Beltone

Sw,fsw,bt SOLUSMAX1.1#2,HOTFIX

Registry build 21.09.26
29manufacturers in China registered for this device type
2,196catalogue 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 Beltone
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 2016-12-07
Record revised 2025-09-30 (version 6)

Specifications

Specifications
MRI safety MR Unsafe
Label carries lot or batch number, manufacturing date, serial number
Distribution end date 2024-04-29

Catalogue Numbers

Catalogue numbers for Beltone
Catalogue number Size Status
22486573 In distribution
22357600 In distribution
22366873 In distribution
22174272 In distribution
21192104 In distribution
21196704 In distribution
22366771 In distribution
AMZ6ITC-DW-MP In distribution
22366871 In distribution
22989900 In distribution
23348271 In distribution
22596870 In distribution
AMZ17CIC-W-HP In distribution
21580602 In distribution
AMZ6CIC-W-HP In distribution
IMG17ITE-DWC-UP In distribution
22174171 In distribution
21581505 In distribution
22173273 In distribution
23304974 In distribution
23369776 In distribution
22174274 In distribution
21312109 In distribution
22878770 In distribution
21211905 In distribution
22486872 In distribution
23369575 In distribution
22790470 In distribution
21310909 In distribution
21224202 In distribution
21214211 In distribution
21900700 In distribution
23348475 In distribution
22790071 In distribution
21347004 In distribution
AMZ17CIC-W-MP In distribution
23370475 In distribution
21582604 In distribution
23348578 In distribution
AMZ17MIH-W-UP In distribution
22173773 In distribution
22339872 In distribution
23348074 In distribution
23348272 In distribution
22790275 In distribution
21347005 In distribution
AMZ9ITC-DW-UP In distribution
23369571 In distribution
ILU17ITC-DW-UP In distribution
22833872 In distribution
23348279 In distribution
SER6ITC-DW-HP In distribution
RLY2ITC-DW-MP In distribution
ILU4ITC-DWC-MP In distribution
21972700 In distribution
22486977 In distribution
22486571 In distribution
22486874 In distribution
23304871 In distribution
21580405 In distribution
23348178 In distribution
22789873 In distribution
23347972 In distribution
21582309 In distribution
21582209 In distribution
22366870 In distribution
21580320 In distribution
22174074 In distribution
21231204 In distribution
20648301 In distribution
AMZ9MIH-WT-MP In distribution
22833574 In distribution
22339973 In distribution
21580504 In distribution
20690905 In distribution
21192109 In distribution
ILU6ITC-DW-HP In distribution
AMZ9MIH-WT-UP In distribution
RLY4CIC-W-LP In distribution
21630704 In distribution
SER6ITC-DWC-HP In distribution
22944900 In distribution
22789874 In distribution
22833874 In distribution
21581602 In distribution
22833575 In distribution
21580509 In distribution
21582409 In distribution
21264401 In distribution
IMP17ITE-DWC-HP In distribution
22833570 In distribution
AMZ17ITC-DW-LP In distribution
22833973 In distribution
22366775 In distribution
23369572 In distribution
23369671 In distribution
21226302 In distribution
22173474 In distribution
22878776 In distribution
23369875 In distribution
SER17ITC-DW-MP In distribution
20690902 In distribution
ILU4ITC-DW-UP In distribution
RLY2ITC-DW-UP In distribution
22790371 In distribution
22790472 In distribution
21211804 In distribution
22338276 In distribution
22087804 In distribution
21226404 In distribution
21581304 In distribution
23370477 In distribution
ILU9ITC-DWC-HP In distribution
ILU6ITE-DWC-HP In distribution
21165311 In distribution
21581204 In distribution
22173374 In distribution
21581104 In distribution
21231320 In distribution
21346820 In distribution
22790074 In distribution
21346902 In distribution
21340900 In distribution
21312709 In distribution
RLY3CIC-W-MP In distribution
21192004 In distribution
ILU4ITC-DWC-UP In distribution
20474702 In distribution
23348677 In distribution
22878772 In distribution
20474705 In distribution
23304770 In distribution
22790376 In distribution
22790272 In distribution
23175870 In distribution
21347020 In distribution
22833670 In distribution
21192002 In distribution
22789871 In distribution
IMP6ITE-DWC-HP In distribution
22338275 In distribution
22878775 In distribution
21164705 In distribution
22486975 In distribution
21580802 In distribution
23347976 In distribution
21625700 In distribution
23348479 In distribution
20648101 In distribution
RLY3ITC-DW-MP In distribution
AMZ9ITC-DW-MP In distribution
22789971 In distribution
20410800 In distribution
22789876 In distribution
22174072 In distribution
22790372 In distribution
22833572 In distribution
23348072 In distribution
RLY2ITE-DW-MP In distribution
21655804 In distribution
23369574 In distribution
SER6ITC-DWC-UP In distribution
21231211 In distribution
21231302 In distribution
22833875 In distribution
21630702 In distribution
22486770 In distribution
22366670 In distribution
23348679 In distribution
22834575 In distribution
23348476 In distribution
22878777 In distribution
21580902 In distribution
21580820 In distribution
22339970 In distribution
22174275 In distribution
22366672 In distribution
23370478 In distribution
22366876 In distribution
22834573 In distribution
IMG6ITC-DWC-UP In distribution
21582602 In distribution
IMG17ITC-DWC-UP In distribution
AMZ17MIH-WT-HP In distribution
22486976 In distribution
21580604 In distribution
20735009 In distribution
22486875 In distribution
20691104 In distribution
22495800 In distribution
23175875 In distribution
21582505 In distribution
22790072 In distribution
22789875 In distribution
22853000 In distribution
22173877 In distribution
21582502 In distribution
23088000 In distribution
RLY3CIC-W-HP In distribution
IMP9ITE-DWC-HP In distribution
22833674 In distribution
23175876 In distribution
23348573 In distribution
21580909 In distribution
RLY3CIC-W-LP In distribution
21264201 In distribution
23175872 In distribution
22173470 In distribution
SER6ITC-DW-LP In distribution
21582605 In distribution
21310409 In distribution
22173770 In distribution
20474701 In distribution
IMG9ITE-DWC-UP In distribution
22173373 In distribution
22338271 In distribution
SER9ITC-DWC-LP In distribution
21581120 In distribution
22790475 In distribution
20474704 In distribution
22790070 In distribution
22173777 In distribution
23369771 In distribution
22215409 In distribution
20993400 In distribution
22173670 In distribution
22833976 In distribution
21569600 In distribution
21192108 In distribution
21211809 In distribution
23348373 In distribution
21226405 In distribution
22358800 In distribution
IMP9ITE-DWC-UP In distribution
22486472 In distribution
22173772 In distribution
21192111 In distribution
22790271 In distribution
23304979 In distribution
23085500 In distribution
21194409 In distribution
22486972 In distribution
23348374 In distribution
ILU9ITC-DWC-LP In distribution
22946900 In distribution
21331009 In distribution
23304978 In distribution
23304973 In distribution
AMZ6ITE-DW-UP In distribution
23347978 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
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
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