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Wayne State Patient Contact Form

Patient Interest Form

NIH Sponsored Clinical Trial for Treatment of Tinnitus for Detroit, Michigan
 

Have you had ringing in your ears, or tinnitus, for more than 12 months?  Have you tried other treatments but still have a bothersome tone in your ear that you always hear?  Are you between the ages of 22 and 65? 

 If so, you may be eligible for a research study of a new device for tinnitus.  It is an implantable device (called the Serenity System), which means it does involve a surgery to place the device in your body. The device involves stimulation to the vagus nerve.  Therefore you must be in generally good health, be an appropriate candidate for surgery (no anesthesia allergies), not be taking medications known to cause or worsen tinnitus, not be taking any medications known to interfere with neuromodulators, and not have any significant cardiac history.

If you believe you meet these health criteria, you will then have audiometric testing and the audiologist must be able to verify your tinnitus is loud enough and that you meet all other study criteria.  (This is only a brief description of the basic eligibility criteria.  The study investigator will assess whether or not you meet all study entry criteria.)

 All patients enrolled in the study will be implanted with the Serenity System, however for the first 6-weeks study subjects will be placed into two groups; one group will receive settings that are thought to be more effective than the other group - but both groups will hear tones and receive stimulation.  The study is "double blinded" - so you and the study audiologist don't know which group you are in (only the device "programmer" knows); this will help the study be as accurate as possible.  After 6-weeks all people in the study will receive the effective settings.

The course of the study will involve a number of baseline testing visits, then the surgery for implantation, then a number of training and follow-up visits.  Because the study has a number of visits over a long period of time (at least one year),you must live within 200 miles of our center to be eligible.

If you are believe you might meet the entry criteria and are still interested in learning more about the device and this research study, please complete the information form and you will be contacted shortly.

Thank you for your interest in this very important study.

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