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Data / Medical devices / Audiometer / United States

FDA-registered makers of Audiometer in the United States: 19 establishments

19 establishments in the United States are registered with the FDA to make Audiometer (product code EWO). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. 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 makers of this device in the United StatesWatch these makers
Device
Audiometer
Product code
EWO
Country
United States

Makers of Audiometer in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Diagnostic Group LLCEden Prairie, MN, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer11May 11, 2018000api.fda.gov
Intelligent Hearing Systems Corp.Miami, FL, United StatesManufacturer, Manufacturer for export3January 8, 2003000api.fda.gov
Circuit Works CorporationWaukegan, IL, United StatesManufacturer1June 18, 1993000api.fda.gov
Etymotic Research, Inc.Schaumburg, IL, United StatesSpecification developer1June 18, 1993000api.fda.gov
Hearing Lab Technology, LLCFort Worth, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1June 18, 1993000api.fda.gov
Ambco Electronics, A California Corp.Tustin, CA, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Apple Inc.Cupertino, CA, United StatesManufacturer0000api.fda.gov
Adonai Technologies LLCMiddletown, OH, United StatesContract manufacturer0000api.fda.gov
Dictum Health, Inc.Malibu, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Examinetics, Inc.Overland Park, KS, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Examinetics, IncBelton, MO, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Gobiquity, Inc.Nashville, TN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Hear.com LLC (tele-Dx)Coral Gables, FL, United StatesManufacturer0000api.fda.gov
JSM SolutionsFaribault, MN, United StatesSpecification developer0000api.fda.gov
Medrx, Inc.Largo, FL, United StatesManufacturer0000api.fda.gov
Micro Audiometrics CorporationDaytona Beach, FL, United StatesManufacturer0000api.fda.gov
Precision Cast Plastic Parts, Inc.Redding, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
WAHTS Hearing LLCWest Lebanon, NH, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesManufacturer0000api.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.