GN Hearing
HI,XD961-DRWC,RIE,AGX9,WRM GRY
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 | GN Hearing A/S, Denmark |
|---|---|
| FDA product code | OSM |
| Device type | Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3305 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-10-17 |
| Record revised | 2025-09-29 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2025-08-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 23899300 | In distribution | |
| 21432000 | In distribution | |
| 23544874 | In distribution | |
| 23723000 | In distribution | |
| 22503071 | In distribution | |
| 23216375 | In distribution | |
| 23545370 | In distribution | |
| 23545474 | In distribution | |
| 23546875 | In distribution | |
| 22502672 | In distribution | |
| 22420171 | In distribution | |
| 23547571 | In distribution | |
| 23179573 | In distribution | |
| 22943975 | In distribution | |
| 22985970 | In distribution | |
| 23760473 | In distribution | |
| XF7ITE-DWC-HP | In distribution | |
| 23576673 | In distribution | |
| 23216672 | In distribution | |
| 21432400 | In distribution | |
| 23425600 | In distribution | |
| XJ9ITC-DWC-LP | In distribution | |
| 24071200 | In distribution | |
| 22821075 | In distribution | |
| 23366972 | In distribution | |
| 23544575 | In distribution | |
| 23545776 | In distribution | |
| 22975875 | In distribution | |
| 19709500 | In distribution | |
| 23217271 | In distribution | |
| 15477400 | In distribution | |
| 22984100 | In distribution | |
| 21710602 | In distribution | |
| 22821176 | In distribution | |
| 22007205 | In distribution | |
| 19082200 | In distribution | |
| 22019620 | In distribution | |
| PM8ITC-DWC-UP | In distribution | |
| 22503175 | In distribution | |
| 23953800 | In distribution | |
| 22020205 | In distribution | |
| 23546970 | In distribution | |
| 22822670 | In distribution | |
| 18628300 | In distribution | |
| 23546976 | In distribution | |
| 23217275 | In distribution | |
| 23788500 | In distribution | |
| 23547170 | In distribution | |
| 23089000 | In distribution | |
| 22986470 | In distribution | |
| 22503477 | In distribution | |
| 23814900 | In distribution | |
| 23216971 | In distribution | |
| 22007302 | In distribution | |
| 22007420 | In distribution | |
| 23669100 | In distribution | |
| 21710601 | In distribution | |
| 18627700 | In distribution | |
| XJ4ITC-DW-MP | In distribution | |
| 23547172 | In distribution | |
| 22277504 | In distribution | |
| 23576575 | In distribution | |
| 23848300 | In distribution | |
| 23760577 | In distribution | |
| 23789200 | In distribution | |
| 22015875 | In distribution | |
| 23545477 | In distribution | |
| 21655904 | In distribution | |
| 22821677 | In distribution | |
| 22975972 | In distribution | |
| XJ7ITC-DWC-HP | In distribution | |
| EP1ITC-C-HP | In distribution | |
| 23548089 | In distribution | |
| 23216870 | In distribution | |
| 22148176 | In distribution | |
| 22503675 | In distribution | |
| 21432800 | In distribution | |
| 22502570 | In distribution | |
| 23445900 | In distribution | |
| 18655700 | In distribution | |
| 22942500 | In distribution | |
| 23544879 | In distribution | |
| 23545778 | In distribution | |
| 22983300 | In distribution | |
| 23547989 | In distribution | |
| 22161801 | In distribution | |
| 22147776 | In distribution | |
| 22502671 | In distribution | |
| 23216677 | In distribution | |
| 22976177 | In distribution | |
| 18939002 | In distribution | |
| 22982574 | In distribution | |
| 23547372 | In distribution | |
| XD9ITE-DWC-HP | In distribution | |
| 22986072 | In distribution | |
| 22020420 | In distribution | |
| 22147972 | In distribution | |
| 22045300 | In distribution | |
| 22976370 | In distribution | |
| XJ9ITC-DW-MP | In distribution | |
| 23786800 | In distribution | |
| 22985571 | In distribution | |
| 22005820 | In distribution | |
| 22924374 | In distribution | |
| 22976371 | In distribution | |
| 22147773 | In distribution | |
| XJ7ITE-DWC-MP | In distribution | |
| 22019405 | In distribution | |
| 22821076 | In distribution | |
| 23786000 | In distribution | |
| 23749274 | In distribution | |
| 20293400 | In distribution | |
| 22147576 | In distribution | |
| 23546287 | In distribution | |
| 22681175 | In distribution | |
| 22148475 | In distribution | |
| 22850376 | In distribution | |
| 23545072 | In distribution | |
| 23216273 | In distribution | |
| 22019820 | In distribution | |
| 22277371 | In distribution | |
| 23788900 | In distribution | |
| 22956000 | In distribution | |
| 23371800 | In distribution | |
| 22007320 | In distribution | |
| 22147020 | In distribution | |
| 20665200 | In distribution | |
| XC4CIC-W-LP | In distribution | |
| 23546675 | In distribution | |
| 21767300 | In distribution | |
| 23544674 | In distribution | |
| 23545573 | In distribution | |
| 23545273 | In distribution | |
| 23273700 | In distribution | |
| 22822372 | In distribution | |
| 22503377 | In distribution | |
| 23216775 | In distribution | |
| 22268500 | In distribution | |
| XF7ITE-DWC-UP | In distribution | |
| 22420077 | In distribution | |
| 22502275 | In distribution | |
| XD5ITC-DWC-MP | In distribution | |
| 23237400 | In distribution | |
| 23547470 | In distribution | |
| 22502976 | In distribution | |
| 23547987 | In distribution | |
| 22268401 | In distribution | |
| 22420073 | In distribution | |
| 24070900 | In distribution | |
| 21587600 | In distribution | |
| 23760377 | In distribution | |
| 23087400 | In distribution | |
| 22006702 | In distribution | |
| 22019720 | In distribution | |
| 23216474 | In distribution | |
| 21991400 | In distribution | |
| 23760976 | In distribution | |
| 19398600 | In distribution | |
| 23509100 | In distribution | |
| 22015673 | In distribution | |
| 22019920 | In distribution | |
| 22822471 | In distribution | |
| 22943970 | In distribution | |
| 22006620 | In distribution | |
| 18629100 | In distribution | |
| EP2ITC-C-MP | In distribution | |
| 22277608 | In distribution | |
| XJ4ITE-DWC-MP | In distribution | |
| 23544772 | In distribution | |
| 22420075 | In distribution | |
| 23216770 | In distribution | |
| 23216970 | In distribution | |
| 21710608 | In distribution | |
| 22503672 | In distribution | |
| 24294500 | In distribution | |
| 23760276 | In distribution | |
| 23760373 | In distribution | |
| 23148900 | In distribution | |
| 23576675 | In distribution | |
| 22419700 | In distribution | |
| 23217175 | In distribution | |
| 17598200 | In distribution | |
| 22502470 | In distribution | |
| 22942400 | In distribution | |
| 22976472 | In distribution | |
| 23545075 | In distribution | |
| 22975577 | In distribution | |
| 21710704 | In distribution | |
| 22928900 | In distribution | |
| 23756100 | In distribution | |
| 20789100 | In distribution | |
| 23787200 | In distribution | |
| JEC1ITC-C-HP | In distribution | |
| 23545771 | In distribution | |
| 22006608 | In distribution | |
| 22982675 | In distribution | |
| 22147404 | In distribution | |
| 22277604 | In distribution | |
| 22860800 | In distribution | |
| 22020604 | In distribution | |
| 22976372 | In distribution | |
| 23749273 | In distribution | |
| 18655500 | In distribution | |
| 22956600 | In distribution | |
| 23216270 | In distribution | |
| 23667700 | In distribution | |
| 20291700 | In distribution | |
| 22821473 | In distribution | |
| XC3ITE-DW-UP | In distribution | |
| 22986176 | In distribution | |
| 22822176 | In distribution | |
| 22944300 | In distribution | |
| 23546570 | In distribution | |
| 22903700 | In distribution | |
| 23547070 | In distribution | |
| 22503271 | In distribution | |
| 22926500 | In distribution | |
| 18628000 | In distribution | |
| 20993700 | In distribution | |
| 23760277 | In distribution | |
| 23385200 | In distribution | |
| 22975877 | In distribution | |
| 22147220 | In distribution | |
| 23546289 | In distribution | |
| XD7ITC-DWC-UP | In distribution | |
| 18500800 | In distribution | |
| XD5ITC-DWC-HP | In distribution | |
| 23423200 | In distribution | |
| 23752900 | In distribution | |
| 23545171 | In distribution | |
| XF5ITE-DWC-MP | In distribution | |
| 22147102 | In distribution | |
| 23544878 | In distribution | |
| 23216972 | In distribution | |
| 23545274 | In distribution | |
| 23372900 | In distribution | |
| 18627200 | In distribution | |
| 15477500 | In distribution | |
| 22924608 | In distribution | |
| 23216177 | In distribution | |
| 23530600 | In distribution | |
| 22237500 | In distribution | |
| 23936800 | In distribution | |
| 23547276 | In distribution | |
| 22251000 | In distribution | |
| XJ7ITC-DW-HP | In distribution | |
| 15477100 | In distribution | |
| 23532300 | In distribution | |
| 23787000 | In distribution | |
| 22161804 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Bernafon | Bernafon, Inc. | 1,154 |
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.