RXEars
Hearing Device (RIC) incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass,…
Hearing Device (RIC) incorporating wireless protocol to be controlled with RxEars Pro APP for basic changes to frequency response of device, for example: volume, memory, bass, treble…etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Who Else Makes It
Concentrated in Guangdong (17), Fujian (6), Jiangsu (3). 9 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 |
| Huizhou Jinghao Medical Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 5 |
| Austar Hearing Science & Technology (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 5 |
| VTech Communications Ltd | Dongguan | Guangdong | 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 |
| Shenzhen Yuezhongxing Technology Co., Ltd. | Huizhou | Guangdong | Repacker / relabeller | 10 |
| Hong YU Kang Technology (Guangdong) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Kangfu Medical Equipment Factory | Wenzhou | Zhejiang | Manufacturer | 6 |
Showing 12 of 29. All 29 manufacturers in China registered for Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Record
| Listed by | Persona Medical |
|---|---|
| FDA product code | OSM |
| Device type | Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3305 |
| Premarket notification | Exempt |
| Record published | 2020-09-01 |
| Record revised | 2020-10-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RxEars RX8 | In distribution | |
| BT1S | In distribution | |
| BT2R | In distribution | |
| RxEars APP | In distribution | |
| BT1R | In distribution | |
| Remote Microphone Wireless Streamer | In distribution | |
| RxEars RX7 | In distribution | |
| BT2S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Widex | Widex A/S | 6,599 |
| GN ReSound | GN Hearing A/S | 5,200 |
| Oticon | Oticon A/S | 3,931 |
| GN Hearing | GN Hearing A/S | 3,076 |
| Signia | WS Audiology USA, Inc. | 2,980 |
| Rexton | WS Audiology USA, Inc. | 2,876 |
| Phonak | Phonak, Inc. | 2,406 |
| Beltone | GN Hearing A/S | 2,196 |
| Unitron | Unitron Hearing Division | 1,901 |
| Unitron | Unitron Hearing | 1,745 |
| HHM | Oticon A/S | 1,329 |
| Miracle-Ear | WS Audiology USA, Inc. | 1,211 |
Showing 12 of 619. All products under Hearing Aid, Air-Conduction With Wireless Technology, 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.