Neurostimulation Device for Treatment of Migraine Headache

Inclusion Criteria:

- On a Monthly basis, at least four, and not more than a total of fourteen Headache
Days (Pain Score between one and ten) of which between four and nine are Migraine
Headache Days (Pain Score between five and ten). NOTE: For clarification, the
occurrence of Headaches is counted taking into account, and making no adjustments
for, the medications that the subjects are taking;

- A history of some responsiveness (incomplete) to at least one and a maximum of two
prophylactic pharmaceutical therapies (utilized concurrently);

- The investigator must have confidence in the patient's ability to reliably complete
and return the Daily Headache Diary.

- Subject must be at least 18 years of age.

Exclusion Criteria:

- Individuals who are pregnant, who have a history of cardiovascular disease, who work
night shifts or who have vestibular migraine, menstrual migraine, posttraumatic
migraine, a history of unstable mood disorder or unstable anxiety, moderate or
greater hearing loss or a history of traumatic brain injury will be excluded from the
Study.

- A history within the last six months of tobacco use, narcotic or barbiturates use or
experiencing one or more analgesic rebound headaches.