Nano
Catalogue number First Ear Plus ITE, listed by Xiamen New Sound Technology Co., Ltd., under Face Plate Hearing Aid. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Fujian (7), Guangdong (3), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xiamen Newsound Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Austar Hearing Science & Technology (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 5 |
| Xiamen Retone Hearing Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 5 |
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Xiamen Vienatone Medical Technology Co., Ltd. | Xiamen | Fujian | Manufacturer | 5 |
| Jiangsu Betterlife Medical Co., Ltd. | Jiangsu | Jiangsu | Manufacturer | 4 |
| Xiamen Melosound Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 4 |
| Xiamen Realink Hearing Technology Co., Ltd. | Xiamen | Fujian | Manufacturer | 4 |
| Shenzhen Byring Hearing Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Shenzhen Zhongde Audio-Technical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 3 |
| Zhongshan XIN Hongsheng Technology Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 2 |
Record
| Listed by | Xiamen New Sound Technology Co., Ltd. |
|---|---|
| FDA product code | LRB |
| Device type | Face Plate Hearing Aid |
| Device class | Class 1 |
| Regulation | 21 CFR 874.3300 |
| Premarket notification | Exempt |
| Record published | 2024-05-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| First Ear Plus ITE | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oticon | Oticon A/S | 472 |
| Bernafon | Bernafon, Inc. | 156 |
| GN ReSound | GN Hearing A/S | 134 |
| Beltone | GN Hearing A/S | 82 |
| Sonic | Sonic Innovations, Inc. | 66 |
| Audina | Audina Hearing Instruments, Inc. | 63 |
| Philips | Sbo Hearing A/S | 24 |
| Oticon | Sbo Hearing A/S | 11 |
| Bernafon | Sbo Hearing A/S | 8 |
| Austar | Austar Hearing Science & Technology (Xiamen) Co., Ltd. men) Co., Ltd. | 6 |
| Birdsong | Sbo Hearing A/S | 6 |
| Retone | Xiamen Retone Hearing Technology Co., Ltd. | 5 |
Showing 12 of 15. All products under Face Plate Hearing Aid
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.