Biomodulator Patch for Subjective Tinnitus

NCT07731230 | Completed

• 1 other identifier: IMU-GOZTEPE-2018-0174
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Tinnitus; Hyperacusis

Keywords

Tinnitus; Biomodulator patch; Hyperacusis

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (4)

• Change in THI Score from Baseline to Day 21

  Baseline and Day 21

• Change in THI Score from Baseline to 1 Year

  Baseline and approximately 1 year

• Change in Hyperacusis Questionnaire (HQ) Score

  Baseline, Day 21, Day 51, and 1 year

• Change in Hospital Anxiety and Depression Scale (HADS) Score

  Baseline, Day 21, and Day 51

Study Arms (2)

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

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

Device: Placebo Patch

Interventions

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.

Biomodulator Patch

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

Placebo Patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than 18 years Subjective tinnitus for at least 4 weeks Absence of dermatological conditions that could cause skin irritation from patch application

You may not qualify if:

• Currently undergoing active tinnitus therapy Known skin sensitivity

Sponsors & Collaborators

• Murat Erinç: lead

Study Sites (1)

İstanbul Göztepe Prof. Dr. Süleyman Yalçın City Hospital

Istanbul, Kadikoy, 34722, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tinnitus; Hyperacusis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Active and placebo patches were sealed in identical, indistinguishable envelopes by a third party, who recorded the allocation key separately. The investigator, who also served as the care provider and outcomes assessor (delivering counseling, dispensing patches, and administering weekly questionnaires), remained unaware of group allocation until the study concluded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Audiology

Model Details: 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

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: June 12, 2018
• Primary Completion: February 27, 2020
• Study Completion: February 27, 2021
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)