Data / Medical devices / Germany / Sivantos GmbH
Sivantos GmbH: FDA-registered device maker in Erlangen Bavaria, Germany, 5 510(k) clearances
Sivantos GmbH is registered with the FDA (registration 3005019184) in Erlangen Bavaria, Germany. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 10, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005019184
- Address
- Henri-Dunant-Str. 100, Erlangen Bavaria, Germany, 91058
- Owner or operator
- WSAUD A/S (10023518)
- Roles
- Manufacturer, Specification developer
- First device listed
- January 29, 2010
- Registered through
- 2026
- Brand names listed
- Active Pro IX, CROS, CROS AX, CROS X, Connexx, Insio, Insio Charge&Go, Insio IX and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Audiometer | EWO | 2 | Specification developer | accessdata.fda.gov |
| Calibrator, Hearing Aid / Earphone And Analysis Systems | ETW | 2 | Specification developer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | 2 | 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 |
| Self-Fitting Air-Conduction Hearing Aid, Prescription | QDD | 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 10, 2026 | K260614 | Tinnitus Therapy | KLW | Substantially Equivalent | Sivantos GmbH | accessdata.fda.gov |
| February 9, 2024 | K233464 | WSA Self-Fitting Hearing Aid Gen 2 | QUH | Substantially Equivalent | Wsaud A/S | accessdata.fda.gov |
| August 12, 2022 | K220403 | Vibe SF Self-Fitting Hearing Aid | QDD | Substantially Equivalent | Wsaud A/S | accessdata.fda.gov |
| June 5, 2007 | K071462 | UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) | ETW | Substantially Equivalent | Siemens Hearing Instruments, Inc. | accessdata.fda.gov |
| June 1, 2001 | K011366 | CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | KLW | Substantially Equivalent | Siemens Hearing Instruments, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Self-Fitting Air-Conduction Hearing Aid, Prescription
- All makers of Self-Fitting Air-Conduction Hearing Aid, Over The Counter
- All makers of Masker, Tinnitus
- All makers of Calibrator, Hearing Aid / Earphone And Analysis Systems
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, Prescription
- All makers of Audiometer
Updated June 10, 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.