An Open Comparative Study on the Effectiveness of Customized and Non-Customized Sound Therapy for Tinnitus Patients

Objectives: Sound therapy is a common treatment for tinnitus. This study aims to explore the efficacy of non-customized and customized sound therapy for subjective tinnitus. Treatment progress was assessed by comparing changes in monthly scales. The main scales used are the Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale, and Loudness Visual Analogue Scale. Methods: The subjects of this study were patients with tinnitus who visited outpatient from 2024 to 2025. Total of 732 patients were included (customized group, n = 653; non-customized group, n = 79). Customized sound therapy is tailored to patient's specific tinnitus condition, while non-customized sound consists of soothing natural sounds. The daily treatment duration was 2 h. Treatment assignment was not randomized; patients were free to choose between customized and non-customized sound therapy, which may have introduced a preference bias. Results: The study found that, in both groups of patients, regardless of whether they were treated or not, the severity of tinnitus was positively correlated with the level of anxiety (p < 0.01)/depression (p < 0.01) and the loudness of tinnitus (p < 0.01). Patients with severe tinnitus were more likely to choose customized sound therapy (p < 0.01). THI score for the non-customized group showed a downward trend at 1 and 3 months after treatment (p < 0.01 at 1 and 3 months). HADS-A score also decreased 1 and 3 months after treatment compared to before treatment (p < 0.05 at 1 and 3 months). THI scores for the customized group showed a downward trend at 1, 3, 6, 9, and 12 months after treatment (p < 0.001 at 1 and 3 & 6 and 9 & 12 months). HADS-A/D scores decreased at 1, 3, 6, 9 and 12 months after treatment (p < 0.01 at 1 & 3 & 6 and 9 & 12 months). The efficacy of the customized group was greater than that of the non-customized group 1 month after treatment (χ² = 6.39, p = 0.011). Conclusions: Both sound therapies can alleviate tinnitus severity and reduce anxiety in the short term. Customized sound therapy is superior to non-customized therapy in terms of short-term efficacy. Additionally, customized sound therapy is more effective than non-customized therapy in alleviating tinnitus severity and managing anxiety and depression over a longer period. Therefore, customized sound therapy may be a more effective treatment option for subjective tinnitus. However, it should be emphasized that this was an open study in which patients freely chose between the two therapies, which may have introduced bias. Therefore, these findings are not as well founded as those from a randomized controlled trial, and future RCTs are warranted to verify the observed benefits.