The purpose of this study is to assess the safety and efficacy of zonisamide for the treatment of noise-induced hearing loss in adults.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients who are scheduled to undergo a skull-based surgery that requires at least 45 minutes of surgical-drilling
* At least 18 years of age
* Air conduction thresholds in the non-operated ears are to be no worse than 25 decibel (dB) hearing loss (HL) for pure tone average 0.5, 1, and 2 kilohertz (kHz) with no individual threshold greater than 30 dB HL, and no worse than 45dB HL at 4 kHz at screening.
* Observed air-bone gap \< 10 dB HL at 0.5, 1, 2, and 4 kHz, with normal tympanometry.
* Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document.
Exclusion Criteria:
* History of known sulfa allergy or hypersensitivity to carbonic anhydrase inhibitors
* History of moderate-to-severe kidney or liver disease
* Acute viral, bacterial, fungal or parasitic infection
* History of seizures
* Currently pregnant or breast-feeding
* Any current or history of ear disorder and/or central auditory dysfunction in the non-operated ear
* History of ototoxic drug use
* Current use of strong/moderate 3A4 inhibitor/inducer and grapefruit juice