TinnitusNCT07731230
Biomodulator Patch for Subjective Tinnitus
A study testing Steady-State Coherent Biomodulator Patch (Antinitus) in people with Tinnitus and Hyperacusis, run by Murat Erinç at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Hyperacusis
- What is being tested?
- Steady-State Coherent Biomodulator Patch (Antinitus)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jun 2018to 27 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18 years Subjective tinnitus for at least 4 weeks Absence of dermatological conditions that could cause skin irritation from patch application
Who cannot join
- Currently undergoing active tinnitus therapy Known skin sensitivity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Göztepe Prof. Dr. Süleyman Yalçın City Hospital
Istanbul, Kadikoy, 34722
About this study
Official title: Effect of a Dermal Biomodulator Patch on Subjective Tinnitus: a Randomized, Double-blind, Placebo-controlled Trial With 1-year Follow-up
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.
Read the detailed description
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.
- Conditions
- Tinnitus, Hyperacusis
- Being tested
- Steady-State Coherent Biomodulator Patch (Antinitus), Placebo Patch
- Keywords
- Tinnitus, Biomodulator patch, Hyperacusis
- Medical subject headings
- Tinnitus, Hyperacusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 PatchDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Biomodulator Patch | Experimental | 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 Receives: Device: Steady-State Coherent Biomodulator Patch (Antinitus) |
| Placebo Patch | Placebo comparator | 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 Receives: Device: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 51 (21 days post-treatment + 30 days)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, Day 21, and Day 51
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start12 Jun 2018
- Primary completion27 Feb 2020
- Study completion27 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel groups: an experimental group receiving the active biomodulator patch (Antinitus) or a control group receiving a visually identical placebo patch. Both groups applied their assigned patch behind the ear daily for three weeks and received the same standardized informative counseling session at study entry. Group allocation remained blinded to both participants and investigators throughout the study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murat Erinç
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Murat Erinç, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731230
- Sponsor's protocol ID
- IMU-GOZTEPE-2018-0174
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Dermal Biomodulator Patch on Subjective Tinnitus: a Randomized, Double-blind, Placebo-controlled Trial With 1-year Follow-up
- ClinicalTrials.gov ID
- NCT07731230
- Acronym / sponsor ID
- IMU-GOZTEPE-2018-0174
- Conditions
- Tinnitus, Hyperacusis
- Keywords
- Tinnitus, Biomodulator patch, Hyperacusis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Murat ErinçUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2021 (actual)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel groups: an experimental group receiving the active biomodulator patch (Antinitus) or a control group receiving a visually identical placebo patch. Both groups applied their assigned patch behind the ear daily for three weeks and received the same standardized informative counseling session at study entry. Group allocation remained blinded to both participants and investigators throughout the study
| Arm | Type | Receives |
|---|---|---|
| Biomodulator Patch | Experimental | Device: Steady-State Coherent Biomodulator Patch (Antinitus)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 |
| Placebo Patch | Placebo comparator | Device: Placebo PatchParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age older than 18 years Subjective tinnitus for at least 4 weeks Absence of dermatological conditions that could cause skin irritation from patch application
Key exclusion criteria (1 listed)
- Currently undergoing active tinnitus therapy Known skin sensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steady-State Coherent Biomodulator Patch (Antinitus)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. | Device | Biomodulator Patch |
| Placebo PatchA patch visually indistinguishable from the active biomodulator patch but without active photon-driven effect, applied behind the ear and replaced daily for three weeks | Device | Placebo Patch |
Primary outcome
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.
4 secondary outcomes
Change in THI Score from Baseline to Day 21
Time frame: Baseline and Day 21
Change in THI Score from Baseline to 1 Year
Time frame: Baseline and approximately 1 year
Change in Hyperacusis Questionnaire (HQ) Score
Time frame: Baseline, Day 21, Day 51, and 1 year
Change in Hospital Anxiety and Depression Scale (HADS) Score
Time frame: Baseline, Day 21, and Day 51
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steady-State Coherent Biomodulator Patch (Antinitus) in people with Tinnitus and Hyperacusis, run by Murat Erinç at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tinnitus Handicap Inventory (THI) Score from Baseline to Day 51 (time frame: Baseline and Day 51 (21 days post-treatment + 30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.