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Sonova USA Inc.: FDA-registered device maker in Aurora, IL, United States, 2 510(k) clearances

Name: Sonova USA Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sonova USA Inc. is registered with the FDA (registration 3008848788) in Aurora, IL, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 16, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008848788
Address: 444 Commerce Street, Aurora, IL, United States, 60504
Owner or operator: Sonova AG (9028479)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed: September 14, 2006
Registered through: 2026
Brand names listed: All-Day Clear ADC1 Hearing Aid, All-Day Clear Slim ADCS1 Hearing Aid, Au 3, Au A, Au B, Au Basic+, Au V, AudioNova B and more

Devices it lists

Device	Product code	Class	Role	Source
Device, Assistive Listening	LZI	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hearing Aid, Air-Conduction With Wireless Technology, Prescription	OSM	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hearing Aid, Air-Conduction, Prescription	ESD	1	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Masker, Tinnitus	KLW	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Self-Fitting Air-Conduction Hearing Aid, Over The Counter	QUH	2	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 16, 2023	K230538	All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid	QUH	Substantially Equivalent	Sonova AG	accessdata.fda.gov
February 11, 2013	K123450	PHONAK TINNITUS BALANCE	KLW	Substantially Equivalent	Phonak, LLC	accessdata.fda.gov

Compare with other makers

Updated June 16, 2023. 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.