GN Hearing

HI,XD961-DRWC,RIE,AGX9,WRM GRY

Registry build 21.09.26
29manufacturers in China registered for this device type
3,076catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code OSM
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

Regulatory record for GN Hearing
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

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 numbers for GN Hearing
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

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer