An interventional study of Steady-State Coherent Biomodulator Patch (Antinitus) and Placebo Patch in Tinnitus and Hyperacusis, sponsored by Murat Erinç. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Murat Erinç · Not applicable, Interventional, and Treatment
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.
444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.
This study's enrollment of 91 is above the median of 60 across 368 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →This is the only study on the registry with Murat Erinç as lead sponsor.
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Age older than 18 years Subjective tinnitus for at least 4 weeks Absence of dermatological conditions that could cause skin irritation from patch application
Exclusion Criteria:
Currently undergoing active tinnitus therapy Known skin sensitivity
Participants applied an active steady-state coherent biomodulator patch (Antinitus, Sensori AB, Sweden) behind the ear daily for three weeks. All participants in this arm also received a standardized one-hour informative counseling session at study entry, covering the auditory system, tinnitus, and management strategies
Device: Steady-State Coherent Biomodulator Patch (Antinitus)
Participants applied a placebo patch, visually indistinguishable from the active patch, behind the ear daily for three weeks. All participants in this arm also received the same standardized one-hour informative counseling session at study entry as the experimental group
Device: Placebo Patch
A passive, light photon-driven biomodulator patch applied behind the ear and replaced daily for three weeks, intended to influence auditory neural activity through effects on tissue water coherency.
A patch visually indistinguishable from the active biomodulator patch but without active photon-driven effect, applied behind the ear and replaced daily for three weeks
Change in Tinnitus Handicap Inventory (THI) Score from Baseline to Day 51
THI is a 25-item questionnaire (score range 0-100), with higher scores indicating greater tinnitus-related handicap.
Time frame: Baseline and Day 51 (21 days post-treatment + 30 days)
Change in THI Score from Baseline to Day 21
The Tinnitus Handicap Inventory (THI) is a 25-item questionnaire scored from 0 to 100, with higher scores indicating greater tinnitus-related handicap (0-16 = no handicap, 18-36 = mild, 38-56 = moderate, 58-100 = severe). Change was calculated as the difference between baseline and Day 21 scores.
Time frame: Baseline and Day 21
Change in THI Score from Baseline to 1 Year
The Tinnitus Handicap Inventory (THI) is a 25-item questionnaire scored from 0 to 100, with higher scores indicating greater tinnitus-related handicap. A subset of participants was contacted by telephone approximately one year after treatment to assess long-term durability of THI change from baseline.
Time frame: Baseline and approximately 1 year
Change in Hyperacusis Questionnaire (HQ) Score
14-item questionnaire (score range 0-42), higher scores indicating greater hyperacusis-related distress.
Time frame: Baseline, Day 21, Day 51, and 1 year
Change in Hospital Anxiety and Depression Scale (HADS) Score
14-item scale divided into anxiety and depression subscales (scores ≥8 indicating increased risk).
Time frame: Baseline, Day 21, and Day 51
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data are not planned to be shared publicly, as this was an investigator-initiated, single-center academic study without a formal data-sharing infrastructure or data dictionary. De-identified data may be made available from the corresponding author upon reasonable request, subject to institutional approval.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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