Skip to the page
Get started free

Data / Medical devices / Hearing Aid, Air-Conduction, Prescription / United States

FDA-registered makers of Hearing Aid, Air-Conduction, Prescription in the United States: 19 establishments

19 establishments in the United States are registered with the FDA to make Hearing Aid, Air-Conduction, Prescription (product code ESD). 2 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
Hearing Aid, Air-Conduction, Prescription
Product code
ESD
Country
United States

Makers of Hearing Aid, Air-Conduction, Prescription in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Ear Technology CorporationJohnson City, TN, United StatesRepackager or relabeler, Specification developer1September 8, 1997000api.fda.gov
Microsonic, Inc.Ambridge, PA, United StatesManufacturer, Repackager or relabeler, Specification developer1March 21, 1995000api.fda.gov
Aha Technologies, Inc.Detroit, MI, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Audina Hearing Instrument, IncLongwood, FL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Dreve America Corp.Eden Prairie, MN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Global TV Concepts, Ltd.Coconut Creek, FL, United StatesSpecification developer0000api.fda.gov
GN Hearing Care CorporationShakopee, MN, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Hearing Lab Technology, LLCFort Worth, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Hearing Lab Technology, LLC.West Bristol, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Kenyon AudiologyBend, OR, United StatesManufacturer0000api.fda.gov
MG Development America Inc.Pittsburgh, PA, United StatesManufacturer0000api.fda.gov
Magnatone Hearing Aid Corp. dba Persona MedicalCasselberry, FL, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Onlycare IncDenver, CO, United StatesManufacturer0000api.fda.gov
Prairie LabsHopkins, MN, United StatesManufacturer, Remanufacturer0000api.fda.gov
Starkey GlencoeGlencoe, MN, United StatesManufacturer0000api.fda.gov
Sonova USA Inc.Aurora, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Starkey Global Distribution CenterPlainfield, IN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Starkey Laboratories, Inc.Eden Prairie, MN, United StatesManufacturer0000api.fda.gov
WS Audiology USA, Inc.Hauppauge, NY, 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.