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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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
QUG
Device class
2
Regulation
874.3305
Medical specialty
Ear, Nose, Throat

Makers by country

CountryMakers
China52
United States15
Taiwan4
Malaysia3
Denmark2
Thailand1
Italy1
South Korea1
Vietnam1
Singapore1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Andon Health Co., LtdTianjin, ChinaManufacturer0000api.fda.gov
Anhui Huami Information Technology Co., Ltd.Hefei Pilot Free Trade Zone Anhui, ChinaExporter to the US, Manufacturer, Specification developer0000api.fda.gov
Audicon CorporationOntario, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Austar Hearing Science & Technology (xiamen) Co., LtdXiamen City Fujian, ChinaContract manufacturer, Manufacturer0000api.fda.gov
AudicusNew York, NY, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
BestNews Electronic Ware(S.Z) CO.,LTDShenZhen Guangdong, ChinaContract manufacturer, Foreign private label distributor, Manufacturer0000api.fda.gov
Cemho Medical Technology (Guangdong) Co., Ltd.Meizhou Guangdong, ChinaManufacturer0000api.fda.gov
Digimax Innovative Products LtdNew Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Eargo IncSan Jose, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Elehear Inc.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Etymotic Research, Inc.Schaumburg, IL, United StatesSpecification developer0000api.fda.gov
Eran Technology (Shenzhen)Co.,LimitedShenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Fastsound Acoustic Technology (hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Fangchenggang shengdong Health Technology Co., Ltd.fangchenggangshi Guangxi, ChinaManufacturer0000api.fda.gov
Ga Trading LLCCheyenne, WY, United StatesSpecification developer0000api.fda.gov
GN Consumer Hearing CorporationShakopee, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
GN Hearing A/SBALLERUP Hovedstaden, DenmarkSpecification developer0000api.fda.gov
GN Hearing Care CorporationShakopee, MN, United StatesContract manufacturer0000api.fda.gov
GN Resound China, Ltd.XIAMEN Fujian, ChinaContract manufacturer0000api.fda.gov
GN ReSound (Malaysia) Sdn Bhd.Kulai Johor, MalaysiaContract manufacturer0000api.fda.gov
GN ReSound (Malaysia) Sdn. BhdSenai Johor, MalaysiaContract manufacturer, Exporter to the US0000api.fda.gov
Goodmi Intelligent (shenzhen) Co.,ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Guangdong Enno Medical Technology Co., Ltd.Huizhou Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Guangdong Jiajianle Technology Co., Ltd.Guangzhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hana Microelectronics Public Co.,ltd.A. Muang Lamphun, ThailandContract manufacturer0000api.fda.gov
Hangzhou Acosound Technology Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0010api.fda.gov
Hearing Lab Technology, LLCFort Worth, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Heyuan Xuanyin Technology Co., Ltd.Heyuan Guangdong, ChinaManufacturer0000api.fda.gov
Hong Yu Kang Technology (guangdong) Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Huiling (xiamen) Medical Technology Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Health & Life CorporationZhonghe District, New Taipei City, TaiwanSpecification developer0000api.fda.gov
Hearing Lab Technology, LLC.West Bristol, PA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Hetaida Technology Co., Ltd.Dongguan Guangdong, ChinaManufacturer, Specification developer0000api.fda.gov
Huizhou Jinghao Medical Technology Co., LtdHuizhou Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Isuniye LLCMilpitas, CA, United StatesManufacturer0000api.fda.gov
JlabCarlsbad, CA, United StatesManufacturer0000api.fda.gov
Kangfu Medical Equipment FactoryWenzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Kunwei Medical Electronics Co.,ltdShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Kyto Fitness Technology Co., LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Legato Audio, Inc.Falmouth, MA, United StatesSpecification developer0000api.fda.gov
Living Science Co., Ltd.Suzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Lizn ApsRisskov Midtjylland, DenmarkExporter to the US, Specification developer0000api.fda.gov
Luxottica Group S.P.AMilan Milano, ItalyManufacturer0000api.fda.gov
MDHearing WarehouseChicago, IL, United StatesManufacturer0000api.fda.gov
Minami Medical Technology (guangdong) Co.,ltd.Zhongshan Guangdong, ChinaContract manufacturer, Foreign private label distributor0000api.fda.gov
N.K Rubber (M) Sdn. Bhd.SKUDAI Johor, MalaysiaContract manufacturer0000api.fda.gov
Ningbo Landing Technology Company Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Novidan, Inc.Golden Valley, MN, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Ok Biotech Co., Ltd.HSINCHU CITY Hsinchu(County), TaiwanManufacturer0000api.fda.gov
Olive Union Inc.Seocho-Gu Seoul, South KoreaSpecification developer0000api.fda.gov
Partron VINA DONG SOC BRANCHVinh Tuong Commune Phu Tho, VietnamContract manufacturer0000api.fda.gov
Rayson Technology (huizhou) Co., Ltd.Huizhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Relajet Tech (taiwan) Co., Ltd.Taipei, TaiwanForeign private label distributor, Manufacturer, Specification developer0000api.fda.gov
Shenzhen Anker Medical Devices Co., Ltd.Shenzhen Guangdong, ChinaComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Shenzhen Byring Hearing Technology Co., Ltd.shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Cannice Technology Co.,ltd.Shenzhen Guangdong, ChinaComplaint file establishment, Manufacturer0000api.fda.gov
Shenzhen Eartech Company Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Flysounds Medical Technology Co., Ltd.Shenzhen Guangdong, ChinaExporter to the US, Manufacturer, Specification developer0000api.fda.gov
Shenzhen Shenbo Energy Manufacturing Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Shenrui Medical Co. LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Tonycore Technology Co.,ltd.Shenzhen Guangdong, ChinaComplaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenzhen Xinzhengyu Technology Co.,ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Ziqing Medical Equipment Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Zowee Smart Manufacturing Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Sivantos Pte LtdSingapore South East, SingaporeManufacturer, Specification developer0000api.fda.gov
Sunstar Digi (H.K.) Co., LtdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Tomore Medical (Shenzhen) Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
WeHear USALittle Rock, AR, United StatesSpecification developer0000api.fda.gov
Xiamen Cleartone Hearing Technologies Co., LtdXiamen City Fujian, ChinaManufacturer0000api.fda.gov
Xiamen Melosound Technology Co.,ltdXiamen Fujian, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Xiamen Newsound Technology Co., LtdXiamen Fujian, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Xiamen Realink Hearing Technology Co., LtdXIAMEN Fujian, ChinaManufacturer0000api.fda.gov
Xiamen Retone Hearing Technology Co., Ltd.Xiamen Fujian, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Xiamen Vienatone Medical Technology Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Xiaowe Sound Technology (shenzhen) Co.,ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Xiamen Mirasing Technology Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Yeasound (xiamen) Hearing Technology Co., LtdXiamen Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zdeer Technology (henan) Co., LtdXuchang City Henan, ChinaExporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Zhongshan Tianle Hearing Technology Co.,ltdZhongshan Guangdong, ChinaManufacturer0000api.fda.gov
Zhongshan Xiaolan Town Senlan Electronic FactoryZhongshan City Guangdong, ChinaManufacturer0000api.fda.gov
Zhuhai Zorosy Technology Co., Ltd.Zhuhai Guangdong, ChinaManufacturer0000api.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.