Audina

Audina Super 70 Intuition 12 AD Module

Registry build 21.09.26
11manufacturers in China registered for this device type
63catalogue 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 Audina
Listed by Audina Hearing Instruments, Inc.
FDA product code LRB
Device type Face Plate Hearing Aid
Device class Class 1
Regulation 21 CFR 874.3300
Premarket notification Exempt
Record published 2023-01-26

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Audina
Catalogue number Size Status
10AS INTUITION 4+ MODULE In distribution
FSS INTUITION 6 MODULE In distribution
IIC INTUITION 4+ MODULE In distribution
FSS INTUITION 12 MODULE In distribution
SUPER 60 SIMPLEX FC MODULE In distribution
312S INTUITION 2+ MODULE In distribution
SUPER 60 INTUITION 4+ MODULE In distribution
FSS INTUITION 2 FC+ MODULE In distribution
SUPER 60 INTUITION 2 ER MODULE In distribution
CIC INTUITION 2 ER MODULE In distribution
FSS SIMPLEX DSP MODULE In distribution
312S INTUITION 4+ MODULE In distribution
10AS INTUITION 2 FC+ MODULE In distribution
SUPER 70 SIMPLEX FC MODULE In distribution
10AS SIMPLEX DSP MODULE In distribution
SUPER 70 INTUITION 12 AD MODULE In distribution
312S SIMPLEX DSP MODULE In distribution
312S INTUITION 6 MODULE In distribution
312S SIMPLEX FC MODULE In distribution
CUE W/SOFT TOUCH MODULE In distribution
IIC INTUITION 2FC+ MODULE In distribution
CIC INTUITION 4+ MODULE In distribution
CIC INTUITION 2 FC+ MODULE In distribution
FSS INTUITION 12 AD MODULE In distribution
10AS INTUITION 2+ MODULE In distribution
FSS INTUITION 4+ MODULE In distribution
SUPER 70 INTUITION 4+ MODULE In distribution
312S INTUITION 12 MODULE In distribution
FSS INTUITION 2+ MODULE In distribution
312S INTUITION 2 FC+ MODULE In distribution
SUPER 70 INTUITION 2FC+ MODULE In distribution
10AS INTUITION 2 ER MODULE In distribution
FSS INTUITION 6 AD MODULE In distribution
SUPER 70 INTUITION 12 MODULE In distribution
SUPER 60 INTUITION 12 AD MODULE In distribution
10AS INTUITION 12 MODULE In distribution
312S INTUITION 2 ER MODULE In distribution
SUPER 70 INTUITION 2 ER MODULE In distribution
SUPER 60 INTUITION 2FC+ MODULE In distribution
FSS ANALOG + MODULE In distribution
FSS SIMPLEX FC MODULE In distribution
SUPER 60 INTUITION 2+ MODULE In distribution
10AS SIMPLEX FC MODULE In distribution
CIC INTUITION 2+ MODULE In distribution
IIC INTUITION 2 ER MODULE In distribution
CIC INTUITION 12 MODULE In distribution
10AS INTUITION 6 MODULE In distribution
CIC ANALOG + MODULE In distribution
CIC INTUITION 6 MODULE In distribution
10AS ANALOG + MODULE In distribution
SUPER 60 SIMPLEX MODULE In distribution
SUPER 60 INTUITION 6 AD MODULE In distribution
SUPER 60 INTUITION 6 MODULE In distribution
IIC INTUITION 6 MODULE In distribution
CIC SIMPLEX FC MODULE In distribution
SUPER 60 ANALOG + MODULE In distribution
IIC INTUITION 12 MODULE In distribution
SUPER 60 INTUITION 12 MODULE In distribution
SUPER 70 INTUITION 6 AD MODULE In distribution
FSS INTUITION 2 ER MODULE In distribution
SUPER 70 INTUITION 6 MODULE In distribution
312S ANALOG + MODULE In distribution
CIC SIMPLEX DSP MODULE 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
Philips Sbo Hearing A/S 24
Oticon Sbo Hearing A/S 11
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