Audigy
284 catalogue numbers from AUDIGY AGXSPI 1600 ITE, listed by Starkey Laboratories, Inc., United States, under Masker, Tinnitus. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
284catalogue numbers in this listing
10510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Sonova Hearing (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Jiangsu Betterlife Medical Co., Ltd. | Jiangsu | Jiangsu | Manufacturer | 4 |
| Starkey (Suzhou) Hearing Technology Co., Ltd. | Guoxiang, Wuzhong District, Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Starkey Laboratories, Inc., United States |
|---|---|
| FDA product code | KLW |
| Device type | Masker, Tinnitus |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3400 |
| Establishment | Manufacturer |
| Record published | 2018-08-27 |
| Record revised | 2025-08-20 (version 4) |
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 number | Size | Status |
|---|---|---|
| AUDIGY AGXSPI 1600 ITE | In distribution | |
| AUDIGY AGXSLIV AI 2400 RIC R | In distribution | |
| AUDIGY AGXSLIV 1200 RIC 312 | In distribution | |
| AGXSM IQ CROSBICROS MRIC 312 | In distribution | |
| AGXSP 2 I2000 RIC 312 | In distribution | |
| AGXSM 1600 ITC | In distribution | |
| AUDIGY AGXSPI 1000 ITE | In distribution | |
| AUDIGY AGXSLIV AI 2400 HS R | In distribution | |
| AGXSM 2000 ITC | In distribution | |
| AUDIGY AGXSLIV EDGE AI CROSBICROS RIC 312 | In distribution | |
| AUDIGY AGXSPI I1600 HALF SHELL | In distribution | |
| AUDIGY AGXSPI I2000 ITE | In distribution | |
| AGXS3S I110 MRIC 312 | In distribution | |
| AUDIGY AGXSEVO AI 1000 BTE R | In distribution | |
| AUDIGY AGXSLIV 1000 MRIC 312 | In distribution | |
| AGXSM 1000 MRIC 312 | In distribution | |
| AUDIGY AGXSLIV AI 2000 ITC R | In distribution | |
| AUDIGY AGXSLIV AI 2000 RIC 312 | In distribution | |
| AUDIGY AGXSLIV 1600 BTE 13 | In distribution | |
| AUDIGY AGXSLIV 1600 ITC R | In distribution | |
| AGXSM IQ I1000 RIC R | In distribution | |
| AGXSM IQ I1200 MRIC 312 | In distribution | |
| AUDIGY AGXS EDGE AI 16 CIC | In distribution | |
| AUDIGY AGXSLIV AI 1600 ITC R | In distribution | |
| AGXSM 1200 BTE 13 PWRPLS | In distribution | |
| AGXSM IQ 2400 BTE 312 | In distribution | |
| AUDIGY AGXS EDGE AI 24 RIC 312 | In distribution | |
| AUDIGY MODEL AGXSS 2 BTE 13 | In distribution | |
| AUDIGY AGXSPI I1000 ITE | In distribution | |
| AGXSSL SYN IQ 2000 IIC | In distribution | |
| AGXSP 2 I2400 RIC 312 | In distribution | |
| AUDIGY AGXS GENESIS AI 24 CIC NW | In distribution | |
| AUDIGY AGXSLIV AI CROSBICROS RIC 312 | In distribution | |
| AGXS3S I90 MRIC 312 | In distribution | |
| AUDIGY AGXS EDGE AI 16 ITE R | In distribution | |
| AUDIGY AGXSPI 2000 ITC | In distribution | |
| AUDIGY AGXS EDGE AI 24 RIC RT (TIER DEMO) | In distribution | |
| AGXSM 2400 MRIC 312 | In distribution | |
| AUDIGY AGXSPI I1600 CIC | In distribution | |
| AUDIGY AGXS GENESIS AI 24 RIC RT (TIER DEMO) | In distribution | |
| AUDIGY AGXS EVOLV AI 1200 ITC R | In distribution | |
| AUDIGY AGXSLIV 1000 BTE 13 | In distribution | |
| AGXSM 2000 MRIC 312 | In distribution | |
| AGXSSL SYN IQ I2000 IIC | In distribution | |
| AUDIGY AGXSLIV AI 1200 BTE R | In distribution | |
| AUDIGY AGXSLIV 1200 ITC R | In distribution | |
| AGXSM IQ I1200 ITC | In distribution | |
| AUDIGY AGXSLIV AI 2000 ITE R | In distribution | |
| AUDIGY AGXSLIV AI 1000 BTE R | In distribution | |
| AUDIGY AGXSLIV 1600 ITE R | In distribution | |
| AGXSM I1200 ITE | In distribution | |
| AGXSM I1000 CIC | In distribution | |
| AUDIGY AGXS SIGNATURE SERIES 12 CIC R NW | In distribution | |
| AGXS3S I20 MRIC 312 | In distribution | |
| AGXSSL SYN IQ I1200 IIC | In distribution | |
| AUDIGY AGXSEVO AI 1200 BTE R | In distribution | |
| AGXSM IQ I1000 CIC | In distribution | |
| AGXSM IQ 2000 BTE 312 | In distribution | |
| AGXSM 1200 BTE 13 PWRPLS | In distribution | |
| AGXSM IQ I1600 ITC | In distribution | |
| AUDIGY AGXSPI 2400 HALF SHELL | In distribution | |
| AGXSP 2 I2000 RIC 13 | In distribution | |
| AGXSM I1200 BTE 13 PWRPLS | In distribution | |
| AUDIGY AGXS EDGE AI 24 HS R | In distribution | |
| AGXSM I1000 BTE 312 | In distribution | |
| AUDIGY AGXSLIV 2000 ITC R | In distribution | |
| AUDIGY AGXSLIV 1200 BTE 13 | In distribution | |
| AUDIGY AGXS SIGNATURE SERIES 24 CIC R NW | In distribution | |
| AGXSM IQ I2000 BTE 13 PWRPLS | In distribution | |
| AGXSSL SYNERGY I2400 IIC | In distribution | |
| AGXSM IQ 1000 MRIC 312R | In distribution | |
| AUDIGY AGXSPI 1000 HALF SHELL | In distribution | |
| AUDIGY AGXS GENESIS AI 24 ITC R | In distribution | |
| AUDIGY AGXSLIV AI 1600 ITE R | In distribution | |
| AGXSM I1200 CIC | In distribution | |
| AGXSM I1200 BTE 312 | In distribution | |
| AUDIGY AGXSLIV AI 1200 HS R | In distribution | |
| AGXSM I1000 BTE 13 PWRPLS | In distribution | |
| AUDIGY AGXSLIV AI 1000 ITC R | In distribution | |
| AUDIGY AGXS EDGE AI 24 RIC 312 (TIER DEMO) | In distribution | |
| AGXSM IQ I1600 HALF SHELL | In distribution | |
| AGXS GENESIS AI 20 ITE R | In distribution | |
| AGXSM I2000 ITC | In distribution | |
| AUDIGY AGXSEVO AI 2400 BTE R | In distribution | |
| AUDIGY AGXSPI I2400 CIC | In distribution | |
| AGXSP IQ I1200 RIC 13 | In distribution | |
| AUDIGY AGXSLIV AI 2000 BTE R | In distribution | |
| AGXSM IQ I2000 MRIC 312R | In distribution | |
| AUDIGY AGXSPI I1600 IIC | In distribution | |
| AUDIGY AGXSPI 2000 ITE | In distribution | |
| AUDIGY AGXSLIV 2400 ITE R | In distribution | |
| AUDIGY AGXS EVOLV AI 2000 POWER PLUS BTE 13 | In distribution | |
| AUDIGY AGXSLIV CROSBICROS RIC R | In distribution | |
| AUDIGY AGXS EDGE AI 20 CIC | In distribution | |
| AUDIGY MODEL AGXSS 3 RIC 312 | In distribution | |
| AGXSM I1200 HALF SHELL | In distribution | |
| AGXSM IQ I2000 BTE 13 | In distribution | |
| AUDIGY AGXSPI 1200 ITE | In distribution | |
| AGXSM I2400 MRIC 312 | In distribution | |
| AGXSM 2400 BTE 312 | In distribution | |
| AUDIGY AGXS EVOLV AI 1200 POWER PLUS BTE 13 | In distribution | |
| AUDIGY AGXS EVOLV AI 1600 RIC R | In distribution | |
| AGXSM IQ I2000 RIC R | In distribution | |
| AGXSM I2000 RIC 312t | In distribution | |
| AGXSM IQ 1600 BTE 13 PWRPLS | In distribution | |
| AUDIGY AGXS EDGE AI 20 MRIC R | In distribution | |
| AGXSM 2400 HALF SHELL | In distribution | |
| AUDIGY AGXSLIV AI 1000 BTE 13 | In distribution | |
| AGXSM IQ I1000 BTE 13 | In distribution | |
| AGXSM IQ I2000 ITC | In distribution | |
| AUDIGY AGXSLIV AI 2000 RIC 312 | In distribution | |
| AUDIGY AGXSLIV AI 1000 RIC R | In distribution | |
| AUDIGY AGXS EDGE AI 24 MRIC R (TIER DEMO) | In distribution | |
| AGXSM 1600 ITE | In distribution | |
| AGXSM IQ I2000 MRIC 312 | In distribution | |
| AGXS3S I30 MRIC 312 | In distribution | |
| AGXSM I1600 ITE | In distribution | |
| AUDIGY AGXS GENESIS AI 12 ITC R | In distribution | |
| AGXSP 2 I1200 RIC 312R | In distribution | |
| AGXSM 1000 CIC | In distribution | |
| AGXSSL SYNERGY 1600 IIC | In distribution | |
| AUDIGY AGXS GENESIS AI 16 CIC NW | In distribution | |
| AGXSM I1600 HALF SHELL | In distribution | |
| AGXSM I2000 BTE 13 PWRPLS | In distribution | |
| AGXSM IQ I2400 MRIC 312 | In distribution | |
| AUDIGY AGXS EVOLV AI 1200 CIC NW | In distribution | |
| AGXSM IQ 1000 BTE 312 | In distribution | |
| AUDIGY AGXS EVOLV AI 2000 RIC R | In distribution | |
| AUDIGY AGXS GENESIS AI 20 IIC NW | In distribution | |
| AGXSSL SYN IQ 1600 IIC | In distribution | |
| AUDIGY AGXSPI I2400 ITE | In distribution | |
| AUDIGY AGXS EDGE AI 20 RIC 312 | In distribution | |
| AUDIGY AGXSLIV 2400 BTE R | In distribution | |
| AUDIGY AGXS EDGE AI 20 RIC RT | In distribution | |
| AUDIGY AGXS SIGNATURE SERIES 16 CIC R NW | In distribution | |
| AUDIGY AGXSLIV 2400 RIC R | In distribution | |
| AUDIGY AGXSLIV 2400 MRIC 312 | In distribution | |
| AUDIGY AGXSLIV EDGE AI 2400 HS R | In distribution | |
| AGXSM IQ I2000 BTE 312 | In distribution | |
| AGXSSL SYN IQ I1600 IIC | In distribution | |
| AUDIGY AGXS EDGE AI 12 ITC R | In distribution | |
| AGXSP IQ I1600 RIC 13 | In distribution | |
| AUDIGY AGXS EDGE AI 24 RIC RT | In distribution | |
| AUDIGY AGXS EVOLV AI 2000 RIC 312 | In distribution | |
| AGXSM 1200 MRIC 312 | In distribution | |
| AUDIGY AGXSPI I2400 ITC | In distribution | |
| AUDIGY AGXSPI 1000 ITC | In distribution | |
| AUDIGY AGXSLIV CROSBICROS BTE 13 | In distribution | |
| AGXSM I1200 ITC | In distribution | |
| AUDIGY AGXSLIV AI 2000 BTE 13 | In distribution | |
| AGXSP 2 I2000 RIC 312R | In distribution | |
| AUDIGY AGXSLIV EDGE AI CROSBICROS BTE 13 | In distribution | |
| AUDIGY AGXSLIV 1600 HS R | In distribution | |
| AGXSM I1600 BTE 13 PWRPLS | In distribution | |
| AUDIGY AGXS GENESIS AI 12 RIC RT | In distribution | |
| AGXSM CROSBICROS MRIC 312 | In distribution | |
| AUDIGY AGXSPI 1200 HALF SHELL | In distribution | |
| AUDIGY AGXSLIV AI 2400 RIC 312 | In distribution | |
| AUDIGY AGXSLIV 1000 BTE R | In distribution | |
| AUDIGY AGXSLIV EDGE AI CROSBICROS RIC R | In distribution | |
| AUDIGY AGXS EVOLV AI 2000 CIC NW | In distribution | |
| AUDIGY AGXS EVOLV AI 1000 HS R | In distribution | |
| AUDIGY AGXS EVOLV AI 1200 ITE R | In distribution | |
| AUDIGY AGXS GENESIS AI 20 MRIC R | In distribution | |
| AUDIGY AGXS EVOLV AI 2400 ITC R | In distribution | |
| AGXSSL SYN IQ 1200 IIC | In distribution | |
| AUDIGY AGXS EVOLV AI CROS RIC R | In distribution | |
| AGXSM I2400 RIC 312t | In distribution | |
| AUDIGY AGXSLIV AI 2000 HS R | In distribution | |
| AGXSM I2000 ITE | In distribution | |
| AGXSM IQ 2000 BTE 13 PWRPLS | In distribution | |
| AGXSM IQ I1200 ITE | In distribution | |
| AGXSM IQ I1000 MRIC 312R | In distribution | |
| AUDIGY AGXSLIV 2400 ITC R | In distribution | |
| AGXsm 1200 BTE 13 | In distribution | |
| AUDIGY AGXS EVOLV AI 1200 RIC 312 | In distribution | |
| AUDIGY AGXSPI I1000 CIC | In distribution | |
| AUDIGY AGXSLIV 1000 RIC 312 | In distribution | |
| AGXSM 2000 BTE 13 PWRPLS | In distribution | |
| AUDIGY AGXS EVOLV AI 1000 ITC R | In distribution | |
| AGXsm i2400 BTE 13 | In distribution | |
| AGXSM 1000 RIC 312t | In distribution | |
| AGXSM CROSBICROS BTE 312 | In distribution | |
| AUDIGY AGXSLIV EDGE AI 2400 ITC R | In distribution | |
| AUDIGY AGXSPI 2400 IIC | In distribution | |
| AUDIGY AGXSPI I1200 ITC | In distribution | |
| AGXSM I2000 MRIC 312 | In distribution | |
| AUDIGY AGXSLIV 1200 MRIC 312 | In distribution | |
| AGXSM IQ I2400 RIC 312 | In distribution | |
| AGXSM 2400 CIC | In distribution | |
| AUDIGY AGXSLIV AI 1600 BTE R | In distribution | |
| AUDIGY AGXSPI I2000 IIC | In distribution | |
| AGXSM I1600 BTE 312 | In distribution | |
| AUDIGY AGXSPI 1200 ITC | In distribution | |
| AUDIGY AGXSLIV 1600 BTE R | In distribution | |
| AUDIGY AGXS EVOLV AI 1000 ITE R | In distribution | |
| AGXSM CROS RIC 312t | In distribution | |
| AGXSM IQ 2000 BTE 13 | In distribution | |
| AUDIGY AGXSLIV EDGE AI 2400 BTE R | In distribution | |
| AUDIGY AGXSLIV 2000 BTE 13 | In distribution | |
| AGXSSL SYNERGY I2000 IIC | In distribution | |
| AUDIGY AGXSLIV AI 1000 ITE R | In distribution | |
| AUDIGY AGXS GENESIS AI 12 MRIC R | In distribution | |
| AUDIGY AGXSLIV 1200 BTE 13 | In distribution | |
| AGXSM IQ I2000 RIC 312 | In distribution | |
| AGXSM IQ I1200 BTE 13 | In distribution | |
| AUDIGY AGXSLIV 2000 RIC 312 | In distribution | |
| AGXSM IQ I2000 CIC | In distribution | |
| AUDIGY AGXSPI 1000 IIC | In distribution | |
| AGXS3S TINNITUS RIC 10 | In distribution | |
| AUDIGY AGXSLIV 1200 BTE R | In distribution | |
| AGXSM IQ CROSBICROS RIC R | In distribution | |
| AGXSM IQ I1200 BTE 312 | In distribution | |
| AUDIGY AGXSPI I2000 CIC | In distribution | |
| AGXSM IQ I1600 BTE 13 | In distribution | |
| AUDIGY AGXSLIV EDGE AI 2400 ITE R | In distribution | |
| AGXSM IQ I2400 ITC | In distribution | |
| AUDIGY AGXS GENESIS AI 24 HS R | In distribution | |
| AUDIGY AGXS GENESIS AI 12 RIC 312 | In distribution | |
| AGXSP IQ I1200 RIC 312R | In distribution | |
| AUDIGY AGXSLIV 1200 ITE R | In distribution | |
| AGXSM IQ 2000 RIC 312 | In distribution | |
| AUDIGY MODEL AGXSS 3 BTE 13 | In distribution | |
| AUDIGY AGXSLIV 2400 HS R | In distribution | |
| AGXSM IQ I1200 BTE 13 PWRPLS | In distribution | |
| AGXSM I1000 ITC | In distribution | |
| AGXSM IQ I1200 CIC | In distribution | |
| AGXSM IQ 1200 MRIC 312R | In distribution | |
| AUDIGY AGXSLIV AI 1600 BTE 13 | In distribution | |
| AGXS3S I70 MRIC 312 | In distribution | |
| AUDIGY AGXS EVOLV AI 2000 ITE R | In distribution | |
| AUDIGY AGXSLIV AI 1000 RIC 312 | In distribution | |
| AUDIGY AGXSLIV 1000 RIC 312 | In distribution | |
| AUDIGY AGXSLIV AI 1200 ITE R | In distribution | |
| AGXSM IQ 1200 BTE 13 | In distribution | |
| AGXS GENESIS AI 24 ITE R | In distribution | |
| AUDIGY AGXS SIGNATURE SERIES 20 CIC R NW | In distribution | |
| AUDIGY AGXSLIV 1600 RIC R | In distribution | |
| AGXSSL SYNERGY I2400 IIC | In distribution | |
| AUDIGY AGXSLIV 1000 BTE 13 | In distribution | |
| AUDIGY SIGNATURE SERIES 20 IIC NW | In distribution | |
| AGXS GENESIS AI 12 ITE R | In distribution | |
| AUDIGY AGXSLIV EDGE AI 2400 BTE 13 | In distribution | |
| AUDIGY AGXS EVOLV AI 1000 CIC | In distribution | |
| AGXSP IQ I2000 RIC 312 | In distribution | |
| AGXSM IQ I1600 BTE 312 | In distribution | |
| AUDIGY AGXS EDGE AI 20 HS R | In distribution | |
| AUDIGY AGXSPI 2000 HALF SHELL | In distribution | |
| AUDIGY AGXS EDGE AI 24 MRIC R (DEMO) | In distribution | |
| AGXSM I2400 ITC | In distribution |
Showing 250 of 284 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oticon | Sbo Hearing A/S | 570 |
| Starkey | Starkey Laboratories, Inc. | 449 |
| Phonak | Sonova AG | 448 |
| Oticon | Oticon A/S | 353 |
| Nuear | Starkey Laboratories, Inc. | 336 |
| Audibel | Starkey Laboratories, Inc. | 318 |
| Unitron | Unitron Hearing Division | 292 |
| Microtech | Starkey Laboratories, Inc. | 284 |
| audifon | Audifon – Gmbh & Co.kg | 277 |
| Philips | Sbo Hearing A/S | 270 |
| Agxo | Sbo Hearing A/S | 260 |
| Hansaton | Hansaton Akustik GmbH | 249 |
Showing 12 of 86. All products under Masker, Tinnitus
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201370 | 2020-06-19 |
| K122876 | 2012-10-31 |
| K030180 | 2003-09-17 |
| K964216 | 1996-12-06 |
| K963838 | 1996-11-26 |
| K963995 | 1996-11-26 |
| K791790 | 1979-10-26 |
| K791142 | 1979-09-28 |
| K791071 | 1979-07-03 |
| K781798 | 1978-11-03 |
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.