ALL American
22 catalogue numbers from PRIDE 2000 CIC, 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
22catalogue 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 |
| Record published | 2016-10-07 |
| 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 |
|---|---|---|
| PRIDE 2000 CIC | In distribution | |
| PRIDE 2400 ITE | In distribution | |
| PRIDE 2000 HALF SHELL | In distribution | |
| PRIDE 1200 CIC | In distribution | |
| PRIDE 1600 MRIC 312 | In distribution | |
| PRIDE 1200 ITE | In distribution | |
| PRIDE 2000 ITE | In distribution | |
| PRIDE 1000 MRIC 312 | In distribution | |
| PRIDE 1000 HALF SHELL | In distribution | |
| PRIDE 2000 BTE 312 | In distribution | |
| PRIDE 1000 BTE 312 | In distribution | |
| PRIDE 1200 BTE 312 | In distribution | |
| PRIDE 1600 HALF SHELL | In distribution | |
| PRIDE 2400 IIC | In distribution | |
| PRIDE 2000 ITC | In distribution | |
| PRIDE 1600 BTE 312 | In distribution | |
| PRIDE 1000 CIC | In distribution | |
| PRIDE 1600 IIC | In distribution | |
| PRIDE 1600 ITC | In distribution | |
| PRIDE 2400 CIC | In distribution | |
| PRIDE CROSBICROS CIC | In distribution | |
| PRIDE 2400 ITC | 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.