Oticon

Oticon JET PX 2 ITE FS

Registry build 21.09.26
11manufacturers in China registered for this device type
11catalogue numbers in this listing

Who Else Makes It

Concentrated in Fujian (7), Guangdong (3), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LRB
Manufacturer City Province Registered as Device types
Xiamen Newsound Technology Co., Ltd. Xiamen Fujian Contract manufacturer 7
Austar Hearing Science & Technology (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 5
Xiamen Retone Hearing Technology Co., Ltd. Xiamen Fujian Contract manufacturer 5
GN Resound China, Ltd. Xiamen Fujian Contract manufacturer 7
Xiamen Vienatone Medical Technology Co., Ltd. Xiamen Fujian Manufacturer 5
Jiangsu Betterlife Medical Co., Ltd. Jiangsu Jiangsu Manufacturer 4
Xiamen Melosound Technology Co., Ltd. Xiamen Fujian Contract manufacturer 4
Xiamen Realink Hearing Technology Co., Ltd. Xiamen Fujian Manufacturer 4
Shenzhen Byring Hearing Technology Co., Ltd. Shenzhen Guangdong Manufacturer 3
Shenzhen Zhongde Audio-Technical Co., Ltd. Shenzhen Guangdong Contract manufacturer 3
Zhongshan XIN Hongsheng Technology Co., Ltd. Zhongshan Guangdong Manufacturer 2

Record

Regulatory record for Oticon
Listed by Sbo Hearing A/S
FDA product code LRB
Device type Face Plate Hearing Aid
Device class Class 1
Regulation 21 CFR 874.3300
Record published 2025-02-10

Specifications

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

Catalogue Numbers

Catalogue numbers for Oticon
Catalogue number Size Status
276891 In distribution
271191 In distribution
284181 In distribution
271192 In distribution
271193 In distribution
271194 In distribution
271195 In distribution
271198 In distribution
271196 In distribution
276887 In distribution
276885 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Oticon Oticon A/S 472
Bernafon Bernafon, Inc. 156
GN ReSound GN Hearing A/S 134
Beltone GN Hearing A/S 82
Sonic Sonic Innovations, Inc. 66
Audina Audina Hearing Instruments, Inc. 63
Philips Sbo Hearing A/S 24
Bernafon Sbo Hearing A/S 8
Austar Austar Hearing Science & Technology (Xiamen) Co., Ltd. men) Co., Ltd. 6
Birdsong Sbo Hearing A/S 6
Retone Xiamen Retone Hearing Technology Co., Ltd. 5
Agxo Sbo Hearing A/S 4

Showing 12 of 15. All products under Face Plate Hearing Aid

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