"The FDA clearance comes as Sanuthera concludes a clinical study at the Cleveland Clinic. In the study, more than 85% of tinnitus sufferers using the Serenity device have shown improvement at 1, 3, and 6 months. To indicate results, the study uses the Tinnitus Handicap Inventory (THI), a self-report tinnitus handicap measure that quantifies the impact of tinnitus on daily living. In the Cleveland Clinic study, the THI has shown a 36% improvement at 6 months, with a 62-point maximum improvement." - See more at: http://www.hearingreview.com/2015/0...nnitus-treatment-device/#sthash.zqY1evmm.dpuf No idea what this means for real-world, but just thought I'd post this.