Comparison of the comfort of De Tinnitus music compared to sound generators in healthy individuals

Introduction: Tinnitus is the perception of sounds that a person hears without external stimulation and can negatively affect the quality of life. There are many ways to manage tinnitus, including using a sound generator. However, there is no significant therapy that can treat tinnitus patients. De Tinnitus is a sound generator plus music developed by the author. This study aims to compare the comfort of music De Tinnitus with a sound generator in healthy individuals. Methods: This study is a Phase I Clinical Trial conducted in healthy individuals in Denpasar, Bali, Indonesia. Samples were randomized to hear a sound generator or De Tinnitus music through a phone application and heard the intervention for 2 hours every day for three months. Before and after the intervention, a visual analog scale (VAS) and audiometry examination were performed. The data was then analyzed using the SPSS application. Results: The results showed that volunteers in the De Tinnitus music group had better audiometric results than the sound generator group, both in the right ear (16.09 ± 5.40 vs. 26.28 ± 10.09; p<0.001) to the left ear (15.99 ± 4.93 vs. 26.22 ± 9.79; p<0.001). In addition, VAS was also significantly lower in the music De Tinnitus group compared to the sound generator (1.01 ± 0.67 vs 2.11 ± 0.57; p=0.023). Conclusion: This study showed that De Tinnitus music is more comfortable than sound generators in healthy individuals. There were no side effects such as ear ringing, blocked ears, dizziness, or other side effects. De Tinnitus music is safe and comfortable for the ears when used for 2 hours daily for three months with a maximum sound threshold of 91dB.