Phase II Clinical Study on Low Intensity Noise Tinnitus Suppression (LINTS) for Tinnitus Treatment

Background: /Objectives: Tinnitus treatment is often based on coping strategies, as still no causal treatment is available. Based on our “Erlangen model” of tinnitus development and two pilot stud-ies, we treated tinnitus patients with individualized, non-masking low intensity noise (LIN) to reduce the tinnitus loudness. Methods: 72 adult patients with a tinnitus severity index below IV (tinnitus health question-naire, THQ), a hearing loss not exceeding 40 dB up to 6 kHz, and without experience in hearing aid (HA) usage were included in this study. Their audiograms, tinnitus pa-rameters, THQ scores and optimal LIN were determined individually. Patients were double-blinded assigned to a treatment only (TO) or placebo-and-treatment (PT) group. The TO patients received treatment for four weeks while the PT patients ini-tially received placebo (low intensity white noise) stimulation for two weeks and hereinafter treatment for four weeks. Every two weeks, the measurements listed above were repeated. Long term effects on THQ were assessed four weeks after the end of treatment. Data were analyzed by parametric and nonparametric statistics. Results: We identified a significant decrease in the THQ score already after two weeks of treatment that was still present four weeks after the end of treatment in the TO group. In individual cases, tinnitus could be suppressed completely by LINTS. The PT group did profit much less, as the initial placebo treatment seemed to counteract the LIN ef-fects. Conclusions: Individually fitted LIN treatment is able to suppress tinnitus. The optimal fitting of the LIN is crucial for treatment success.