TinnitusNCT05710172
Evaluation of Auditory Mirror-therapy for Tinnitus
A study testing Auditory Mirror Therapy in people with Tinnitus, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
The investigators will evaluate the effects of wearing auditory mirror earmuffs on tinnitus and on audiometry.The auditory mirror earmuffs is a device that re-routes auditory input from the left side of the head to the right ear, and vice verse, thereby flipping the auditory input. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Auditory Mirror Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2022to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female
- Ages 18-80 years old
- Chronic Tinnitus (> 3months)
Who cannot join
- Use of hearing aids
- No history of significant drug or alcohol use
- No history of debilitating neurological or psychiatric illnesses
- No current or past history of balance-, vertigo- and/or vestibular- symptoms including Ménières disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129
About this study
The investigators will evaluate the effects of wearing auditory mirror earmuffs on tinnitus and on audiometry.The auditory mirror earmuffs is a device that re-routes auditory input from the left side of the head to the right ear, and vice verse, thereby flipping the auditory input. This procedure is called Auditory Mirror Therapy (AMT).
Read the detailed description
The goal of this study is to determine efficacy of a 21 day, 3 hours per day intervention of auditory mirror therapy (AMT) for chronic tinnitus. Hypothesis: AMT, as contrasted to a sham device, will significantly reduce symptom ratings on the Tinnitus Functional Index (TFI) scale. Along with TFI, additional measures will be collected every two days throughout the intervention; Tinnitus Handicap Index, Visual Analogue Scale, Minimum Masking Level (MML) and Residual Inhibition (RI), and Auditory Mirror Therapy Questionnaire.
- Conditions
- Tinnitus
- Being tested
- Auditory Mirror Therapy
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory Mirror TherapyDevice
21 days, up to 3 hours per day intervention
| Study group | Role | What they receive |
|---|---|---|
| Auditory Mirror Therapy Device | Experimental | Modified 3M Peltor Tactical 300 Electronic Hearing Protector. The modification consists of connecting the left microphone to the right microphone tab on the circuit board, and vice versa. Receives: Device: Auditory Mirror Therapy |
| Sham Headphone Device | Sham comparator | Non-Modified 3M Peltor Tactical 300 Electronic Hearing Protector Receives: Device: Auditory Mirror Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tinnitus Functional Index (TFI)
The Tinnitus Functional Index (TFI) is a 25-item questionnaire measuring tinnitus severity on a 0-100 scale. Scores are calculated by averaging item responses and scaling to 0-100, where higher scores signify greater distress.
The change in TFI score between baseline and follow up is reported, with negative numbers indicating a decrease in tinnitus severity.
Measured: 3 weeks
Secondary outcomes (3)
Change in Tinnitus Handicap Inventory (THI)
a brief and psychometrically robust self-report measure used to quantify the impact of tinnitus on daily living.
Measured: 3 weeks
Change in Visual Analogue Scale (VAS)
Scale from 0 to 100 for tinnitus awareness, loudness and annoyance, on separate VAS.
VAS loudness and annoyance are valid and effective measurements for capturing reductions in tinnitus severity in patients with chronic tinnitus
Measured: 3 weeks
Change in Minimum Masking Level (MML) and Residual Inhibition (RI)
MML is defined as the lowest tone intensity level required to cover or mask and individual's tinnitus.
Correspondingly, the RI is considered the temporary decrease of tinnitus after a prolonged acoustic stimulation.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start4 Oct 2022
- Primary completion20 Nov 2023
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University
- Responsible party
- Principal investigator, Nils Clas Linnman, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710172
- Sponsor's protocol ID
- 2016P000820
- Status last verified
- Apr 2026
- First submitted
- 15 Jan 2023
- Last updated
- 15 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Linnman C. Auditory Mirror Therapy for Tinnitus: A Pilot Study. J Am Acad Audiol. 2022 Apr;33(4):220-223. doi: 10.1055/a-1749-9279. Epub 2022 Dec 6.
PubMed 35079989
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Auditory Mirror-therapy for Tinnitus
- ClinicalTrials.gov ID
- NCT05710172
- Acronym / sponsor ID
- 2016P000820
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Harvard University
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Posted 15 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will evaluate the effects of wearing auditory mirror earmuffs on tinnitus and on audiometry.The auditory mirror earmuffs is a device that re-routes auditory input from the left side of the head to the right ear, and vice verse, thereby flipping the auditory input. This procedure is called Auditory Mirror Therapy (AMT).
Detailed description
The goal of this study is to determine efficacy of a 21 day, 3 hours per day intervention of auditory mirror therapy (AMT) for chronic tinnitus. Hypothesis: AMT, as contrasted to a sham device, will significantly reduce symptom ratings on the Tinnitus Functional Index (TFI) scale. Along with TFI, additional measures will be collected every two days throughout the intervention; Tinnitus Handicap Index, Visual Analogue Scale, Minimum Masking Level (MML) and Residual Inhibition (RI), and Auditory Mirror Therapy Questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auditory Mirror Therapy Device | Experimental | Device: Auditory Mirror TherapyModified 3M Peltor Tactical 300 Electronic Hearing Protector. The modification consists of connecting the left microphone to the right microphone tab on the circuit board, and vice versa. |
| Sham Headphone Device | Sham comparator | Device: Auditory Mirror TherapyNon-Modified 3M Peltor Tactical 300 Electronic Hearing Protector |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female
- Ages 18-80 years old
- Chronic Tinnitus (> 3months)
Key exclusion criteria (4 listed)
- Use of hearing aids
- No history of significant drug or alcohol use
- No history of debilitating neurological or psychiatric illnesses
- No current or past history of balance-, vertigo- and/or vestibular- symptoms including Ménières disease
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 |
|---|---|---|
| Auditory Mirror Therapy21 days, up to 3 hours per day intervention | Device | Auditory Mirror Therapy Device, Sham Headphone Device |
Primary outcome
Change in Tinnitus Functional Index (TFI)
Time frame: 3 weeks
The Tinnitus Functional Index (TFI) is a 25-item questionnaire measuring tinnitus severity on a 0-100 scale. Scores are calculated by averaging item responses and scaling to 0-100, where higher scores signify greater distress. The change in TFI score between baseline and follow up is reported, with negative numbers indicating a decrease in tinnitus severity.
3 secondary outcomes
Change in Tinnitus Handicap Inventory (THI)
Time frame: 3 weeks
Change in Visual Analogue Scale (VAS)
Time frame: 3 weeks
Change in Minimum Masking Level (MML) and Residual Inhibition (RI)
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35079989Linnman C. Auditory Mirror Therapy for Tinnitus: A Pilot Study. J Am Acad Audiol. 2022 Apr;33(4):220-223. doi: 10.1055/a-1749-9279. Epub 2022 Dec 6.
- Individual participant dataSharing planned: Undecided
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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 Auditory Mirror Therapy in people with Tinnitus, run by Spaulding Rehabilitation Hospital at 1 site in United States.
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 3 inclusion and 4 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 15 May 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Functional Index (TFI) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05710172, which also lists 1 linked publication.
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 15 May 2026.