Pilot Investigation of a Topographical Filter Dermal Patch in Patients with Tinnitus

Abstract

Objective: A new topographical filter in a dermal administration patch that organizes water molecules has been suggested as an alternative treatment for manifested tinnitus. The aim of this study was to evaluate this patch in a pilot study. Materials and Methods: 12 patients were included (10 completed) in an open study all receiving treatment with daily changed patches. The objectives were to evaluate safety and performance of the patch during and after treatment. The primary objective was to evaluate the tinnitus severity (by Tinnitus Severity Questionnaire, TSQ) and tinnitus annoyance (by Visual Analogue Scale, VAS). The secondary objective was to evaluate if the patch could improve the patient's quality of life (by SF-36 Quality of life questionnaire) and sleep initiation time (self-rated). Results: At visit 4, after 21 days of treatment, an improvement (decrease in TSQ score) was seen in 5 responder patients, which was sustained at the post-treatment visit. A marginal increase in TSQ score was seen also initially in 5 non-responder patients, 4 of which were responders post-treatment. The rated tinnitus annoyance, quality of life and sleep initiation time did not show significant changes. The safety evaluation did not present any safety concerns. Conclusion: This small pilot study indicates that it can be reasonable to recommend on a risk-benefit and safety perspective treatment with the dermal patch to patients with tinnitus as a consumer product based on the lack of other effective alternative treatment. Further and larger studies, and also proven experience, are recommended for stronger evidence.

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

“…efficiency. In this interventional uncontrolled study about half of the patients reported a relief of tinnitus at the end of the treatment and they continued to experience relief one month after the end of the treatment schedule 8 . The 2-years follow-up after the treatment showed that still one third reported a sustainable relief of their tinnitus.…”

A Randomized, Placebo-Controlled, Double-Blind, Parallel Groups Study Evaluating the Performance and Safety of a Steady State Coherent Biomodulator Patch in the Treatment of Subjective Tinnitus

“…In addition, one third of the patients also reported a sustainable relief of their tinnitus up to 2 years after treatment. There were no safety concerns in this pilot study 26 .…”

“…In a previously published open pilot clinical investigation of tinnitus, about half of the patients treated with this biomodulator patch for 21 days experienced relief of symptoms at the end of the 3-week treatment. Patients continued to experience relief of symptoms one month after the end of the treatment period 26 . In addition, one third of the patients also reported a sustainable relief of their tinnitus up to 2 years after treatment.…”

“…To put this into perspective, we can compare this to NNT = 11 for the treatment with systemic corticosteroids for Bell's Palsy or NNT between 6 to 10 for different antidepressants treating major depressive disorder 43,44 . Taken under consideration the low frequency and mildness of the side effects of the Antinitus patch shown in this and the previous study of the patch 26 the NNT of 5 seems even more convincing in the decisionmaking approach for tinnitus sufferers.…”