Biomodulator Patch for Subjective Tinnitus

Overview

This study tested whether a skin patch, worn behind the ear, could help reduce tinnitus (ringing or buzzing in the ears) in adults. Eighty participants took part. Half wore an active patch, and half wore a patch that looked the same but had no active effect (a placebo). Neither the participants nor the researchers knew who received which patch until the study ended. All participants also received an educational counseling session about tinnitus and how to manage it. Participants were assessed before treatment, three weeks later, about seven weeks later, and again about one year later. The researchers measured how much tinnitus affected their daily life, their sensitivity to sound, and their anxiety or mood.

Tinnitus is a common condition without a universally accepted pharmacological treatment. The steady-state coherent biomodulator patch (Antinitus, Sensori AB, Sweden) uses passive, light photon-driven technology intended to influence water coherency in tissue and modulate neural activity along auditory pathways. Its performance and safety have previously been evaluated in earlier randomized controlled trials and post-market surveys, with follow-up data reported up to one year after treatment in prior literature. This single-center, randomized, double-blind, placebo-controlled trial evaluated the clinical effectiveness of the biomodulator patch in adults with subjective tinnitus, examining both short-term and long-term (up to one year) outcomes. Participants were randomly assigned to receive either the active patch or a visually identical placebo patch, applied behind the ear and replaced daily for three weeks. Active and placebo patches were distributed in sealed envelopes to preserve blinding; neither participants nor investigators were aware of group allocation during the trial. All participants received a standardized informative counseling session at study entry (approximately one hour), covering the auditory system, the nature and causes of tinnitus, available management approaches, and instruction on correct patch application. Assessments were conducted at baseline, after 21 days of treatment, one month after treatment completion (day 51), and via telephone follow-up at approximately one year post-treatment. Continuous data are summarized as median and interquartile range given non-normal distributions. Within-group longitudinal changes were assessed using Wilcoxon signed-rank and Friedman tests; between-group comparisons used the Mann-Whitney U test. Exploratory correlation and regression analyses examined associations between tinnitus handicap, emotional distress, hyperacusis, age, and tinnitus duration at each assessment point.