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FDA 510(k)

HISONIC-TRD TINNITUS RELIEF DEVICE

K-Number: K013253 · 2002-04-05

ApplicantHearing Innovations, Inc.
Decision Date2002-04-05
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HISONIC-TRD TINNITUS RELIEF DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Hearing Innovations, Inc.. It received FDA 510(k) clearance on 2002-04-05 under 510(k) number K013253. 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 HISONIC-TRD TINNITUS RELIEF DEVICE?

HISONIC-TRD TINNITUS RELIEF DEVICE is a medical device that received FDA 510(k) clearance on 2002-04-05. The listed applicant is Hearing Innovations, Inc.. The 510(k) number is K013253.

When did HISONIC-TRD TINNITUS RELIEF DEVICE receive FDA 510(k) clearance?

HISONIC-TRD TINNITUS RELIEF DEVICE received FDA 510(k) clearance on 2002-04-05, under 510(k) number K013253.

Who is the listed applicant for HISONIC-TRD TINNITUS RELIEF DEVICE?

The FDA 510(k) record lists Hearing Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HISONIC-TRD TINNITUS RELIEF DEVICE?

The FDA product code for HISONIC-TRD TINNITUS RELIEF DEVICE 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.

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Other records listing Hearing Innovations, Inc. 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.

K963745MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR)K951678HI SONIC 2000 DIGITAL HEARING INSTRUMENT

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

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

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