Treatment of tinnitus with a customized acoustic neural stimulus: a controlled clinical study.

In patients with tinnitus, achieving consistently positive treatment results is a challenge. We conducted a controlled clinical study of a new treatment approach (Neuromonics Tinnitus Treatment) that involves the use of a customized neural stimulus. This stimulus is delivered to the patient in the form of a pleasant acoustic sensation that is spectrally modified according to each patient's individual audiometric profile. This treatment approach is provided as part of a structured rehabilitation program. In our study, patients who received the customized stimulus (Neuromonics group) reported significantly greater and more consistent alleviation of tinnitus symptoms than did patients who participated in a counseling and support program with and without delivery of a broadband noise stimulus (Noise+Counseling group and Counseling-Only group, respectively). After 6 months of treatment, 86% of the Neuromonics patients met the minimum criterion for clinical success, defined as an alleviation of tinnitus disturbance of at least 40% (as determined by the Tinnitus Reaction Questionnaire score). By contrast, only 47 and 23% of the Noise+Counseling and Counseling-Only groups, respectively, reported a successful result according to this criterion. Mean improvements in tinnitus disturbance scores in the Neuromonics, Noise+Counseling, and Counseling-Only groups were 66, 22, and 15%, respectively. The differences between the Neuromonics group and the control groups were statistically significant. Significant differences were observed in other clinical outcomes. Patient reports of user acceptability were more consistently positive in the Neuromonics group.