• Tinnitus Handicap Inventory (THI) [ Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
  

• Tinnitus Severity Index (TSI) [ Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
  

Although tinnitus is especially problematic for veterans, the DVA has no established protocol for tinnitus rehabilitation. We recently completed a randomized clinical trial to evaluate the efficacy of tinnitus treatment for veterans. Tinnitus Masking and Tinnitus Retraining Therapy (TRT) were both shown to be effective for the majority of veterans treated with these methods by expert tinnitus clinicians. The objective of the present study is to determine if the same level of treatment efficacy observed in the previous study can be obtained by typical VA audiologists in their clinical environment. In addition, a third group has been added, called Comprehensive Audiological Tinnitus Treatment (CATT), which will serve as a control group for nonspecific effects of treatment using a standardized protocol of hearing aids and education.

Veterans with clinically significant tinnitus were recruited to receive treatment with Masking, TRT, or CATT in Audiology Clinics at the Bay Pines, Portland, San Diego, and Seattle VAMCs. There are three Treatment Audiologists at each of the sites, one for each of the three treatment methods. Each method uses a variation of sound therapy and of educational counseling. Sound therapy involves the use of wearable ear-level devices, including sound generators (maskers), hearing aids, or combination devices (hearing aid and masker combined). Only the CATT group is restricted to the use of hearing aids only (note: CATT subjects who do not require hearing aids are the only subjects in this study who do not receive ear-level devices). TRT uses a structured counseling protocol that teaches concepts that are unique to TRT. The Masking protocol has been created to match the TRT counseling with respect to comparable formatting and length of counseling sessions, but containing information specific to the concepts of Masking. The CATT counseling protocol is similarly matched in format and length, but the information conveyed is of a more generic nature (general audiologic counseling information). Assessment of outcomes will utilize questionnaires that are administered at intervals before, during, and after the 18 months of treatment.

Potential participants at all sites were telephone-screened by the Project Audiologist in Portland to determine if the tinnitus is a clinically significant problem warranting 18 months of treatment. Veterans who passed the screening were scheduled to meet with the Research Coordinator (RC) at the respective study site. At this first visit, veterans were consented, completed questionnaires and were then informed as to their group placement. Per a randomization schedule, they were placed into one of the three treatment groups, or into the 6-month waiting list group (with treatment starting 6 months later). At the initial evaluation with the respective Treatment Audiologist, a tinnitus verbal interview was administered, hearing and tinnitus testing were performed, and ear mold impressions were taken to order the custom ear-level devices. The veteran returned approximately 3-4 weeks later to be fitted with the devices and to receive the counseling/education that initiates treatment. Subjects return for follow-up treatment at 3, 6, 12 and 18 months. At the follow-up appointments, the RC collects and checks the questionnaires, and the Treatment Audiologist administers the follow-up verbal interview and repeats the counseling protocol. One year following treatment, the Project Audiologist will mail out written questionnaires that will be returned by mail, and will telephone the subjects to repeat the follow-up verbal interview.