Phonak
Roger 21 (02) Demo instrument
45manufacturers in China registered for this device type
46catalogue numbers in this listing
1510(k) clearance
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 | Sonova AG, Switzerland |
|---|---|
| FDA product code | ESD |
| Device type | Hearing Aid, Air-Conduction, Prescription |
| Device class | Class 1 |
| Regulation | 21 CFR 874.3300 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-02-16 |
| Record revised | 2020-10-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 063-0494-01 | In distribution | |
| 052-3469-D02V2 | In distribution | |
| 052-3469-D02V38 | In distribution | |
| 052-3317-D02M1 | In distribution | |
| 078-0065 | In distribution | |
| 063-0497-01 | In distribution | |
| 052-3470-D02 | In distribution | |
| 063-0489-01 | In distribution | |
| 052-3317-D02T1 | In distribution | |
| 052-3469-D02V3 | In distribution | |
| 052-3215-D03P69 | In distribution | |
| 052-3469-D02V18 | In distribution | |
| 063-0495-01 | In distribution | |
| 078-0066 | In distribution | |
| 063-0490-01 | In distribution | |
| 078-0062 | In distribution | |
| 063-0482-01 | In distribution | |
| 052-3469-D02V28 | In distribution | |
| 063-0248-01 | In distribution | |
| 052-3469-D02V48 | In distribution | |
| 078-0061 | In distribution | |
| 052-3469-D02V1 | In distribution | |
| 052-3469-D02V5 | In distribution | |
| 052-3215-X03P59 | In distribution | |
| 052-3469-D02V6 | In distribution | |
| 052-3323-D02 | In distribution | |
| 063-0496-01 | In distribution | |
| 063-0493-01 | In distribution | |
| 078-0060 | In distribution | |
| 052-3317-D02L8 | In distribution | |
| 052-3469-D02V58 | In distribution | |
| 078-0064 | In distribution | |
| 063-0197-01 | In distribution | |
| 052-3317-D02T2 | In distribution | |
| 063-0196-01 | In distribution | |
| 078-0063 | In distribution | |
| 052-3469-D02V4 | In distribution | |
| 063-0484-01 | In distribution | |
| 063-0288-01 | In distribution | |
| 052-3113-X02P59 | In distribution | |
| 063-0492-01 | In distribution | |
| 063-0491-01 | In distribution | |
| 052-3317-D02L9 | In distribution | |
| 052-3469-D02V68 | In distribution | |
| 063-0483-01 | In distribution | |
| 063-0488-01 | 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 |
|---|---|
| K232999 | 2024-04-11 |
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.