Clinical Research Directory

Inclusion Criteria: Human subjects will be male or female Veterans selected without regard to race or ethnic background. All subjects will be 18 years of age or older and no more than 60 years old. On the QCuBE, all subjects must report at least one exposure to high-intensity blast (e.g., RPG, IED, mortar) close enough to feel the heat or pressure of the blast wave. All subjects must also score 20 or higher on the Hearing Handicap Inventory for Adults (HHIA). The remaining inclusion criteria for all subjects are: 1. pure-tone average (PTA) at 0.5, 1, 2, 4 kHz of 35 dB HL or better in each ear; 2. pure-tone thresholds no worse than 40 dB HL at any two audiometric frequencies up to 8 kHz; 3. no differences in pure-tone thresholds exceeding 10 dB between the two ears at more than one audiometric frequency up to 4 kHz; 4. native speaker of English; and 5. a score of at least 25 on the Mini Mental State Exam. Exclusion Criteria: 1. a conductive hearing impairment or other otological pathology; 2. chronic disease or use of medication that might affect the auditory system or the subject's ability to perform the experimental tasks; 3. an inability to perform the experimental tasks; 4. any contraindications for MRI scanning (this may specifically exclude subjects who have a pacemaker, metal clips, or any other metal device in their body, or who have any other contraindication for MRI as determined by an MRI screening questionnaire); and 5. experience with hearing aids prior to the study. Potential subjects meeting criterion 4 (contraindications for fMRI) will remain eligible to complete the non-MRI components of the trial (all visits other than V3, V10). These will be included in a Intent to Treat (ITT) cohort. Additional subjects who are eligible for MRI will be recruited into a Per Protocol (PP) cohort until the PP cohort meets target for total sample size (N = 60).