Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sound Options Tinnitus Treatment

K-Number: K161562 · 2016-09-28

ApplicantSound Options Tinnitus Treatments, Inc.
Decision Date2016-09-28
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Sound Options Tinnitus Treatment is a medical device manufactured by Sound Options Tinnitus Treatments, Inc.. It received FDA 510(k) clearance on 2016-09-28 under approval number K161562. 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 Sound Options Tinnitus Treatment?

Sound Options Tinnitus Treatment is a medical device that received FDA 510(k) clearance on 2016-09-28. It is manufactured by Sound Options Tinnitus Treatments, Inc.. The 510(k) number is K161562.

When was Sound Options Tinnitus Treatment approved by the FDA?

Sound Options Tinnitus Treatment received FDA 510(k) clearance on 2016-09-28, under approval number K161562.

What company makes Sound Options Tinnitus Treatment?

Sound Options Tinnitus Treatment is manufactured by Sound Options Tinnitus Treatments, Inc..

What is the FDA product code for Sound Options Tinnitus Treatment?

The FDA product code for Sound Options Tinnitus Treatment is KLW.

Related Clinical Trials

NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT07175129 Transverse Tibial Transport for Chronic Limb-Threatening Ischemia (CLTI) WITHDRAWN NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT07607353 Biodegradable Stents in Primary Sclerosing Cholangitis RECRUITING NCT07000383 Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome RECRUITING

Related Devices (Code: KLW)

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 K181586Tinnitus 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.

↑