Nuear
336 catalogue numbers from NUEAR SAVANT AI 2000 CIC, 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
336catalogue 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 | 2023-06-30 |
| 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 |
|---|---|---|
| NUEAR SAVANT AI 2000 CIC | In distribution | |
| NUEAR SAVANT AI 2400 RIC R | In distribution | |
| NUEAR EDGE AI CROS RIC 312 | In distribution | |
| NuEar Noble AI 24 HS R | In distribution | |
| NUEAR CIRCA AI 1000 ITE R | In distribution | |
| NUEAR CIRCA 2000 BTE R | In distribution | |
| NOW PRESTIGE HALF SHELL | In distribution | |
| SDS TINNITUS PRO RIC 10 | In distribution | |
| NUEAR CIRCA EDGE AI 2400 ITC R | In distribution | |
| Now Premier Wrls BTE 13 | In distribution | |
| NOW IQ 1200 WRLS RIC 312 | In distribution | |
| NOW PRO HALF SHELL | In distribution | |
| NUEAR NE NXG AI 20 IIC NW | In distribution | |
| INTRO 1000 WRLS RIC 13 | In distribution | |
| MINISCOPIC SYNERGY PRO WRLS IIC | In distribution | |
| NuEar NE Series AI 10 RIC R | In distribution | |
| NOW PREMIER CIC | In distribution | |
| NUEAR NE NXG AI 16 MRIC R | In distribution | |
| NUEAR CIRCA 1600 BTE 13 | In distribution | |
| NUEAR CIRCA AI 1600 HS R | In distribution | |
| NOW PREMIER BTE 312 | In distribution | |
| NOW CROS RIC 312t | In distribution | |
| INTRO 1000 WRLS ITE | In distribution | |
| NOW IQ PRESTIGE WRLS BTE 13 PWRPLS | In distribution | |
| NUEAR CIRCA 2400 ITC R | In distribution | |
| NUEAR SAVANT AI 1600 CIC | In distribution | |
| NUEAR CIRCA AI 1000 RIC R | In distribution | |
| NUEAR NE NXG AI 12 HS R | In distribution | |
| NOW IQ PRO WRLS RIC R | In distribution | |
| NUEAR CANVAS 1000 IIC | In distribution | |
| NOW IQ PRESTIGE HALF SHELL | In distribution | |
| NUEAR SAVANT AI 2000 RIC 312 | In distribution | |
| NUEAR CIRCA CROSBICROS RIC R | In distribution | |
| NUEAR CANVAS I1200 HALF SHELL | In distribution | |
| NUEAR CIRCA AI 2400 BTE 13 | In distribution | |
| NOW IQ 1200 RIC 312 | In distribution | |
| NOW IQ PRO CIC | In distribution | |
| MINISCOPIC SYN IQ PREMIER WRLS IIC | In distribution | |
| NUEAR CANVAS 2000 CIC | In distribution | |
| NUEAR NE NXG AI 16 HS R | In distribution | |
| NOW PRO WRLS CIC | In distribution | |
| (DEMO) NUEAR SAVANT AI 2400 BTE 13 | In distribution | |
| INTRO 1200 WRLS MRIC 312 | In distribution | |
| NOW IQ 1000 ITE | In distribution | |
| NUEAR CANVAS 1200 ITE | In distribution | |
| NUEAR NE NXG AI 12 RIC RT | In distribution | |
| INOW IQ PREMIER WRLS RIC 13 | In distribution | |
| NUEAR CIRCA 1600 HS R | In distribution | |
| NUEAR SAVANT AI 1600 MRIC 312 | In distribution | |
| NUEAR EDGE AI 24 MRIC R (TIER DEMO) | In distribution | |
| NOW IQ CROSBICROS RIC 312 | In distribution | |
| NUEAR SAVANT AI 1200 ITC R | In distribution | |
| NUEAR CIRCA 1600 MRIC 312 | In distribution | |
| NUEAR CIRCA EDGE AI 2400 HS R | In distribution | |
| NUEAR CIRCA EDGE AI 2400 BTE 13 | In distribution | |
| NOW PREMIER ITC | In distribution | |
| NOW PRO BTE 312 | In distribution | |
| NUEAR EDGE AI 16 ITC R | In distribution | |
| MINISCOPIC SYN IQ 1200 WRLS IIC | In distribution | |
| INTRO 1000 WRLS CIC | In distribution | |
| NOW IQ PRO WRLS CIC | In distribution | |
| NOW IQ 1000 WRLS HALF SHELL | In distribution | |
| NOW PREMIER ITE | In distribution | |
| NUEAR SAVANT AI 2400 RIC 312 | In distribution | |
| NUEAR SAVANT AI 1000 RIC R | In distribution | |
| INOW PRESTIGE WRLS RIC 13 | In distribution | |
| Now Pro Wrls BTE 13 | In distribution | |
| NUEAR CIRCA AI 1600 RIC R | In distribution | |
| INTRO 1200 WRLS RIC 312t | In distribution | |
| INOW IQ PRO WRLS RIC 312R | In distribution | |
| NOW CROSBICROS MRIC 312 | In distribution | |
| NUEAR CIRCA EDGE AI CROSBICROS RIC R | In distribution | |
| NUEAR EDGE AI 12 ITC R | In distribution | |
| NUEAR CIRCA 1600 RIC R | In distribution | |
| INTRO 1200 WRLS HALF SHELL | In distribution | |
| NUEAR CIRCA 1200 BTE R | In distribution | |
| NOW IQ PREMIER MRIC 312 | In distribution | |
| NOW IQ PRESTIGE MRIC 312 | In distribution | |
| NuEar NE Series AI 12 RIC R | In distribution | |
| NUEAR CIRCA AI 2400 RIC 312 | In distribution | |
| NUEAR NE NXG AI 12 ITE R | In distribution | |
| NUEAR CIRCA AI 1200 BTE R | In distribution | |
| SDS PREMIER WRLS MRIC 312 | In distribution | |
| NUEAR SAVANT AI 2000 HS R | In distribution | |
| NOW PRESTIGE WRLS ITC | In distribution | |
| NUEAR NE NXG AI 24 HS R | In distribution | |
| NOW PRO WRLS ITC | In distribution | |
| NUEAR EDGE AI 20 ITE R | In distribution | |
| NUEAR SAVANT AI 2000 IIC NW | In distribution | |
| NOW PREMIER BTE 312 | In distribution | |
| NUEAR SAVANT AI 1600 IIC NW | In distribution | |
| NUEAR CIRCA AI 2400 RIC R | In distribution | |
| NUEAR CIRCA AI 1600 RIC 312 | In distribution | |
| NUEAR CANVAS 1600 ITE | In distribution | |
| NUEAR Noble AI 16 RIC 312 | In distribution | |
| INTRO 1200 WRLS BTE 13 PWRPLS | In distribution | |
| NuEar Noble AI 16 HS R | In distribution | |
| NUEAR SAVANT AI 2400 BTE R | In distribution | |
| NOW PRESTIGE CIC | In distribution | |
| NUEAR CANVAS I2000 HALF SHELL | In distribution | |
| NUEAR EDGE AI 20 ITC R | In distribution | |
| NUEAR CIRCA AI 2000 BTE R | In distribution | |
| NuEar Noble AI 16 CIC | In distribution | |
| INOW IQ PREMIER WRLS RIC 312R | In distribution | |
| NOW IQ PREMIER WRLS BTE 13 PWRPLS | In distribution | |
| NOW IQ PRESTIGE WRLS CIC | In distribution | |
| NUEAR CANVAS I2400 HALF SHELL | In distribution | |
| NUEAR SAVANT AI 1600 RIC R | In distribution | |
| NUEAR NE NXG AI 16 CIC 312 | In distribution | |
| NUEAR CIRCA AI 1200 HS R | In distribution | |
| NuEar Noble AI 16 RIC RT | In distribution | |
| NUEAR EDGE AI 16 MRIC R | In distribution | |
| NUEAR SAVANT AI 1000 BTE R | In distribution | |
| NOW PREMIER RIC 312t | In distribution | |
| NUEAR EDGE AI 12 HS R | In distribution | |
| INTRO 1200 HALF SHELL | In distribution | |
| Intro 1200 Wrls BTE 13 | In distribution | |
| NUEAR CIRCA EDGE AI CROSBICROS RIC 312 | In distribution | |
| NUEAR CIRCA RIC R | In distribution | |
| NUEAR CIRCA AI 2000 ITE R | In distribution | |
| INOW PRO WRLS RIC 13 | In distribution | |
| NUEAR CIRCA BTE 13 | In distribution | |
| NOW PRO WRLS MRIC 312 | In distribution | |
| NOW PRESTIGE BTE 13 PWRPLS | In distribution | |
| NUEAR SAVANT AI 1000 HS R | In distribution | |
| NUEAR CIRCA AI 2400 HS R | In distribution | |
| NOW IQ CROSBICROS RIC R | In distribution | |
| NUEAR NE NXG AI 24 CIC 312 | In distribution | |
| (Demo) NUEAR CIRCA BTE 13 | In distribution | |
| NUEAR CIRCA 2400 RIC 312 | In distribution | |
| NuEar Noble AI 24 mRIC R (DEMO) | In distribution | |
| NUEAR SIGNATURE SERIES 20 CIC NW | In distribution | |
| MINISCOPIC SYNERGY PREMIER IIC | In distribution | |
| NOW IQ PREMIER WRLS MRIC 312R | In distribution | |
| NUEAR EDGE AI 24 RIC 312 | In distribution | |
| NUEAR CIRCA 2000 ITE R | In distribution | |
| NOW IQ PRESTIGE WRLS ITC | In distribution | |
| INTRO 1200 WRLS CIC | In distribution | |
| NUEAR MODEL N 3 BTE 13 | In distribution | |
| INTRO 1000 WRLS HALF SHELL | In distribution | |
| NOW IQ PREMIER BTE 13 | In distribution | |
| NUEAR SAVANT AI 1200 CIC NW | In distribution | |
| NUEAR CIRCA AI 2000 HS R | In distribution | |
| NOW PREMIER WRLS HALF SHELL | In distribution | |
| NOW IQ PRESTIGE WRLS RIC R | In distribution | |
| NUEAR CIRCA 2000 HS R | In distribution | |
| NUEAR CIRCA 1000 RIC 312 | In distribution | |
| NUEAR NE NXG AI 24 RIC RT | In distribution | |
| NOW IQ PRO WRLS BTE 13 | In distribution | |
| INTRO 1200 WRLS RIC 13 | In distribution | |
| (TIER DEMO) NUEAR SAVANT AI BTE 13 | In distribution | |
| NOW CROSBICROS BTE 13 | In distribution | |
| NUEAR CIRCA 2400 HS R | In distribution | |
| NUEAR CIRCA AI CROSBICROS BTE 13 | In distribution | |
| NOW IQ PRO WRLS ITC | In distribution | |
| NUEAR CANVAS I1000 ITE | In distribution | |
| INTRO 1000 MRIC 312 | In distribution | |
| NUEAR Noble AI 20 RIC 312 | In distribution | |
| NUEAR CANVAS 2400 IIC | In distribution | |
| NUEAR CIRCA BTE R | In distribution | |
| NUEAR CIRCA AI 2400 MRIC 312 | In distribution | |
| NUEAR SAVANT AI CROS RIC 312 | In distribution | |
| NOW PRESTIGE WRLS HALF SHELL | In distribution | |
| NOW IQ PRO BTE 312 | In distribution | |
| NOW IQ 1000 WRLS BTE 13 PWRPLS | In distribution | |
| NOW PRESTIGE WRLS ITE | In distribution | |
| NUEAR CIRCA 1600 ITC R | In distribution | |
| NOW PREMIER WRLS BTE 13 PWRPLS | In distribution | |
| NUEAR CIRCA 1600 ITE R | In distribution | |
| MINISCOPIC SYN IQ 1200 IIC | In distribution | |
| NUEAR CIRCA CROSBICROS BTE 13 | In distribution | |
| NOW IQ PREMIER RIC 312 | In distribution | |
| NUEAR CIRCA MRIC 312 | In distribution | |
| NUEAR CIRCA 2400 MRIC 312 | In distribution | |
| NUEAR NE NXG AI 24 RIC 312 | In distribution | |
| NUEAR CIRCA AI 1200 RIC R | In distribution | |
| NUEAR CIRCA AI 2400 RIC 312 | In distribution | |
| INTRO 1200 WRLS RIC 312t | In distribution | |
| NUEAR CANVAS 1600 CIC | In distribution | |
| NOW PREMIER CIC | In distribution | |
| NOW PRESTIGE WRLS CIC | In distribution | |
| NUEAR CIRCA AI 1000 ITC R | In distribution | |
| NOW IQ 1000 BTE 13 PWRPLS | In distribution | |
| NOW PRO BTE 13 PWRPLS | In distribution | |
| NUEAR EDGE AI 12 CIC | In distribution | |
| INTRO 1200I WRLS RIC 312R | In distribution | |
| NUEAR CIRCA CROSBICROS RIC 312 | In distribution | |
| INOW IQ 1000I WRLS RIC 13 | In distribution | |
| NUEAR SAVANT AI CROS BTE 13 | In distribution | |
| NUEAR NE NXG AI CROS RIC RT | In distribution | |
| NUEAR NE NXG AI 16 ITC R | In distribution | |
| NUEAR CANVAS I1600 HALF SHELL | In distribution | |
| NOW IQ PRO ITC | In distribution | |
| MINISCOPIC SYN IQ PRESTIGE WRLS IIC | In distribution | |
| NUEAR SAVANT AI 1000 RIC 312 | In distribution | |
| NUEAR CIRCA 1000A MRIC 312 | In distribution | |
| NUEAR SAVANT AI 1000 CIC NW | In distribution | |
| INSPIRE X | In distribution | |
| NUEAR NE NXG AI 12 ITC R | In distribution | |
| NUEAR CIRCA 1000 ITE R | In distribution | |
| NOW IQ PRESTIGE RIC 312 | In distribution | |
| NUEAR CIRCA 2400 BTE 13 | In distribution | |
| INOW PRO WRLS RIC 312R | In distribution | |
| NUEAR CANVAS 1600 IIC | In distribution | |
| NuEar NE Series AI 10 RIC 312 | In distribution | |
| NOW IQ PRO ITE | In distribution | |
| NUEAR NE NXG AI 20 RIC 312 | In distribution | |
| NOW PRESTIGE ITE | In distribution | |
| NUEAR CIRCA EDGE AI 2400 MRIC 312 | In distribution | |
| NUEAR Noble AI 24 RIC 312 | In distribution | |
| NUEAR CIRCA 1000A RIC R | In distribution | |
| NUEAR CANVAS I1200 CIC | In distribution | |
| NOW IQ PREMIER WRLS MRIC 312 | In distribution | |
| INOW PRESTIGE WRLS RIC 312R | In distribution | |
| NUEAR CANVAS I1000 ITC | In distribution | |
| INTRO 1000 RIC 312t | In distribution | |
| NUEAR CANVAS 1600 HALF SHELL | In distribution | |
| NOW IQ 1200 WRLS HALF SHELL | In distribution | |
| NUEAR CANVAS I1200 ITC | In distribution | |
| NOW IQ PREMIER ITC | In distribution | |
| NUEAR NE NXG AI 12 CIC NW | In distribution | |
| INTRO TINNITUS 5 RIC 10 | In distribution | |
| NOW IQ 1200 WRLS ITE | In distribution | |
| NUEAR CIRCA AI 1600 ITE R | In distribution | |
| NOW PREMIER WRLS ITC | In distribution | |
| NOW IQ PRO WRLS BTE 312 | In distribution | |
| NOW IQ 1200 BTE 13 PWRPLS | In distribution | |
| NUEAR SAVANT AI 2400 POWER PLUS BTE 13 | In distribution | |
| NUEAR CANVAS I2400 IIC | In distribution | |
| NUEAR NE NXG AI 20 MRIC R | In distribution | |
| NuEar NE Series AI RIC 312 | In distribution | |
| NUEAR CANVAS 1200 HALF SHELL | In distribution | |
| NOW PRO RIC 312t | In distribution | |
| NOW IQ PRO WRLS ITE | In distribution | |
| NUEAR CIRCA 1200 BTE 13 | In distribution | |
| NUEAR CANVAS 2400 ITE | In distribution | |
| INOW PRESTIGE WRLS RIC 312 | In distribution | |
| NOW IQ 1000 WRLS BTE 13 | In distribution | |
| NUEAR EDGE AI 16 CIC | In distribution | |
| NUEAR SIGNATURE SERIES 16 IIC NW | In distribution | |
| NUEAR EDGE AI 24 MRIC R (DEMO) | In distribution | |
| Intro 1200 BTE 13 | In distribution | |
| NOW PREMIER WRLS RIC 312t | In distribution | |
| NOW IQ PREMIER WRLS HALF SHELL | In distribution | |
| NUEAR CIRCA 1000 BTE 13 | In distribution | |
| MINISCOPIC SYNERGY PREMIER WRLS IIC | In distribution | |
| NUEAR NE NXG AI DEMO RIC 312 (TIER DEMO) | In distribution | |
| NOW IQ CROSBICROS BTE 13 | In distribution | |
| NUEAR CANVAS I2400 ITE | In distribution | |
| NOW IQ PRO HALF SHELL | In distribution |
Showing 250 of 300 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 |
| 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 |
| 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.