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Data / Medical devices / Cushion, Earphone (For Audiometric Testing)

Cushion, Earphone (For Audiometric Testing) (ETT): 15 FDA-registered makers in 6 countries

15 establishments in 6 countries are registered with the FDA to make Cushion, Earphone (For Audiometric Testing) (product code ETT, Class 1, 21 CFR 874.1100). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
ETT
Device class
1
Regulation
874.1100
Medical specialty
Ear, Nose, Throat

Makers by country

CountryMakers
United States7
Denmark3
Poland2
China1
Ireland1
Germany1

Makers of Cushion, Earphone (For Audiometric Testing)

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
Arimon Technologies, Inc.Peshtigo, WI, United StatesContract manufacturer0000api.fda.gov
Auditdata A/SCopenhagen Hovedstaden, DenmarkComplaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer0000api.fda.gov
DGS Diagnostics Sp. z o.oKolbaskowo Zachodniopomorskie, PolandContract manufacturer, Manufacturer0000api.fda.gov
Etymotic Research, Inc.Schaumburg, IL, United StatesSpecification developer0000api.fda.gov
Gobiquity, Inc.Nashville, TN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Grason & Associates, LLCRindge, NH, United StatesManufacturer0000api.fda.gov
Guangdong Kelihuan Biotechnology Co., Ltd.Huizhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hearing Lab Technology, LLCFort Worth, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Interacoustics A/SMiddelfart Syddanmark, DenmarkComplaint file establishment, Specification developer0000api.fda.gov
JSM SolutionsFaribault, MN, United StatesSpecification developer0000api.fda.gov
Natus Manufacturing LimitedGORT, Co. Galway(County), IrelandComplaint file establishment, Manufacturer0000api.fda.gov
Natus Medical Denmark ApSTAASTRUP Hovedstaden, DenmarkComplaint file establishment, Specification developer0000api.fda.gov
Nordes Sp. z o.o.Wroclaw Dolnoslaskie, PolandContract manufacturer0000api.fda.gov
PathGermering Bavaria, GermanyManufacturer0000api.fda.gov
R & D Medical Products, Inc.Lake Forest, CA, United StatesContract manufacturer0000api.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.