The International Tinnitus Journal

Advancing Personalized Tinnitus Care: A Prospective Multicentre Evaluation of the MyTMD Tinnitus Matching Device and TMe-Solution in the tinnitus patients in India

Shilpa Rajeev Huzurbazar, Nandkishor Gosavi, Ketki Pimpalkhute Prabhu, Kalpana Rajivkumar, Neeleshkumar Pandit, Rajashree Mane

Background: Tinnitus is the conscious perception of sound, such as ringing, buzzing, or hissing, in one or both ears or within the head in the absence of an external acoustic stimulus. It is a highly prevalent condition, affecting more than 740 million adults worldwide, with over 120 million individuals experiencing bothersome symptoms that substantially impair their quality of life. Despite its high prevalence, tinnitus remains a significant clinical challenge due to its heterogeneous presentation, largely idiopathic etiology, and complex underlying pathophysiology. These factors complicate accurate diagnosis and the selection of effective treatment strategies for ENT specialists and audiologists. The novel Tinnitus Matching Device (MyTMD), combined with the IoT-based personalized tinnitus management platform (TMe-Solution), offers a comprehensive approach for precise tinnitus characterization and customized management. Preliminary evaluations have demonstrated its potential to improve the accuracy of tinnitus assessment and support individualized treatment. Methodology: This was a multicentre, open-label clinical study involving patients aged 18–65 years with idiopathic moderate-to-severe tinnitus. Eligible participants were enrolled and followed for 60 days. All participants attended followup visits on Day 30 and Day 60 for the assessment of treatment efficacy and safety. The primary efficacy endpoint was the change in the Tinnitus Handicap Inventory (THI) score from baseline to the end of treatment (Day 60). Secondary efficacy endpoints included changes from baseline to Day 60 in the Numerical Rating Scale (NRS) scores for tinnitus loudness, duration, and annoyance. Result: A total of 43 patients were enrolled in the study. The mean age of the participants was 47.9 years. The study population comprised 22 men and 21 women, indicating a nearly equal sex distribution. At the end of the 60-day treatment period, the mean Tinnitus Handicap Inventory (THI) score decreased by 59.75% compared with baseline. Similarly, the Numerical Rating Scale (NRS) scores showed a progressive reduction in symptom severity, including ear fullness (56.19% reduction), tinnitus loudness (69.29% reduction), degree of annoyance (67.85% reduction), and tinnitus duration (70.22% reduction) from baseline to Day 60. Conclusion: Precise tinnitus matching and effective tinnitus management continue to pose significant challenges for clinicians. Many patients remain dissatisfied with the currently available treatment options due to their limited effectiveness and lack of personalization. The novel, non-invasive tinnitus matching device (MyTMD) enables precise characterization of tinnitus, facilitating individualized assessment. The accompanying tinnitus management software (TMe-Solution) provides a comprehensive IoT-based platform that supports personalized treatment through customized tinnitus masking, Tinnitus Retraining Therapy (TRT), attention diversion techniques, and cognitive behavioral therapy (CBT). Together, the MyTMD and TMe-Solution offer an integrated, multimodal appr