Status:
UNKNOWN
Customized Acoustic Stimulation for Long Term Medical Benefit for the Relief of Tinnitus and Hyperacusis
Lead Sponsor:
Neuromonics, Inc.
Conditions:
Tinnitus
Hyperacusis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 tre...
Eligibility Criteria
Inclusion
- 18 years of age,
- TRQ of at least 17 or above,
- Able to pay for the treatment,
- Not using any other treatment for tinnitus,
- Access to computer and internet,
- Compliant patient
Exclusion
- Hearing PTA \> 50 dB, score on HADS of greater than 11 on the anxiety and depression scale,
- Not willing to follow the protocol
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00730834
Start Date
June 1 2007
End Date
December 1 2010
Last Update
August 25 2009
Active Locations (1)
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1
Silverstein Ear Institute
Sarasota, Florida, United States, 34239