About the Study

Welcome,

This is an informational page for a U.S. clinical trial for the treatment of tinnitus.  The trial is using a new therapy developed by MicroTransponder (www.microtransponder.com).

ENROLLMENT FOR THIS STUDY HAS NOW BEEN COMPLETED.  A LINK TO ALL RESULTS FROM THE STUDY WILL BE POSTED ON THIS PAGE WHEN AVAILABLE, LATER IN 2015.

The trial is supported by the National Institute on Deafness and Other Communication Disorders of the National Institutes of Health under award number U44DC010084.

Summary

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.

vnsfortinnitus

 

 

IF YOU  WOULD LIKE TO BE PLACED ON OUR TINNITUS UPDATE LIST TO GET UPDATES ON U.S. TRIALS OR FUTURE EUROPEAN SALES  – PLEASE CLICK THE BUTTON BELOW.

Tinnitus Update List

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute on Deafness and Other Communication Disorders or the National Institutes of Health.