FDA 510(k)

HyperSound Tinnitus Module

K-Number: K161331 · 2016-08-23

Decision Date2016-08-23

Product CodeKLW

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

HyperSound Tinnitus Module is a medical device manufactured by Turtle Beach Corporation. It received FDA 510(k) clearance on 2016-08-23 under approval number K161331. 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 HyperSound Tinnitus Module?

HyperSound Tinnitus Module is a medical device that received FDA 510(k) clearance on 2016-08-23. It is manufactured by Turtle Beach Corporation. The 510(k) number is K161331.

When was HyperSound Tinnitus Module approved by the FDA?

HyperSound Tinnitus Module received FDA 510(k) clearance on 2016-08-23, under approval number K161331.

What company makes HyperSound Tinnitus Module?

HyperSound Tinnitus Module is manufactured by Turtle Beach Corporation.

What is the FDA product code for HyperSound Tinnitus Module?

The FDA product code for HyperSound Tinnitus Module is KLW.

Related Devices (Code: KLW)

K161562Sound Options Tinnitus TreatmentSound Options Tinnitus Treatments, Inc. 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 K181586Tinnitus 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.