FDA 510(k)

Tinnitus Therapy

K-Number: K260614 · 2026-06-10

Decision Date2026-06-10

Product CodeKLW

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Tinnitus Therapy is the device name listed in this FDA 510(k) record. The listed applicant is Sivantos GmbH. It received FDA 510(k) clearance on 2026-06-10 under 510(k) number K260614. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tinnitus Therapy?

Tinnitus Therapy is a medical device that received FDA 510(k) clearance on 2026-06-10. The listed applicant is Sivantos GmbH. The 510(k) number is K260614.

When did Tinnitus Therapy receive FDA 510(k) clearance?

Tinnitus Therapy received FDA 510(k) clearance on 2026-06-10, under 510(k) number K260614.

Who is the listed applicant for Tinnitus Therapy?

The FDA 510(k) record lists Sivantos GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tinnitus Therapy?

The FDA product code for Tinnitus Therapy is KLW.

Related Devices (Code: KLW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233435Peace N Quiet (0.7.0)Pnq Health K223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity AB K221168Tinnitogram Signal GeneratorGoldenear Company, Inc.K221125SilentCloudAureliym GmbH K201370Multiflex Tinnitus TechnologyStarkey Laboratories, Inc.K193303Tinnitus Sound Generator ModuleGN Hearing A/S

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.