Audiosync
37 catalogue numbers from A4 GOLD RIC 312t, 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
37catalogue 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 | 2017-01-10 |
| Record revised | 2025-08-20 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature -40 to 60 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A4 GOLD RIC 312t | In distribution | |
| AUDIOSYNC INTRIGUE AI 20 CIC NW | In distribution | |
| AUDIOSYNC SIGNATURE SERIES 16 CIC R NW | In distribution | |
| START 1000 RIC 312t | In distribution | |
| AUDIOSYNC INTRIGUE AI 24 IIC NW | In distribution | |
| AudioSync Start 1000 BTE 13 | In distribution | |
| AUDIOSYNC SIGNATURE SERIES 12 CIC R NW | In distribution | |
| AUDIOSYNC SIGNATURE SERIES 20 IIC NW | In distribution | |
| AudioSync Start 1200 BTE 13 | In distribution | |
| AudioSync Axio 8 BTE 312d | In distribution | |
| AudioSync Axio 12 BTE 13d | In distribution | |
| AUDIOSYNC ARC AI 2400 IIC NW | In distribution | |
| A4 PLATINUM RIC 312t | In distribution | |
| AudioSync A4 Gold BTE 13 | In distribution | |
| AudioSync Axio 6 BTE 13d | In distribution | |
| AUDIOSYNC SIGNATURE SERIES 20 CIC R NW | In distribution | |
| AUDIOSYNC ARC AI 1000 CIC NW | In distribution | |
| AudioSync Axio 12 BTE 312d | In distribution | |
| AUDIOSYNC SIGNATURE SERIES 24 CIC R NW | In distribution | |
| AudioSync Axio 4 BTE 312d | In distribution | |
| AudioSync Axio 4 BTE 13d | In distribution | |
| AudioSync Axio 16 BTE 13d | In distribution | |
| AudioSync Axio 6 BTE 13d | In distribution | |
| START 1200 RIC 312t | In distribution | |
| AudioSync Axio 8 BTE 13d | In distribution | |
| AudioSync Axio 6 BTE 312d | In distribution | |
| AUDIOSYNC INTRIGUE AI 16 CIC NW | In distribution | |
| AUDIOSYNC ARC AI 1600 CIC NW | In distribution | |
| AUDIOSYNC SIGNATURE SERIES 24 CIC NW | In distribution | |
| AudioSync Start 1200 BTE 13 | In distribution | |
| AUDIOSYNC INTRIGUE AI 16 IIC NW | In distribution | |
| AudioSync A4 Platinum BTE 13 | In distribution | |
| AudioSync Axio 16 BTE 312d | In distribution | |
| AudioSync Axio 6 BTE 312d | In distribution | |
| AUDIOSYNC SIGNATURE SERIES 20 CIC NW | In distribution | |
| START 1200 RIC 312t | In distribution | |
| AUDIOSYNC INTRIGUE AI 20 IIC 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.