Phonak
Phonak Audeo B70-Direct Demo (sand beige)
4manufacturers in China registered for this device type
448catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Fujian (1). 2 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 |
| Sonova Hearing (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Jiangsu Betterlife Medical Co., Ltd. | Jiangsu | Jiangsu | Manufacturer | 4 |
| Starkey (Suzhou) Hearing Technology Co., Ltd. | Guoxiang, Wuzhong District, Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Sonova AG, Switzerland |
|---|---|
| FDA product code | KLW |
| Device type | Masker, Tinnitus |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3400 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-17 |
| Record revised | 2020-10-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 050-0495-P8 | In distribution | |
| 050-0440-P1 | In distribution | |
| 050-0635-Q3 | In distribution | |
| 050-0533-P8 | In distribution | |
| 050-0533-P6 | In distribution | |
| 050-0479-P6 | In distribution | |
| 050-0319-P8 | In distribution | |
| 050-0635-M8 | In distribution | |
| 050-0635-P4 | In distribution | |
| 050-0483-M7 | In distribution | |
| 050-0404-P1 | In distribution | |
| 050-0519-P4 | In distribution | |
| 050-0397-P3 | In distribution | |
| 050-0481-P4 | In distribution | |
| 050-0471-M8 | In distribution | |
| 050-0481-Q3 | In distribution | |
| 050-0519-T7 | In distribution | |
| 050-0475-M7 | In distribution | |
| 050-0535-P6 | In distribution | |
| 050-0535-P5 | In distribution | |
| 050-0516-P5 | In distribution | |
| 050-0474-P8 | In distribution | |
| 050-0674-P1 | In distribution | |
| 050-0478-Q2 | In distribution | |
| 050-0745-P5 | In distribution | |
| 050-0763-P6 | In distribution | |
| 050-0483-P8 | In distribution | |
| 050-0496-P4 | In distribution | |
| 050-0429-01 | In distribution | |
| 050-0489-P1 | In distribution | |
| 050-0675-P4 | In distribution | |
| 050-0486-H0 | In distribution | |
| 050-0744-M7 | In distribution | |
| 050-0473-T3 | In distribution | |
| 050-0516-T7 | In distribution | |
| 050-0477-0000005 | In distribution | |
| 050-0473-P155 | In distribution | |
| 050-0532-H0 | In distribution | |
| 050-0494-P1 | In distribution | |
| 050-0279-01 | In distribution | |
| 050-0474-P1 | In distribution | |
| 050-0744-P8 | In distribution | |
| 050-0674-P5 | In distribution | |
| 050-0403-P3 | In distribution | |
| 050-0478-M7 | In distribution | |
| 050-0404-P3 | In distribution | |
| 050-0467-Q3 | In distribution | |
| 050-0278-T7 | In distribution | |
| 050-0472-T3 | In distribution | |
| 050-0677-P7 | In distribution | |
| 050-0429-P155 | In distribution | |
| 050-0497-P5 | In distribution | |
| 050-0489-P3 | In distribution | |
| 050-0483-Q2 | In distribution | |
| 050-0676-P5 | In distribution | |
| 050-0628-P6 | In distribution | |
| 050-0647-P3 | In distribution | |
| 050-0278-P7 | In distribution | |
| 050-0492-P5 | In distribution | |
| 050-0463-0000005 | In distribution | |
| 050-0470-P8 | In distribution | |
| 050-0470-M6 | In distribution | |
| 050-0746-P5 | In distribution | |
| 050-0482-P3 | In distribution | |
| 050-0436-P4 | In distribution | |
| 050-0462-T7 | In distribution | |
| 050-0634-T3 | In distribution | |
| 050-0494-P6 | In distribution | |
| 050-0518-T7 | In distribution | |
| 050-0517-P1 | In distribution | |
| 050-0470-Q2 | In distribution | |
| 050-0318-01 | In distribution | |
| 050-0467-P3 | In distribution | |
| 050-0483-P3 | In distribution | |
| 050-0483-P5 | In distribution | |
| 050-0746-Q2 | In distribution | |
| 050-0467-M6 | In distribution | |
| 050-0486-P8 | In distribution | |
| 050-0462-M7 | In distribution | |
| 050-0404-P5 | In distribution | |
| 050-0475-P1 | In distribution | |
| 050-0535-P3 | In distribution | |
| 050-0404-0000005 | In distribution | |
| 050-0534-P1 | In distribution | |
| 050-0403-P6 | In distribution | |
| 050-0532-P3 | In distribution | |
| 050-0485-P5 | In distribution | |
| 050-0635-P6 | In distribution | |
| 050-0437-P3 | In distribution | |
| 050-0465-M6 | In distribution | |
| 050-0487-P1 | In distribution | |
| 050-0482-01 | In distribution | |
| 050-0744-Q2 | In distribution | |
| 050-0403-P4 | In distribution | |
| 050-0491-P1 | In distribution | |
| 050-0402-P4 | In distribution | |
| 050-0534-P8 | In distribution | |
| 050-0677-P5 | In distribution | |
| 050-0319-P155 | In distribution | |
| 050-0677-T7 | In distribution | |
| 050-0492-T7 | In distribution | |
| 050-0498-P3 | In distribution | |
| 050-0635-P5 | In distribution | |
| 050-0472-P8 | In distribution | |
| 050-0482-Q3 | In distribution | |
| 050-0467-P5 | In distribution | |
| 050-0745-Q2 | In distribution | |
| 050-0399-P5 | In distribution | |
| 063-0224-01 | In distribution | |
| 050-0481-P5 | In distribution | |
| 050-0519-P1 | In distribution | |
| 050-0674-P3 | In distribution | |
| 063-0218-01 | In distribution | |
| 050-0479-M8 | In distribution | |
| 050-0516-P3 | In distribution | |
| 050-0482-M6 | In distribution | |
| 050-0492-P1 | In distribution | |
| 050-0497-P3 | In distribution | |
| 050-0477-01 | In distribution | |
| 050-0743-Q2 | In distribution | |
| 050-0440-P4 | In distribution | |
| 050-0468-P1 | In distribution | |
| 050-0495-P7 | In distribution | |
| 050-0482-P1 | In distribution | |
| 050-0517-P7 | In distribution | |
| 050-0467-T3 | In distribution | |
| 050-0490-P7 | In distribution | |
| 050-0429-P5 | In distribution | |
| 050-0635-Q2 | In distribution | |
| 050-0471-P6 | In distribution | |
| 050-0634-M8 | In distribution | |
| 050-0764-P6 | In distribution | |
| 050-0475-M6 | In distribution | |
| 050-0493-P1 | In distribution | |
| 050-0475-P3 | In distribution | |
| 050-0489-P4 | In distribution | |
| 050-0464-P3 | In distribution | |
| 050-0676-H0 | In distribution | |
| 050-0477-M7 | In distribution | |
| 050-0468-Q3 | In distribution | |
| 050-0467-P8 | In distribution | |
| 050-0516-P8 | In distribution | |
| 050-0488-T7 | In distribution | |
| 050-0743-H0 | In distribution | |
| 050-0439-P3 | In distribution | |
| 050-0399-P6 | In distribution | |
| 050-0279-P8 | In distribution | |
| 050-0647-Q2 | In distribution | |
| 050-0462-0000005 | In distribution | |
| 050-0466-P4 | In distribution | |
| 050-0477-P3 | In distribution | |
| 050-0318-P3 | In distribution | |
| 050-0472-0000005 | In distribution | |
| 050-0485-P3 | In distribution | |
| 050-0483-P4 | In distribution | |
| 050-0486-P1 | In distribution | |
| 050-0399-P7 | In distribution | |
| 050-0647-P1 | In distribution | |
| 050-0318-P155 | In distribution | |
| 050-0518-P4 | In distribution | |
| 050-0533-P5 | In distribution | |
| 050-0475-P4 | In distribution | |
| 050-0634-P1 | In distribution | |
| 050-0404-01 | In distribution | |
| 050-0470-M8 | In distribution | |
| 050-0517-P5 | In distribution | |
| 050-0440-T7 | In distribution | |
| 050-0517-P4 | In distribution | |
| 050-0477-P5 | In distribution | |
| 050-0465-P3 | In distribution | |
| 050-0481-P1 | In distribution | |
| 050-0465-Q2 | In distribution | |
| 050-0533-P7 | In distribution | |
| 063-0159-01 | In distribution | |
| 050-0398-P7 | In distribution | |
| 050-0745-T7 | In distribution | |
| 050-0517-P6 | In distribution | |
| 050-0491-P7 | In distribution | |
| 050-0519-P7 | In distribution | |
| 050-0493-P6 | In distribution | |
| 050-0675-H0 | In distribution | |
| 050-0473-0000005 | In distribution | |
| 050-0466-P5 | In distribution | |
| 050-0469-P4 | In distribution | |
| 050-0402-P5 | In distribution | |
| 050-0517-P3 | In distribution | |
| 050-0402-P7 | In distribution | |
| 063-0214-01 | In distribution | |
| 050-0278-P8 | In distribution | |
| 050-0494-P3 | In distribution | |
| 050-0489-P8 | In distribution | |
| 050-0677-P3 | In distribution | |
| 050-0475-P5 | In distribution | |
| 050-0466-M8 | In distribution | |
| 050-0467-Q2 | In distribution | |
| 050-0404-P4 | In distribution | |
| 063-0236-01 | In distribution | |
| 050-0481-M8 | In distribution | |
| 050-0746-M8 | In distribution | |
| 050-0647-P5 | In distribution | |
| 050-0436-P155 | In distribution | |
| 050-0464-Q3 | In distribution | |
| 050-0534-P3 | In distribution | |
| 050-0278-0000005 | In distribution | |
| 050-0479-P8 | In distribution | |
| 050-0398-P1 | In distribution | |
| 050-0648-T7 | In distribution | |
| 050-0491-T7 | In distribution | |
| 050-0319-P4 | In distribution | |
| 050-0469-P6 | In distribution | |
| 050-0402-P155 | In distribution | |
| 050-0744-P3 | In distribution | |
| 050-0437-P5 | In distribution | |
| 050-0493-P8 | In distribution | |
| 050-0496-P6 | In distribution | |
| 050-0402-P3 | In distribution | |
| 050-0278-P6 | In distribution | |
| 050-0476-P4 | In distribution | |
| 050-0675-P6 | In distribution | |
| 050-0488-P4 | In distribution | |
| 050-0489-P7 | In distribution | |
| 050-0475-M8 | In distribution | |
| 050-0468-P155 | In distribution | |
| 050-0479-P155 | In distribution | |
| 050-0467-P1 | In distribution | |
| 050-0532-P7 | In distribution | |
| 050-0464-Q2 | In distribution | |
| 050-0475-P155 | In distribution | |
| 050-0676-P7 | In distribution | |
| 050-0635-T7 | In distribution | |
| 050-0481-01 | In distribution | |
| 050-0479-01 | In distribution | |
| 050-0464-T7 | In distribution | |
| 050-0470-M7 | In distribution | |
| 050-0487-P6 | In distribution | |
| 050-0473-M8 | In distribution | |
| 050-0480-P3 | In distribution | |
| 050-0674-P7 | In distribution | |
| 050-0399-P155 | In distribution | |
| 050-0648-Q2 | In distribution | |
| 050-0436-P6 | In distribution | |
| 050-0674-P6 | In distribution | |
| 050-0480-T7 | In distribution | |
| 050-0629-P6 | In distribution | |
| 063-0208-01 | In distribution | |
| 050-0463-P8 | In distribution | |
| 050-0479-P1 | In distribution | |
| 050-0745-P8 | In distribution | |
| 050-0746-M7 | In distribution | |
| 050-0465-Q3 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oticon | Sbo Hearing A/S | 570 |
| Starkey | Starkey Laboratories, Inc. | 449 |
| Oticon | Oticon A/S | 353 |
| Nuear | Starkey Laboratories, Inc. | 336 |
| Audibel | Starkey Laboratories, Inc. | 318 |
| Unitron | Unitron Hearing Division | 292 |
| Audigy | Starkey Laboratories, Inc. | 284 |
| Microtech | Starkey Laboratories, Inc. | 284 |
| audifon | Audifon – Gmbh & Co.kg | 277 |
| Philips | Sbo Hearing A/S | 270 |
| Agxo | Sbo Hearing A/S | 260 |
| Hansaton | Hansaton Akustik GmbH | 249 |
Showing 12 of 86. All products under Masker, Tinnitus
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.