ENROLLMENT FOR THIS STUDY HAS NOW BEEN COMPLETED. A LINK TO ALL EARLY RESULTS FROM THE STUDY WILL BE POSTED ON THIS PAGE WHEN AVAILABLE, LIKELY IN SPRING 2016. NEW PUBLICATIONS WILL BE POSTED WHEN AVAILABLE.
The trial is supported by the National Institute on Deafness and Other Communication Disorders of the National Institutes of Health under award number U44DC010084.
The Serenity System clinical trial for the treatment of moderate to severe tinnitus was open to all U.S. residents who have had tinnitus for more than 12 months and have already tried at least one other treatment. There are 4 sites and a total of 30 patients have been enrolled.
This randomized clinical trial utilizes an implantable device (called the Serenity System), which will require an outpatient procedure to place the device inside your body. (the stimulator is placed in your upper chest and the lead is placed on the vagus nerve in your neck) All study participants will be implanted with the Serenity System. During the first 6 weeks, study participants will be randomly divided into two groups: one group will receive the test therapy that is potentially effective, while the other group will receive a very similar therapy that is not expected to be effective – but both groups will hear tones and receive some stimulation. The study is “double blinded,” that is, neither the audiologist nor the participant will know which group they are in. This approach helps the study to be as accurate as possible and is considered the gold standard for testing the effectiveness of health care interventions. After the initial 6-week period, all study participants will receive the potentially effective (test) version of the therapy.
For more information on the therapy, click on button below.
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