Starkey

810 catalogue numbers from STARLINK 2.0 PREM CHARGER CUSTOM 002, 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
810catalogue 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 Starkey
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 2024-11-29
Record revised 2025-08-20 (version 5)

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 Starkey
Catalogue number Size Status
STARLINK 2.0 PREM CHARGER CUSTOM 002 In distribution
WI SERIES I90 HALF SHELL In distribution
STARKEY LIVIO 1000 HS R In distribution
STARKEY EVOLV AI 2000 BTE 13 In distribution
STARLINK 2.0 CHARGER CUSTOM 002 In distribution
STARKEY LIVIO AI 1600 ITC R In distribution
STARKEY EVOLV AI BTE 13 In distribution
(DEMO) STARKEY EVOLV AI 2400 BTE 13 POWER PLUS In distribution
GS CUSTOM CHARGER – (1 NA PLUG) In distribution
3 SERIES I70 ITC In distribution
STARLINK PREMIUM MINI CHARGER (MRIC R) In distribution
STARKEY EVOLV AI 1000 POWER PLUS BTE 13 (PL) In distribution
Z SERIES I30 ITC In distribution
STARKEY LIVIO AI 2400 BTE 13 In distribution
STARKEY GENESIS AI 16 RIC RT In distribution
STARKEY LIVIO 2000 RIC R In distribution
MUSE IQ I1000 ITC In distribution
STARKEY GENESIS AI CROS RIC RT In distribution
WI SERIES I110 ITC In distribution
MUSE I1000 MRIC 312 In distribution
3 SERIES I30 HALF SHELL In distribution
STARKEY SL 2.0 PREM CHARGER RIC RT 000 In distribution
MUSE I2400 RIC 312t In distribution
MUSE I2400 CIC In distribution
SOUNDLENS SYNERGY I2400 IIC In distribution
STARKEY PICASSO 2400 HALF SHELL In distribution
STARKEY LIVIO AI 1600 RIC R In distribution
HALO I90 BTE 13 In distribution
3 SERIES I20 HALF SHELL In distribution
3 SERIES I110 CIC In distribution
STARKEY EVOLV AI 1600 ITE R In distribution
STARKEY LIVIO EDGE AI 2400 BTE 13 In distribution
MUSE IQ 1600 BTE 13 PWRPLS In distribution
3 SERIES I30 RIC 312 In distribution
HALO 2 I1600 RIC 312 In distribution
HALO 2 I1600 RIC 312R In distribution
Z SERIES I70 ITE In distribution
MUSE 1200 BTE 13 PWRPLS In distribution
Starkey G Series AI UP BTE 13 (TIER DEMO) In distribution
STARKEY SL 2.0 PREM CHARGER RIC RT 001 In distribution
Z SERIES I70 BTE 312 In distribution
3 SERIES I30 ITE In distribution
HALO I20 BTE 13 In distribution
MUSE IQ 2000 BTE 312 In distribution
3 SERIES I30 ITC In distribution
SOUNDLENS SYN IQ I1000 IIC In distribution
STARKEY LIVIO 2400 RIC R In distribution
HALO 2 I2400 RIC 312R In distribution
Z SERIES I110 RIC 312 In distribution
GS STARLINK PREMIUM CHARGER 2.0 (MRIC R)(1NA PLUG) In distribution
STARKEY GENESIS AI 24 HS R In distribution
Z SERIES I110 BTE 312 In distribution
TruLink RIC 312 ZPower Charger Kit NA In distribution
STARLINK PREMIUM MINI CHARGER (RIC RT) In distribution
Starkey Omega AI 24 CIC In distribution
IGNITE I30 ITE In distribution
3 SERIES I90 ITC In distribution
3 SERIES I70 BTE 312 In distribution
Z SERIES I90 BTE 312 In distribution
Axio i4 BTE 312d In distribution
STARKEY GENESIS AI 20 RIC RT In distribution
STARKEY EVOLV AI 1200 RIC 312 In distribution
STARKEY LIVIO AI 2000 RIC R In distribution
Z SERIES I30 BTE 13 In distribution
STARKEY LIVIO BTE 13 In distribution
MUSE IQ I1200 RIC R In distribution
HALO 2 I1200 RIC 312R In distribution
Z SERIES I30 MRIC 312 In distribution
Z SERIES I20 BTE 312 In distribution
STARKEY SL 2.0 CHARGER RIC RT 000 In distribution
STARKEY SL 2.0 PREM CHARGER CUSTOM 002 In distribution
Starkey Omega AI 24 ITC R In distribution
3 SERIES 30 HALF SHELL In distribution
STARLINK 2.0 PREM CHARGER RIC RT 002 In distribution
MUSE IQ I1200 HALF SHELL In distribution
HALO I30 BTE 13 In distribution
HALO IQ I1600 RIC 13 In distribution
HALO I70 BTE 13 In distribution
3 SERIES I110 ITE In distribution
Starkey G Series AI 24 UP BTE 13 (DEMO) In distribution
Starkey Legacy Premium Charger In distribution
STARKEY PICASSO I2400 ITE In distribution
IGNITE I30 CIC In distribution
MUSE I2400 BTE 13 PWRPLS In distribution
Starkey Omega AI RIC 312 (TIER DEMO) In distribution
(DEMO) STARKEY EVOLV AI 2400 BTE R In distribution
STARKEY LIVIO 1200 HS R In distribution
MUSE IQ I1200 BTE 13 PWRPLS In distribution
STARKEY EVOLV AI 2000 ITE R In distribution
STARKEY GENESIS AI 24 CIC 312 In distribution
MUSE IQ I2400 MRIC 312 In distribution
STARKEY EVOLV AI 2400 RIC R In distribution
Z SERIES I70 MRIC 312 In distribution
STARKEY EVOLV AI 2400 ITC R In distribution
Z SERIES I90 BTE 13 In distribution
3 SERIES I110 BTE 312 In distribution
Z SERIES I90 HALF SHELL In distribution
MUSE IQ I1600 BTE 13 In distribution
STARKEY GENESIS AI RIC 312 (GS TIER DEMO) In distribution
3 SERIES I90 BTE 13 In distribution
Starkey Legacy Premium Custom Charger In distribution
Starkey G Series AI 24 UP BTE 13 In distribution
3 SERIES I20 BTE 13 In distribution
MUSE I1200 BTE 312 In distribution
Z SERIES I110 BTE 13 In distribution
HALO IQ I2000 RIC 312 In distribution
STARKEY GENESIS AI RIC 312 (GS DEMO) In distribution
MUSE IQ 2400 ITC In distribution
STARKEY PICASSO I1600 CIC In distribution
3 SERIES I20 BTE 13 In distribution
Z SERIES I110 CIC In distribution
STARKEY PICASSO 2400 IIC In distribution
StarLink Edge Remote Microphone In distribution
STARLINK TV STREAMER (LP) In distribution
STARKEY PICASSO 1200 HALF SHELL In distribution
Axio i8 PL BTE 312d In distribution
STARKEY GENESIS AI 24 RIC 312 (GS) In distribution
Z SERIES I110 BTE 13 In distribution
STARKEY LIVIO AI 1200 RIC R In distribution
WI SERIES I110 HALF SHELL In distribution
STARKEY LIVIO 1600 RIC R In distribution
3 SERIES I90 ITC In distribution
SOUNDLENS SYN IQ I2000 IIC In distribution
Z SERIES I30 HALF SHELL In distribution
Axio i8 PL BTE 13d In distribution
HALO 2 I2000 RIC 312 In distribution
3 SERIES I110 HALF SHELL In distribution
Z SERIES I110 BTE 13 In distribution
Axio i6 PL BTE 13d In distribution
Axio i16 PL BTE 312d In distribution
MUSE I1000 BTE 312 In distribution
STARLINK 2.0 PREM CHARGER MRIC 000 In distribution
MUSE IQ I2400 BTE 312 In distribution
HALO 2 I2400 RIC 13 In distribution
Z SERIES I110 ITE In distribution
MUSE I2000 HALF SHELL In distribution
STARKEY PICASSO 2400 ITC In distribution
STARKEY LIVIO 1600 MRIC 312 In distribution
Starkey Omega AI 16 mRIC R In distribution
STARKEY LIVIO AI 1200 ITE R In distribution
STARKEY GENESIS AI 16 MRIC R In distribution
STARKEY LIVIO 1000 ITE R In distribution
STARKEY LIVIO 1600 RIC 312 In distribution
Z SERIES I70 BTE 13 In distribution
STARKEY PICASSO 1200 ITE In distribution
STARKEY SL 2.0 PREM CHARGER MRIC 002 In distribution
Starkey Omega AI mRIC R (TIER DEMO) In distribution
STARLINK PREMIUM MINI CHARGER (RIC RT) (1NA PLUG) In distribution
3 SERIES I70 RIC 312 In distribution
3 SERIES I30 BTE 13 In distribution
3 SERIES I90 BTE 13 In distribution
Z SERIES I90 BTE 312 In distribution
STARKEY LIVIO 2400 BTE R In distribution
Muse i2000 PL BTE 13 In distribution
Z SERIES I70 ITC In distribution
Muse i2000 mRIC 312t In distribution
STARKEY SL 2.0 CHARGER MRIC 002 In distribution
STARKEY LIVIO AI 2400 RIC R In distribution
Muse i1000 BTE 13 In distribution
ACCESSORY CHARGER In distribution
STARLINK TV STREAMER In distribution
STARLINK CHARGER (MRIC R) (1NA PLUG) In distribution
3 SERIES I90 HALF SHELL In distribution
Starkey Omega AI 20 RIC RT In distribution
STARKEY PICASSO I2400 CIC In distribution
MUSE IQ 2000 HALF SHELL In distribution
MUSE IQ 2000 ITC In distribution
STARLINK 2.0 CHARGER RIC RT 002 In distribution
MUSE IQ I1200 CIC In distribution
MUSE IQ CROSBICROS MRIC 312 In distribution
Starkey Legacy Premium Custom Charger In distribution
Z SERIES I20 ITE In distribution
WI SERIES I110 CIC In distribution
STARKEY LIVIO 2400 RIC 312 In distribution
Z SERIES I110 ITE In distribution
Starkey Legacy Premium Charger In distribution
STARKEY GENESIS AI 24 RIC RT (GS) In distribution
STARKEY LIVIO CROSBICROS BTE 13 In distribution
MUSE IQ 2400 HALF SHELL In distribution
MUSE I1000 MRIC 312 In distribution
WI SERIES I110 HALF SHELL In distribution
Z SERIES I90 RIC 312 In distribution
Starkey Omega AI mRIC R In distribution
STARKEY EVOLV AI MRIC 312 In distribution
HALO IQ I1000 RIC 312 In distribution
Starkey G Series AI 20 UP BTE 13 In distribution
STARKEY LIVIO 1000A MRIC 312 In distribution
MUSE 1200 BTE 13 PWRPLS In distribution
MUSE IQ I2000 ITE In distribution
IGNITE I30 ITC In distribution
MUSE IQ 2400 MRIC 312R In distribution
STARKEY SOUNDGEAR PHANTOM ITE In distribution
Starkey G Series AI P BTE 13 (TIER DEMO) In distribution
STARKEY LIVIO EDGE AI 2400 RIC 312 In distribution
Z SERIES I20 RIC 312 In distribution
WI SERIES I110 CIC In distribution
3 SERIES I110 RIC 312 In distribution
STARKEY SL 2.0 CHARGER MRIC 000 In distribution
STARLINK EDGE TV STREAMER In distribution
GS Starkey SL 2.0 Prem Charger Custom In distribution
3 SERIES I90 HALF SHELL In distribution
3 SERIES I110 HALF SHELL In distribution
STARKEY EDGE AI RIC RT In distribution
Z SERIES I20 CIC In distribution
3 SERIES I70 BTE 13 In distribution
3 SERIES I20 RIC 312 In distribution
MUSE IQ 1000 RIC 312 In distribution
Z SERIES I110 MRIC 312 In distribution
HALO I110 RIC 13 In distribution
STARKEY EVOLV AI 1000 RIC 312 In distribution
3 SERIES I110 ITC In distribution
Z SERIES I70 RIC 312 In distribution
Z SERIES I30 RIC 312 In distribution
STARLINK TABLE MICROPHONE (1 NA PLUG) In distribution
HALO IQ I1600 RIC 312R In distribution
STARKEY LIVIO AI 2400 RIC 312 In distribution
Z SERIES I110 BTE 13 In distribution
STARLINK EDGE TV STREAMER (LP) In distribution
StarLink Edge Remote Microphone 000 In distribution
3 SERIES I30 ITE In distribution
MUSE I1000 ITC In distribution
3 SERIES I110 BTE 13 In distribution
STARKEY LIVIO AI 2000 BTE R In distribution
GS STARLINK CHARGER 2.0 (MRIC R) – 1 NA PLUG In distribution
STARKEY EDGE AI 12 HS R In distribution
Starkey G Series AI 10 RIC 312 In distribution
IGNITE I30 ITE In distribution
Z SERIES I90 BTE 13 In distribution
STARKEY PICASSO I2400 HALF SHELL In distribution
MUSE 2000 BTE 13 PWRPLS In distribution
MUSE IQ CROSBICROS RIC R In distribution
MUSE IQ 1200 MRIC 312 In distribution
STARKEY LIVIO AI 2000 RIC 312 In distribution
STARKEY EDGE AI 20 ITC R In distribution
STARKEY LIVIO AI 2400 BTE 13 In distribution
MUSE IQ 1600 BTE 13 PWRPLS In distribution
Z SERIES I20 BTE 13 In distribution
STARKEY EDGE AI 24 MRIC R (TIER DEMO) In distribution
STARLINK 2.0 CHARGER MRIC 002 In distribution
HALO 2 I1000 RIC 312 In distribution
3 SERIES I70 CIC In distribution
STARKEY EVOLV AI 2400 POWER PLUS BTE 13 (PL) In distribution
STARLINK TABLE MICROPHONE In distribution
MUSE IQ 2400 MRIC 312 In distribution
Starkey Custom Charger-(1 NA plug) In distribution
STARKEY EVOLV AI 1600 BTE 13 In distribution
XPERIA XPERIA ITC In distribution
STARKEY PICASSO I1200 ITE In distribution
STARKEY LIVIO 2400 MRIC 312 In distribution
MUSE I2000 RIC 312t 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