HHM

VN1 B 105, 2.4G NFM Sabe/Msil Demo Viron 1

Registry build 21.09.26
29manufacturers in China registered for this device type
1,329catalogue 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 Oticon 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 Specification developer, Manufacturer
Premarket notification Exempt
Record published 2016-09-19
Record revised 2020-10-06 (version 3)

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries serial number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for HHM
Catalogue number Size Status
132317 In distribution
126110 In distribution
150781 In distribution
119538 In distribution
133403 In distribution
158444 In distribution
133320 In distribution
126109 In distribution
201740 In distribution
150154 In distribution
126469 In distribution
201802 In distribution
148934 In distribution
176119 In distribution
151168 In distribution
119606 In distribution
201757 In distribution
125608 In distribution
108936 In distribution
119546 In distribution
155181 In distribution
151152 In distribution
201046 In distribution
104-24-132-00 In distribution
177208 In distribution
118714 In distribution
201779 In distribution
119540 In distribution
133456 In distribution
158457 In distribution
148979 In distribution
104-39-132-00 In distribution
140264 In distribution
126276 In distribution
132444 In distribution
133372 In distribution
177203 In distribution
151894 In distribution
149081 In distribution
133371 In distribution
103-24-323-00 In distribution
201790 In distribution
104-37-230-00 In distribution
150445 In distribution
119600 In distribution
118508 In distribution
108884 In distribution
201810 In distribution
115293 In distribution
167415 In distribution
133451 In distribution
174877 In distribution
150156 In distribution
104-24-433-00 In distribution
108929 In distribution
150324 In distribution
150147 In distribution
103-37-763-00 In distribution
101427 In distribution
115321 In distribution
108980 In distribution
140246 In distribution
155185 In distribution
151026 In distribution
216019 In distribution
119544 In distribution
151269 In distribution
149086 In distribution
150945 In distribution
133407 In distribution
150741 In distribution
216017 In distribution
140251 In distribution
158466 In distribution
150986 In distribution
103-37-261-00 In distribution
126475 In distribution
149215 In distribution
149226 In distribution
158455 In distribution
132279 In distribution
150814 In distribution
150825 In distribution
201776 In distribution
150233 In distribution
201689 In distribution
201021 In distribution
201737 In distribution
140253 In distribution
126280 In distribution
133453 In distribution
174870 In distribution
132364 In distribution
149359 In distribution
216018 In distribution
214955 In distribution
108150 In distribution
150821 In distribution
125613 In distribution
103-24-321-00 In distribution
132272 In distribution
150399 In distribution
151021 In distribution
150978 In distribution
201026 In distribution
201066 In distribution
119599 In distribution
201007 In distribution
151266 In distribution
201079 In distribution
176069 In distribution
201006 In distribution
150987 In distribution
104-37-130-00 In distribution
179699 In distribution
201679 In distribution
201774 In distribution
103-39-763-00 In distribution
149227 In distribution
103-39-114-00 In distribution
116407 In distribution
150776 In distribution
201743 In distribution
104-39-333-00 In distribution
119493 In distribution
168450 In distribution
176070 In distribution
132326 In distribution
103-24-124-00 In distribution
115323 In distribution
149592 In distribution
104-24-534-00 In distribution
150936 In distribution
201808 In distribution
103-37-023-00 In distribution
104-39-334-00 In distribution
167409 In distribution
108847 In distribution
126267 In distribution
103-37-022-00 In distribution
201010 In distribution
201065 In distribution
103-39-110-00 In distribution
119541 In distribution
132365 In distribution
158441 In distribution
126347 In distribution
118618 In distribution
118631 In distribution
201042 In distribution
151022 In distribution
108979 In distribution
140245 In distribution
149221 In distribution
119598 In distribution
115317 In distribution
104-24-432-00 In distribution
201047 In distribution
201812 In distribution
150210 In distribution
155938 In distribution
103-24-324-00 In distribution
177200 In distribution
108149 In distribution
176118 In distribution
158459 In distribution
103-39-760-00 In distribution
104-24-130-00 In distribution
133495 In distribution
150732 In distribution
176071 In distribution
201039 In distribution
148985 In distribution
201764 In distribution
103-37-029-00 In distribution
119539 In distribution
201054 In distribution
132278 In distribution
101452 In distribution
103-37-269-00 In distribution
155886 In distribution
118620 In distribution
201741 In distribution
216041 In distribution
158454 In distribution
151024 In distribution
158465 In distribution
216039 In distribution
201681 In distribution
176122 In distribution
150779 In distribution
201788 In distribution
101528 In distribution
201767 In distribution
132453 In distribution
148941 In distribution
201773 In distribution
103-39-762-00 In distribution
150734 In distribution
103-37-111-00 In distribution
115292 In distribution
151644 In distribution
118706 In distribution
118719 In distribution
133363 In distribution
150358 In distribution
167420 In distribution
151025 In distribution
150820 In distribution
108934 In distribution
150313 In distribution
155946 In distribution
108842 In distribution
133367 In distribution
201685 In distribution
118498 In distribution
201016 In distribution
177207 In distribution
150236 In distribution
116403 In distribution
103-39-714-00 In distribution
133489 In distribution
201688 In distribution
104-37-131-00 In distribution
207159 In distribution
148943 In distribution
103-37-260-00 In distribution
119481 In distribution
174878 In distribution
132412 In distribution
201762 In distribution
103-37-712-00 In distribution
149218 In distribution
140252 In distribution
118499 In distribution
168448 In distribution
176067 In distribution
201017 In distribution
103-39-111-00 In distribution
151171 In distribution
103-39-713-00 In distribution
118500 In distribution
103-39-764-00 In distribution
118503 In distribution
101536 In distribution
150730 In distribution
101531 In distribution
108147 In distribution
108972 In distribution
215227 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
Beltone GN Hearing A/S 2,196
Unitron Unitron Hearing Division 1,901
Unitron Unitron Hearing 1,745
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