GN ReSound

HI,RT988-DWHC,BTE,DEMO,SPK SIL

Registry build 21.09.26
29manufacturers in China registered for this device type
5,200catalogue 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 ReSound
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 2020-02-07
Record revised 2025-09-29 (version 6)

Specifications

Specifications
MRI safety MR Unsafe
Label carries lot or batch number, manufacturing date, serial number
Distribution end date 2025-07-04

Catalogue Numbers

Catalogue numbers for GN ReSound
Catalogue number Size Status
21213509 In distribution
20686210 In distribution
22176173 In distribution
22788772 In distribution
21495604 In distribution
22485575 In distribution
21197320 In distribution
21419320 In distribution
20648052 In distribution
20993200 In distribution
22175671 In distribution
20413908 In distribution
21435709 In distribution
22060800 In distribution
22176277 In distribution
23370379 In distribution
RE5ITE-DW-HP In distribution
SN5ITC-DWC-MP In distribution
23347478 In distribution
21197309 In distribution
21213818 In distribution
21190402 In distribution
22175873 In distribution
21164514 In distribution
21211632 In distribution
23347674 In distribution
21211514 In distribution
21263709 In distribution
PZ8ITC-DW-UP In distribution
23369270 In distribution
21225902 In distribution
22338170 In distribution
21213806 In distribution
21370002 In distribution
23676300 In distribution
21435511 In distribution
23347374 In distribution
23175777 In distribution
RU9ITE-DWC-UP In distribution
21196429 In distribution
21263705 In distribution
21506809 In distribution
21419305 In distribution
22325776 In distribution
20739001 In distribution
21495820 In distribution
SN7ITE-DWC-MP In distribution
22364777 In distribution
22834773 In distribution
21196405 In distribution
21311102 In distribution
22176476 In distribution
22366471 In distribution
21213850 In distribution
23369278 In distribution
RE7ITC-DWT-HP In distribution
21226700 In distribution
21190404 In distribution
21193901 In distribution
22175874 In distribution
NX9ITC-DW-LP In distribution
21230806 In distribution
23347670 In distribution
23412600 In distribution
21495805 In distribution
22087720 In distribution
22338172 In distribution
23179700 In distribution
23347271 In distribution
21213802 In distribution
23386785 In distribution
SN9ITC-DWC-LP In distribution
21230709 In distribution
21435611 In distribution
21263804 In distribution
21496002 In distribution
20647925 In distribution
21015109 In distribution
22445577 In distribution
22176672 In distribution
21193951 In distribution
21211520 In distribution
21211602 In distribution
22364776 In distribution
22485177 In distribution
22087708 In distribution
20686305 In distribution
22978600 In distribution
22338171 In distribution
RE4CIC-W-HP In distribution
21263650 In distribution
NX9ITE-DWC-HP In distribution
NX7ITC-DWC-UP In distribution
RE4ITE-DW-UP In distribution
22339676 In distribution
23304577 In distribution
20959901 In distribution
20647929 In distribution
22176573 In distribution
23386889 In distribution
PZ8ITC-DW-HP In distribution
22364771 In distribution
21496302 In distribution
23175772 In distribution
22485574 In distribution
21370102 In distribution
22834973 In distribution
23347571 In distribution
23098474 In distribution
21900500 In distribution
23652900 In distribution
20928601 In distribution
21263710 In distribution
23347274 In distribution
23653200 In distribution
23795304 In distribution
22176271 In distribution
22176671 In distribution
21419311 In distribution
23369475 In distribution
SA2ITC-DW-HP In distribution
RT5ITE-DWC-UP In distribution
21193904 In distribution
22834873 In distribution
21225814 In distribution
16987200 In distribution
SN4ITC-DW-HP In distribution
21211509 In distribution
21496408 In distribution
22485373 In distribution
23369477 In distribution
21435608 In distribution
23369371 In distribution
21184814 In distribution
22366375 In distribution
22370800 In distribution
RE7CIC-W-HP In distribution
RE5ITC-DWT-HP In distribution
21184809 In distribution
20686220 In distribution
21263802 In distribution
20686250 In distribution
21213518 In distribution
20686202 In distribution
21213550 In distribution
21190425 In distribution
21190552 In distribution
20648002 In distribution
23347471 In distribution
22596576 In distribution
RU9ITE-DWC-HP In distribution
21227900 In distribution
RE9CIC-W-LP In distribution
NX5ITC-DW-HP In distribution
23386687 In distribution
21197325 In distribution
22835172 In distribution
21193918 In distribution
21230832 In distribution
21263701 In distribution
22485378 In distribution
22495500 In distribution
21193510 In distribution
22176174 In distribution
22485777 In distribution
21496308 In distribution
22788676 In distribution
23483500 In distribution
23347773 In distribution
21213552 In distribution
21495505 In distribution
RE7ITC-DW-HP In distribution
RE7ITE-DW-MP In distribution
23370372 In distribution
22834776 In distribution
23347671 In distribution
21497505 In distribution
21398000 In distribution
SN9ITC-DW-MP In distribution
21496102 In distribution
21230818 In distribution
RE5ITE-DWT-UP In distribution
20647810 In distribution
20413909 In distribution
RE9CIC-W-HP In distribution
23119900 In distribution
22485276 In distribution
21762000 In distribution
22944600 In distribution
21164502 In distribution
SN7ITE-DWC-UP In distribution
21230801 In distribution
20648018 In distribution
20686309 In distribution
21230720 In distribution
21230732 In distribution
23369375 In distribution
KE2ITC-DW-MP In distribution
20647818 In distribution
21230718 In distribution
22445578 In distribution
21496205 In distribution
22495100 In distribution
23347172 In distribution
22060200 In distribution
23369472 In distribution
22338175 In distribution
21190505 In distribution
SN5ITE-DWC-MP In distribution
23347473 In distribution
21213406 In distribution
20686351 In distribution
23386887 In distribution
21312502 In distribution
21227000 In distribution
21225908 In distribution
23304671 In distribution
20648010 In distribution
KE3CIC-W-LP In distribution
22819500 In distribution
21263610 In distribution
SA2ITC-DW-LP In distribution
22598374 In distribution
23653000 In distribution
21184802 In distribution
SN7ITC-DW-LP In distribution
NX7ITC-DWC-HP In distribution
23347573 In distribution
SA3ITC-DWC-MP In distribution
21211601 In distribution
21506909 In distribution
20647820 In distribution
23098470 In distribution
21165009 In distribution
21190532 In distribution
23304575 In distribution
22978700 In distribution
NX9ITC-DWC-MP In distribution
22819100 In distribution
21227800 In distribution
21165018 In distribution
20739420 In distribution
20739401 In distribution
22364775 In distribution
21763000 In distribution
22176176 In distribution
21213514 In distribution
21312302 In distribution
22485174 In distribution
20959908 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
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
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