Amplifon

Amplifon HA AMPLI-CONNECT R 4 AX 312 DBR Hearing aid

Registry build 21.09.26
29manufacturers in China registered for this device type
361catalogue 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 Amplifon
Listed by WS Audiology USA, Inc., United States
FDA product code OSM
Device type Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Device class Class 2
Regulation 21 CFR 874.3305
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2024-01-17
Record revised 2025-10-14 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries serial number
Distribution end date 2025-11-01

Catalogue Numbers

Catalogue numbers for Amplifon
Catalogue number Size Status
AMPLI-ENERGY R 4 5W R In distribution
ampli-energy B 5MC RUP In distribution
AMPLI-CROS R 5W R In distribution
ampli-power E 4 5w B-RUP In distribution
ampli-charge R-D 1 Portable In distribution
ampli-power E 3 5w B-RP In distribution
ampli-energy B 4MC RUP In distribution
ampli-mini R 2 AX 312 In distribution
ampli-energy B 4MC RP In distribution
AMPLI-ENERGY R 5 5W R In distribution
ampli-connect R 4 AX 312 In distribution
ampli-cros R AX R In distribution
ampli-cros R MC R In distribution
ampli-mini I 5MC 10STD L In distribution
ampli-mini I 5 5w CIC-R In distribution
ampli-connect R 5 AX 312 In distribution
ampli-energy B 2MC R In distribution
ampli-energy B 2MC R In distribution
ampli-energy R 4 5w R-D In distribution
ampli-mini 10 3 5w AS In distribution
ampli-energy B 4MC R In distribution
ampli-energy R 3 5w R-D In distribution
AMPLI-ENERGY R 3 5W R T In distribution
ampli-mini 10S 5 5w AS In distribution
ampli-power E 3 5w B-RP In distribution
ampli-power E 1 5w B-RP In distribution
AMPLI-ENERGY R X 5W R In distribution
ampli-energy R 5 5w R-D In distribution
ampli-energy R 5 AX R In distribution
ampli-energy B 5MC R In distribution
ampli-power E 3 5w B-RUP In distribution
AMPLI-MINI 312 38C AS In distribution
AMPLI-ENERGY R X 5W In distribution
ampli-energy B 4MC RUP In distribution
AMPLI-ENERGY R 5 5W R In distribution
ampli-energy B 3MC RUP In distribution
ampli-cros R AX 312 In distribution
ampli-mini 10 5 5w AS In distribution
ampli-energy R 2 5w R T In distribution
AMPLI-MINI 10 38C AS In distribution
ampli-mini R 3 AX 312 In distribution
ampli-energy B 5MC RP In distribution
ampli-energy B 5MC RUP In distribution
ampli-connect R 312 3MC In distribution
ampli-mini R 3 AX 312 In distribution
ampli-energy I 2 5w RSTD In distribution
ampli-energy R 3 5w R-D In distribution
ampli-power E 5 5w B-RUP In distribution
ampli-energy B 5MC RUP In distribution
ampli-cros R AX R In distribution
ampli-power E 1 5w B-RP In distribution
ampli-energy B 3MC R In distribution
ampli-cros R AX R In distribution
ampli-energy B 3MC R In distribution
ampli-energy R 3 5w R-D In distribution
ampli-power E 1 5w B-RUP In distribution
ampli-energy I 2 5w RSTD In distribution
AMPLI-ENERGY R X 5W R In distribution
ampli-energy R 5 AX R In distribution
ampli-energy I 2 5w RSTD In distribution
ampli-connect R 312T 3MC In distribution
ampli-power E 4 5w B-RUP In distribution
AMPLI-ENERGY R X 5W R In distribution
ampli-mini 10S 1 5w AS In distribution
ampli-energy B 3MC R In distribution
ampli-connect R 5 AX 312 In distribution
AMPLI-CROS R AX In distribution
ampli-energy R 5 5w R-D In distribution
ampli-connect R 4 AX 312 In distribution
ampli-charge R-D 1 Portable In distribution
ampli-cros R AX 312 In distribution
AMPLI-CROS I 5W R S R In distribution
ampli-connect R 5 AX 312 In distribution
ampli-mini R 2 AX 312 In distribution
ampli-energy R 2 5w R T In distribution
ampli-power E 3 5w B-RUP In distribution
ampli-mini I 4 5w CIC-R In distribution
ampli-connect R 5 AX 312 In distribution
ampli-energy R MC R-D Demo In distribution
ampli-power E 1 5w B-RUP In distribution
AMPLI-ENERGY R 5 5W R In distribution
AMPLI-ENERGY R 4 5W R In distribution
ampli-power E 3 5w B-RUP In distribution
ampli-connect R 312T 3MC In distribution
AMPLI-ENERGY R 4 5W R In distribution
ampli-energy R 5 AX R In distribution
ampli-power E 1 5w B-RUP In distribution
ampli-energy B 3MC R In distribution
ampli-mini I 4MC 10STD R In distribution
AMPLI-CROS R 5W R In distribution
AMPLI-ENERGY R 5 5W R In distribution
ampli-energy B 5MC R In distribution
AMPLI-ENERGY R 3 5W R In distribution
ampli-energy I 2 5w RSTD In distribution
ampli-connect R 5 AX 312 In distribution
ampli-energy B MC RUP D In distribution
AMPLI-CROS I 5W R S R In distribution
ampli-mini R 3 AX 312 In distribution
ampli-power E 5 5w B-RP In distribution
ampli-mini R 1 AX 312 In distribution
AMPLI-ENERGY R 5 5W R T In distribution
ampli-energy R 5 AX R In distribution
AMPLI-ENERGY R 4 5W R T In distribution
ampli-connect R 4 AX 312 In distribution
ampli-energy B 5MC RP In distribution
AMPLI-ENERGY R 4 5W R T In distribution
ampli-cros R AX 312 In distribution
ampli-power E 1 5w B-RP In distribution
ampli-power E 2 5w B-RUP In distribution
ampli-energy B 4MC RUP In distribution
AMPLI-ENERGY R 4 5W R T In distribution
AMPLIENERGY I 5 5W In distribution
ampli-cros R AX 312 In distribution
ampli-cros R MC R In distribution
ampli-mini R 2 AX 312 In distribution
ampli-power E 1 5w B-RUP In distribution
AMPLI-CHARGE B/R 1 SI In distribution
ampli-energy B 4MC R In distribution
ampli-mini I 3MC 10STD R In distribution
ampli-power E 3 5w B-RUP In distribution
ampli-energy B 4MC RP In distribution
ampli-energy R 2MC R-D In distribution
ampli-mini I 4MC 10STD L In distribution
ampli-mini I 3 5w CIC-R In distribution
ampli-power E D 5w B-RUP In distribution
ampli-mini 10S 4 5w AS In distribution
ampli-mini 10S 3 5w AS In distribution
ampli-cros R AX R In distribution
ampli-cros R AX 312 In distribution
ampli-cros R AX R In distribution
ampli-power E 2 5w B-RUP In distribution
ampli-mini 10 4 5w AS In distribution
ampli-energy B 3MC R In distribution
ampli-power E 2 5w B-RP In distribution
ampli-power E 4 5w B-RUP In distribution
ampli-energy B 3MC RUP In distribution
AMPLI-CROS I 5W R S L In distribution
ampli-energy B 5MC RP In distribution
AMPLI-CROS R AX In distribution
ampli-energy B 4MC R In distribution
ampli-energy B 4MC RP In distribution
ampli-power E 5 5w B-RP In distribution
ampli-energy B 3MC RP In distribution
ampli-power E 5 5w B-RUP In distribution
ampli-mini R 1 AX 312 In distribution
ampli-cros R AX R In distribution
AMPLI-ENERGY R 4 5W R T In distribution
ampli-power E 4 5w B-RP In distribution
AMPLI-TV 1 SI In distribution
ampli-cros R AX 312 In distribution
ampli-connect R 312 3MC In distribution
ampli-energy R 4 5w R-D In distribution
ampli-connect R 312T 3MC In distribution
AMPLI-MINI 312 48C AS In distribution
ampli-energy B 5MC RP In distribution
AMPLI-ENERGY R 5 5W R T In distribution
AMPLI-ENERGY R 3 5W R In distribution
ampli-energy B MC RP In distribution
ampli-mini R 3 AX 312 In distribution
ampli-connect R 312 3MC In distribution
ampli-energy B 5MC RUP In distribution
ampli-connect R 312T 3MC In distribution
ampli-connect R 5 AX 312 In distribution
ampli-power I 5 5w ITC-312 In distribution
ampli-energy B 3MC RP In distribution
AMPLI-CROS R 5W R In distribution
AMPLI-ENERGY R X 5W In distribution
AMPLI-ENERGY R 5 5W R T In distribution
ampli-energy B 5MC R In distribution
AMPLI-ENERGY R 3 5W R T In distribution
AMPLI-CROS R 5W R In distribution
ampli-mini I 3MC 10STD L In distribution
AMPLI-ENERGY R 4 5W R In distribution
ampli-energy B 4MC RUP In distribution
AMPLI-ENERGY R 5 5W R In distribution
ampli-energy B 5MC R In distribution
ampli-power E 5 5w B-RP In distribution
AMPLI-CROS R AX In distribution
AMPLI-ENERGY R 3 5W R T In distribution
AMPLI-ENERGY R 5 5W R T In distribution
AMPLI-ENERGY R 5 5W R In distribution
ampli-connect R 312 3MC In distribution
ampli-power E 4 5w B-RP In distribution
ampli-energy B 4MC RP In distribution
ampli-power E 3 5w B-RP In distribution
ampli-energy B 5MC R In distribution
ampli-energy R 5 5w R-D In distribution
ampli-charge R-D 1 Portable In distribution
ampli-energy B 4MC RP In distribution
TH Standard 7 CIC LI In distribution
AMPLI-CROS I 5W R S L MOC In distribution
AMPLI-CROS I 5W R S L In distribution
AMPLI-CROS I 5W R S R In distribution
ampli-mini 10 2 5w AS In distribution
ampli-energy B 5MC RP In distribution
AMPLI-ENERGY R 5 5W R T In distribution
AMPLI-ENERGY R 3 5W R In distribution
ampli-cros R MC R In distribution
ampli-mini 10S 2 5w AS In distribution
AMPLI-ENERGY R 3 5W R In distribution
ampli-energy B MC R In distribution
ampli-energy B 5MC R In distribution
ampli-connect R 312T 3MC In distribution
ampli-energy R 5 AX R In distribution
ampli-power E 5 5w B-RUP In distribution
ampli-mini R 2 AX 312 In distribution
ampli-energy R 3 5w R-D In distribution
ampli-power E 4 5w B-RUP In distribution
ampli-connect R 312 3MC In distribution
ampli-connect R AX 312 D In distribution
ampli-mini R 2 AX 312 In distribution
AMPLI-ENERGY R 3 5W R In distribution
ampli-energy R 2 5w R T In distribution
ampli-mini R 1 AX 312 In distribution
ampli-energy B 4MC R In distribution
ampli-energy B 3MC RUP In distribution
AMPLI-MINI 312 58C AS In distribution
ampli-connect R 4 AX 312 In distribution
ampli-energy B 3MC RP In distribution
ampli-mini R 2 AX 312 In distribution
AMPLI-ENERGY R 3 5W R T In distribution
ampli-energy I 2 5w RSTD In distribution
ampli-power E 3 5w B-RP In distribution
AMPLI-ENERGY R 5 5W R T In distribution
AMPLI-ENERGY R 4 5W R In distribution
TH Advanced 7 CIC LI In distribution
ampli-energy B 2MC R In distribution
ampli-energy R 2MC R-D In distribution
AMPLI-ENERGY R 3 5W R In distribution
ampli-power E 2 5w B-RP In distribution
ampli-energy R 2 5w R T In distribution
AMPLI-CROS R AX In distribution
ampli-power E 2 5w B-RP In distribution
AMPLI-CROS R 5W R In distribution
ampli-energy B 3MC RP In distribution
ampli-power E 2 5w B-RUP In distribution
ampli-connect R 312T 3MC In distribution
ampli-power I 4 5w ITC-312 In distribution
AMPLI-CROS R AX In distribution
ampli-energy R 5 5w R-D In distribution
ampli-power E 4 5w B-RP In distribution
AMPLI-ENERGY R 3 5W R T In distribution
ampli-power E 2 5w B-RUP In distribution
AMPLI-ENERGY R 4 5W R T In distribution
AMPLI-CROS R AX In distribution
ampli-cros R MC R In distribution
ampli-power E D 5w B-RP In distribution
ampli-energy B 3MC R In distribution
ampli-mini 10 1 5w AS In distribution
TH Premium 7 CIC LI 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
HHM Oticon A/S 1,329
Miracle-Ear WS Audiology USA, Inc. 1,211

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