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

Status unconfirmed · Phase 4

Conditions studied: Tinnitus, Hyperacusis

In brief

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).

Key facts

Study ID

NCT00730834

Run by

Neuromonics, Inc.

People needed

53

Starts

2007-06-01

Expected to finish

2010-12-01

Last updated by the study team

2009-08-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Hearing PTA > 50 dB, score on HADS of greater than 11 on the anxiety and depression scale,
• Not willing to follow the protocol

Where it is running

• Silverstein Ear Institute — Sarasota, Florida, United States

Full record on ClinicalTrials.gov

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