Signia
Styletto 1X Kit Snow White White Gloss
4manufacturers in China registered for this device type
70catalogue 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 | WS Audiology USA, Inc., United States |
|---|---|
| FDA product code | KLW |
| Device type | Masker, Tinnitus |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3400 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-08 |
| Record revised | 2025-10-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2025-10-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Pure 312 2X | In distribution | |
| Motion Charge&Go SP | In distribution | |
| Pure 312 1X | In distribution | |
| Pure 312 1X | In distribution | |
| Pure 312 2X | In distribution | |
| Pure 312 1X | In distribution | |
| Pure 312 2X | In distribution | |
| Motion Charge&Go P | In distribution | |
| Pure 312 1X | In distribution | |
| Pure 312 1X | In distribution | |
| Pure 312 2X | In distribution | |
| Pure 312 1X | In distribution | |
| Motion C&G M 1IX | In distribution | |
| Pure 312 1X | In distribution | |
| Pure 312 1X | In distribution | |
| Pure 312 2X | In distribution | |
| Insio 3IX CIC | In distribution | |
| Pure 312 1X | In distribution | |
| Pure 312 1X | In distribution | |
| Pure 312 1X | In distribution | |
| Pure 312 1X | In distribution | |
| Pure 312 2X | In distribution | |
| Pure 312 2X | In distribution | |
| Styletto 1X Kit | In distribution | |
| Motion Charge&Go P | In distribution | |
| Pure 312 2X | In distribution | |
| Pure 312 1X | In distribution | |
| Pure 312 2X | In distribution | |
| Styletto 3X Kit | In distribution | |
| Styletto 1X Kit | In distribution | |
| Pure 312 1X | In distribution | |
| Pure 312 2X | In distribution | |
| KIT Styletto 7AX | In distribution | |
| Pure 312 2X | In distribution | |
| Kit Styletto 7AX | In distribution | |
| Pure 312 2X | In distribution | |
| Pure 312 1X | In distribution | |
| Pure 312 2X | In distribution | |
| Pure 312 2X | In distribution | |
| Styletto 2X Kit | In distribution | |
| Pure 312 1X | In distribution | |
| Pure 312 2X | In distribution | |
| Pure 312 2X | In distribution | |
| Pure 312 1X | In distribution | |
| Pure 312 1X | In distribution | |
| Insio 5IX CIC | In distribution | |
| Pure 312 1X | In distribution | |
| Insio 5IX IIC | In distribution | |
| Motion Charge&Go P | In distribution | |
| Pure 312 1X | In distribution | |
| Pure Charge&Go 2X | Withdrawn | |
| Pure Charge&Go 1X | Withdrawn | |
| Pure Charge&Go 2X | Withdrawn | |
| Pure Charge&Go 2X | Withdrawn | |
| Pure Charge&Go 2X | Withdrawn | |
| Pure Charge&Go 2X | Withdrawn | |
| Pure Charge&Go 1X | Withdrawn | |
| Pure Charge&Go 1X | Withdrawn | |
| Pure Charge&Go 1X | Withdrawn | |
| Pure Charge&Go 1X | Withdrawn | |
| Pure Charge&Go 2X | Withdrawn | |
| Pure Charge&Go 2X | Withdrawn | |
| Pure Charge&Go 1X | Withdrawn | |
| Pure Charge&Go 2X | Withdrawn | |
| Pure Charge&Go 2X | Withdrawn | |
| Pure Charge&Go 1X | Withdrawn | |
| Pure Charge&Go 1X | Withdrawn | |
| Pure Charge&Go 1X | Withdrawn | |
| Pure Charge&Go 2X | Withdrawn | |
| Pure Charge&Go 1X | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oticon | Sbo Hearing A/S | 570 |
| Starkey | Starkey Laboratories, Inc. | 449 |
| Phonak | Sonova AG | 448 |
| 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 |
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.