Nuear
48 catalogue numbers from INTRO 1000 HALF SHELL, 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
48catalogue 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 |
|---|---|---|
| INTRO 1000 HALF SHELL | In distribution | |
| INTRO 1000 ITC | In distribution | |
| NOW PRO CIC | In distribution | |
| Axio 4 BTE 13d | In distribution | |
| INTRO 1000 BTE 312 | In distribution | |
| Axio 12 BTE 13d | In distribution | |
| INTRO 1200 CIC | In distribution | |
| NUEAR SIGNATURE SERIES 12 CIC R NW | In distribution | |
| NOW PRO MRIC 312 | In distribution | |
| NOW PRESTIGE RIC 312t | In distribution | |
| Axio 4 BTE 312d | In distribution | |
| NUEAR SAVANT AI 2000 CIC NW | In distribution | |
| Axio 6 BTE 13d | In distribution | |
| INTRO 1000 CIC | In distribution | |
| NUEAR SIGNATURE SERIES 24 CIC R NW | In distribution | |
| NOW Pro BTE 13 | In distribution | |
| NOW Prestige BTE 13 | In distribution | |
| NUEAR SAVANT AI 1600 CIC NW | In distribution | |
| MINISCOPIC SYNERGY PRO IIC | In distribution | |
| NOW PRESTIGE ITC | In distribution | |
| Axio 8 BTE 312d | In distribution | |
| INTRO 1200 ITE | In distribution | |
| NUEAR NE NXG AI 16 IIC NW | In distribution | |
| NUEAR NE NXG AI 24 CIC NW | In distribution | |
| NOW Premier BTE 13 | In distribution | |
| NUEAR NE NXG AI 16 CIC NW | In distribution | |
| NUEAR NE NXG AI 20 CIC NW | In distribution | |
| Axio 16 BTE 312d | In distribution | |
| INTRO 1200 MRIC 312 | In distribution | |
| INTRO 1200 RIC 312t | In distribution | |
| Axio 8 BTE 13d | In distribution | |
| NUEAR SIGNATURE SERIES 24 CIC NW | In distribution | |
| NOW PRESTIGE MRIC 312 | In distribution | |
| INTRO 1200 ITC | In distribution | |
| NOW PRO ITE | In distribution | |
| SDS TINNITUS RIC 10 | In distribution | |
| Axio 12 BTE312d | In distribution | |
| NOW PREMIER MRIC 312 | In distribution | |
| INTRO 1200 BTE 312 | In distribution | |
| NOW PRO ITC | In distribution | |
| MINISCOPIC SYNERGY PRESTIGE IIC | In distribution | |
| INTRO 1200 RIC 312t | In distribution | |
| NUEAR SIGNATURE SERIES 16 CIC NW | In distribution | |
| NUEAR SAVANT AI 2400 CIC NW | In distribution | |
| NOW PREMIER HALF SHELL | In distribution | |
| NUEAR NE NXG AI 24 IIC NW | In distribution | |
| Axio 6 BTE 312d | In distribution | |
| Axio 16 BTE 13d | 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.