Austar
41 catalogue numbers from FHW120-W, listed by Austar Hearing Science & Technology (Xiamen) Co., Ltd. men) Co., Ltd., under Hearing Aid, Air-Conduction With Wireless Technology, Prescription. 29 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (17), Fujian (6), Jiangsu (3). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| 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 |
| VTech Communications Ltd | Dongguan | Guangdong | 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 |
| Sonova Hearing (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Shenzhen Yuezhongxing Technology Co., Ltd. | Huizhou | Guangdong | Repacker / relabeller | 10 |
| Hong YU Kang Technology (Guangdong) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Kangfu Medical Equipment Factory | Wenzhou | Zhejiang | Manufacturer | 6 |
Showing 12 of 29. All 29 manufacturers in China registered for Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Record
| Listed by | Austar Hearing Science & Technology (Xiamen) Co., Ltd. men) Co., Ltd. |
|---|---|
| FDA product code | OSM |
| Device type | Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3305 |
| Premarket notification | Exempt |
| Record published | 2024-08-29 |
| Record revised | 2023-12-05 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
| Distribution end date | 2024-08-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FHW120-W | In distribution | |
| FH312-B | In distribution | |
| FHE405-B | Withdrawn | |
| FHE504-B | Withdrawn | |
| FHE407-B | Withdrawn | |
| FH212-B | Withdrawn | |
| FH208-B | Withdrawn | |
| FHE507-B | Withdrawn | |
| FH309-B | Withdrawn | |
| FH204-B | Withdrawn | |
| FH311-B | Withdrawn | |
| FHE404-B | Withdrawn | |
| FH203-B | Withdrawn | |
| FHE510-B | Withdrawn | |
| FH207-B | Withdrawn | |
| FH210-B | Withdrawn | |
| FHE408-B | Withdrawn | |
| FHE508-B | Withdrawn | |
| FHE410-B | Withdrawn | |
| FHE411-B | Withdrawn | |
| FH303-B | Withdrawn | |
| FHE412-B | Withdrawn | |
| FH211-B | Withdrawn | |
| FHE512-B | Withdrawn | |
| FHE403-B | Withdrawn | |
| FHE509-B | Withdrawn | |
| FH310-B | Withdrawn | |
| FHE406-B | Withdrawn | |
| FH305-B | Withdrawn | |
| FH206-B | Withdrawn | |
| FH209-B | Withdrawn | |
| FHE511-B | Withdrawn | |
| FHE503-B | Withdrawn | |
| FH307-B | Withdrawn | |
| FHE409-B | Withdrawn | |
| FHE506-B | Withdrawn | |
| FH306-B | Withdrawn | |
| FH205-B | Withdrawn | |
| FHE505-B | Withdrawn | |
| FH304-B | Withdrawn | |
| FH308-B | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Widex | Widex A/S | 6,599 |
| GN ReSound | GN Hearing A/S | 5,200 |
| Oticon | Oticon A/S | 3,931 |
| GN Hearing | GN Hearing A/S | 3,076 |
| Signia | WS Audiology USA, Inc. | 2,980 |
| Rexton | WS Audiology USA, Inc. | 2,876 |
| Phonak | Phonak, Inc. | 2,406 |
| Beltone | GN Hearing A/S | 2,196 |
| Unitron | Unitron Hearing Division | 1,901 |
| Unitron | Unitron Hearing | 1,745 |
| HHM | Oticon A/S | 1,329 |
| Miracle-Ear | WS Audiology USA, Inc. | 1,211 |
Showing 12 of 619. All products under Hearing Aid, Air-Conduction With Wireless Technology, Prescription
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.