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Completed

NCT Number: NCT07731230

Biomodulator Patch for Subjective Tinnitus

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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Hyperacusis Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul Göztepe Prof. Dr. Süleyman Yalçın City Hospital

Istanbul, Kadikoy, 34722, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Steady-State Coherent Biomodulator Patch (Antinitus)

Device

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.

Placebo Patch

Device

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

Primary outcomes

  1. Change in Tinnitus Handicap Inventory (THI) Score from Baseline to Day 51

    Time frame: Baseline and Day 51 (21 days post-treatment + 30 days)

    THI is a 25-item questionnaire (score range 0-100), with higher scores indicating greater tinnitus-related handicap.

Secondary outcomes

  1. Change in THI Score from Baseline to Day 21

    Time frame: Baseline and 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.

  2. Change in THI Score from Baseline to 1 Year

    Time frame: Baseline and approximately 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.

  3. Change in Hyperacusis Questionnaire (HQ) Score

    Time frame: Baseline, Day 21, Day 51, and 1 year

    14-item questionnaire (score range 0-42), higher scores indicating greater hyperacusis-related distress.

  4. Change in Hospital Anxiety and Depression Scale (HADS) Score

    Time frame: Baseline, Day 21, and Day 51

    14-item scale divided into anxiety and depression subscales (scores ≥8 indicating increased risk).

Sponsors and collaborators

Lead sponsor

Murat Erinç

Other

Registry information

Official study title

Effect of a Dermal Biomodulator Patch on Subjective Tinnitus: a Randomized, Double-blind, Placebo-controlled Trial With 1-year Follow-up

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jul 28, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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