Bernafon
ZR1 MNR T, 2.4G NFM DPB Sabe/Msil Demo Zerena 1
29manufacturers in China registered for this device type
1,154catalogue numbers in this listing
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 | Bernafon, Inc., United States |
|---|---|
| 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 | 2020-12-17 |
| Record revised | 2025-03-05 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2028-03-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 222079 | In distribution | |
| 196541 | In distribution | |
| 111488 | In distribution | |
| 216558 | In distribution | |
| 193700 | In distribution | |
| 176908 | In distribution | |
| 177132 | In distribution | |
| 214985 | In distribution | |
| 113631 | In distribution | |
| 216550 | In distribution | |
| 168632 | In distribution | |
| 208811 | In distribution | |
| 212618 | In distribution | |
| 191323 | In distribution | |
| 132565 | In distribution | |
| 197303 | In distribution | |
| 212560 | In distribution | |
| 137197 | In distribution | |
| 176791 | In distribution | |
| 176790 | In distribution | |
| 131360 | In distribution | |
| 212639 | In distribution | |
| 113630 | In distribution | |
| 196500 | In distribution | |
| 182849 | In distribution | |
| 111622 | In distribution | |
| 196518 | In distribution | |
| 214961 | In distribution | |
| 192045 | In distribution | |
| 216548 | In distribution | |
| 212570 | In distribution | |
| 140304 | In distribution | |
| 179869 | In distribution | |
| 192025 | In distribution | |
| 215209 | In distribution | |
| 212596 | In distribution | |
| 216543 | In distribution | |
| 119342 | In distribution | |
| 196534 | In distribution | |
| 108211 | In distribution | |
| 212883 | In distribution | |
| 182072 | In distribution | |
| 113646 | In distribution | |
| 192061 | In distribution | |
| 151494 | In distribution | |
| 111626 | In distribution | |
| 145377 | In distribution | |
| 176904 | In distribution | |
| 136451 | In distribution | |
| 156015 | In distribution | |
| 108209 | In distribution | |
| 186040 | In distribution | |
| 192023 | In distribution | |
| 185294 | In distribution | |
| 212586 | In distribution | |
| 197045 | In distribution | |
| 137043 | In distribution | |
| 153896 | In distribution | |
| 222078 | In distribution | |
| 111679 | In distribution | |
| 182150 | In distribution | |
| 119348 | In distribution | |
| 190121 | In distribution | |
| 205377 | In distribution | |
| 119360 | In distribution | |
| 212611 | In distribution | |
| 216545 | In distribution | |
| 176794 | In distribution | |
| 215206 | In distribution | |
| 176902 | In distribution | |
| 212603 | In distribution | |
| 137041 | In distribution | |
| 215220 | In distribution | |
| 153784 | In distribution | |
| 153780 | In distribution | |
| 212612 | In distribution | |
| 212629 | In distribution | |
| 212670 | In distribution | |
| 197342 | In distribution | |
| 146658 | In distribution | |
| 176799 | In distribution | |
| 145524 | In distribution | |
| 162292 | In distribution | |
| 119345 | In distribution | |
| 182141 | In distribution | |
| 212642 | In distribution | |
| 118222 | In distribution | |
| 192071 | In distribution | |
| 197035 | In distribution | |
| 212557 | In distribution | |
| 176903 | In distribution | |
| 205601 | In distribution | |
| 205610 | In distribution | |
| 111840 | In distribution | |
| 222099 | In distribution | |
| 122243 | In distribution | |
| 216538 | In distribution | |
| 122248 | In distribution | |
| 131933 | In distribution | |
| 212566 | In distribution | |
| 131932 | In distribution | |
| 205385 | In distribution | |
| 215039 | In distribution | |
| 127859 | In distribution | |
| 145527 | In distribution | |
| 212607 | In distribution | |
| 197034 | In distribution | |
| 212625 | In distribution | |
| 159661 | In distribution | |
| 196564 | In distribution | |
| 192003 | In distribution | |
| 196553 | In distribution | |
| 186090 | In distribution | |
| 159574 | In distribution | |
| 132573 | In distribution | |
| 176806 | In distribution | |
| 131941 | In distribution | |
| 212623 | In distribution | |
| 131934 | In distribution | |
| 182185 | In distribution | |
| 215199 | In distribution | |
| 192012 | In distribution | |
| 215213 | In distribution | |
| 156055 | In distribution | |
| 196491 | In distribution | |
| 153898 | In distribution | |
| 212552 | In distribution | |
| 146662 | In distribution | |
| 153894 | In distribution | |
| 156054 | In distribution | |
| 197306 | In distribution | |
| 118227 | In distribution | |
| 212584 | In distribution | |
| 197039 | In distribution | |
| 205382 | In distribution | |
| 140312 | In distribution | |
| 182048 | In distribution | |
| 197305 | In distribution | |
| 153889 | In distribution | |
| 186022 | In distribution | |
| 191315 | In distribution | |
| 140296 | In distribution | |
| 176782 | In distribution | |
| 177128 | In distribution | |
| 196556 | In distribution | |
| 131231 | In distribution | |
| 136448 | In distribution | |
| 190111 | In distribution | |
| 131721 | In distribution | |
| 196532 | In distribution | |
| 212878 | In distribution | |
| 140301 | In distribution | |
| 212881 | In distribution | |
| 190115 | In distribution | |
| 212585 | In distribution | |
| 149389 | In distribution | |
| 137042 | In distribution | |
| 132566 | In distribution | |
| 137240 | In distribution | |
| 146929 | In distribution | |
| 197054 | In distribution | |
| 111834 | In distribution | |
| 162289 | In distribution | |
| 196508 | In distribution | |
| 191311 | In distribution | |
| 182050 | In distribution | |
| 215215 | In distribution | |
| 196495 | In distribution | |
| 197051 | In distribution | |
| 196494 | In distribution | |
| 212587 | In distribution | |
| 215045 | In distribution | |
| 212595 | In distribution | |
| 212674 | In distribution | |
| 111812 | In distribution | |
| 122250 | In distribution | |
| 192044 | In distribution | |
| 158089 | In distribution | |
| 152701 | In distribution | |
| 146669 | In distribution | |
| 192031 | In distribution | |
| 119346 | In distribution | |
| 131365 | In distribution | |
| 113648 | In distribution | |
| 185290 | In distribution | |
| 137201 | In distribution | |
| 153900 | In distribution | |
| 197033 | In distribution | |
| 141772 | In distribution | |
| 137243 | In distribution | |
| 177122 | In distribution | |
| 184873 | In distribution | |
| 155988 | In distribution | |
| 184871 | In distribution | |
| 197037 | In distribution | |
| 185934 | In distribution | |
| 122239 | In distribution | |
| 197048 | In distribution | |
| 145585 | In distribution | |
| 212651 | In distribution | |
| 156019 | In distribution | |
| 182848 | In distribution | |
| 212650 | In distribution | |
| 196488 | In distribution | |
| 140310 | In distribution | |
| 111408 | In distribution | |
| 111419 | In distribution | |
| 145581 | In distribution | |
| 192054 | In distribution | |
| 216556 | In distribution | |
| 212601 | In distribution | |
| 176786 | In distribution | |
| 191300 | In distribution | |
| 196558 | In distribution | |
| 215040 | In distribution | |
| 156017 | In distribution | |
| 155993 | In distribution | |
| 107808 | In distribution | |
| 212576 | In distribution | |
| 215198 | In distribution | |
| 182069 | In distribution | |
| 182871 | In distribution | |
| 216561 | In distribution | |
| 155987 | In distribution | |
| 176798 | In distribution | |
| 155828 | In distribution | |
| 122244 | In distribution | |
| 176797 | In distribution | |
| 212561 | In distribution | |
| 111833 | In distribution | |
| 212547 | In distribution | |
| 182056 | In distribution | |
| 179318 | In distribution | |
| 176907 | In distribution | |
| 196499 | In distribution | |
| 186007 | In distribution | |
| 222065 | In distribution | |
| 111627 | In distribution | |
| 131820 | In distribution | |
| 182052 | In distribution | |
| 187293 | In distribution | |
| 212567 | In distribution | |
| 215218 | In distribution | |
| 185933 | In distribution | |
| 215043 | In distribution | |
| 215202 | In distribution | |
| 216547 | In distribution | |
| 177125 | In distribution | |
| 186095 | In distribution | |
| 191290 | In distribution |
Showing 250 of 300 catalogue numbers.
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.