Clinical Trial: Customized Acoustic Stimulation for Long Term Medical Benefit for the Relief of Tinnitus and Hyperacusis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase 4 Study of Use of a Customized Acoustic Stimulus to Reduce the Disturbing Symptoms of Tinnitus and Hyperacusis

Brief Summary: Neuromonics TInnitus Treatment CALM study is a multi site study of 100 adult subjects with clinically significant disturbing tinnitus to evaluate outcome measures using the FDA cleared Neuromonics treatment after 6, 12, 24 and 36 months. Patients must be meet certain inclusion criteria and they are also required to pay for the all costs of the treatment. Subjects will be provided a modest participation fee at 6, 12, 24 and 36 months upon completion of patient questionnaires (subjects must have access to a computer and internet in order to complete on line questionnaires).

Detailed Summary:
Sponsor: Neuromonics, Inc.

Current Primary Outcome: Pre and post treatment scores on Tinnitus reaction questionnaire [ Time Frame: 6, 12, 24, 36 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale, [ Time Frame: 6, 12, 24, 36 months ]

Original Secondary Outcome: Same as current

Information By: Neuromonics, Inc.

Dates:
Date Received: August 5, 2008
Date Started: June 2007
Date Completion: December 2010
Last Updated: August 24, 2009
Last Verified: August 2009