Audiosync
186 catalogue numbers from AUDIOSYNC VIA 1600 HS R, 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
186catalogue 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 | 2020-03-11 |
| 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 |
|---|---|---|
| AUDIOSYNC VIA 1600 HS R | In distribution | |
| AUDIOSYNC VIA 2400 MRIC 312 | In distribution | |
| AUDIOSYNC VIA 1200 BTE 13 | In distribution | |
| AUDIOSYNC ARC AI 1600 POWER PLUS BTE 13 | In distribution | |
| AUDIOSYNC EDGE AI 16 CIC | In distribution | |
| AUDIOSYNC INTRIGUE AI 24 CIC NW | In distribution | |
| AUDIOSYNC ARC AI 2400 RIC R | In distribution | |
| Audiosync Aris AI RIC 312 (TIER DEMO) | In distribution | |
| AudioSync Aris AI mRIC R (TIER DEMO) | In distribution | |
| AUDIOSYNC VIA AI 2400 RIC 312 | In distribution | |
| AUDIOSYNC ARC AI 2000 ITE R | In distribution | |
| AUDIOSYNC VIA 2000 ITE R | In distribution | |
| AudioSync Aris AI 20 HS R | In distribution | |
| AUDIOSYNC ARC AI CROS RIC R | In distribution | |
| AUDIOSYNC ARC AI 2000 RIC 312 | In distribution | |
| AUDIOSYNC VIA 1600 BTE R | In distribution | |
| AUDIOSYNC INTRIGUE AI DEMO RIC 312 | In distribution | |
| START 1200 WRLS RIC 312t | In distribution | |
| AUDIOSYNC VIA 1600 ITC R | In distribution | |
| AudioSync A Series AI 12 RIC R | In distribution | |
| AUDIOSYNC VIA 2400 BTE 13 | In distribution | |
| AUDIOSYNC INTRIGUE AI 24 MRIC R (TIER DEMO) | In distribution | |
| AUDIOSYNC EDGE AI 24 HS R | In distribution | |
| START 1200 WRLS RIC 312t | In distribution | |
| AUDIOSYNC VIA AI 1200 RIC R | In distribution | |
| AUDIOSYNC EDGE AI 24 MRIC R (TIER DEMO) | In distribution | |
| AUDIOSYNC EDGE AI 24 CIC | In distribution | |
| AUDIOSYNC VIA AI 1200 RIC 312 | In distribution | |
| AUDIOSYNC VIA AI 2000 RIC R | In distribution | |
| AUDIOSYNC VIA AI 2000 BTE R | In distribution | |
| AUDIOSYNC VIA AI 1600 RIC R | In distribution | |
| AUDIOSYNC INTRIGUE AI 12 ITC R | In distribution | |
| AUDIOSYNC VIA RIC 312 | In distribution | |
| AUDIOSYNC VIA 2400 RIC 312 | In distribution | |
| AUDIOSYNC INTRIGUE AI 16 MRIC R | In distribution | |
| AUDIOSYNC ARC AI 1000 POWER PLUS BTE 13 | In distribution | |
| AudioSync Aris AI 16 mRIC R | In distribution | |
| AUDIOSYNC ARC AI 1600 IIC NW | In distribution | |
| AudioSync A Series AI RIC 312 | In distribution | |
| AUDIOSYNC VIA EDGE AI 2400 RIC R | In distribution | |
| AUDIOSYNC VIA AI 2000 HS R | In distribution | |
| AUDIOSYNC INTRIGUE AI CROSBICROS RIC 312 | In distribution | |
| AUDIOSYNC VIA 1200 RIC 312 | In distribution | |
| Audiosync Aris AI RIC RT (TIER DEMO) | In distribution | |
| AUDIOSYNC ARC AI 1200 MRIC 312 | In distribution | |
| AUDIOSYNC VIA 2000 BTE 13 | In distribution | |
| AUDIOSYNC VIA AI 1200 ITE R | In distribution | |
| AUDIOSYNC VIA AI 1600 BTE 13 | In distribution | |
| AudioSync Aris AI 24 mRIC R (DEMO) | In distribution | |
| START 1200I WRLS RIC 312 | In distribution | |
| AUDIOSYNC EDGE AI 16 HS R | In distribution | |
| AudioSync Aris AI 16 ITC R | In distribution | |
| AUDIOSYNC VIA AI 2400 RIC 312 | In distribution | |
| AUDIOSYNC VIA 1200 BTE 13 | In distribution | |
| AUDIOSYNC VIA AI 2000 ITC R | In distribution | |
| AUDIOSYNC VIA 2400 BTE 13 | In distribution | |
| AUDIOSYNC SIGNATURE SERIES 24 IIC NW | In distribution | |
| AUDIOSYNC INTRIGUE AI 16 ITC R | In distribution | |
| AUDIOSYNC VIA 1200 ITC R | In distribution | |
| AUDIOSYNC ARC AI 2400 HS R | In distribution | |
| (DEMO) AUDIOSYNC ARC AI 2400 RIC R | In distribution | |
| AUDIOSYNC VIA AI 2000 ITE R | In distribution | |
| AUDIOSYNC ARC AI 1600 ITE R | In distribution | |
| AUDIOSYNC EDGE AI 20 HS R | In distribution | |
| AUDIOSYNC EDGE AI 12 HS R | In distribution | |
| AUDIOSYNC INTRIGUE AI 20 MRIC R | In distribution | |
| AUDIOSYNC INTRIGUE AI 24 ITC R | In distribution | |
| AUDIOSYNC EDGE AI 24 ITE R | In distribution | |
| AUDIOSYNC VIA 1000 MRIC 312 | In distribution | |
| AUDIOSYNC INTRIGUE AI 12 CIC NW | In distribution | |
| AUDIOSYNC ARC AI 1000 BTE 13 | In distribution | |
| AUDIOSYNC VIA AI 1000 RIC R | In distribution | |
| AUDIOSYNC ARC AI 1600 CIC | In distribution | |
| AUDIOSYNC VIA 1200 RIC R | In distribution | |
| AUDIOSYNC VIA AI 2400 ITE R | In distribution | |
| AUDIOSYNC EDGE AI 20 CIC | In distribution | |
| AudioSync Start 1200 Wrls BTE 13 | In distribution | |
| AUDIOSYNC MODEL MI 3 RIC 312 | In distribution | |
| (DEMO) AUDIOSYNC ARC AI 2400 BTE R | In distribution | |
| AUDIOSYNC VIA EDGE AI 2400 RIC 312 | In distribution | |
| AUDIOSYNC ARC AI 1600 RIC 312 | In distribution | |
| AUDIOSYNC EDGE AI MRIC R | In distribution | |
| Audiosync Aris AI 24 RIC 312 (DEMO) | In distribution | |
| AudioSync A Series AI RIC R | In distribution | |
| AUDIOSYNC VIA 2400 RIC 312 | In distribution | |
| AUDIOSYNC EDGE AI 16 ITC R | In distribution | |
| AUDIOSYNC ARC AI 1000 BTE R | In distribution | |
| AUDIOSYNC VIA AI 1600 ITC R | In distribution | |
| START 1000 WRLS RIC 312t | In distribution | |
| Audiosync Aris AI 16 RIC RT | In distribution | |
| AudioSync Aris AI 20 ITE R | In distribution | |
| AUDIOSYNC ARC AI 2400 POWER PLUS BTE 13 | In distribution | |
| START 1000I WRLS RIC 312 | In distribution | |
| AUDIOSYNC VIA AI 1200 BTE R | In distribution | |
| AUDIOSYNC ARC AI 2000 HS R | In distribution | |
| A4 SILVER RIC 312t | In distribution | |
| AUDIOSYNC MODEL MI 3 BTE 13 | In distribution | |
| A2 PLATINUM WRLS MRIC 312 | In distribution | |
| AudioSync A Series AI 16 RIC R | In distribution | |
| AUDIOSYNC VIA AI 1000 RIC 312 | In distribution | |
| AUDIOSYNC INTRIGUE AI 24 CIC 312 | In distribution | |
| AUDIOSYNC VIA 2000 RIC 312 | In distribution | |
| AUDIOSYNC VIA 2000 MRIC 312 | In distribution | |
| AUDIOSYNC VIA 1000A BTE 13 | In distribution | |
| AUDIOSYNC EDGE AI 20 RIC RT | In distribution | |
| AudioSync A4 Silver BTE 13 | In distribution | |
| AUDIOSYNC EDGE AI 24 ITC R | In distribution | |
| AUDIOSYNC VIA AI 1600 HS R | In distribution | |
| AUDIOSYNC VIA 1000A RIC R | In distribution | |
| AUDIOSYNC VIA AI 1200 MRIC 312 | In distribution | |
| AUDIOSYNC VIA AI 1200 ITC R | In distribution | |
| AUDIOSYNC MODEL MI 2 BTE 13 | In distribution | |
| AUDIOSYNC EDGE AI 20 ITC R | In distribution | |
| AUDIOSYNC VIA 1000 HS R | In distribution | |
| AUDIOSYNC ARC AI 2400 CIC NW | In distribution | |
| AUDIOSYNC VIA EDGE AI CROSBICROS RIC R | In distribution | |
| AUDIOSYNC ARC AI 1600 RIC R | In distribution | |
| AUDIOSYNC VIA EDGE AI 2400 HS R | In distribution | |
| AUDIOSYNC VIA AI 1200 BTE 13 | In distribution | |
| AUDIOSYNC EDGE AI 16 RIC 312 | In distribution | |
| AUDIOSYNC VIA 1600 MRIC 312 | In distribution | |
| AUDIOSYNC VIA EDGE AI 2400 BTE 13 | In distribution | |
| AUDIOSYNC INTRIGUE AI 20 RIC RT | In distribution | |
| AUDIOSYNC INTRIGUE AI 16 RIC 312 | In distribution | |
| AUDIOSYNC VIA 1200 MRIC 312 | In distribution | |
| AUDIOSYNC VIA 2400 BTE R | In distribution | |
| INTRIGUE AI 12 ITE R | In distribution | |
| Audiosync Aris AI 20 RIC RT | In distribution | |
| AUDIOSYNC VIA 1000 BTE R | In distribution | |
| A2 SILVER WRLS MRIC 312 | In distribution | |
| AUDIOSYNC VIA AI CROSBICROS RIC R | In distribution | |
| AUDIOSYNC ARC AI 2000 RIC R | In distribution | |
| AUDIOSYNC INTRIGUE AI 16 HS R | In distribution | |
| A4 CROS RIC 312t | In distribution | |
| AUDIOSYNC EDGE AI RIC RT | In distribution | |
| AUDIOSYNC VIA CROSBICROS RIC R | In distribution | |
| AUDIOSYNC SIGNATURE SERIES 16 IIC NW | In distribution | |
| AUDIOSYNC INTRIGUE AI 20 CIC 312 | In distribution | |
| AUDIOSYNC VIA 2400 ITC R | In distribution | |
| AUDIOSYNC VIA AI 2400 BTE R | In distribution | |
| AUDIOSYNC VIA 1600 RIC R | In distribution | |
| AUDIOSYNC VIA 1000A RIC 312 | In distribution | |
| AUDIOSYNC VIA 1600 ITE R | In distribution | |
| A4I GOLD WRLS RIC 312 | In distribution | |
| AUDIOSYNC VIA AI 2400 BTE 13 | In distribution | |
| AUDIOSYNC VIA 1200 RIC 312 | In distribution | |
| AUDIOSYNC EDGE AI 24 RIC RT | In distribution | |
| AUDIOSYNC VIA AI 2400 BTE 13 | In distribution | |
| AUDIOSYNC VIA AI 1200 RIC R | In distribution | |
| AUDIOSYNC VIA 1000A MRIC 312 | In distribution | |
| AUDIOSYNC SIGNATURE SERIES 16 CIC NW | In distribution | |
| AudioSync Aris AI 24 mRIC R | In distribution | |
| AUDIOSYNC ARC AI 2000 CIC NW | In distribution | |
| AUDIOSYNC EDGE AI 24 RIC RT (TIER DEMO) | In distribution | |
| AUDIOSYNC VIA 1000 RIC R | In distribution | |
| Audiosync Aris AI 24 RIC RT | In distribution | |
| AUDIOSYNC ARC AI 1200 BTE R | In distribution | |
| AUDIOSYNC ARC AI 1600 HS R | In distribution | |
| AUDIOSYNC ARC AI CROS BTE 13 | In distribution | |
| AUDIOSYNC VIA MRIC 312 | In distribution | |
| AUDIOSYNC VIA 2000 BTE R | In distribution | |
| AUDIOSYNC VIA 1000 ITE R | In distribution | |
| (DEMO) AUDIOSYNC ARC AI 2400 BTE 13 POWER PLUS | In distribution | |
| AUDIOSYNC ARC AI 2400 ITC R | In distribution | |
| AUDIOSYNC VIA CROSBICROS BTE 13 | In distribution | |
| START 1200I WRLS RIC 312 | In distribution | |
| AUDIOSYNC VIA EDGE AI CROSBICROS RIC 312 | In distribution | |
| AUDIOSYNC VIA AI CROSBICROS RIC 312 | In distribution | |
| AUDIOSYNC ARC AI 1600 BTE 13 | In distribution | |
| AUDIOSYNC ARC AI 1200 CIC NW | In distribution | |
| AUDIOSYNC ARC AI 2000 IIC NW | In distribution | |
| AUDIOSYNC ARC AI 2400 CIC | In distribution | |
| AUDIOSYNC VIA EDGE AI 2400 ITC R | In distribution | |
| AUDIOSYNC ARC AI 1000 MRIC 312 | In distribution | |
| Audiosync Aris AI 24 RIC 312 | In distribution | |
| AudioSync A Series AI 10 RIC R | In distribution | |
| AUDIOSYNC ARC AI 2000 MRIC 312 | In distribution | |
| AUDIOSYNC INTRIGUE AI 12 CIC 312 | In distribution | |
| AUDIOSYNC ARC AI 2400 BTE 13 | In distribution | |
| AUDIOSYNC SIGNATURE SERIES 12 CIC NW | In distribution | |
| AUDIOSYNC VIA CROSBICROS RIC 312 | In distribution | |
| AudioSync Aris AI 24 ITE R | In distribution | |
| AUDIOSYNC INTRIGUE AI CROS RIC RT | In distribution | |
| AUDIOSYNC VIA 1200 MRIC 312 | In distribution | |
| (DEMO) AUDIOSYNC ARC AI 2400 BTE 13 | In distribution | |
| A4I SILVER WRLS RIC 312 | In distribution |
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 |
| Audigy | Starkey Laboratories, Inc. | 284 |
| Microtech | Starkey Laboratories, Inc. | 284 |
| audifon | Audifon – Gmbh & Co.kg | 277 |
| Philips | Sbo Hearing A/S | 270 |
| Agxo | Sbo Hearing A/S | 260 |
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.