Tinnitus Therapy— 510(k) K260614
Substantially EquivalentSivantos GmbH
FDA 510(k) clearance K260614 for Tinnitus Therapy, Substantially Equivalent on 2026-06-10. Applicant: Sivantos GmbH. Device class: 2.
Summary
Sivantos' Tinnitus Therapy is filed under KLW, tinnitus maskers. The name is generic, and the record gives no model numbers or description.
Class II, 21 CFR 874.3400. Ear, Nose, and Throat is both the classification panel and the review panel. It came in as a Special 510(k).
Sivantos filed from Erlangen, Germany. Review took 105 calendar days (February 25 to June 10, 2026).
Clearance details
- Applicant
- Sivantos GmbH
- Product code
- Product code KLW
- Device class
- Class 2
- Regulation
- 21 CFR 874.3400
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Erlangen, DE
Recent devices under product code KLW
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