Philips
HL 9000, KIT 312 NFM 85 PB T L BE Hearlink 9000
29manufacturers in China registered for this device type
1,065catalogue 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 | Sbo Hearing A/S |
|---|---|
| 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 | 2021-08-10 |
| Record revised | 2025-03-06 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2028-10-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 230693 | In distribution | |
| 239938 | In distribution | |
| 276755 | In distribution | |
| 290782 | In distribution | |
| 196573 | In distribution | |
| 289564 | In distribution | |
| 234802 | In distribution | |
| 234797 | In distribution | |
| 249257 | In distribution | |
| 289566 | In distribution | |
| 215161 | In distribution | |
| 236359 | In distribution | |
| 289730 | In distribution | |
| 208818 | In distribution | |
| 240452 | In distribution | |
| 245445 | In distribution | |
| 215412 | In distribution | |
| 215428 | In distribution | |
| 234794 | In distribution | |
| 237663 | In distribution | |
| 196636 | In distribution | |
| 196566 | In distribution | |
| 197689 | In distribution | |
| 215164 | In distribution | |
| 222315 | In distribution | |
| 205982 | In distribution | |
| 196637 | In distribution | |
| 197780 | In distribution | |
| 229401 | In distribution | |
| 197789 | In distribution | |
| 250777 | In distribution | |
| 237693 | In distribution | |
| 240757 | In distribution | |
| 276429 | In distribution | |
| 240450 | In distribution | |
| 279747 | In distribution | |
| 270497 | In distribution | |
| 197677 | In distribution | |
| 228439 | In distribution | |
| 284523 | In distribution | |
| 285060 | In distribution | |
| 215406 | In distribution | |
| 290780 | In distribution | |
| 230680 | In distribution | |
| 197787 | In distribution | |
| 197771 | In distribution | |
| 197681 | In distribution | |
| 197788 | In distribution | |
| 251750 | In distribution | |
| 258814 | In distribution | |
| 228424 | In distribution | |
| 234790 | In distribution | |
| 196585 | In distribution | |
| 245433 | In distribution | |
| 276643 | In distribution | |
| 264998 | In distribution | |
| 250740 | In distribution | |
| 205409 | In distribution | |
| 197065 | In distribution | |
| 259857 | In distribution | |
| 276759 | In distribution | |
| 249258 | In distribution | |
| 215157 | In distribution | |
| 240460 | In distribution | |
| 258820 | In distribution | |
| 250591 | In distribution | |
| 245426 | In distribution | |
| 196567 | In distribution | |
| 276432 | In distribution | |
| 236338 | In distribution | |
| 237687 | In distribution | |
| 215394 | In distribution | |
| 239935 | In distribution | |
| 230676 | In distribution | |
| 234786 | In distribution | |
| 229403 | In distribution | |
| 237674 | In distribution | |
| 250739 | In distribution | |
| 259839 | In distribution | |
| 196603 | In distribution | |
| 197655 | In distribution | |
| 205629 | In distribution | |
| 228445 | In distribution | |
| 255288 | In distribution | |
| 250587 | In distribution | |
| 197763 | In distribution | |
| 240761 | In distribution | |
| 196592 | In distribution | |
| 250915 | In distribution | |
| 276539 | In distribution | |
| 196570 | In distribution | |
| 215388 | In distribution | |
| 237694 | In distribution | |
| 238508 | In distribution | |
| 240760 | In distribution | |
| 245425 | In distribution | |
| 269913 | In distribution | |
| 234778 | In distribution | |
| 236330 | In distribution | |
| 257487 | In distribution | |
| 240457 | In distribution | |
| 289727 | In distribution | |
| 276532 | In distribution | |
| 215404 | In distribution | |
| 264988 | In distribution | |
| 279768 | In distribution | |
| 197064 | In distribution | |
| 196580 | In distribution | |
| 197704 | In distribution | |
| 233670 | In distribution | |
| 237666 | In distribution | |
| 276644 | In distribution | |
| 273922 | In distribution | |
| 289710 | In distribution | |
| 205634 | In distribution | |
| 289558 | In distribution | |
| 228431 | In distribution | |
| 230674 | In distribution | |
| 264788 | In distribution | |
| 240456 | In distribution | |
| 215430 | In distribution | |
| 262874 | In distribution | |
| 222319 | In distribution | |
| 234031 | In distribution | |
| 197779 | In distribution | |
| 215413 | In distribution | |
| 234803 | In distribution | |
| 196583 | In distribution | |
| 251751 | In distribution | |
| 289567 | In distribution | |
| 229388 | In distribution | |
| 196645 | In distribution | |
| 197678 | In distribution | |
| 290776 | In distribution | |
| 255275 | In distribution | |
| 290804 | In distribution | |
| 276543 | In distribution | |
| 290791 | In distribution | |
| 256438 | In distribution | |
| 230687 | In distribution | |
| 196628 | In distribution | |
| 276536 | In distribution | |
| 257478 | In distribution | |
| 276750 | In distribution | |
| 196582 | In distribution | |
| 197785 | In distribution | |
| 197745 | In distribution | |
| 196647 | In distribution | |
| 197320 | In distribution | |
| 222331 | In distribution | |
| 197693 | In distribution | |
| 197782 | In distribution | |
| 236354 | In distribution | |
| 197664 | In distribution | |
| 215427 | In distribution | |
| 196590 | In distribution | |
| 236362 | In distribution | |
| 215393 | In distribution | |
| 291088 | In distribution | |
| 236360 | In distribution | |
| 196609 | In distribution | |
| 196589 | In distribution | |
| 215392 | In distribution | |
| 245437 | In distribution | |
| 197074 | In distribution | |
| 269934 | In distribution | |
| 290803 | In distribution | |
| 197679 | In distribution | |
| 215409 | In distribution | |
| 197062 | In distribution | |
| 197362 | In distribution | |
| 197767 | In distribution | |
| 197680 | In distribution | |
| 228442 | In distribution | |
| 265707 | In distribution | |
| 279770 | In distribution | |
| 212510 | In distribution | |
| 196569 | In distribution | |
| 279745 | In distribution | |
| 228429 | In distribution | |
| 290774 | In distribution | |
| 196625 | In distribution | |
| 212516 | In distribution | |
| 197672 | In distribution | |
| 240458 | In distribution | |
| 265015 | In distribution | |
| 197732 | In distribution | |
| 197675 | In distribution | |
| 236348 | In distribution | |
| 245442 | In distribution | |
| 250774 | In distribution | |
| 276646 | In distribution | |
| 205631 | In distribution | |
| 197358 | In distribution | |
| 234785 | In distribution | |
| 255272 | In distribution | |
| 258817 | In distribution | |
| 205406 | In distribution | |
| 250776 | In distribution | |
| 256441 | In distribution | |
| 197701 | In distribution | |
| 196576 | In distribution | |
| 289572 | In distribution | |
| 197702 | In distribution | |
| 212523 | In distribution | |
| 196629 | In distribution | |
| 259836 | In distribution | |
| 274906 | In distribution | |
| 215414 | In distribution | |
| 265987 | In distribution | |
| 234800 | In distribution | |
| 197315 | In distribution | |
| 240762 | In distribution | |
| 257476 | In distribution | |
| 215421 | In distribution | |
| 229407 | In distribution | |
| 276753 | In distribution | |
| 279757 | In distribution | |
| 208817 | In distribution | |
| 258826 | In distribution | |
| 196619 | In distribution | |
| 201909 | In distribution | |
| 274970 | In distribution | |
| 197347 | In distribution | |
| 229389 | In distribution | |
| 276427 | In distribution | |
| 238486 | In distribution | |
| 205410 | In distribution | |
| 201905 | In distribution | |
| 240764 | In distribution | |
| 215156 | In distribution | |
| 234799 | In distribution | |
| 228427 | In distribution | |
| 269906 | In distribution | |
| 197072 | In distribution | |
| 287676 | In distribution | |
| 205630 | In distribution | |
| 255270 | In distribution | |
| 250737 | In distribution | |
| 289575 | In distribution | |
| 237692 | In distribution | |
| 236356 | In distribution | |
| 255273 | In distribution | |
| 257494 | In distribution | |
| 222330 | In distribution | |
| 196623 | In distribution | |
| 285226 | In distribution | |
| 276650 | In distribution | |
| 250919 | In distribution | |
| 196639 | 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.