Data / Medical devices / Switzerland / Sonova AG
Sonova AG: FDA-registered device maker in STAEFA Zurich, Switzerland, 3 510(k) clearances
Sonova AG is registered with the FDA (registration 3005085999) in STAEFA Zurich, Switzerland. It lists 5 device types. The FDA files 3 510(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
- 3005085999
- Address
- 28 Laubisruetistrasse, STAEFA Zurich, Switzerland, 8712
- Owner or operator
- Sonova AG (9028479)
- Roles
- Manufacturer, Specification developer
- 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 | Manufacturer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Prescription | ESD | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Masker, Tinnitus | KLW | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Self-Fitting Air-Conduction Hearing Aid, Over The Counter | QUH | 2 | Manufacturer, Specification developer | 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 |
| January 4, 2023 | K221125 | SilentCloud | KLW | Substantially Equivalent | Aureliym GmbH | accessdata.fda.gov |
| February 11, 2013 | K123450 | PHONAK TINNITUS BALANCE | KLW | Substantially Equivalent | Phonak, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Masker, Tinnitus
- All makers of Hearing Aid, Air-Conduction, Prescription
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, Prescription
- All makers of Device, Assistive Listening
- All makers of Self-Fitting Air-Conduction Hearing Aid, Over The Counter
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.