Phase Out as a treatment for chronic untreatable Tinnitus

Approximately 10-15% of the general population complains about tinnitus. In
spite of the investigations of many years, little is known about the
pathophysiology and the treatment of tinnitus. A new therapy was developed and
called *Phase Out*. This therapy is based on the physical mechanism of sound.
In physics, sound is a wave and can shift in phase over 360 degrees. The
hypothesis is that, shifting phase provides a better residual inhibition.
Following the hypothesis there is a better efficacy in comparison with placebo
sound. This means that the intensity and frequency of tinnitus are decreased
with the Phase Out treatment and effects will be sustained.

The major aim of this study is changes in tinnitus loudness (daily report mark)
and annoyance (daily report mark) and the duration of this change (time).

Prospective, double blind, randomized placebo controlled crossover trail.

A subject will receive Phase Out treatment for thirty minutes three times a
week for one week and placebo sound treatment on the same regime during
another. One month interval is in between these two stets of treatment. If a
treatment is started, the subject fills in a report mark on the *tinnitus
loudness* and *tinnitus annoyance* in the tinnitus diary every evening till
three weeks after the treatment session. One week after each week of therapy a
subject receives the evaluating questionnaires and will sent them back after
filling in.

The study will take 9 weeks and comprises 6 meetings. The patient selection
will be done during the tinnitus consultation, which includes an interview and
examination of the Ear-, Nose-, Throat (ENT) area, filling out questionnaires
and audiologic examination. A participating subject will receive a week with
Phase Out treatment (three treatments of thirty minutes) and a week with
placebo sound (three treatments of thirty minutes), with an interval of one
month. Placebo sound and Phase Out treatment gives a tone at tinnitus frequency
and matches the tinnitusintensity by means of a headphone. The phase of the
sound wave shifts every 30 seconds with 6 degrees. A subject will keep a
tinnitus diary and fill in specific questionnaires one week after both
intervention weeks to evaluate the changes. If the treatment is effective, the
treated subjects and patients with the same complaints will benefit with Phase
Out treatment. The headphone is uncomfortable with hearing aids, so subjects
will be asked to remove the hearing aid during the treatment session. One
patient is known with a temporarily tinnitus increasing during the treatment.
The tinnitus normalized within a month after treatment.