Persona Medical
These are a line of custom fitted hearing aids from Fullshell (In The Ear) to CIC (Custom In the Canal) . The devices are used for mild to severe hearing loss; these are non-programmable in…
These are a line of custom fitted hearing aids from Fullshell (In The Ear) to CIC (Custom In the Canal). The devices are used for mild to severe hearing loss; these are non-programmable in the field and adjustments ONLY made by the factory for a patient’s hearing loss and related factors.
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 | Persona Medical |
|---|---|
| FDA product code | ESD |
| Device type | Hearing Aid, Air-Conduction, Prescription |
| Device class | Class 1 |
| Regulation | 21 CFR 874.3300 |
| Premarket notification | Exempt |
| Record published | 2022-01-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2028-10-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Sombra 8P | In distribution | |
| Sombra 9R | In distribution | |
| Sombra 4S | In distribution | |
| Sombra 4R | In distribution | |
| Sombra 4P | In distribution | |
| Evok 800 | In distribution | |
| Sombra 8S | In distribution | |
| Sombra 9S | In distribution | |
| Evok 400 | In distribution | |
| Sombra 8R | In distribution | |
| Claret 400 OTE/BTE Hearing Aid | In distribution | |
| Evok 927 | In distribution | |
| Sombra 9P | In distribution | |
| Evok 900 Series Custom Hearing Aid | Withdrawn | |
| Ole Deep CIC Custom Hearing Aid | Withdrawn | |
| Claret 300 Series Custom Hearing Aid | Withdrawn | |
| Evok 500 Series Custom Hearing Aid | Withdrawn |
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
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.