Starkey
124 catalogue numbers from Axio 4 PL BTE 312d, 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
124catalogue 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 |
|---|---|---|
| Axio 4 PL BTE 312d | In distribution | |
| Axio 4 PL BTE 13d | In distribution | |
| STARKEY SIGNATURE SERIES 20 CIC NW | In distribution | |
| XINO TINNITUS 90 RIC 10 | In distribution | |
| MUSE 1200 MRIC 312 | In distribution | |
| MUSE 1000 ITC | In distribution | |
| 3 Series 70 Mini BTE 312 | In distribution | |
| 3 Series 90 Mini BTE 312 | In distribution | |
| Axio 6 PL BTE 13d | In distribution | |
| Axio 8 BTE 13d | In distribution | |
| MUSE 1000 BTE 312 | In distribution | |
| 3 Series 20 BTE Power Plus 13 | In distribution | |
| MUSE 1600 RIC 312t | In distribution | |
| Soundlens 2 70 | In distribution | |
| Muse 1000 BTE 13 | In distribution | |
| Axio 6 PL BTE 312d | In distribution | |
| MUSE 2400 CIC | In distribution | |
| STARKEY SIGNATURE SERIES 24 CIC R NW | In distribution | |
| Axio 8 PL BTE 312d | In distribution | |
| 3 Series 20 ITE | In distribution | |
| 3 Series30 ITC | In distribution | |
| SOUNDLENS SYNERGY 2000 IIC | In distribution | |
| Axio 16 PL BTE 312d | In distribution | |
| STARKEY SIGNATURE SERIES 24 CIC R NW (GS) | In distribution | |
| STARKEY SIGNATURE SERIES 12 CIC NW | In distribution | |
| 3 Series 90 RIC 312 | In distribution | |
| MUSE 2000 ITE | In distribution | |
| MUSE 1000 CIC | In distribution | |
| 3 Series 110 BTE Power Plus 13 | In distribution | |
| MUSE 1000 ITE | In distribution | |
| STARKEY SIGNATURE SERIES 16 CIC NW | In distribution | |
| STARKEY SIGNATURE SERIES 24 CIC NW (GS) | In distribution | |
| STARKEY GENESIS AI 16 IIC NW | In distribution | |
| Axio 4 BTE 312d | In distribution | |
| 3 Series 110 Mini BTE 312 | In distribution | |
| Muse 1200 PL BTE 13 | In distribution | |
| STARKEY SIGNATURE SERIES 16 IIC NW | In distribution | |
| 3 Series 90 ITC | In distribution | |
| Axio 16 BTE 13d | In distribution | |
| MUSE 1200 BTE 312 | In distribution | |
| MUSE 1600 BTE 312 | In distribution | |
| 3 Series 110 BTE 13 | In distribution | |
| MUSE 2000 RIC 312t | In distribution | |
| STARKEY EVOLV AI 2400 IIC NW | In distribution | |
| STARKEY SIGNATURE SERIES 20 IIC NW | In distribution | |
| MUSE 2000 MRIC 312 | In distribution | |
| 3 Series 20 ITC | In distribution | |
| Axio 6 BTE 312d | In distribution | |
| Axio 12 BTE 312d | In distribution | |
| 3 Series 70 ITC | In distribution | |
| 3 Series 70 HC | In distribution | |
| 3 Series 30 Mini BTE 312 | In distribution | |
| Axio 12 BTE 13d | In distribution | |
| 3 Series 110 ITE | In distribution | |
| Axio 8 BTE 312d | In distribution | |
| STARKEY SIGNATURE SERIES 24 IIC NW | In distribution | |
| STARKEY SIGNATURE SERIES 16 CIC R NW | In distribution | |
| MUSE 2400 MRIC 312 | In distribution | |
| 3 Series 20 HC | In distribution | |
| STARKEY SIGNATURE SERIES 20 CIC R NW | In distribution | |
| STARKEY GENESIS AI 12 CIC NW | In distribution | |
| 3 Series 30 BTE Power Plus 13 | In distribution | |
| MUSE 2000 RIC 312t | In distribution | |
| EVOLV AI IIC NW | In distribution | |
| MUSE 2000 MRIC 312 | In distribution | |
| XINO TINNITUS RIC 10 | In distribution | |
| MUSE 1000 BTE 312 | In distribution | |
| STARKEY GENESIS AI 24 CIC NW | In distribution | |
| MUSE 2400 RIC 312t | In distribution | |
| 3 Series 70 ITE | In distribution | |
| MUSE 1600 MRIC 312 | In distribution | |
| Muse 1600 PL BTE 13 | In distribution | |
| MUSE 1000 RIC 312t | In distribution | |
| Axio 8 PL BTE 13d | In distribution | |
| Soundlens 2 110 | In distribution | |
| Axio 6 BTE 13d | In distribution | |
| 3 Series 20 BTE 13 | In distribution | |
| 3 Series 70 BTE 13 | In distribution | |
| 3 Series 110 HC | In distribution | |
| MUSE 1200 BTE 312 | In distribution | |
| 3 Series 20 RIC 312 | In distribution | |
| STARKEY EVOLV AI 1600 IIC NW | In distribution | |
| Axio 16 BTE 312d | In distribution | |
| 3 Series 30 BTE 13 | In distribution | |
| 3 Series 30 RIC 312 | In distribution | |
| STARKEY EVOLV AI 1200 CIC NW | In distribution | |
| MUSE 1200 RIC 312t | In distribution | |
| MUSE 1600 BTE 312 | In distribution | |
| STARKEY GENESIS AI 16 CIC NW | In distribution | |
| MUSE 2000 CIC | In distribution | |
| STARKEY SIGNATURE SERIES 12 CIC R NW | In distribution | |
| MUSE 1600 HALF SHELL | In distribution | |
| Soundlens 2 90 | In distribution | |
| SOUNDLENS SYNERGY 2400 IIC | In distribution | |
| Axio 4 BTE 13d | In distribution | |
| XINO TINNITUS 30 RIC 10 | In distribution | |
| 3 Series 110 HC | In distribution | |
| Axio 12 PL BTE312d | In distribution | |
| 3 Series 90 HC | In distribution | |
| Muse 1600 BTE 13 | In distribution | |
| 3 Series30 HC | In distribution | |
| 3 Series 70 RIC 312 | In distribution | |
| 3 Series 110 CIC | In distribution | |
| 3 Series 90 BTE Power Plus 13 | In distribution | |
| 3 Series 30 ITE | In distribution | |
| Axio 12 PL BTE 13d | In distribution | |
| 3 Series 110 ITC | In distribution | |
| MUSE 2400 ITE | In distribution | |
| 3 Series 20 Mini BTE 312 | In distribution | |
| 3 Series 70 BTE Power Plus 13 | In distribution | |
| Muse 1000 PL BTE 13 | In distribution | |
| MUSE 1200 CIC | In distribution | |
| 3 Series 90 BTE 13 | In distribution | |
| MUSE 1600 CIC | In distribution | |
| 3 Series 70 CIC | In distribution | |
| Axio 16 PL BTE 13d | In distribution | |
| MUSE 1200 ITC | In distribution | |
| 3 Series 90 CIC | In distribution | |
| 3 Series30 CIC | In distribution | |
| XINO TINNITUS 30 RIC 10 | In distribution | |
| MUSE 1200 ITE | In distribution | |
| STARKEY GENESIS AI 20 CIC NW | In distribution | |
| 3 Series 110 RIC 312 | In distribution | |
| MUSE 1000 MRIC 312 | 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.