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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 a medical device manufactured by GN Hearing A/S. It received FDA 510(k) clearance on 2018-07-13 under approval 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. It is manufactured by GN Hearing A/S. The 510(k) number is K181586.

When was Tinnitus Sound Generator Module approved by the FDA?

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

What company makes Tinnitus Sound Generator Module?

Tinnitus Sound Generator Module is manufactured by GN Hearing A/S.

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

NCT06106594 VOLT CE Mark Study ACTIVE_NOT_RECRUITING NCT06223789 VOLT-AF IDE Clinical Study COMPLETED NCT07548320 Efficacy and Safety of the Soricle for Subjective Tinnitus Relief COMPLETED NCT07393880 Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus RECRUITING

Other Devices by GN Hearing A/S

K180495Tinnitus Sound Generator Module K193303Tinnitus Sound Generator Module K213424Jabra Enhance Plus

Related Devices (Code: KLW)

K161562Sound Options Tinnitus TreatmentSound Options Tinnitus Treatments, Inc. K161331HyperSound Tinnitus ModuleTurtle Beach Corporation K151558Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro SystemNeurotherapies Reset GmbH K171243audifon Tinnitus-ModuleAudiofon USA, Inc. K163094TinniLogic Mobile Tinnitus Management DeviceJiangsu Betterlife Medical Co., Ltd. K180495Tinnitus Sound Generator ModuleGN Hearing A/S

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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