Automated Variable Pattern Insufflator Device (AVPI) for the Acute Treatment of Migraine

Inclusion Criteria:

1. At least 18 years of age at the time of the baseline visit.
2. Episodic migraine with or without aura diagnosed according to the InternationalClassification of Headache Disorders 3 beta diagnostic criteria.
3. Migraine onset before the age of 50 years
4. Migraine present for at least 1 year at the time of the Baseline Visit.
5. Frequency of 1-12 migraine attacks per month in each of the 2 months prior toscreening.
6. Willingness, ability, and commitment to participate in baseline and follow-upevaluations without concurrent participation in another clinical trial.
7. Signed patient informed consent form.

Exclusion Criteria:

1. Prior or current diagnosis of migraine with brainstem aura, hemiplegic migraine,retinal migraine, migraine aura without headache, vestibular migraine.
2. Use of acute headache medication within previous 48 hours of treatment visit (for eachtreatment visit).
3. Use of acute medication for headache on >15 days per month in the 3 months prior tothe Baseline Visit.
4. Change in migraine preventive therapies or dosage within the preceding 1 month ofBaseline Visit.
5. Use of an opioid or barbiturate on more than 4 days per month in each of the 3 monthsprior to the Baseline Visit.
6. Other primary headache disorder, other than tension-type headache on 3 or fewer daysper month.
7. History of secondary non-migraine headache disorders.
8. Medical history of Meniere's disease; endolymphatic hydrops; loss of hearing in eitherear that is either complete, requires a hearing aid, or has deteriorated noticeablyover the past year; ear surgery (including ear tubes); chronic continuous or currenttinnitus; superior canal dehiscence.
9. Discomfort, infection, or other abnormal symptoms or disorders of either ear within 1month prior to the enrollment Screening or Treatment Visit.
10. Pregnant or trying to become pregnant.
11. Unable to provide informed consent.
12. Inability to present to the medical clinic for study treatment during a migraineattack.
13. Unable or unlikely to follow instructions for proper use of the device.
14. Presence of any condition or state that would prevent the subject from sitting orlying down during the course of the treatment (up to 30 minutes).
15. History of receiving ear pressure therapy (insufflation) to treat any condition.
16. Personal or family affiliation as a service provider (e.g. employee, contractor,consultant, or volunteer) with a migraine treatment device company other than thestudy sponsor.
17. Perforated or compromised tympanic membrane, and which is confirmed by otoscopeinspection by the Investigator before or upon presentation of the subject for theTreatment Visit.
18. Any other information about the subject's medical condition that, in the reasonableprofessional judgement of the Investigator, may adversely affect the intended safetyor results of the treatment as intended and as a reasonable basis to exclude thesubject.