Audina

Audina 10A Stock Intuition 6 W/ VC L

Registry build 21.09.26
45manufacturers in China registered for this device type
144catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (27), Fujian (9), Jiangsu (4). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ESD
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
Guangdong Southvo Medical Technology Co., Ltd. Qingyuan Guangdong Contract manufacturer 6
Huizhou Jinghao Medical Technology Co., Ltd. Huizhou Guangdong Contract manufacturer 5
Austar Hearing Science & Technology (Xiamen) Co., Ltd. Xiamen Fujian 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
Zhongshan Great-Ears Electronic Technology Co., Ltd. Zhongshan Guangdong Contract manufacturer 3
Guangzhou Nuoning Medical Supplies Co., Ltd. Guangzhou Guangdong Contract manufacturer 62
Saferlife Products Co., Ltd. Guangzhou Guangdong Contract manufacturer 58

Showing 12 of 45. All 45 manufacturers in China registered for Hearing Aid, Air-Conduction, Prescription

Record

Regulatory record for Audina
Listed by Audina Hearing Instruments, Inc.
FDA product code ESD
Device type Hearing Aid, Air-Conduction, Prescription
Device class Class 1
Regulation 21 CFR 874.3300
Premarket notification Exempt
Record published 2023-02-01

Specifications

Specifications
MRI safety MR Unsafe
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Audina
Catalogue number Size Status
BTE INTUITION 6 In distribution
FSS ANALOG + In distribution
OTE ARRO 6 In distribution
INSTAFIT I2 ER W/VC R In distribution
RIC ARRO 2 In distribution
10AS SIMPLEX DSP In distribution
312S SIMPLEX DSP In distribution
SUPER 70 INTUITION 2 ER In distribution
10A STOCK DIGITAL R In distribution
FSS INTUITION 6 AD In distribution
BTE OCTANE HP 6 WHEEL In distribution
INSTAFIT SIMPLEX FC /VC L In distribution
10AS INTUITION 4+ In distribution
OTE INTUITION 4 In distribution
AUDINA GOHEAR 4 In distribution
CIC Simplex DSP In distribution
RIC ARRO 12 In distribution
10A STOCK INTUITION I2FC L In distribution
1/2 SHELL INTUITION 2+ In distribution
10A INTUITION 2ER In distribution
FJMM-D75 In distribution
BTE OCTANE HP 12 WHEEL In distribution
AUDINA LEFT GOHEAR-IN 2 In distribution
FJMM-D60 In distribution
1/2SHELL INTUITION 2FC+ In distribution
SUPER 70 INTUITION 4+ In distribution
312S INTUITION 2 ER In distribution
312S INTUITION 4+ In distribution
1/2 SHELL INTUITION 12 AD In distribution
BTE D PROGRAMMABLE + In distribution
312S INTUITION 2 FC+ In distribution
SUPER 60 INTUITION 12 In distribution
CIC SIMPLEX FC In distribution
AUDINA RIGHT GOHEAR-IN 2 In distribution
INSTAFIT SIMPLEX FC /VC R In distribution
SUPER 60 INTUITION 2+ In distribution
OTE ARRO 12 In distribution
SUPER 60 INTUITION 6 In distribution
1/2 SHELL SIMPLEX FC In distribution
OTE ARRO 2 In distribution
10A STOCK INTUITION I2FC R In distribution
SUPER 70 INTUITION 6 In distribution
SUPER 60 INTUITION 4+ In distribution
BTE D2 HIGH POWER In distribution
BTE D275 In distribution
10AS INTUITION 2+ In distribution
SUPER 60 In distribution
SUPER 70 INTUITION 6 AD In distribution
1/2 SHELL SIMPLEX DSP In distribution
SUPER 70 INTUITION 2FC+ In distribution
AUDINA LEFT GOHEAR-IN 3 In distribution
312S SIMPLEX FC In distribution
SUPER 60 SIMPLEX FC In distribution
BTE 478 PROGRAMMABLE + In distribution
RIC ARRO 6 In distribution
BTE INTUITION 2 In distribution
SUPER 60 INTUITION 12AD In distribution
BTE 13D2 In distribution
BTE INTUITION 2FC In distribution
FSS INTUITION 12 AD In distribution
FSS INTUITION 12 In distribution
BTE D6 PROGRAMMABLE In distribution
FJMM-SFC R In distribution
INSTAFIT INTUITION 4+ L In distribution
AUDINA RIGHT GOHEAR-IN 4 In distribution
CUE W/SOFT TOUCH In distribution
10AS INTUITION 6 In distribution
INSTAFIT I2 ER L In distribution
CIC INTUITION 4+ In distribution
INSTAFIT I2 ER R In distribution
AUDINA GOHEAR 2 In distribution
BTE D6 HIGH POWER In distribution
10A STOCK INTUITION 6 W/ VC L In distribution
10A STOCK INTUITION 6 L In distribution
IIC INTUITION 2FC+ In distribution
FJMM-D55 In distribution
10AS INTUITION 12 In distribution
INSTAFIT INTUITION 4+ VC L In distribution
IIC INTUITION 12 In distribution
BTE D2 In distribution
IIC INTUITION 2 ER In distribution
FSS INTUITION 2 FC+ In distribution
FSS INTUITION 4+ In distribution
BTE 478 In distribution
BTE INTUITION 4 In distribution
IIC INTUITION 4+ In distribution
INSTAFIT CUE R In distribution
SUPER 70 SIMPLEX FC In distribution
312S INTUITION 12 In distribution
CIC INTUITION 12 In distribution
IIC INTUITION 6 In distribution
312S INTUITION 12 In distribution
BTE SIMPLEX 2 In distribution
CIC ANALOG + In distribution
INSTAFIT INTUITION 4+ R In distribution
SUPER 60 SIMPLEX In distribution
CIC INTUITION 2FC+ In distribution
BTE SIMPLEX 2 PROGRAM.+ In distribution
OTE ARRO 6 AD In distribution
SUPER 70 INTUITION 12 In distribution
SUPER 60 INTUITION 6 AD In distribution
FJMM-SFC L In distribution
1/2 SHELL INTUITION 4+ In distribution
1/2 SHELL INTUITION 6 In distribution
1/2 SHELL ANALOG+ In distribution
AUDINA LEFT GOHEAR-IN 1 In distribution
INSTAFIT CUE L In distribution
1/2 SHELL INTUITION 12 In distribution
INSTAFIT SIMPLEX FC R In distribution
SUPER 70 INTUITION 12 AD In distribution
BTE OPTI-TRIM In distribution
FSS INTUITION 2 ER In distribution
10A STOCK DIGITAL L In distribution
10A STOCK INTUITION 6 W/ VC R In distribution
SUPER 60 INTUITION 2 ER In distribution
10A STOCK INTUITION 6 R In distribution
312S INTUITION 6 In distribution
AUDINA RIGHT GOHEAR-IN 3 In distribution
BTE OCTANE HP T In distribution
10AS SIMPLEX FC In distribution
AUDINA GOHEAR 1 In distribution
FSS SIMPLEX FC In distribution
BTE Intuition 12 In distribution
CIC INTUITION 2 ER In distribution
FSS INTUITION 2+ In distribution
FSS SIMPLEX DSP In distribution
10A INTUITION 2FC+ In distribution
1/2 SHELL INTUITION 2 ER In distribution
AUDINA GOHEAR 3 In distribution
INSTAFIT INTUITION 4+ VC R In distribution
CIC INTUITION 6 In distribution
CIC INTUITION 2+ In distribution
312S ANALOG + In distribution
AUDINA EZHEAR DIGITAL In distribution
AUDINA LEFT GOHEAR-IN 4 In distribution
SUPER 60 INTUITION 2FC+ In distribution
AUDINA RIGHT GOHEAR-IN 1 In distribution
BTE OCTANE HP 4 WHEEL In distribution
INSTAFIT SIMPLEX FC L In distribution
10AS ANALOG+ In distribution
FSS INTUITION 6 In distribution
INSTAFIT I2 ER W/VC L In distribution
312S INTUITION 2+ In distribution
1/2 SHELL INTUITION 6 AD In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Audio Service WS Audiology USA, Inc. 1,148
Phonak Phonak, Inc. 610
GN ReSound GN Hearing A/S 510
Rexton WS Audiology USA, Inc. 363
GN Hearing GN Hearing A/S 329
Beltone GN Hearing A/S 313
Siemens WS Audiology USA, Inc. 301
Unitron Unitron Hearing 278
Widex Widex A/S 177
Tianle Zhongshan Tianle Hearing Technology Co., Ltd. 146
Newsound Xiamen New Sound Technology Co., Ltd. 142
Biopor® AB Dreve Otoplastik GmbH 133

Showing 12 of 347. All products under Hearing Aid, Air-Conduction, 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