Tinnitus Clinical Trial
Official title:
Clinical Evaluation of the Inhibitor Tinnitus Treatment Masking Device & SCN9 Gene Expression
To evaluate the effectiveness of the Inhibitorâ„¢ Tinnitus Masking Device. To determine if there is a higher incident of expression of the sodium channel, voltage gated, type IX alpha subunit (SCN9) gene in those subjects with disturbing tinnitus than subjects that are not disturbed by tinnitus.
Up to 50 million Americans have tinnitus on a regular basis with between 2-3 million suffering from tinnitus where it affects daily living. The Inhibitorâ„¢ Tinnitus Masking Device is a new tinnitus treatment device recently available in the United States for use of temporary relief of tinnitus. The device emits an ultra high frequency sound for 60 seconds via bone conduction when applied to the mastoid. Patients reporting tinnitus will be provided the opportunity to demonstrate the device to observe any changes in their tinnitus. The device may be demonstrated up to 5 times. The investigators will be recording the the degree and duration of change in tinnitus perception following treatment with the Inhibitorâ„¢ Tinnitus Masking Device. Patients may provide a genetic sample (typically via saliva sample) to look for expression of a particular genetic marker that may be associated with tinnitus. The investigators will be collect samples from both people with tinnitus and those without tinnitus to use as a control. ;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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