Beltone
PKGASM,312,R,LHT,AMZ6MIH-WT-HP
11manufacturers in China registered for this device type
82catalogue numbers in this listing
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 | GN Hearing A/S, Denmark |
|---|---|
| FDA product code | LRB |
| Device type | Face Plate Hearing Aid |
| Device class | Class 1 |
| Regulation | 21 CFR 874.3300 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-01-17 |
| Record revised | 2025-09-29 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2023-03-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 21284600 | In distribution | |
| 21185300 | In distribution | |
| 21180200 | In distribution | |
| 21189400 | In distribution | |
| 21178300 | In distribution | |
| 21180700 | In distribution | |
| 21189300 | In distribution | |
| 21179900 | In distribution | |
| 21283300 | In distribution | |
| 21283100 | In distribution | |
| 21180300 | In distribution | |
| 21283400 | In distribution | |
| 21283500 | In distribution | |
| 21190200 | In distribution | |
| 21178100 | In distribution | |
| 21283200 | In distribution | |
| 21178200 | In distribution | |
| 21185400 | In distribution | |
| 21283600 | In distribution | |
| 21284000 | In distribution | |
| 21284700 | In distribution | |
| 21284300 | In distribution | |
| 21284800 | In distribution | |
| 21178400 | In distribution | |
| 21284100 | In distribution | |
| 21284400 | In distribution | |
| 21190100 | In distribution | |
| 21180800 | In distribution | |
| 21283900 | In distribution | |
| 21284200 | In distribution | |
| 21180400 | In distribution | |
| 21283800 | In distribution | |
| 21283700 | In distribution | |
| 21284500 | In distribution | |
| 21180100 | In distribution | |
| 21180000 | In distribution | |
| 19785500 | Withdrawn | |
| 19382000 | Withdrawn | |
| 19376500 | Withdrawn | |
| 19786000 | Withdrawn | |
| 19785300 | Withdrawn | |
| 19787600 | Withdrawn | |
| 19376600 | Withdrawn | |
| 19394700 | Withdrawn | |
| 19395900 | Withdrawn | |
| 19785900 | Withdrawn | |
| 19787200 | Withdrawn | |
| 19807100 | Withdrawn | |
| 19441300 | Withdrawn | |
| 19787100 | Withdrawn | |
| 19383200 | Withdrawn | |
| 19394800 | Withdrawn | |
| 19785100 | Withdrawn | |
| 19787000 | Withdrawn | |
| 19784400 | Withdrawn | |
| 19434800 | Withdrawn | |
| 19787500 | Withdrawn | |
| 19440100 | Withdrawn | |
| 19786800 | Withdrawn | |
| 19786700 | Withdrawn | |
| 19785600 | Withdrawn | |
| 19441400 | Withdrawn | |
| 19805200 | Withdrawn | |
| 19383100 | Withdrawn | |
| 19783800 | Withdrawn | |
| 19395000 | Withdrawn | |
| 19784300 | Withdrawn | |
| 19396000 | Withdrawn | |
| 19785200 | Withdrawn | |
| 19786900 | Withdrawn | |
| 19389400 | Withdrawn | |
| 19381900 | Withdrawn | |
| 19784000 | Withdrawn | |
| 19783700 | Withdrawn | |
| 19389300 | Withdrawn | |
| 19434700 | Withdrawn | |
| 19785400 | Withdrawn | |
| 19783600 | Withdrawn | |
| 19803100 | Withdrawn | |
| 19783500 | Withdrawn | |
| 19783900 | Withdrawn | |
| 19440200 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oticon | Oticon A/S | 472 |
| Bernafon | Bernafon, Inc. | 156 |
| GN ReSound | GN Hearing A/S | 134 |
| 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 |
| Agxo | Sbo Hearing A/S | 4 |
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.