Audigy

369 catalogue numbers from AGXSM I1600 MRIC 312, listed by Starkey Laboratories, Inc., United States, under Hearing Aid, Air-Conduction With Wireless Technology, Prescription. 29 manufacturers in China are registered for this product code.

Registry build 21.09.26
29manufacturers in China registered for this device type
369catalogue 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 Audigy
Listed by Starkey Laboratories, 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 Manufacturer
Premarket notification Exempt
Record published 2016-09-15
Record revised 2025-08-20 (version 4)

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries manufacturing date, serial number
Storage Storage environment humidity 10 to 95 % RH; Storage environment temperature -40 to 60 °C
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Audigy
Catalogue number Size Status
AGXSM I1600 MRIC 312 In distribution
AUDIGY AGXS EDGE AI 16 ITC R In distribution
AUDIGY AGXSLIV 1600 BTE 13 In distribution
AGXSM IQ I1600 RIC 312 In distribution
AUDIGY AGXS EVOLV AI 1600 ITC R In distribution
AUDIGY AGXS GENESIS AI 20 ITC R In distribution
AUDIGY AGXSLIV AI 2000 BTE 13 In distribution
AGXSZ I70 ITE In distribution
AGXSZ I110 ITE In distribution
AGXSSL SYNERGY I1600 IIC In distribution
AGXSM IQ 1200 RIC 312 In distribution
AGXSWI 110 ITC In distribution
AUDIGY AGXS EVOLV AI 2400 RIC R In distribution
AGXS3S I110 CIC In distribution
AUDIGY AGXSPI I2400 HALF SHELL In distribution
AGXSM I1200 MRIC 312 In distribution
AGXSZ I110 BTE 13 In distribution
AGXSP IQ I1200 RIC 312 In distribution
AGXSZ I70 CIC In distribution
AUDIGY AGXS EVOLV AI 2400 CIC In distribution
AGXS3S I30 ITE In distribution
AUDIGY AGXS GENESIS AI 20 HS R In distribution
AGXSZ I30 CIC In distribution
AGXS3S I110 ITC In distribution
AUDIGY AGXS GENESIS AI CROSBICROS RIC 312 In distribution
AGXSM I2000 CIC In distribution
Audigy AGXs G Series AI 16 RIC R In distribution
AGXS3S I110 HALF SHELL In distribution
AGXS3S I20 ITC In distribution
AGXS3S I20 BTE 13 In distribution
AUDIGY AGXSLIV AI 2000 MRIC 312 In distribution
AUDIGY AGXS EDGE AI 24 CIC In distribution
AGXSM IQ I2400 MRIC 312R In distribution
AUDIGY AGXS GENESIS AI 24 RIC 312 In distribution
AGXSP 2 I1000 RIC 312 In distribution
AGXS3S I70 ITC In distribution
AUDIGY AGXSLIV AI 2000 RIC R In distribution
AGXSM IQ I1000 ITC In distribution
AUDIGY AGXSLIV 2000 BTE R In distribution
AUDIGY AGXS EVOLV AI 1000 RIC R In distribution
AGXSZ I20 ITE In distribution
AGXSM 2400 BTE 13 PWRPLS In distribution
AUDIGY AGXSLIV AI 1000 MRIC 312 In distribution
AGXS3S I20 ITE In distribution
AUDIGY AGXSPI I2000 ITC In distribution
AUDIGY AGXSPI I1000 IIC In distribution
AGXSP IQ I1000 RIC 13 In distribution
AUDIGY AGXSLIV 2400 BTE 13 In distribution
AUDIGY AGXSLIV 1000 ITC R In distribution
AGXsm CROS BTE 13 In distribution
AUDIGY AGXSLIV 1200 RIC 312 In distribution
AGXS3S I30 ITC In distribution
AUDIGY AGXS GENESIS AI 16 HS R In distribution
AGXS3S I90 HALF SHELL In distribution
AGXSM IQ I2000 HALF SHELL In distribution
AGXSM IQ 1000 RIC 312 In distribution
AGXSM IQ I2400 BTE 13 In distribution
AGXSM IQ I1600 MRIC 312R In distribution
AUDIGY AGXSPI 1200 IIC In distribution
AUDIGY AGXS EVOLV AI CROS BTE 13 In distribution
AGXSM IQ I2000 ITE In distribution
AGXSM IQ I2400 RIC R In distribution
AGXS3S I20 CIC In distribution
AGXSP IQ I2400 RIC 312 In distribution
AGXSWI 110 HALF SHELL In distribution
AGXSM IQ 1200 MRIC 312 In distribution
AGXSM I2400 BTE 312 In distribution
AGXS3S I110 ITC In distribution
AGXS3S I110 ITE In distribution
AUDIGY AGXSLIV 1200 RIC R In distribution
AGXsm i1200 BTE 13 In distribution
AGXSM I2400 CIC In distribution
AGXSZ I20 MRIC 312 In distribution
AUDIGY AGXS EVOLV AI 1600 HS R In distribution
AGXSZ I20 BTE 13 In distribution
AGXSZ I70 HALF SHELL In distribution
AUDIGY AGXS EVOLV AI 1200 CIC In distribution
AGXSP 2 I1000 RIC 13 In distribution
AGXS3S I110 ITE In distribution
AGXSM I2400 ITC In distribution
AGXSZ I90 BTE 13 In distribution
AGXS3S I110 BTE 13 In distribution
AGXSM IQ 1600 MRIC 312R In distribution
AGXSM I1600 CIC In distribution
AUDIGY AGXSLIV AI 1200 RIC 312 In distribution
AGXS3S I70 BTE 13 In distribution
AGXS3S I90 ITC In distribution
AGXSM IQ 1000 BTE 13 PWRPLS In distribution
AUDIGY AGXSLIV 2400 BTE 13 In distribution
AUDIGY AGXS GENESIS AI 24 RIC RT In distribution
AGXSZ I30 MRIC 312 In distribution
AUDIGY AGXSLIV AI 1600 RIC 312 In distribution
AGXSWI I110 ITE In distribution
AGXS3S I30 HALF SHELL In distribution
AGXS3S I70 HALF SHELL In distribution
AGXSZ I70 RIC 312 In distribution
AGXSZ I90 HALF SHELL In distribution
AUDIGY AGXSPI I2400 IIC In distribution
AGXSP 2 I1600 RIC 13 In distribution
AUDIGY AGXSLIV AI 2400 ITE R In distribution
AGXSSL SYN IQ 2400 IIC In distribution
AUDIGY AGXSLIV AI 2400 ITC R In distribution
AGXS3S I70 CIC In distribution
AGXSZ I70 MRIC 312 In distribution
AGXS3S I90 BTE 13 In distribution
AUDIGY AGXS EDGE AI 12 ITE R In distribution
AUDIGY AGXS EDGE AI 24 RIC 312 (DEMO) In distribution
AGXSM IQ I2400 HALF SHELL In distribution
AGXSZ I90 BTE 13 In distribution
AUDIGY AGXSLIV AI 1200 BTE 13 In distribution
AGXSZ I20 HALF SHELL In distribution
AGXSM IQ I1200 RIC R In distribution
AGXSM IQ 2400 BTE 13 In distribution
AUDIGY AGXSLIV AI 2400 BTE 13 In distribution
AGXsm i1600 BTE 13 In distribution
AGXSZ I90 RIC 312 In distribution
AGXSP IQ I1600 RIC 312R In distribution
AUDIGY AGXSLIV AI 1600 MRIC 312 In distribution
AGXSWI 110 CIC In distribution
AUDIGY AGXS EVOLV AI 1000 POWER PLUS BTE 13 In distribution
AGXSZ I110 RIC 312 In distribution
AGXSZ I110 CIC In distribution
AGXS3S I90 HALF SHELL In distribution
AUDIGY AGXSLIV AI 1200 RIC 312 In distribution
AGXS3S I20 ITC In distribution
AGXSZ I30 ITC In distribution
AUDIGY AGXS EVOLV AI 1000 RIC 312 In distribution
AGXSP 2 I1200 RIC 13 In distribution
AGXS3S I110 HALF SHELL In distribution
AGXS3S I90 RIC 312 In distribution
AGXSM IQ I1200 MRIC 312R In distribution
AGXS3S I70 RIC 312 In distribution
AGXS3S I90 CIC In distribution
AUDIGY AGXS EDGE AI 12 HS R In distribution
AUDIGY AGXSLIV AI 2400 RIC 312 In distribution
AGXSSL SYN IQ I2400 IIC In distribution
AGXSZ I110 ITC In distribution
AGXsm i2000 BTE 13 In distribution
(DEMO) AUDIGY AGXS EVOLV AI 2400 RIC 312 In distribution
AGXSZ I70 BTE 13 In distribution
AGXSZ I110 BTE 312 In distribution
AGXSM IQ I1600 RIC R In distribution
AGXSM I1000 ITE In distribution
AGXSM IQ I1000 RIC 312 In distribution
AUDIGY AGXS GENESIS AI 24 MRIC R In distribution
AGXSP I110 RIC 13 In distribution
AUDIGY AGXS EVOLV AI 2400 BTE 13 In distribution
AUDIGY AGXS GENESIS AI 16 CIC 312 In distribution
AGXSZ I110 HALF SHELL In distribution
AGXSM I2400 HALF SHELL In distribution
AUDIGY AGXSPI I1000 ITC In distribution
AGXSM IQ 1600 MRIC 312 In distribution
AGXSP 2 I2400 RIC 13 In distribution
AUDIGY AGXS EDGE AI 24 RIC RT (DEMO) In distribution
AUDIGY AGXSLIV AI 1200 BTE 13 In distribution
AUDIGY AGXS EVOLV AI 1200 BTE 13 In distribution
AGXSM IQ I1200 RIC 312 In distribution
AGXS3S I90 BTE 312 In distribution
AGXSM I2400 CIC In distribution
AGXSZ I70 ITC In distribution
AGXS3S I70 BTE 13 In distribution
AGXS3S I110 BTE 312 In distribution
AUDIGY AGXS EVOLV AI 2000 ITC R In distribution
AGXSM IQ I2400 ITE In distribution
AUDIGY AGXS EDGE AI CROS RIC RT In distribution
AUDIGY AGXS EDGE AI CROS RIC 312 In distribution
AGXSP I70 RIC 13 In distribution
AUDIGY AGXSPI I1600 ITE In distribution
AGXSZ I90 ITE In distribution
AUDIGY AGXS GENESIS AI 16 ITC R In distribution
AUDIGY AGXS EDGE AI 24 ITE R In distribution
AUDIGY AGXSPI 1600 ITC In distribution
AUDIGY AGXS EVOLV AI 2400 RIC 312 In distribution
AGXSZ I30 BTE 13 In distribution
Audigy AGXs G Series AI 10 RIC R In distribution
AGXS3S I90 ITE In distribution
AGXSM CROSBICROS BTE 13 In distribution
AUDIGY AGXS GENESIS AI CROS RIC RT In distribution
AGXSZ I70 BTE 312 In distribution
AGXSM IQ 2400 BTE 13 PWRPLS In distribution
AUDIGY AGXS EDGE AI 20 ITE R In distribution
AGXS3S I110 HALF SHELL In distribution
AUDIGY AGXS GENESIS AI 20 RIC RT In distribution
AUDIGY AGXSPI I2000 HALF SHELL In distribution
AGXS3S I70 BTE 312 In distribution
Audigy AGXs G Series AI 16 RIC 312 In distribution
AUDIGY AGXSLIV AI 1600 RIC 312 In distribution
AUDIGY AGXSLIV AI 1000 RIC 312 In distribution
AUDIGY AGXSPI 1000 CIC In distribution
AUDIGY AGXSLIV 1000 ITE R In distribution
AGXSM I1600 ITE In distribution
AGXSP IQ I1600 RIC 312 In distribution
AUDIGY AGXSLIV EDGE AI 2400 RIC 312 In distribution
AGXS3S I20 ITC In distribution
AGXSM IQ CROSBICROS RIC 312 In distribution
AGXSM IQ CROSBICROS BTE 13 In distribution
AGXSM IQ I1600 CIC In distribution
AGXSZ I20 CIC In distribution
AUDIGY AGXSLIV 1000 HS R In distribution
AGXSSL SYN IQ I1000 IIC In distribution
AUDIGY AGXSLIV AI CROSBICROS BTE 13 In distribution
AUDIGY AGXSLIV AI 1600 BTE 13 In distribution
AGXSM IQ I1000 HALF SHELL In distribution
AGXS3S I90 BTE 13 In distribution
AUDIGY AGXSLIV EDGE AI 2400 MRIC 312 In distribution
AUDIGY AGXSLIV 2000 BTE 13 In distribution
AUDIGY AGXS EVOLV AI 1000 MRIC 312 In distribution
AGXSM IQ I2400 BTE 13 PWRPLS In distribution
AUDIGY AGXSLIV EDGE AI 2400 RIC R In distribution
AGXSM I2000 BTE 312 In distribution
AUDIGY AGXSLIV 2400 RIC 312 In distribution
AUDIGY AGXS EDGE AI 16 MRIC R In distribution
AUDIGY AGXS GENESIS AI 12 CIC 312 In distribution
AUDIGY AGXS EVOLV AI 1600 BTE 13 In distribution
AGXSM IQ I1000 ITE In distribution
AGXS3S I90 ITE In distribution
AGXS3S I20 HALF SHELL In distribution
AGXSM IQ 2000 MRIC 312 In distribution
AUDIGY AGXS EDGE AI 12 CIC In distribution
AUDIGY AGXS GENESIS AI 20 CIC 312 In distribution
AGXSP I110 BTE 13 In distribution
AUDIGY AGXSLIV AI 1200 ITC R In distribution
AGXSZ I20 RIC 312 In distribution
AGXS3S I20 ITE In distribution
AGXSZ I90 CIC In distribution
AUDIGY AGXSPI 2000 IIC In distribution
AUDIGY AGXSPI 2400 CIC In distribution
Audigy AGXs G Series AI 12 RIC 312 In distribution
AGXS3S I20 CIC In distribution
AGXSM IQ 2000 MRIC 312R In distribution
AGXSM I2400 BTE 13 PWRPLS In distribution
AUDIGY AGXSLIV AI 1200 RIC R In distribution
AUDIGY AGXSPI 1600 HALF SHELL In distribution
AGXSZ I110 ITC In distribution
AGXS3S I70 ITE In distribution
AUDIGY AGXS EDGE AI 16 HS R In distribution
AGXS3S I30 BTE 312 In distribution
AGXSM IQ I2400 CIC In distribution
AUDIGY AGXSLIV CROSBICROS RIC 312 In distribution
AUDIGY AGXS EVOLV AI 2400 MRIC 312 In distribution
AUDIGY AGXSLIV AI 1000 BTE 13 In distribution
AGXSM 1600 BTE 13 PWRPLS In distribution
AGXS3S I110 RIC 312 In distribution
AUDIGY AGXS GENESIS AI 12 HS R In distribution
AGXSM IQ 2400 MRIC 312 In distribution
AUDIGY AGXS EDGE AI 24 MRIC R In distribution
AGXS3S I20 HALF SHELL In distribution
AGXSZ I30 BTE 312 In distribution
AGXSM I1000 MRIC 312 In distribution
AGXS3S I110 ITE 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