Audibel
37 catalogue numbers from AUDIBEL SIGNATURE SERIES 20 IIC NW, 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 | 2025-06-25 |
| 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 |
|---|---|---|
| AUDIBEL SIGNATURE SERIES 20 IIC NW | In distribution | |
| AUDIBEL INTRIGUE AI 16 IIC NW | In distribution | |
| AUDIBEL ARC AI 2000 IIC NW | In distribution | |
| A4 PLATINUM ITE | In distribution | |
| AUDIBEL SIGNATURE SERIES 16 IIC NW | In distribution | |
| A4 SILVER CIC | In distribution | |
| AUDIBEL ARC AI 1600 CIC NW | In distribution | |
| A2 TINNITUS GOLD RIC 10 | In distribution | |
| A4 PLATINUM HALF SHELL | In distribution | |
| Axio 6 BTE 312d | In distribution | |
| A2 TINNITUS RIC 10 | In distribution | |
| A4 GOLD ITE | In distribution | |
| AUDIBEL SIGNATURE SERIES 24 IIC NW | In distribution | |
| A4 PLATINUM BTE 312 | In distribution | |
| A4 Silver BTE 13 | In distribution | |
| START TINNITUS 8 RIC 10 | In distribution | |
| Axio 6 BTE 13d | In distribution | |
| START 1200 CIC | In distribution | |
| AUDIBEL ARC AI 1200 CIC NW | In distribution | |
| Axio 16 BTE 312d | In distribution | |
| Axio 4 BTE 312d | In distribution | |
| AUDIBEL SIGNATURE SERIES 12 CIC R NW | In distribution | |
| START 1200 ITC | In distribution | |
| Axio 8 BTE 312d | In distribution | |
| START 1000 BTE 312 | In distribution | |
| Axio 4 BTE 13d | In distribution | |
| Axio 12 BTE 13d | In distribution | |
| Axio 12 BTE 312d | In distribution | |
| START 1000 MRIC 312 | In distribution | |
| Axio 8 BTE 13d | In distribution | |
| START 1000 ITC | In distribution | |
| AUDIBEL ARC AI 1000 CIC NW | In distribution | |
| A4 GOLD RIC 312t | In distribution | |
| AUDIBEL SIGNATURE SERIES 12 CIC NW | In distribution | |
| Axio 16 BTE 13d | In distribution | |
| AUDIBEL INTRIGUE AI 20 IIC NW | In distribution | |
| Start 1000 BTE 13 | 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.