SPI-1005 for the Treatment of Meniere's Disease (Open Label)

Inclusion Criteria:

• Adult males/females, 18-75 years of age at the time of enrollment.

• Diagnosis of probable or definite Meniere's Disease by AAO-HNS Amended 2015Criteria.

• At least two of three active symptoms (fluctuating hearing; tinnitus; auralfullness; vertigo or dizziness) of Meniere's disease, within 3 months of studyenrollment.

• Type A tympanogram at screening.

• Air conduction thresholds ≤ 90 dB at all tested frequencies (250-8000 Hz) in bothears.

• Subject is willing and able to provide informed consent and perform study proceduresand assessments per protocol.

• Reproductive requirements

Exclusion Criteria:

• Current, or within 60 days prior to study enrollment, use of IV or intratympanicototoxic medications such as chemotherapy including cisplatin, carboplatin, oroxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin,kanamycin, or streptomycin; or loop diuretics including furosemide.

• History of otosclerosis or vestibular schwannoma.

• History of significant middle ear or inner ear surgery in the affected ear.

• Conductive hearing loss with air-bone gap ≥15 dB, otitis media, or mixed hearingloss.

• Significant cardiovascular, pulmonary, hepatic, renal, hematologic,gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease.

• Current use or within 30 days prior to study enrollment systemic steroids.

• Current use or within 7 days prior to study enrollment intratympanic steroids.

• Hypersensitivity or idiosyncratic reaction to compounds related to ebselen orexcipients.

• Female patients who are pregnant or breastfeeding.

• Participation in another investigational drug or device study within 30 days priorto study consent.

• Participant resides more than 100 miles from the study site.