A Review of a Steady State Coherent Bio-modulator for Tinnitus Relief and Summary of Efficiency and Safety Data from the Clinical Study Program and Post Market Clinical Follow-up.

OBJECTIVES: To evaluate a non-energy consuming light bio-modulator patch creating coherency for tinnitus relief.

MATERIALS AND METHODS: Three independent clinical studies and continuous post market clinical follow up have been performed during the year 2012 to 2018. The first study was a limited interventional investigation with 10 patients, the second was a larger interventional study with finally 48 patients further investigated, and the third a randomized, placebo-controlled, double-blind study with 82 patients. In the clinical studies patch performance evaluated with questionnaires related to tinnitus, quality-of-life, and safety were assessed prior, during and after the end of treatment. In all studies the treatment time was 3 weeks and the patches were placed behind one year.

RESULTS: The first study indicated a relief with half of the patients at the end of the treatment. Still two years after the study one third reported tinnitus relief. However, the numbers of patients were low. The second study showed a responder relief in 58% directly after end of treatment and 60% one month after. The third study showed that the biomodulator patch had statistical significant three times more responders than placebo one month after end of treatment, measured as a decrease from baseline in at least 2 points in tinnitus annoyance visual analogue scale as a minimal clinical significant difference. Tinnitus handicap inventory was improved by mean-16 points significantly for the active responder group, but with no statistically significant changes for the placebo group or between the groups. The biomodulator patch was safe and well-tolerated in all three studies. The post market clinical follow up has shown a 30% reported relief and with no new risks or unexpected issues affecting the effectiveness or safety.

CONCLUSION: Taken under consideration the lack of easy-to-use alternative and the low risk profile, this patch device could highly be recommended to try for tinnitus relief as a conclusion based on the clinical studies and post market surveys. Further studies of how this bio-modulator more specific act on the auditory system, how long this may sustain and if there can be subgroups of patients or variations in the treatment time, delayed onset, number of patches, and frequency for more efficiency needs to be considered.