Data / Medical devices / Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter (QUG): 81 FDA-registered makers in 10 countries
81 establishments in 10 countries are registered with the FDA to make Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter (product code QUG, Class 2, 21 CFR 874.3305). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QUG
- Device class
- 2
- Regulation
- 874.3305
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| China | 52 |
| United States | 15 |
| Taiwan | 4 |
| Malaysia | 3 |
| Denmark | 2 |
| Thailand | 1 |
| Italy | 1 |
| South Korea | 1 |
| Vietnam | 1 |
| Singapore | 1 |
Makers of Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Andon Health Co., Ltd | Tianjin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Huami Information Technology Co., Ltd. | Hefei Pilot Free Trade Zone Anhui, China | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Audicon Corporation | Ontario, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Austar Hearing Science & Technology (xiamen) Co., Ltd | Xiamen City Fujian, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Audicus | New York, NY, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BestNews Electronic Ware(S.Z) CO.,LTD | ShenZhen Guangdong, China | Contract manufacturer, Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cemho Medical Technology (Guangdong) Co., Ltd. | Meizhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digimax Innovative Products Ltd | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eargo Inc | San Jose, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elehear Inc. | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Etymotic Research, Inc. | Schaumburg, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eran Technology (Shenzhen)Co.,Limited | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fastsound Acoustic Technology (hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fangchenggang shengdong Health Technology Co., Ltd. | fangchenggangshi Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ga Trading LLC | Cheyenne, WY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GN Consumer Hearing Corporation | Shakopee, MN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GN Hearing A/S | BALLERUP Hovedstaden, Denmark | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GN Hearing Care Corporation | Shakopee, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GN Resound China, Ltd. | XIAMEN Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GN ReSound (Malaysia) Sdn Bhd. | Kulai Johor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GN ReSound (Malaysia) Sdn. Bhd | Senai Johor, Malaysia | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Goodmi Intelligent (shenzhen) Co.,ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Enno Medical Technology Co., Ltd. | Huizhou Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Jiajianle Technology Co., Ltd. | Guangzhou Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hana Microelectronics Public Co.,ltd. | A. Muang Lamphun, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Acosound Technology Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Hearing Lab Technology, LLC | Fort Worth, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heyuan Xuanyin Technology Co., Ltd. | Heyuan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hong Yu Kang Technology (guangdong) Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huiling (xiamen) Medical Technology Co., Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Health & Life Corporation | Zhonghe District, New Taipei City, Taiwan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hearing Lab Technology, LLC. | West Bristol, PA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hetaida Technology Co., Ltd. | Dongguan Guangdong, China | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huizhou Jinghao Medical Technology Co., Ltd | Huizhou Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isuniye LLC | Milpitas, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jlab | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kangfu Medical Equipment Factory | Wenzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kunwei Medical Electronics Co.,ltd | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kyto Fitness Technology Co., Ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Legato Audio, Inc. | Falmouth, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Living Science Co., Ltd. | Suzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lizn Aps | Risskov Midtjylland, Denmark | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Luxottica Group S.P.A | Milan Milano, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MDHearing Warehouse | Chicago, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minami Medical Technology (guangdong) Co.,ltd. | Zhongshan Guangdong, China | Contract manufacturer, Foreign private label distributor | 0 | 0 | 0 | 0 | api.fda.gov | |
| N.K Rubber (M) Sdn. Bhd. | SKUDAI Johor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Landing Technology Company Co., Ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novidan, Inc. | Golden Valley, MN, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ok Biotech Co., Ltd. | HSINCHU CITY Hsinchu(County), Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olive Union Inc. | Seocho-Gu Seoul, South Korea | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Partron VINA DONG SOC BRANCH | Vinh Tuong Commune Phu Tho, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rayson Technology (huizhou) Co., Ltd. | Huizhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Relajet Tech (taiwan) Co., Ltd. | Taipei, Taiwan | Foreign private label distributor, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Anker Medical Devices Co., Ltd. | Shenzhen Guangdong, China | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Byring Hearing Technology Co., Ltd. | shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Cannice Technology Co.,ltd. | Shenzhen Guangdong, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Eartech Company Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Flysounds Medical Technology Co., Ltd. | Shenzhen Guangdong, China | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Shenbo Energy Manufacturing Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Shenrui Medical Co. Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Tonycore Technology Co.,ltd. | Shenzhen Guangdong, China | Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Xinzhengyu Technology Co.,ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Ziqing Medical Equipment Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Zowee Smart Manufacturing Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sivantos Pte Ltd | Singapore South East, Singapore | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunstar Digi (H.K.) Co., Ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tomore Medical (Shenzhen) Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WeHear USA | Little Rock, AR, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Cleartone Hearing Technologies Co., Ltd | Xiamen City Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Melosound Technology Co.,ltd | Xiamen Fujian, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Newsound Technology Co., Ltd | Xiamen Fujian, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Realink Hearing Technology Co., Ltd | XIAMEN Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Retone Hearing Technology Co., Ltd. | Xiamen Fujian, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Vienatone Medical Technology Co., Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiaowe Sound Technology (shenzhen) Co.,ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Mirasing Technology Co., Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yeasound (xiamen) Hearing Technology Co., Ltd | Xiamen Fujian, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zdeer Technology (henan) Co., Ltd | Xuchang City Henan, China | Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Tianle Hearing Technology Co.,ltd | Zhongshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Xiaolan Town Senlan Electronic Factory | Zhongshan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhuhai Zorosy Technology Co., Ltd. | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.