NCT00730834

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Neuromonics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Tinnitus
• Hyperacusis

Interventions

Type	Name	Description
DEVICE	Oasis	Digital sound player that provides customized acoustic stimulus based on subjects hearing thresholds

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-08-08
• Last updated: 2009-08-25

Locations

1 site across 1 country: United States