Transcranial Magnetic Stimulation for Tinnitus

Inclusion Criteria:

- Diagnosis of chronic tinnitus.

- Able to provide written informed consent.

- Subject is naive regarding rTMS.

- Age/Gender: minimum 18 years old, with an attempt to sample equal numbers of male and
female subjects.

- Other concurrent treatments: A four-week washout from any other tinnitus treatment or
management program is required prior to entering this study.

- Other medications: No restrictions, provided the dosages have been in place for at
least 6 months.

- Psychological status: Stable enough to complete this study per the opinion of the
Study Physician.

- Hearing function: All degrees of hearing function can be included recognizing that
profound, bilateral losses will not be able to perform tinnitus evaluations and
hearing tests, but will be able to rate subjective tinnitus loudness, annoyance and
impact on life. This is an important subpopulation because of the challenges in
treating them with acoustic therapy and the need for a medical intervention.

- Tinnitus characteristics: All forms of tinnitus etiology will be accepted, providing
the following criteria are met:

- Tinnitus duration: Not less than 1 year. Cases of less than 1 year duration have
increased likelihood of resolving spontaneously.

- Stability: Constant (not pulsatile, intermittent, varying to a high degree in
loudness or changing in location of perception). Fluctuating tinnitus reduces
the reliability of test-retest measures for loudness.

- Self-rated tinnitus loudness: >= 6 on a visual numerical scale (VNS: 0 labeled
"No Tinnitus", 10 labeled "Very Loud"). This outcome measure will provide a
subjective indication of immediate changes in perceived loudness.

- Location of tinnitus perception: Unrestricted. Tinnitus may be unilateral,
bilateral, or perceived in the head.

Exclusion Criteria:

- Medical conditions: No active neurologic or otologic disease processes that may
impact tinnitus perception. No auto-immune diseases. No pregnancy or planned
pregnancy during the study. No women who are lactating or are of child-bearing-age
without using contraception.

- Objective Tinnitus - tinnitus that is audible to other people in addition to the
patient. This type of tinnitus is rare and is unlikely to respond to rTMS because it
is not associated with abnormal neural activity in the central auditory system.

- History or evidence of significant brain malformation or neoplasm, head injury,
cerebral vascular events (such as strokes), neurodegenerative disorders affecting the
brain (such as Parkinson's Disease, ALS, Huntington's Disease or Multiple Sclerosis)
or prior brain surgery.

- Cardiac pace makers, other electronic implants (including cochlear implants),
intracranial or intraocular metallic particles.

- History of seizures or epileptic activity.

- Patients who cannot communicate reliably with the investigator or who are not likely
to cope with the requirements of the trial.

- Participation in a clinical trial within the last 30 days before the start of this
one.

- Maximum number of previous clinical trials for tinnitus in which subjects may have
participated: two.