |
| Rusun Medical Co., Ltd. | Yichun | Jiangxi | Manufacturer | 37 |
| Winner Medical Co., Ltd. | Shenzhen | Guangdong | Specification developer | 25 |
| Cofoe Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 22 |
Showing 12 of 57. All 57 manufacturers in China registered for Hearing Aid, Air-Conduction, Over The Counter
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | QUF |
| Device type | Hearing Aid, Air-Conduction, Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 874.3300 |
| Premarket notification | Exempt |
| Record published | 2023-11-28 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 86 to 106 KiloPascal; Handling environment temperature -10 to 40 °C; Special storage condition: Keep Dry, Protect from freezing, Avoid excessive heat; Handling environment humidity 30 to 75 % RH; Storage environment temperature -10 to 55 °C; Storage environment humidity 10 to 90 % RH |
| Packaging | Case of 30 |
| Sizes | Width 10.5 mm; length 33.1 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MDSHEARAIDBK1 | 2 | In distribution | |
| MDSHEARAIDWT1 | Width 10.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tianle | Zhongshan Tianle Hearing Technology Co., Ltd. | 146 |
| Tomore | Tomore Medical (Shenzhen) Co., Ltd. | 70 |
| Tomore | Tomore Healthcare (Dongguan) Co., Ltd. | 65 |
| Austar | Austar Hearing Science & Technology (Xiamen) Co., Ltd. men) Co., Ltd. | 41 |
| Retone | Xiamen Retone Hearing Technology Co., Ltd. | 39 |
| Melosound | Xiamen Melosound Technology Co., Ltd. | 27 |
| Mirasing | Xiamen Mirasing Technology Co., Ltd. | 18 |
| Ceretone | Audicon Corporation | 16 |
| Cofoe | Cofoe Medical Technology Co., Ltd. | 16 |
| RCA | Voxx Accessories Corp. | 15 |
| AcoSound | Hangzhou Acosound Technology Co., Ltd. | 15 |
| RCA | Huizhou Gold Rose Technology Co., Ltd. | 12 |
Showing 12 of 96. All products under Hearing Aid, Air-Conduction, 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.