A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache

INCLUSION CRITERIA:

- The patient must have been diagnosed with episodic Migraine Headache at least 6 months
prior to entering into the Study, consistent with the International Headache
Classification of Headache Disorders-II (ICHD-II) guidelines.

- The patient must have a history of at least three consecutive months of stable
Migraine Headaches prior to entering the Study. The patients will not have had changes
in medication usage for the three Months leading up to the Study, nor will they
introduce new medications during the Study period. Patients will satisfy these
criteria: On a Monthly basis, at least four, and not more than a total of fourteen
(4-14), Headache Days (Pain Score between one and ten) of which between four and nine
(4-14) are Migraine Headache Days

- The patient must not have failed on more than two classes of properly administered
prophylactic pharmaceutical therapies for migraine headache. The patient may be on a
single migraine prophylactic as long as the dosage has not been altered within 3
months of starting the study and the dosage must not be altered for the duration of
the study.

- The Investigator must have confidence in the patient's ability to reliably use the
Experimental Device and promptly complete the Daily Headache Diary forms. The Daily
Headache Diary will be completed from the beginning of the Pre-Treatment Baseline
Period through the end of the Pivotal Study.

EXCLUSION CRITERIA:

Individuals who:

- are pregnant

- have a history of cardiovascular disease

- work night shifts

- have been diagnosed with vestibular migraine

- have been diagnosed with migraine with aura

- have menstrual migraine exclusively

- have been diagnosed with post-traumatic migraine

- have a history of unstable mood disorder or unstable anxiety disorder

- use a hearing aid

- have a cochlear implant

- have chronic tinnitus

- have temporomandibular joint disease

- have been diagnosed with traumatic brain injury

- have been diagnosed with neurological disease other than Headaches

- have a diagnosed vestibular dysfunction

- abuse alcohol or other drugs

- are experiencing medication overuse Headaches (individuals with respect to whom the
Investigator is concerned that analgesic abuse is involved based on the ICHD-II
guidelines).

- are less than 18 years old or greater than 65 years old

- have had eye surgery within the previous three months or ear surgery within the
previous six months

- have active ear infections or a perforated tympanic membrane

- have participated in another clinical trial within the last 30 days or are currently
enrolled in another clinical trial

- are using Botox treatments for migraines

- Though not excluded, patients taking anti-histamines or anti-nausea drugs will be
encouraged not to take such medications within four hours prior to using the Device.
The Investigator should review other medications taken by the patient with properties
that mimic anti-nausea or anti-dizziness drugs as these may reduce responsiveness to
stimulation. Such medications should also be avoided within four hours prior to a
treatment.