AVPI Migraine Study

Inclusion Criteria:

1. 18-75 years of age, inclusive, with at least a one-year history of migraine consistentwith the ICHD-3 criteria
2. Migraine onset before the age of 50 years
3. Migraine attack frequency of 2-10 attacks per month with no more than 20 headache daysper month on average over the last 3 months
4. Willingness, ability, and commitment to participate in baseline and follow-upevaluations without concurrent participation in another clinical trial.
5. Signed subject informed consent form.
6. Typical untreated migraines are historically at least moderate to severe, by patientreport.
7. Subjects on prophylactic migraine medication must have been on a stable dose for atleast 3 months prior to study entry and must remain on the same therapy with stabledosing during the study.
8. Subjects must have wireless access to the internet via mobile computing or smartphonedevice for audio and/or video contacts

Exclusion Criteria:

1. Failure to meet any of the inclusion criteria.
2. Unwilling or unable to provide informed consent.
3. Pregnancy or intent to become pregnant over the course of the study.
4. Inability to distinguish migraine from other primary headache phenotypes.
5. Presence of any condition or state that would prevent the subject from sitting orlying down comfortably during the course of the treatment (up to at least 30 minutes).
6. Unable or unlikely to follow instructions for proper use of the device includingconnection of the phone to a wireless connection.
7. Personal or family affiliation as a service provider - e.g., employee, contractor,consultant, or volunteer (other than as a subject in a previous clinical trial) - witha migraine treatment device company.
8. Subjects with vital sign values that are outside acceptable norms.
9. Systolic blood pressure > 160 mmHg
10. Diastolic blood pressure > 100mmHg
11. Resting heart rate >100 beats per minute
12. Temperature > 100.5°F
13. History of significant vestibular, auditory or external ear diagnoses or symptoms,including but not limited to Meniere's disease; endolymphatic hydrops; complete lossof hearing in either ear, significant hearing loss in either ear that requires ahearing aid or has deteriorated noticeably over the past year; previous ear surgery (including tympanostomy tubes); superior canal dehiscence, current or ongoingdizziness or vertigo, perforated or compromised tympanic membrane, external auditorycanal obstruction which cannot be removed prior to treatment
14. Current diagnosis or significant prior diagnosis of secondary headache (except MOHheadache), cerebral aneurysm, intracranial hemorrhage, brain tumor, chiarimalformation, or currently active occipital neuralgia that in the investigator'sopinion would interfere with study-related assessments.
15. Recent or current diagnoses of post-concussion syndrome, significant head trauma,substance abuse, addiction, syncope, or epilepsy, that in that the investigator'sopinion would interfere in the assessments.
16. Another significant pain disorder that in the investigator's opinion would interferewith study-related assessments.
17. Any other information about the subject's medical condition that, in the reasonableprofessional judgement of the Investigator, may adversely affect the intendedperformance or safety of the study device, or that would confound understanding of thesubjects' response to treatment with the device.
18. Subjects who have been diagnosed with and/or being treated for currently activechronic neck pain conditions including, but not limited to, failed neck surgery,discogenic pain, radiculopathy, or whiplash.
19. Psychiatric or cognitive disorders that in the investigator's opinion would interferewith the conduct of the study
20. Unstable medical conditions which in the investigator's opinion could impede orpreclude successful participation in the study, cause significant risk of seriousadverse events in the study, or limit the subject's ability to complete study relatedtreatments or assessments. MEDICATIONS & MIGRAINE TREATMENTS
21. Change in migraine preventive therapies or dosage within the preceding 3 months ofBaseline Visit OR at any point during the study.
22. Head or neck nerve block injections in the past 2 months.
23. Post-COVID-19 patients with new presentations of dysautonomia, cognitive sensorychanges, and imbalance presenting complaints which would limit the subject's abilityto accurately and reliably identify and assess migraine pain, in the investigator'sopinion.
24. Previous use of pressure therapy or surgery in the ear for headache or any othercondition (excluding diagnostic ear insufflation). Subjects enrolling in Group Ib willhave participated in the NC05 study and will be allowed to enter as an exception tothis criterion.
25. Subjects treated with acute migraine medication via IV infusion within two weeks priorto screening.
26. Subjects with previous absence of therapeutic response to 3 or more acute migraineneuromodulation devices. (Does not include failure of therapy due to side effects orintolerance.)
27. Subjects with previous absence of therapeutic response to 3 or more classes ofprescription migraine-specific abortive therapies as judged by the investigator. (Doesnot include failure of therapy due to side effects, drug interactions, orintolerance.)
28. Use of an opioid or barbiturate on more than 4 days per month on average for the 3months prior to the Baseline Visit. Individual migraine attacks are excluded from treatment and/or analysis in this study if:
29. Treated >45 days after enrollment into active participation in each study Phase,applicable for all Groups. Subjects entering into active participation for Phase Iand/or II will have 45 days to treat migraines for that respective Phase. For PhaseII, the 45 days begins after the subject is trained and sent home with an AVPI devicesystem.
30. Migraine treated more than 10 hours (for Phase I) or 6 hours (for Phase II) afterinitial onset of the migraine. Migraines for which the subject cannot reasonablyidentify the initial onset.
31. The migraine onset is <24 hours after the complete resolution of a prior migraineattack.
32. The migraine attack was previously treated with any drug or medical device.
33. The attack is characterized by neck pain that the subject indicates is greater than orequal to the severity of the headache pain.
34. The subject has developed an ear infection or other new disorder of either ear sinceenrollment in the study.
35. The subject has used acute headache or migraine medication or a neuromodulation devicefor migraine within previous 24 hours of treatment (for each treatment).
36. The migraine headache intended for treatment during a randomized arm of either Phaseis not at least moderate to severe. Note: Treatment of mild headaches are allowedduring the open-label use arm of either Phase II.