Microtech
284 catalogue numbers from (DEMO) MICROTECH ENVY AI 2400 BTE 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
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 | 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 temperature -40 to 60 °C; Storage environment humidity 10 to 95 % RH |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| (DEMO) MICROTECH ENVY AI 2400 BTE R | In distribution | |
| SUMMIT CROSBICROS MRIC 312 | In distribution | |
| SUMMIT I2400 ITE | In distribution | |
| MICROTECH ENVY AI 1600 BTE R | In distribution | |
| KINNECT 2 I1000 RIC 312 | In distribution | |
| SUMMIT 2000 RIC 312t | In distribution | |
| SUMMIT 1200 CIC | In distribution | |
| MICROTECH MT NXG AI 24 RIC 312 | In distribution | |
| MICROTECH ESENTIA AI 2400 RIC R | In distribution | |
| SUMMIT I1000 RIC 312t | In distribution | |
| MICROTECH ESENTIA AI 1600 BTE R | In distribution | |
| MICROTECH ENVY AI 1200 MRIC 312 | In distribution | |
| SUMMIT IQ I2000 BTE 312 | In distribution | |
| MICROTECH MT NXG AI 20 RIC RT | In distribution | |
| MICROTECH ESENTIA EDGE AI 2400 RIC 312 | In distribution | |
| MICROTECH MT NXG AI 16 ITE R | In distribution | |
| SUMMIT IQ I1200 RIC 312 | In distribution | |
| MICROTECH PORTRAIT 1200 HALF SHELL | In distribution | |
| MICROTECH ESENTIA 1200 ITE R | In distribution | |
| MICROTECH ESENTIA 1200 MRIC 312 | In distribution | |
| MICROTECH ESENTIA EDGE AI CROSBICROS BTE 13 | In distribution | |
| Summit i2400 BTE 13 | In distribution | |
| SUMMIT 2000 CIC | In distribution | |
| MICROTECH SIGNATURE SERIES 24 CIC NW | In distribution | |
| KINNECT 2 I1600 RIC 312 | In distribution | |
| MICROTECH ESENTIA 1200 BTE 13 | In distribution | |
| MICROTECH ESENTIA AI 1600 BTE 13 | In distribution | |
| MICROLENS SYNERGY I2400 IIC | In distribution | |
| MICROTECH MT NXG AI CROS RIC RT | In distribution | |
| MICROLENS SYNERGY 2400 IIC | In distribution | |
| KINNECT IQ I2400 RIC 312 | In distribution | |
| MICROTECH ESENTIA AI 1600 RIC R | In distribution | |
| SUMMIT I1200 ITC | In distribution | |
| SUMMIT 2000 BTE 312 | In distribution | |
| KINNECT 2 I1000 RIC 312R | In distribution | |
| MICROTECH PORTRAIT I1000 ITE | In distribution | |
| SUMMIT IQ I2000 ITE | In distribution | |
| KINNECT 2 I1000 RIC 13 | In distribution | |
| MICROTECH ESENTIA AI 2000 ITE R | In distribution | |
| MICROTECH ESENTIA AI 1000 BTE R | In distribution | |
| MICROTECH ENVY AI 1200 CIC | In distribution | |
| Summit i2000 BTE 13 | In distribution | |
| SUMMIT IQ 1000 BTE 13 PWRPLS | In distribution | |
| SUMMIT 2400 MRIC 312 | In distribution | |
| MICROTECH ESENTIA 2000 BTE 13 | In distribution | |
| MICROTECH ESENTIA 2000 BTE R | In distribution | |
| SUMMIT IQ 1200 BTE 13 | In distribution | |
| SUMMIT IQ 1200 MRIC 312R | In distribution | |
| MICROTECH PORTRAIT I2400 ITE | In distribution | |
| SUMMIT IQ I2000 MRIC 312 | In distribution | |
| SUMMIT IQ CROSBICROS BTE 13 | In distribution | |
| MICROTECH ESENTIA 1000A RIC R | In distribution | |
| SUMMIT IQ I1000 ITE | In distribution | |
| SUMMIT IQ 2400 RIC 312 | In distribution | |
| MICROTECH MT NXG AI 20 HS R | In distribution | |
| MICROTECH ESENTIA 1200 RIC 312 | In distribution | |
| MICROTECH MT NXG AI 12 ITC R | In distribution | |
| MICROTECH MT NXG AI 24 RIC RT (TIER DEMO) | In distribution | |
| MICROTECH MT NXG AI 16 RIC 312 | In distribution | |
| MICROTECH ESENTIA 1000 RIC 312 | In distribution | |
| KINNECT 2 I1200 RIC 13 | In distribution | |
| SUMMIT I2400 RIC 312t | In distribution | |
| MICROTECH ESENTIA 2400 RIC R | In distribution | |
| SUMMIT I1000 BTE 312 | In distribution | |
| SUMMIT IQ I1600 ITC | In distribution | |
| KINNECT IQ I1200 RIC 312 | In distribution | |
| MICROTECH SIGNATURE SERIES 20 CIC R NW | In distribution | |
| SUMMIT IQ 2000 BTE 13 PWRPLS | In distribution | |
| MICROTECH ENVY AI CROS RIC 312 | In distribution | |
| MICROTECH ESENTIA EDGE AI 2400 HS R | In distribution | |
| SUMMIT IQ 1200 BTE 13 PWRPLS | In distribution | |
| MICROTECH PORTRAIT 1200 ITE | In distribution | |
| MICROTECH ENVY AI 1000 RIC 312 | In distribution | |
| MICROTECH MODEL M 2 RIC 312 | In distribution | |
| SUMMIT 1200 HALF SHELL | In distribution | |
| KINNECT IQ 2 I2400 RIC 312R | In distribution | |
| MICROTECH ESENTIA AI 1000 RIC R | In distribution | |
| MICROTECH PORTRAIT 2400 HALF SHELL | In distribution | |
| MICROTECH MT NXG AI RIC 312 | In distribution | |
| Summit 2400 BTE 13 | In distribution | |
| SUMMIT I2000 RIC 312t | In distribution | |
| MICROLENS SYNERGY I2000 IIC | In distribution | |
| MICROLENS SYN IQ 1000 IIC | In distribution | |
| MICROTECH ESENTIA 1200 HS R | In distribution | |
| MICROTECH ESENTIA AI 1200 RIC 312 | In distribution | |
| SUMMIT I2000 CIC | In distribution | |
| MICROTECH ESENTIA 1600 ITE R | In distribution | |
| MICROTECH MODEL M 3 BTE 13 | In distribution | |
| (DEMO) MICROTECH ENVY AI 2400 BTE 13 | In distribution | |
| MICROTECH ENVY AI 1000 POWER PLUS BTE 13 | In distribution | |
| SUMMIT IQ I2000 RIC R | In distribution | |
| SUMMIT IQ I1200 ITE | In distribution | |
| SUMMIT IQ I2400 ITC | In distribution | |
| MICROTECH ENVY AI 1600 RIC 312 | In distribution | |
| MICROTECH ENVY AI 1200 ITE R | In distribution | |
| KINNECT IQ I1200 RIC 312R | In distribution | |
| KINNECT 2 I2000 RIC 13 | In distribution | |
| SUMMIT 1000 RIC 312t | In distribution | |
| MICROTECH PORTRAIT 2400 ITE | In distribution | |
| MICROTECH ENVY AI 2400 BTE 13 | In distribution | |
| MICROTECH PORTRAIT 1600 HALF SHELL | In distribution | |
| MICROTECH ESENTIA BTE R | In distribution | |
| MICROTECH ESENTIA 2400 RIC R | In distribution | |
| MICROTECH ESENTIA 2000 ITE R | In distribution | |
| MICROTECH ESENTIA 2400 MRIC 312 | In distribution | |
| PROPEL W40 MRIC 312 | In distribution | |
| MICROTECH ESENTIA 2000 HS R | In distribution | |
| MICROTECH MT NXG AI 12 RIC RT | In distribution | |
| MICROTECH ESENTIA EDGE AI 2400 MRIC 312 | In distribution | |
| SUMMIT IQ 2400 ITE | In distribution | |
| MICROTECH ENVY AI 2400 HS R | In distribution | |
| SUMMIT IQ I2400 MRIC 312 | In distribution | |
| MICROTECH ESENTIA 1200 ITC R | In distribution | |
| SUMMIT IQ I2400 RIC R | In distribution | |
| MICROTECH PORTRAIT I1000 CIC | In distribution | |
| SUMMIT 2400 CIC | In distribution | |
| SUMMIT IQ 1000 HALF SHELL | In distribution | |
| MICROTECH MT NXG AI RIC RT | In distribution | |
| SUMMIT I2000 ITE | In distribution | |
| SUMMIT 1000 ITE | In distribution | |
| MICROTECH SIGNATURE SERIES 12 CIC NW | In distribution | |
| MICROTECH PORTRAIT I2000 ITE | In distribution | |
| MICROTECH PORTRAIT 1600 CIC | In distribution | |
| MICROTECH PORTRAIT 1000 ITE | In distribution | |
| SUMMIT IQ I1200 CIC | In distribution | |
| SUMMIT IQ I1600 MRIC 312 | In distribution | |
| MICROTECH MT NXG AI 20 CIC NW | In distribution | |
| MICROTECH ENVY AI 2000 RIC R | In distribution | |
| MICROTECH MT NXG AI 12 ITE R | In distribution | |
| MICROTECH MT NXG AI 16 RIC RT | In distribution | |
| MICROTECH PORTRAIT 1000 CIC | In distribution | |
| MICROTECH ESENTIA AI 1000 HS R | In distribution | |
| SUMMIT IQ I1000 MRIC 312 | In distribution | |
| SUMMIT I1200 BTE 312 | In distribution | |
| MICROTECH ESENTIA 1200 RIC R | In distribution | |
| SUMMIT IQ 1600 BTE 13 | In distribution | |
| MICROTECH ESENTIA 1000 ITC R | In distribution | |
| MICROLENS SYN IQ 1200 IIC | In distribution | |
| MICROTECH ESENTIA 1600 MRIC 312 | In distribution | |
| MICROTECH PORTRAIT 2000 ITC | In distribution | |
| MICROTECH MT NXG AI 16 MRIC R | In distribution | |
| SUMMIT IQ I1000 RIC 312 | In distribution | |
| Summit i1000 BTE 13 | In distribution | |
| MICROTECH ESENTIA 1600 HS R | In distribution | |
| MICROTECH ESENTIA AI CROSBICROS RIC R | In distribution | |
| MICROTECH ESENTIA 2400 BTE R | In distribution | |
| SUMMIT IQ I1200 RIC R | In distribution | |
| SUMMIT I2400 CIC | In distribution | |
| SUMMIT I2400 ITE | In distribution | |
| SUMMIT IQ 2000 BTE 312 | In distribution | |
| MICROTECH ESENTIA 1600 BTE 13 | In distribution | |
| MICROTECH ENVY AI 2400 POWER PLUS BTE 13 | In distribution | |
| MICROTECH ENVY AI 1600 POWER PLUS BTE 13 | In distribution | |
| SUMMIT IQ 2000 MRIC 312 | In distribution | |
| MICROTECH ESENTIA 1000A MRIC 312 | In distribution | |
| SUMMIT I1200 BTE 13 PWRPLS | In distribution | |
| SUMMIT IQ 2400 MRIC 312 | In distribution | |
| MICROTECH ENVY AI 1600 IIC NW | In distribution | |
| SUMMIT 2000 BTE 13 PWRPLS | In distribution | |
| MICROTECH ESENTIA 2000 RIC 312 | In distribution | |
| MICROTECH ESENTIA 1000A BTE 13 | In distribution | |
| MICROTECH SIGNATURE SERIES 24 IIC NW | In distribution | |
| MICROLENS SYN IQ 2000 IIC | In distribution | |
| MICROTECH MT NXG AI 24 HS R | In distribution | |
| MICROTECH ESENTIA AI 2400 MRIC 312 | In distribution | |
| SUMMIT IQ 2000 CIC | In distribution | |
| MICROTECH ESENTIA AI 1600 ITE R | In distribution | |
| MICROTECH ESENTIA AI 2400 ITE R | In distribution | |
| MICROTECH ENVY AI 2000 MRIC 312 | In distribution | |
| MICROTECH ESENTIA RIC R | In distribution | |
| SUMMIT 2400 BTE 13 PWRPLS | In distribution | |
| MICROTECH ESENTIA AI 1200 HS R | In distribution | |
| SUMMIT IQ I2400 CIC | In distribution | |
| MICROTECH ENVY AI 2400 IIC NW | In distribution | |
| MICROTECH PORTRAIT I1200 HALF SHELL | In distribution | |
| MICROTECH PORTRAIT I2000 HALF SHELL | In distribution | |
| SUMMIT IQ CROSBICROS BTE 13 | In distribution | |
| MOBILITY 30 CIC | In distribution | |
| MICROTECH ESENTIA AI 1200 MRIC 312 | In distribution | |
| MICROTECH PORTRAIT 2000 HALF SHELL | In distribution | |
| MICROTECH ESENTIA CROSBICROS RIC 312 | In distribution | |
| SUMMIT 2000 CIC | In distribution | |
| MICROTECH ENVY AI 1200 RIC 312 | In distribution | |
| SUMMIT IQ I2000 BTE 13 | In distribution | |
| MICROTECH MT NXG AI 20 RIC 312 | In distribution | |
| MICROTECH ESENTIA AI 2400 RIC 312 | In distribution | |
| MICROTECH PORTRAIT I1600 HALF SHELL | In distribution | |
| MICROTECH ESENTIA RIC 312 | In distribution | |
| SUMMIT IQ 1200 HALF SHELL | In distribution | |
| MICROTECH ESENTIA 2400 ITE R | In distribution | |
| KINNECT IQ I1600 RIC 13 | In distribution | |
| MICROTECH ESENTIA 2400 RIC 312 | In distribution | |
| MICROTECH MT NXG AI 24 MRIC R | In distribution | |
| MICROTECH ESENTIA AI 1000 ITC R | In distribution | |
| SUMMIT IQ I2400 ITE | In distribution | |
| SUMMIT 1200 BTE 13 PWRPLS | In distribution | |
| MICROTECH ENVY AI 2000 CIC NW | In distribution | |
| MICROTECH ESENTIA EDGE AI 2400 BTE 13 | In distribution | |
| SUMMIT IQ 1000 RIC 312 | In distribution | |
| MICROTECH ESENTIA AI 2000 RIC 312 | In distribution | |
| MICROTECH ESENTIA AI 1200 BTE R | In distribution | |
| MICROTECH PORTRAIT 1600 IIC | In distribution | |
| MICROTECH ESENTIA AI 1600 HS R | In distribution | |
| MICROTECH PORTRAIT I2000 ITC | In distribution | |
| SUMMIT IQ 2000 RIC 312 | In distribution | |
| SUMMIT 1000 BTE 312 | In distribution | |
| SUMMIT I2400 MRIC 312 | In distribution | |
| PROPEL W10 MRIC 312 | In distribution | |
| SUMMIT IQ I1600 HALF SHELL | In distribution | |
| MICROTECH MT NXG AI 24 CIC NW | In distribution | |
| MICROTECH PORTRAIT 2400 CIC | In distribution | |
| MICROTECH ESENTIA AI 1000 MRIC 312 | In distribution | |
| SUMMIT 2400 BTE 312 | In distribution | |
| MICROTECH ESENTIA 2400 BTE 13 | In distribution | |
| SUMMIT I2000 BTE 312 | In distribution | |
| MICROTECH PORTRAIT 2400 IIC | In distribution | |
| MICROTECH ENVY AI CROS RIC R | In distribution | |
| MICROTECH PORTRAIT I1000 ITC | In distribution | |
| MICROTECH ENVY AI 1000 BTE 13 | In distribution | |
| SUMMIT IQ I1200 BTE 312 | In distribution | |
| SUMMIT I2000 HALF SHELL | In distribution | |
| MICROTECH ESENTIA AI 2000 BTE 13 | In distribution | |
| MICROTECH ESENTIA 2400 BTE 13 | In distribution | |
| MICROTECH ENVY AI 1600 ITE R | In distribution | |
| MICROTECH PORTRAIT 2400 ITC | In distribution | |
| INSPIRE X | In distribution | |
| SUMMIT IQ I2400 HALF SHELL | In distribution | |
| MICROTECH PORTRAIT 2000 ITE | In distribution | |
| SUMMIT IQ I1000 MRIC 312R | In distribution | |
| SUMMIT IQ 1600 MRIC 312R | In distribution | |
| MICROTECH PORTRAIT I1200 IIC | In distribution | |
| MICROTECH PORTRAIT I1000 HALF SHELL | In distribution | |
| SUMMIT 2000 MRIC 312 | In distribution | |
| MICROTECH ESENTIA 2400 HS R | In distribution | |
| SUMMIT I1200 RIC 312t | In distribution | |
| MICROTECH ESENTIA AI 1200 BTE 13 | In distribution | |
| SUMMIT 1000 CIC | In distribution | |
| MICROLENS SYN IQ I2400 IIC | In distribution | |
| SUMMIT IQ 1000 BTE 312 | In distribution | |
| KINNECT IQ I1600 RIC 312R | In distribution | |
| SUMMIT IQ I1600 BTE 13 PWRPLS | In distribution | |
| MICROTECH MT NXG AI 16 CIC 312 | In distribution | |
| MICROTECH ESENTIA EDGE AI 2400 RIC R | In distribution | |
| SUMMIT 2000 ITE | In distribution | |
| SUMMIT IQ 1000 MRIC 312 | In distribution | |
| MICROTECH SIGNATURE SERIES 24 CIC R NW | In distribution | |
| MICROTECH ESENTIA 1600 RIC 312 | In distribution | |
| MICROTECH ESENTIA AI 2000 ITC R | In distribution | |
| MICROTECH ENVY AI 1200 HS R | In distribution | |
| SUMMIT IQ I1000 HALF SHELL | 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 |
| Audigy | 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.