GN Hearing
REC TMRIE,M&RIE,SF3C,MM,0R,BLT
45manufacturers in China registered for this device type
329catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Guangdong (27), Fujian (9), Jiangsu (4). 10 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 |
| Guangdong Southvo Medical Technology Co., Ltd. | Qingyuan | Guangdong | Contract manufacturer | 6 |
| Huizhou Jinghao Medical Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 5 |
| Austar Hearing Science & Technology (Xiamen) Co., Ltd. | Xiamen | Fujian | 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 |
| Zhongshan Great-Ears Electronic Technology Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 3 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
Showing 12 of 45. All 45 manufacturers in China registered for Hearing Aid, Air-Conduction, Prescription
Record
| Listed by | GN Hearing A/S, Denmark |
|---|---|
| FDA product code | ESD |
| Device type | Hearing Aid, Air-Conduction, Prescription |
| Device class | Class 1 |
| Regulation | 21 CFR 874.3300 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-05-08 |
| Record revised | 2025-09-29 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2020-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 21307300 | In distribution | |
| XH2CIC-LP | In distribution | |
| XF5CIC-LP | In distribution | |
| 18581300 | In distribution | |
| 18582400 | In distribution | |
| EP2CIC-LP | In distribution | |
| EP1CIC-LP | In distribution | |
| XF5CIC-HP | In distribution | |
| JEC1CIC-MP | In distribution | |
| 21879208 | In distribution | |
| 18580700 | In distribution | |
| 18580600 | In distribution | |
| 21642900 | In distribution | |
| 21644300 | In distribution | |
| 21384800 | In distribution | |
| 21641600 | In distribution | |
| 21642700 | In distribution | |
| XJ5CIC-LP | In distribution | |
| 21306000 | In distribution | |
| 21642500 | In distribution | |
| 18582600 | In distribution | |
| 22406501 | In distribution | |
| 21306500 | In distribution | |
| XD9CIC-LP | In distribution | |
| 21643900 | In distribution | |
| 18581500 | In distribution | |
| 18581700 | In distribution | |
| 21308200 | In distribution | |
| XD7CIC-HP | In distribution | |
| XF9CIC-MP | In distribution | |
| XD5CIC-LP | In distribution | |
| XJ7CIC-HP | In distribution | |
| 21878805 | In distribution | |
| 18580300 | In distribution | |
| 21305500 | In distribution | |
| XB9CIC-LP | In distribution | |
| XD5CIC-MP | In distribution | |
| XJ7CIC-MP | In distribution | |
| 21307700 | In distribution | |
| XD5CIC-HP | In distribution | |
| XH3CIC-LP | In distribution | |
| 21384100 | In distribution | |
| 21643400 | In distribution | |
| XJ5CIC-MP | In distribution | |
| 21644400 | In distribution | |
| 21385700 | In distribution | |
| XD7CIC-LP | In distribution | |
| 22406505 | In distribution | |
| 21306100 | In distribution | |
| 21385600 | In distribution | |
| 21307900 | In distribution | |
| XH3CIC-HP | In distribution | |
| 18520300 | In distribution | |
| 21307100 | In distribution | |
| 21878808 | In distribution | |
| 21385800 | In distribution | |
| XJ7CIC-LP | In distribution | |
| 21641800 | In distribution | |
| 21306200 | In distribution | |
| 18582800 | In distribution | |
| XF9CIC-LP | In distribution | |
| 21385000 | In distribution | |
| 21384900 | In distribution | |
| 21879205 | In distribution | |
| 22406509 | In distribution | |
| XD9CIC-HP | In distribution | |
| 21878804 | In distribution | |
| XJ5CIC-HP | In distribution | |
| 22406508 | In distribution | |
| XJ4CIC-HP | In distribution | |
| 21384200 | In distribution | |
| 21878809 | In distribution | |
| XF7CIC-MP | In distribution | |
| 21644100 | In distribution | |
| 18521800 | In distribution | |
| 18580500 | In distribution | |
| XB7CIC-LP | In distribution | |
| XJ4CIC-MP | In distribution | |
| 21643700 | In distribution | |
| 18521700 | In distribution | |
| 21878807 | In distribution | |
| 21308100 | In distribution | |
| 21879200 | In distribution | |
| 21307600 | In distribution | |
| 21642800 | In distribution | |
| 21878801 | In distribution | |
| 21641700 | In distribution | |
| XB5CIC-HP | In distribution | |
| XF9CIC-HP | In distribution | |
| 22406507 | In distribution | |
| 21385200 | In distribution | |
| 21305600 | In distribution | |
| EP1CIC-MP | In distribution | |
| XD9CIC-MP | In distribution | |
| 21641500 | In distribution | |
| 21385900 | In distribution | |
| 21643800 | In distribution | |
| 21386000 | In distribution | |
| 21306700 | In distribution | |
| 18520600 | In distribution | |
| 21307000 | In distribution | |
| 22406506 | In distribution | |
| 21879207 | In distribution | |
| 21307400 | In distribution | |
| 21642200 | In distribution | |
| 21306300 | In distribution | |
| 21384300 | In distribution | |
| EP1CIC-HP | In distribution | |
| 21879201 | In distribution | |
| 18521900 | In distribution | |
| 21307200 | In distribution | |
| 21642400 | In distribution | |
| 21642300 | In distribution | |
| 21879209 | In distribution | |
| 21385400 | In distribution | |
| 21305900 | In distribution | |
| 21305700 | In distribution | |
| 22406502 | In distribution | |
| 21878800 | In distribution | |
| XF7CIC-HP | In distribution | |
| 18582500 | In distribution | |
| XJ9CIC-LP | In distribution | |
| 18580400 | In distribution | |
| 18521600 | In distribution | |
| 18520400 | In distribution | |
| 18582300 | In distribution | |
| XF5CIC-MP | In distribution | |
| 21385500 | In distribution | |
| 21306800 | In distribution | |
| XH3CIC-MP | In distribution | |
| 21305800 | In distribution | |
| 21308000 | In distribution | |
| 21306400 | In distribution | |
| 21644200 | In distribution | |
| XF7CIC-LP | In distribution | |
| 18520700 | In distribution | |
| 21643300 | In distribution | |
| 18520500 | In distribution | |
| 18581800 | In distribution | |
| XJ9CIC-MP | In distribution | |
| XB7CIC-HP | In distribution | |
| 18520800 | In distribution | |
| 21644000 | In distribution | |
| 21879202 | In distribution | |
| XB9CIC-HP | In distribution | |
| 18581600 | In distribution | |
| 21306900 | In distribution | |
| 21879206 | In distribution | |
| 18521500 | In distribution | |
| 21384500 | In distribution | |
| 21643500 | In distribution | |
| 21307500 | In distribution | |
| 21308300 | In distribution | |
| 21385100 | In distribution | |
| 21643600 | In distribution | |
| XB5CIC-MP | In distribution | |
| 21642600 | In distribution | |
| 21384400 | In distribution | |
| 21879203 | In distribution | |
| 21384700 | In distribution | |
| XH2CIC-MP | In distribution | |
| XJ9CIC-HP | In distribution | |
| 18522000 | In distribution | |
| 21385300 | In distribution | |
| XJ4CIC-LP | In distribution | |
| 21643100 | In distribution | |
| XD7CIC-MP | In distribution | |
| 18581400 | In distribution | |
| 18580800 | In distribution | |
| XB7CIC-MP | In distribution | |
| 18582700 | In distribution | |
| 21878802 | In distribution | |
| 21878803 | In distribution | |
| JEC1CIC-LP | In distribution | |
| JEC1CIC-HP | In distribution | |
| 21642100 | In distribution | |
| XB9CIC-MP | In distribution | |
| 21642000 | In distribution | |
| 21643200 | In distribution | |
| 21308400 | In distribution | |
| 21306600 | In distribution | |
| 21643000 | In distribution | |
| 21307800 | In distribution | |
| XB5CIC-LP | In distribution | |
| 21641900 | In distribution | |
| 22406500 | In distribution | |
| EP2CIC-HP | In distribution | |
| XH2CIC-HP | In distribution | |
| 22406504 | In distribution | |
| 21879204 | In distribution | |
| 21384600 | In distribution | |
| EP2CIC-MP | In distribution | |
| 22406503 | In distribution | |
| 21878806 | In distribution | |
| PKX7ITC-UP | Withdrawn | |
| FP9MIH-HP | Withdrawn | |
| FP9IIC | Withdrawn | |
| FP9MIH-S-MP | Withdrawn | |
| PKX7CIC-LP | Withdrawn | |
| PK9ITE-D-HP | Withdrawn | |
| PKX7ITC-HP | Withdrawn | |
| PK7CIC-UP | Withdrawn | |
| FP9ITC-D-UP | Withdrawn | |
| FP7CIC-LP | Withdrawn | |
| PKX9IIC | Withdrawn | |
| FP9ITE-MP | Withdrawn | |
| PK9CIC-LP | Withdrawn | |
| PK9MIH-MP | Withdrawn | |
| PKX9ITC-MP | Withdrawn | |
| PK9ITC-UP | Withdrawn | |
| PK9ITC-D-MP | Withdrawn | |
| PK9MIH-S-MP | Withdrawn | |
| FP7ITC-D-UP | Withdrawn | |
| PKX9MIH-MP | Withdrawn | |
| FP9ITC-UP | Withdrawn | |
| PK9ITC-D-LP | Withdrawn | |
| FP9ITC-D-MP | Withdrawn | |
| FP7CIC-MP | Withdrawn | |
| PK7ITE-UP | Withdrawn | |
| PKX7CIC-MP | Withdrawn | |
| FP7ITE-D-HP | Withdrawn | |
| FP9CIC-HP | Withdrawn | |
| FP7ITE-UP | Withdrawn | |
| PKX9ITC-UP | Withdrawn | |
| FP7ITE-HP | Withdrawn | |
| FP9ITE-D-UP | Withdrawn | |
| PKX7ITC-D-UP | Withdrawn | |
| PK9CIC-HP | Withdrawn | |
| FP9ITC-LP | Withdrawn | |
| PKX7ITC-D-MP | Withdrawn | |
| PKX9ITE-HP | Withdrawn | |
| FP9ITE-D-MP | Withdrawn | |
| FP9CIC-MP | Withdrawn | |
| PK9ITE-D-UP | Withdrawn | |
| PKX7ITE-D-HP | Withdrawn | |
| PK7ITC-MP | Withdrawn | |
| FP9MIH-S-HP | Withdrawn | |
| PK7CIC-MP | Withdrawn | |
| PK9ITC-D-HP | Withdrawn | |
| PKX9CIC-LP | Withdrawn | |
| PKX9MIH-LP | Withdrawn | |
| FP9ITE-UP | Withdrawn | |
| PK7CIC-LP | Withdrawn | |
| FP7ITC-D-LP | Withdrawn | |
| PK9MIH-S-HP | Withdrawn | |
| FP9ITC-HP | Withdrawn | |
| FP9MIH-LP | Withdrawn | |
| PKX9MIH-S-MP | Withdrawn | |
| PKX9ITE-MP | Withdrawn | |
| PK7ITC-D-LP | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Audio Service | WS Audiology USA, Inc. | 1,148 |
| Phonak | Phonak, Inc. | 610 |
| GN ReSound | GN Hearing A/S | 510 |
| Rexton | WS Audiology USA, Inc. | 363 |
| Beltone | GN Hearing A/S | 313 |
| Siemens | WS Audiology USA, Inc. | 301 |
| Unitron | Unitron Hearing | 278 |
| Widex | Widex A/S | 177 |
| Tianle | Zhongshan Tianle Hearing Technology Co., Ltd. | 146 |
| Audina | Audina Hearing Instruments, Inc. | 144 |
| Newsound | Xiamen New Sound Technology Co., Ltd. | 142 |
| Biopor® AB | Dreve Otoplastik GmbH | 133 |
Showing 12 of 347. All products under Hearing Aid, Air-Conduction, Prescription
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-09-18 | Class II | Other | GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a limited number of repaired hearing aids. The software bug cause | 590 units | 2023-05-31 |
| 2019-09-18 | Class II | Other | GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a limited number of repaired hearing aids. The software bug cause | 285 units | 2023-05-31 |
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.