Widex

Widex EVOKE RIC is a receiver-in-canal hearing-aid family. In this design, the case sits behind the ear and connects by a thin wire to a receiver placed in the ear, where it delivers…

Registry build 21.09.26

Widex EVOKE RIC is a receiver-in-canal hearing-aid family. In this design, the case sits behind the ear and connects by a thin wire to a receiver placed in the ear, where it delivers amplified sound through the ear piece.

The listed example is an EVOKE RIC 312D ERB2D in the ZPower rechargeable configuration. Widex offers different receiver and ear-set arrangements across its EVOKE models, allowing the sound outlet and ear interface to be configured for the selected hearing aid.

Listed Item

WIDEX EVOKE ERB2D (Mediterranean turquise ) 110, Telecoil, RC coil, Zpower, RIC 312 D

Example Configuration

The RIC layout separates the behind-the-ear case from the receiver, which is positioned in the ear. Widex documents multiple receiver, ear-set and application options within the EVOKE line.

For the listed ERB2D example, the supplied item identity specifies a ZPower rechargeable configuration. Battery or charging arrangements vary across models in the broader family.

29manufacturers in China registered for this device type
6,599catalogue 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 Widex
Listed by Widex 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 2018-04-20
Record revised 2023-11-03 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number
Storage Storage environment temperature -20 to 55 °C; Storage environment humidity 10 to 95 % RH; Handling environment temperature 0 to 50 °C

Catalogue Numbers

Catalogue numbers for Widex
Catalogue number Size Status
E-IP In distribution
EVOKE ERB0 330 In distribution
ERB2D In distribution
MBB2 In distribution
U-IP In distribution
D-CIC In distribution
E-F2 In distribution
MRR2D In distribution
ERB0 In distribution
M-IM In distribution
E-FS In distribution
ENJOY EBB3D 440 In distribution
ALLURE ARRD1 110 In distribution
ENJOY EBB3D 100 In distribution
MRB2D In distribution
E-FP In distribution
ERB2D In distribution
E-F2 In distribution
EBB3D In distribution
D-FA P In distribution
C3-m-CB In distribution
B-F2 In distribution
MRR2D 440 In distribution
U-FS In distribution
ENJOY E-FS 220 In distribution
U-IP In distribution
D-CIC In distribution
E-FS In distribution
U-FS In distribution
ERB2D In distribution
M-CIC 220 In distribution
D-FA In distribution
ENJOY E-FM In distribution
E-FA In distribution
MAGNIFY MBR3D M10 In distribution
ALLURE ARRD1 220 In distribution
E-FS In distribution
D-9 In distribution
C4-PA In distribution
E-FA In distribution
E-F2 In distribution
MBB3D In distribution
MRB2D 440 In distribution
E-F2 In distribution
U-FS In distribution
EBB3D In distribution
MRR2D In distribution
D-FS In distribution
E-IM In distribution
EVOKE ERB0 440 In distribution
E-F2 In distribution
EVOKE ERB0 330 In distribution
D-CIC In distribution
U-XP In distribution
E-CIC In distribution
U-CIC-M In distribution
MBB3D 30 In distribution
E-FM In distribution
U-CIC-M In distribution
U-CIC In distribution
E-XP In distribution
MOMENT MRB0 220 In distribution
MRB2D In distribution
M-IP In distribution
E-FM In distribution
C3-m-CB In distribution
D-FA In distribution
D-FA In distribution
ENJOY E-FP 110 In distribution
CROS-FS BTE In distribution
U-FM In distribution
MBB3D 30 In distribution
ALLURE ARRD2 220 In distribution
E-F2 In distribution
C3-m In distribution
D-CIC-M In distribution
E-FA In distribution
E-F2 In distribution
M-XP 110 In distribution
B-F2 In distribution
MRR2D In distribution
MBB3D 50 In distribution
MAGNIFY MBR3D In distribution
MAGNIFY MRR2D M05 DEMO In distribution
U-CIC In distribution
M-CIC In distribution
E-FM In distribution
C4-m-CB In distribution
D-CIC In distribution
B-F2 In distribution
MRB0 100 In distribution
M-CIC M 100 In distribution
E-FP In distribution
C2-FS In distribution
D-PA In distribution
D-FA In distribution
UNIQUE U-PA 220 In distribution
U-IP In distribution
ERB2D In distribution
M-IM 110 In distribution
M-CIC 330 In distribution
U-FA In distribution
E-FS In distribution
ENJOY E-CIC In distribution
M-CIC In distribution
MBB3D 50 In distribution
U-FA In distribution
U-CIC In distribution
D-FA P In distribution
U-FS In distribution
ENJOY E-F2 In distribution
ENJOY E-CIC 110 In distribution
C3-PA In distribution
C4-PA In distribution
UNIQUE U-PA 220 In distribution
D-CIC-M In distribution
E-IP In distribution
E-XP In distribution
ENJOY E-F2 100 In distribution
MRB2D In distribution
MBB3D 100 In distribution
M3-m In distribution
M2-19 In distribution
MRB0 110 In distribution
MBB2 220 In distribution
E-F2 In distribution
UNIQUE U-FP 30 In distribution
U-PA In distribution
U-CIC-M In distribution
E-FM In distribution
D-FA P In distribution
MBB3D 110 In distribution
EBB3D In distribution
ENJOY E-FA 330 In distribution
ENJOY E-FM 110 In distribution
MBB2 330 In distribution
M-XP In distribution
EVOKE E-F2 110 In distribution
UNIQUE U-FS 100 In distribution
KIT MOMENT MRRLD In distribution
MRB2D In distribution
E-CIC In distribution
EVOKE E-F2 110 In distribution
E-FA In distribution
EBB3D In distribution
ENJOY E-FS 220 In distribution
MRR2D In distribution
MRB2D In distribution
KIT MOMENT MRRLD 440 In distribution
M3-CIC In distribution
EVOKE E-F2 110 In distribution
E-PA In distribution
MRB2D 100 In distribution
UNIQUE U-FM 30 In distribution
E-F2 In distribution
E-FS In distribution
U-PA In distribution
MBB2 50 In distribution
MAGNIFY MRR2D M05 In distribution
ENJOY E-FS In distribution
E-PA In distribution
E-FS In distribution
ENJOY EBB3D 330 In distribution
CROS-FS BTE In distribution
E-FA In distribution
E-FS In distribution
MOMENT MRRLD 110 In distribution
UNIQUE U-FA 50 In distribution
MOMENT MBR3D 330 In distribution
ALLURE ABRD1 In distribution
E-FS In distribution
UNIQUE U-FA 100 In distribution
D-CIC-M In distribution
E-PA In distribution
C3-9 In distribution
E-FA In distribution
E-F2 In distribution
U-FS In distribution
U-IM In distribution
MBB3D 30 In distribution
EVOKE E-F2 330 In distribution
ENJOY E-FP 30 In distribution
M3-m CB In distribution
M2-CIC In distribution
UNIQUE U-FS 100 In distribution
ENJOY E-FM 50 In distribution
U-PA In distribution
MRR2D 440 In distribution
ENJOY E-FP 330 In distribution
U-FA In distribution
D-FA P In distribution
U-FP In distribution
E-XP In distribution
U-CIC In distribution
CROS-FS BTE In distribution
UNIQUE U-PA 50 In distribution
EVOKE E-F2 In distribution
D-FS In distribution
D-CIC In distribution
UNIQUE U-FM 100 In distribution
D-FA In distribution
ENJOY E-F2 In distribution
D-m CB In distribution
ALLURE ARRD1 In distribution
UNIQUE U-FM 100 In distribution
U-CIC In distribution
M-IP In distribution
E-PA In distribution
ENJOY E-FA 440 In distribution
B-F2 In distribution
MBB3D 30 In distribution
E-FA In distribution
D-CIC In distribution
E-FS In distribution
U-CIC In distribution
E-FA In distribution
E-FP In distribution
ENJOY EBB3D 100 In distribution
E-FM In distribution
MBB3D In distribution
MBB2 440 In distribution
E-FA In distribution
ENJOY E-F2 100 DEMO In distribution
D-CIC In distribution
UNIQUE U-PA 30 In distribution
UNIQUE U-FA 30 In distribution
D-PA In distribution
D-CIC-M In distribution
MBB2 110 In distribution
E-FP In distribution
E-F2 In distribution
E-F2 In distribution
MBB2 220 In distribution
D-FA P In distribution
E-CIC In distribution
E-FS In distribution
EVOKE ERB0 330 In distribution
U-CIC In distribution
MRB0 In distribution
ENJOY E-FS 440 In distribution
ENJOY E-F2 330 In distribution
E-IM In distribution
U-FS In distribution
ENJOY E-FS 440 In distribution
MBB2 440 In distribution
E-CIC In distribution
U-CIC In distribution
M-CIC-M In distribution
U-PA In distribution
D-FS In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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
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