A Real-World, Multicenter Clinical Study Conducted in Private Clinics Evaluating the Effectiveness and Safety of MEMOTIN® in Patients with Tinnitus: The M.E.S.T Study

Introduction Tinnitus is a common auditory condition characterized by the perception of ringing, buzzing, or other phantom sounds without an external auditory stimulus, affecting approximately 10–15% of the population. Tinnitus is not a disease itself; however, it is often associated with hearing loss, noise exposure, aging, or other underlying medical conditions resulting in a various degrees of severity impact on daily life. The subjective character of tinnitus among individuals necessitates the evaluation of its impact on quality of life through validated patient-reported outcome measures (PROMs). One of the most widely used instruments for tinnitus assessment is the Tinnitus Handicap Inventory (THI), a 25-item questionnaire designed to quantify the degree to which tinnitus affects a patient's daily life. By employing validated assessment tools, such as the THI, this study seeks to provide objective evidence regarding the potential benefits of MEMOTIN® as a supportive intervention for individuals suffering from tinnitus. Material and Methods This study is a prospective, non-interventional, non-placebo-controlled, multicenter clinical study conducted in private clinics. The study aims to evaluate the effectiveness and safety of MEMOTIN®, a dietary supplement formulated for individuals with subjective tinnitus. The study was scheduled across two visits. Patients were instructed to take one capsule daily, 30 minutes before bedtime, for a duration of 3 months. No additional recommendations regarding dietary modifications or exercise regiments were provided during the study. The study will include adult patients diagnosed with subjective tinnitus persisting for more than six months, however, excluding patients with specific pathologies. The primary objective was to assess the effectiveness of MEMOTIN® in reducing the impact of tinnitus on patients’ quality of life over a 3-month treatment period. Results A total of 174 patients were included, of whom 161 (92.5%) completed the study. Two patients were lost to follow up, nine patients had symptoms for less than 6 months and two patients received the product less than a month.Following the administration of MEMOTIN®, the mean THI total score significantly decreased from 46.67 ± 21.33 at baseline to 25.11 ± 14.49 after 90 days of treatment. This corresponds to a mean reduction of 21.56 points (p = 0.0001), which exceeds both the clinically significant threshold of 7 points and the 20% reduction criterion (9.33 points relative to baseline). A statistically significant reduction was observed in the THI Emotional Subscale score, which decreased from 14.83 ± 8.21 at baseline to 8.30 ± 5.73 after treatment (p = 0.0001). This suggests a meaningful improvement in patients’ emotional responses to tinnitus. Analysis of insomnia-related responses showed that Category 2 (indicating that tinnitus sometimes affects sleep) was the most frequently reported category at baseline. Following the administration of MEMOTIN®, there was a statistically significant reduction in the impact of tinnitus on sleep (p < 0.05), demonstrating an improvement in sleep quality. Conclusion This study provides compelling evidence that MEMOTIN® supplementation may lead to statistically and clinically significant improvements in tinnitus severity, emotional burden, and sleep quality. The results underscore the potential role of dietary supplements as an adjunctive therapy for tinnitus management. Moreover, the multicenter design in private clinics enhances the validity and applicability of the findings in real-world clinical practice.