Signia
Signia HA PURE 13 SDEMO DNX [T] / T GNT Hearing Aid
29manufacturers in China registered for this device type
2,980catalogue 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 | WS Audiology USA, 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 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-21 |
| Record revised | 2025-12-15 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | serial number |
| Distribution end date | 2025-11-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KIT Styletto 3AX | In distribution | |
| CROS Silk X | In distribution | |
| PURE 312 7AX | In distribution | |
| Intuis SP 4.7 | In distribution | |
| Pure C&G BCT 7IX | In distribution | |
| HA STYLETTO CONNECT 3 S L2 COS | In distribution | |
| CROS PURE CHARGE&GO NX | In distribution | |
| Styletto 7AX | In distribution | |
| KIT Styletto 7AX | In distribution | |
| Motion Charge&Go SP | In distribution | |
| CROS Styletto SD | In distribution | |
| Pure C&G BCT 1IX | In distribution | |
| CROS Pure C&G IX | In distribution | |
| PURE C&G T 2AX | In distribution | |
| HA STYLETTO CONNECT 7 S L3 BLK | In distribution | |
| HA STYLETTO 2 B L2 BLK | In distribution | |
| CROS Pure 312 X | In distribution | |
| Motion Charge&Go 2X | In distribution | |
| CHARGER BTE P | In distribution | |
| CROS Pure 312 AX | In distribution | |
| Motion C&G SP 1IX | In distribution | |
| KIT Styletto 7AX | In distribution | |
| Motion Charge&Go P | In distribution | |
| CROS Styletto IX | In distribution | |
| HA PURE 312 5X/T BLK | In distribution | |
| Motion C&G M 2IX | In distribution | |
| Set CROS Pure 312 Nx | In distribution | |
| Motion C&G SP 7IX | In distribution | |
| Motion Charge&Go P | In distribution | |
| Pure Charge&Go | In distribution | |
| KIT Styletto 3IX | In distribution | |
| KIT Styletto 7AX | In distribution | |
| Kit Styletto 7AX | In distribution | |
| KIT Styletto 3IX | In distribution | |
| HA PURE 312 3X BG | In distribution | |
| Pure C&G T 7IX | In distribution | |
| KIT Styletto 5AX | In distribution | |
| STYLETTO 1AX | In distribution | |
| KIT Styletto 5AX | In distribution | |
| Active IX | In distribution | |
| HA MOTION 13 2NX / T GNT | In distribution | |
| Pure C&G 7AX | In distribution | |
| HA STYLETTO CONNECT 3 S L3 BLK | In distribution | |
| Kit Styletto 5AX | In distribution | |
| Motion Charge&Go 7X | In distribution | |
| Pure C&G 7AX | In distribution | |
| Pure Charge&Go | In distribution | |
| Kit Styletto 7AX | In distribution | |
| Motion C&G P 5IX | In distribution | |
| Motion Charge&Go SP | In distribution | |
| Pure C&G 5AX | In distribution | |
| Styletto 3AX | In distribution | |
| KIT Styletto 3AX | In distribution | |
| EARQ M 13 1NX | In distribution | |
| Motion Charge&Go 7X | In distribution | |
| HA PURE 312 7X DBR | In distribution | |
| Motion Charge&Go P | In distribution | |
| PURE 312 1AX | In distribution | |
| KIT Styletto 7IX | In distribution | |
| Pure C&G 3IX | In distribution | |
| Pure C&G 7IX | In distribution | |
| CROS Silk C&G IX | In distribution | |
| S_ITE SILK 2NX L BLK TBLU | In distribution | |
| KIT Styletto 2AX | In distribution | |
| Kit Styletto 5AX | In distribution | |
| HA PURE 312 1NX GB | In distribution | |
| Motion C&G M 5IX | In distribution | |
| PURE+ 7PX | In distribution | |
| Pure C&G BCT 7IX | In distribution | |
| HA STYLETTO 2 B R3 SNW | In distribution | |
| AGXsicg 7X | In distribution | |
| HA MOTION 13 1NX / T DGT | In distribution | |
| Pure C&G T 7IX | In distribution | |
| EARQ MP 13 2NX | In distribution | |
| HA PURE 312 7X SLH | In distribution | |
| HA PURE 13 2NX [T] / T PRL | In distribution | |
| Motion C&G SP 5IX | In distribution | |
| HA STYLETTO CONNECT 7 B L3 BLK | In distribution | |
| HA PURE 10 2NX SB | In distribution | |
| Silk C&G 3IX | In distribution | |
| CROS PURE CHARGE&GO NX | In distribution | |
| Motion Charge&Go P | In distribution | |
| Motion C&G SP 5IX | In distribution | |
| HA PURE 10 1NX DGT | In distribution | |
| HA MOTION 13 1NX SB | In distribution | |
| KIT Styletto 1AX | In distribution | |
| HA PURE 10 2NX SLV | In distribution | |
| KIT Silk C&G 3IX RB | In distribution | |
| HA PURE 312 2NX DBR | In distribution | |
| Styletto 5AX | In distribution | |
| KIT Styletto 5AX | In distribution | |
| Motion C&G M 5IX | In distribution | |
| HA PURE 312 3X/T GNT | In distribution | |
| Pure C&G T 5IX | In distribution | |
| EARQ MP 13 1NX | In distribution | |
| HA INTUIS 3 RIC 312 SLV | In distribution | |
| Pure 312 2X | In distribution | |
| Pure C&G T 5IX | In distribution | |
| HA STYLETTO CONNECT 3 S L2 BLK | In distribution | |
| Intuis P 4.2 | In distribution | |
| HA PURE 10 1NX DBR | In distribution | |
| HA STYLETTO 2 S R2 SNW | In distribution | |
| Silk X sDemoL | In distribution | |
| CROS Styletto IX | In distribution | |
| KIT Styletto 3IX RB | In distribution | |
| Intuis P 4.2 | In distribution | |
| Pure C&G BCT 1IX | In distribution | |
| CHARGER RIC | In distribution | |
| Kit Styletto 1X | In distribution | |
| CROS Pure Charge&Go X | In distribution | |
| KIT Styletto 7AX | In distribution | |
| PURE 312 3AX | In distribution | |
| AGXsip 312 [T] 7X | In distribution | |
| HA STYLETTO CONNECT 3 S L2 SNW | In distribution | |
| Motion Charge&Go SP | In distribution | |
| KIT Silk C&G 3IX | In distribution | |
| Motion C&G P 7IX | In distribution | |
| KIT Silk C&G 2IX RB | In distribution | |
| HA STYLETTO 7AX | In distribution | |
| KIT Styletto 5AX | In distribution | |
| Pure C&G 2AX | In distribution | |
| KIT Styletto 5AX | In distribution | |
| Intuis M 4.3 | In distribution | |
| Motion C&G SP 3IX | In distribution | |
| AGXsicg 1X | In distribution | |
| KIT Styletto 3AX | In distribution | |
| Motion C&G P 5IX | In distribution | |
| Insio 5Nx ITC | In distribution | |
| HA PURE 13 1NX [T] GR | In distribution | |
| HA MOTION 13P 1NX SB | In distribution | |
| Motion Charge&Go P | In distribution | |
| Silk C&G 1IX | In distribution | |
| KIT Silk C&G 3IX | In distribution | |
| Intuis M 4.3 | In distribution | |
| Motion C&G P 2IX | In distribution | |
| Styletto 3AX | In distribution | |
| Motion Charge&Go P | In distribution | |
| CROS Pure Charge&Go X | In distribution | |
| Styletto 5AX | In distribution | |
| Active IX | In distribution | |
| EarQ CG 1X | In distribution | |
| Kit Styletto 3AX | In distribution | |
| Kit Styletto 7AX | In distribution | |
| KIT Styletto 5AX | In distribution | |
| D&C CHARGER BTE P | In distribution | |
| Motion C&G M 1IX | In distribution | |
| EARQ MP 13 2NX | In distribution | |
| PROMPT P | In distribution | |
| D&C Charger BTE SP | In distribution | |
| Active Mini 2IX | In distribution | |
| HA PURE 312 1NX GR | In distribution | |
| CROS Pure 312 X | In distribution | |
| Pure C&G BCT 2IX | In distribution | |
| Styletto 7X Kit | In distribution | |
| EarQ P 312 [T] 5X | In distribution | |
| Motion Charge&Go P | In distribution | |
| KIT Styletto 7AX | In distribution | |
| KIT Styletto 5AX | In distribution | |
| Styletto 5AX | In distribution | |
| EARQ MP 13 1NX | In distribution | |
| Motion Charge&Go P | In distribution | |
| Pure C&G 1IX | In distribution | |
| Motion Charge&Go SP | In distribution | |
| KIT Silk C&G 7IX | In distribution | |
| CROS Pure 312 X | In distribution | |
| Motion C&G SP 3IX | In distribution | |
| INSIO 3AX C&G | In distribution | |
| Kit Styletto 5X | In distribution | |
| KIT SILK C&G 5IX | In distribution | |
| AGXsip 312 [T] 5X | In distribution | |
| Intuis SP 4.2 | In distribution | |
| KIT Styletto 7IX | In distribution | |
| Motion Charge&Go 1X | In distribution | |
| Motion C&G M 1IX | In distribution | |
| Motion Charge&Go 3X | In distribution | |
| HA STYLETTO 7AX | In distribution | |
| Motion C&G P 1IX | In distribution | |
| RUN P | In distribution | |
| HA STYLETTO CONNECT 7 B R2 SNW | In distribution | |
| PURE 312 5AX | In distribution | |
| Intuis M 4.0 | In distribution | |
| HA MOTION 13 1NX / T BG | In distribution | |
| Pure C&G 7AX | In distribution | |
| HA MOTION 13 2NX / T DKC | In distribution | |
| Motion C&G P 7IX | In distribution | |
| CHARGER BTE SP | In distribution | |
| KIT Styletto 5AX | In distribution | |
| KIT Styletto sDemo DAX | In distribution | |
| KIT Styletto 5AX | In distribution | |
| Silk C&G 7IX | In distribution | |
| KIT Styletto 3IX | In distribution | |
| CROS Styletto IX | In distribution | |
| Styletto 3X Kit | In distribution | |
| Motion C&G P 7IX | In distribution | |
| HA PURE 312 1NX GNT | In distribution | |
| HA PURE 13 2NX [T] GB | In distribution | |
| CROS Pure C&G BCT IX | In distribution | |
| HA STYLETTO CONNECT 7 S R2 BLK | In distribution | |
| HA PURE 312 1NX SB | In distribution | |
| KIT Styletto 5AX | In distribution | |
| KIT Styletto 5IX | In distribution | |
| HA STYLETTO CONNECT 3 S R3 BLK | In distribution | |
| HA STYLETTO 5AX | In distribution | |
| CROS Pure312 AX | In distribution | |
| HA MOTION 13P 1NX DKC | In distribution | |
| S_ITE SILK 1NX L BLK TBLU | In distribution | |
| Pure C&G T 1IX | In distribution | |
| EarQ CG 2X | In distribution | |
| Silk Charger | In distribution | |
| Intuis SP 4.7 | In distribution | |
| Active Pro IX | In distribution | |
| D&C Charger BTE SP | In distribution | |
| D&C Charger BTE SP | In distribution | |
| KIT Styletto sDemo DIX RB | In distribution | |
| Pure Charge&Go | In distribution | |
| Motion Charge&Go 2X | In distribution | |
| Pure Charge&Go | In distribution | |
| Motion Charge&Go 5X | In distribution | |
| Pure C&G 3AX | In distribution | |
| S_ITE SILK 1NX R BLK TRD | In distribution | |
| Motion Charge&Go SP | In distribution | |
| CROS Styletto IX | In distribution | |
| Styletto 5IX | In distribution | |
| HA MOTION 13P 2NX/T BG | In distribution | |
| PURE+ 7PX | In distribution | |
| Motion Charge&Go 2X | In distribution | |
| KIT Styletto 2AX | In distribution | |
| Kit Styletto 3AX | In distribution | |
| HA MOTION 13P 1NX GNT | In distribution | |
| HA STYLETTO CONNECT 5 S L3 COS | In distribution | |
| PURE C&G T 2AX | In distribution | |
| Kit Styletto 3X | In distribution | |
| S_ITE CROS SILK NX L BLK TBLU | In distribution | |
| Motion C&G SP 1IX | In distribution | |
| PURE 312 2AX | In distribution | |
| D&C Charger BTE SP | In distribution | |
| KIT Styletto 5IX RB | In distribution | |
| Kit Styletto 5X | In distribution | |
| HA PURE 312 7X/T GR | In distribution | |
| Intuis M 4.7 | In distribution | |
| HA STYLETTO 2 S L3 SNW | In distribution | |
| HA MOTION 13P 2NX/T GB | In distribution | |
| Styletto 3AX | In distribution | |
| HA MOTION 13 1NX GB | In distribution | |
| Kit Styletto 3X | In distribution | |
| STYLETTO 2AX | In distribution | |
| Motion C&G P 7IX | In distribution | |
| AGXsip 312 [T] 5X | In distribution | |
| Silk C&G 3IX | In distribution | |
| Portable Charger Active Mini | 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 |
| 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 |
| Bernafon | Bernafon, Inc. | 1,154 |
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.