Cofoe
Behind-the-ear hearing aid, single ear (ABS, wireless charging, charging case size: 76*60*32 (mm) Hearing aid size: 45*36*11(mm)
57manufacturers in China registered for this device type
16catalogue 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 | Cofoe Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | QUF |
| Device type | Hearing Aid, Air-Conduction, Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 874.3300 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-01-10 |
| Record revised | 2026-02-25 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2031-05-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CC330 | In distribution | |
| PTT920 | In distribution | |
| ICS920-B | In distribution | |
| ICS300-B | In distribution | |
| DM379 | In distribution | |
| SPTT920 | In distribution | |
| CC10 | In distribution | |
| CC920 | In distribution | |
| ICS330 | In distribution | |
| PTT330 | In distribution | |
| F300 | In distribution | |
| ZA-01 | In distribution | |
| RC330 | In distribution | |
| ZBC24 | In distribution | |
| CN920 | In distribution | |
| SPTT330 | 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 |
| RCA | Voxx Accessories Corp. | 15 |
| AcoSound | Hangzhou Acosound Technology Co., Ltd. | 15 |
| RCA | Huizhou Gold Rose Technology Co., Ltd. | 12 |
| Jinghao | Huizhou Jinghao Medical Technology Co., Ltd. | 10 |
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.