HHM

HHM F500 Minirite T C090 Demo

Registry build 21.09.26
29manufacturers in China registered for this device type
33catalogue 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 HHM
Listed by Sbo Hearing A/S
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 2022-02-09
Record revised 2022-04-21 (version 2)

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries lot or batch number, manufacturing date, serial number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for HHM
Catalogue number Size Status
236763 In distribution
226355 In distribution
230307 In distribution
230300 In distribution
230297 In distribution
230315 In distribution
230295 In distribution
220675 In distribution
278396 In distribution
265982 In distribution
268276 In distribution
200301 In distribution
230303 In distribution
230302 In distribution
230299 In distribution
236827 In distribution
231011 In distribution
230298 In distribution
230305 In distribution
225681 In distribution
230293 In distribution
220341 In distribution
230306 In distribution
230294 In distribution
236825 In distribution
230301 In distribution
230310 In distribution
278451 In distribution
230309 In distribution
230296 In distribution
230308 In distribution
230316 In distribution
230304 In distribution

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
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.

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