Clinical Research Directory

Inclusion Criteria: * Healthy subjects at the time of enrollment. * Each subject will give informed consent to participate in this study and agrees to the treatment protocol. * Each subject will be interviewed regarding hearing and health to reveal any history of hearing loss, tinnitus, known ear pathology, use of any potentially ototoxic medications (i.e. diuretics, minocycline). * Non-occupational sound exposure (e.g., concerts, firearms, fireworks, power tools) will be avoided during the 24-hour period preceding baseline testing and throughout the duration of the study. * Subjects will have vital signs (i.e., heart rate, blood pressure, respirations, temperature) within normal limits upon medical examination. * Subjects must have normal audiologic assessment at baseline consisting of: * Baseline audiometric evaluation confirms that subjects have symmetric hearing with air conduction thresholds no worse than 25 decibels of Hearing Loss (dBHL) at frequencies between 0.25 to 8 kilo Hertz (kHz) bilaterally. * No significant threshold asymmetry (i.e. greater than 15 dB) between the ears at any tested frequency. * No significant air-bone gaps (i.e. greater than 10 dB) * Type A tympanograms bilaterally, defined as a range of -140 to +40 dekaPascals (daPa) based on the 90% range for adults (Margolis and Hunter 2000) Exclusion Criteria: * • Subjects with abnormal hearing levels \> 25 dBHL at any tested frequency (250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz) for either ear. * Exposure to any duration of non-occupational high-level sound (e.g., concerts, firearms, fireworks, power tools) during the 24 hour period preceding baseline audiometric testing as revealed in the subject questionnaire or during the medical examination. * Pathology of the external ear discovered upon otoscopic examination. * Pathology of the middle ear revealed by otoscopic examination, abnormal tympanometry, or reported history of middle ear problems. * Pathology of the inner ear or auditory nerve as revealed by reported history. * Subject complaints of aural pain, pressure, fullness, or drainage. * Subjects testing positive for pregnancy will be excluded from the study. * Subjects with other medical/health issues that would preclude voluntary participation in a drug study may be excluded at the discretion of the Principal Investigator. * Subjects that have previously received any known potentially ototoxic medication. This includes, but is not limited to, high dose salicylates (\>2 g/day), platinum-based chemotherapeutics and aminoglycoside antibiotics, such as streptomycin, gentamicin,tobramycin, amikacin, neomycin, and netilmycin. * Subjects that are currently using of any potentially ototoxic medications (i.e. diuretics or minocycline). * Subjects that have received any investigational treatment (drug or device) in the six months prior to this study. * Subjects exhibiting or self-reporting shortness of breath, wheezing, coughing, or hemoptysis