Microtech
49 catalogue numbers from SUMMIT 2000 ITC, listed by Starkey Laboratories, Inc., United States, under Hearing Aid, Air-Conduction, Prescription. 45 manufacturers in China are registered for this product code.
45manufacturers in China registered for this device type
49catalogue numbers in this listing
39510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (27), Fujian (9), Jiangsu (4). 10 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 |
| Xiamen Newsound Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Guangdong Southvo Medical Technology Co., Ltd. | Qingyuan | Guangdong | Contract manufacturer | 6 |
| Huizhou Jinghao Medical Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 5 |
| Austar Hearing Science & Technology (Xiamen) Co., Ltd. | Xiamen | Fujian | 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 |
| Zhongshan Great-Ears Electronic Technology Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 3 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
Showing 12 of 45. All 45 manufacturers in China registered for Hearing Aid, Air-Conduction, Prescription
Record
| Listed by | Starkey Laboratories, Inc., United States |
|---|---|
| FDA product code | ESD |
| Device type | Hearing Aid, Air-Conduction, Prescription |
| Device class | Class 1 |
| Regulation | 21 CFR 874.3300 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| 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 |
|---|---|---|
| SUMMIT 2000 ITC | In distribution | |
| SUMMIT 1000 CIC | In distribution | |
| SUMMIT 2400 HALF SHELL | In distribution | |
| SUMMIT 1600 RIC 312t | In distribution | |
| SUMMIT 1200 CIC | In distribution | |
| MICROLENS SYNERGY 2000 IIC | In distribution | |
| SUMMIT 1600 MRIC 312 | In distribution | |
| PROPEL W50 CIC | In distribution | |
| MICROTECH ENVY AI 1600 CIC NW | In distribution | |
| MICROTECH MT NXG AI 24 IIC NW | In distribution | |
| SUMMIT 2400 ITC | In distribution | |
| SUMMIT 1600 CIC | In distribution | |
| SUMMIT 1200 BTE 312 | In distribution | |
| SUMMIT 1600 ITC | In distribution | |
| SUMMIT CROSBICROS BTE 312 | In distribution | |
| SUMMIT 1200 ITE | In distribution | |
| SUMMIT 1000 MRIC 312 | In distribution | |
| MICROTECH SIGNATURE SERIES 20 IIC NW | In distribution | |
| PROPEL TINNITUS 20 RIC 10 | In distribution | |
| MICROTECH MT NXG AI 20 IIC NW | In distribution | |
| MICROTECH SIGNATURE SERIES 16 CIC NW | In distribution | |
| PROPEL TINNITUS 40 RIC 10 | In distribution | |
| MICROTECH MT NXG AI 12 CIC NW | In distribution | |
| Summit 2000 BTE 13 | In distribution | |
| MICROLENS SYNERGY 1600 IIC | In distribution | |
| MICROTECH SIGNATURE SERIES 16 IIC NW | In distribution | |
| MICROTECH SIGNATURE SERIES 16 CIC R NW | In distribution | |
| MICROLENS SYNERGY 2400 IIC | In distribution | |
| Summit 1600 BTE 13 | In distribution | |
| SUMMIT 1200 RIC 312t | In distribution | |
| SUMMIT 1200 ITC | In distribution | |
| SUMMIT 1000 HALF SHELL | In distribution | |
| MICROTECH SIGNATURE SERIES 12 CIC R NW | In distribution | |
| SUMMIT 2000 HALF SHELL | In distribution | |
| MICROTECH MT NXG AI 16 IIC NW | In distribution | |
| MICROTECH MT NXG AI 16 CIC NW | In distribution | |
| SUMMIT 2400 ITE | In distribution | |
| SUMMIT 2400 RIC 312t | In distribution | |
| SUMMIT 2400 BTE 312 | In distribution | |
| SUMMIT 2400 CIC | In distribution | |
| SUMMIT 1600 ITE | In distribution | |
| MICROTECH SIGNATURE SERIES 20 CIC NW | In distribution | |
| SUMMIT 1600 BTE 312 | In distribution | |
| SUMMIT 1200 MRIC 312 | In distribution | |
| PROPEL TINNITUS RIC 10 | In distribution | |
| SUMMIT 1000 ITC | In distribution | |
| Summit 1000 BTE 13 | In distribution | |
| SUMMIT 1600 HALF SHELL | In distribution | |
| MICROTECH ENVY AI 1000 CIC NW | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Audio Service | WS Audiology USA, Inc. | 1,148 |
| Phonak | Phonak, Inc. | 610 |
| GN ReSound | GN Hearing A/S | 510 |
| Rexton | WS Audiology USA, Inc. | 363 |
| GN Hearing | GN Hearing A/S | 329 |
| Beltone | GN Hearing A/S | 313 |
| Siemens | WS Audiology USA, Inc. | 301 |
| Unitron | Unitron Hearing | 278 |
| Widex | Widex A/S | 177 |
| Tianle | Zhongshan Tianle Hearing Technology Co., Ltd. | 146 |
| Audina | Audina Hearing Instruments, Inc. | 144 |
| Newsound | Xiamen New Sound Technology Co., Ltd. | 142 |
Showing 12 of 347. All products under Hearing Aid, Air-Conduction, Prescription
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K970952 | 1997-05-02 |
| K964245 | 1997-02-04 |
| K964214 | 1996-11-27 |
| K964244 | 1996-11-27 |
| K963519 | 1996-09-27 |
| K960494 | 1996-03-01 |
| K943687 | 1994-10-20 |
| K943682 | 1994-08-17 |
| K940667 | 1994-08-09 |
| K942594 | 1994-07-05 |
| K942036 | 1994-06-24 |
| K932269 | 1994-05-13 |
| K941636 | 1994-05-04 |
| K940978 | 1994-05-04 |
| K941635 | 1994-05-04 |
| K934416 | 1993-11-29 |
| K934417 | 1993-11-29 |
| K933988 | 1993-10-07 |
| K933989 | 1993-10-07 |
| K933407 | 1993-10-07 |
| K933113 | 1993-07-27 |
| K930805 | 1993-03-18 |
| K930853 | 1993-03-18 |
| K923784 | 1992-08-26 |
| K911579 | 1991-05-07 |
| K903145 | 1990-12-21 |
| K901833 | 1990-08-09 |
| K901860 | 1990-07-20 |
| K880969 | 1988-04-11 |
| K880334 | 1988-03-18 |
| K880335 | 1988-03-18 |
| K880333 | 1988-03-18 |
| K791203 | 1979-08-10 |
| K790745 | 1979-05-01 |
| K790651 | 1979-04-10 |
| K790482 | 1979-04-03 |
| K780309 | 1978-02-28 |
| K772100 | 1977-11-21 |
| K772101 | 1977-11-21 |
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.