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FDA 510(k)

Tinnitus Sound Generator Module

K-Number: K181586 · 2018-07-13

ApplicantGN Hearing A/S
Decision Date2018-07-13
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Tinnitus Sound Generator Module is the device name listed in this FDA 510(k) record. The listed applicant is GN Hearing A/S. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K181586. 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 Sound Generator Module?

Tinnitus Sound Generator Module is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is GN Hearing A/S. The 510(k) number is K181586.

When did Tinnitus Sound Generator Module receive FDA 510(k) clearance?

Tinnitus Sound Generator Module received FDA 510(k) clearance on 2018-07-13, under 510(k) number K181586.

Who is the listed applicant for Tinnitus Sound Generator Module?

The FDA 510(k) record lists GN Hearing A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tinnitus Sound Generator Module?

The FDA product code for Tinnitus Sound Generator Module is KLW.

Related Clinical Trials

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.

NCT07711249Clinical Benefit of Hearing Aid Tinnitus Feature on Tinnitus-Related Annoyance in Tinnitus Patients in BelgiumNOT_YET_RECRUITING

Other records listing GN Hearing A/S as applicant

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.

K254108Jabra Enhance Select Self-fit (Jabra Enhance Select 550)K213424Jabra Enhance PlusK193303Tinnitus Sound Generator ModuleK180495Tinnitus Sound Generator Module

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.

K260413Levo Gen 2 Tinnitus Therapy SystemLevo Medical CorporationK260614Tinnitus TherapySivantos GmbHK233435Peace N Quiet (0.7.0)Pnq HealthK223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity ABK221168Tinnitogram Signal GeneratorGoldenear Company, Inc.K221125SilentCloudAureliym GmbH

Official Source

View on FDA Database →

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

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