What side effects are associated with this type of intervention?

Common treatments for tinnitus, particularly non-invasive methods like sound therapy and neuromodulation, generally have mild side effects. For sound therapy, side effects may include temporary discomfort or irritation from the use of devices. Neuromodulation techniques, such as transcranial magnetic stimulation (TMS), can cause mild side effects like lightheadedness, tingling, and tinnitus itself. The Auditory Mirror Earmuffs, which re-route auditory input, are expected to have minimal side effects, primarily related to initial discomfort or adaptation to the altered auditory input.

What prior FDA approvals exist?

There are currently no FDA-approved treatments specifically for tinnitus that involve re-routing auditory input to opposite ears, such as the Auditory Mirror Earmuffs. Most FDA-approved treatments for tinnitus focus on managing symptoms through hearing aids, sound-masking devices, and cognitive behavioral therapy. Pharmacological treatments are generally aimed at underlying conditions or symptoms associated with tinnitus rather than directly addressing the tinnitus itself.

What other types of research exist?

Promising novel alternatives to Auditory Mirror Earmuffs for tinnitus treatment include: 1) Amplitude Modulated Noise, which has shown significant effects, especially for noise-like tinnitus. 2) Sound therapies derived from the principles of residual inhibition (RI). 3) Advanced hearing aids and cochlear implants that incorporate tinnitus management features. 4) Neuromodulation techniques, such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). These alternatives offer various mechanisms to potentially alleviate tinnitus symptoms.

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Behavioural Intervention

Auditory Mirror Therapy for Tinnitus

N/A

Waitlist Available

Research Sponsored by Spaulding Rehabilitation Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks

Awards & highlights

Summary

This trial tests special earmuffs that switch sounds between ears to help people with chronic tinnitus. The goal is to see if this can reduce their symptoms by changing how their brain processes sounds. Auditory mirror therapy (AMT) involves swapping sounds between ears to reduce tinnitus, similar to mirror box therapy used for phantom limb pain.

Who is the study for?

This trial is for adults aged 18-80 who have been experiencing chronic tinnitus, which means a constant ringing or noise in the ears, for more than three months. It's not specified if there are any specific exclusions other than age and duration of tinnitus.

What is being tested?

The study is testing Auditory Mirror Therapy (AMT) using special earmuffs that flip sounds from one ear to the other. The goal is to see if this can help reduce the symptoms of tinnitus.

What are the potential side effects?

Potential side effects aren't detailed here, but since AMT involves non-invasive auditory input redirection, significant side effects may be unlikely compared to drug treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Tinnitus Functional Index (TFI)

Secondary study objectives

Change in Minimum Masking Level (MML) and residual inhibition (RI)

Change in Tinnitus Handicap Inventory (THI)

Change in Visual Analogue Scale (VAS)

Other study objectives

Auditory Mirror Therapy Questionnaire

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Auditory Mirror Therapy DeviceExperimental Treatment1 Intervention

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.

Group II: Sham Headphone DevicePlacebo Group1 Intervention

Non-Modified 3M Peltor Tactical 300 Electronic Hearing Protector

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for tinnitus include sound therapy, cognitive behavioral therapy (CBT), and medications. Sound therapy works by providing external noise to mask the tinnitus or by using devices that produce customized sounds to reduce the perception of tinnitus. CBT helps patients manage the emotional and psychological impact of tinnitus by changing their response to the condition. Medications may be used to treat underlying conditions or to alleviate symptoms such as anxiety or depression. The Auditory Mirror Earmuffs, which re-route auditory input to the opposite ears, aim to alter the brain's processing of sound, potentially reducing the perception of tinnitus. This approach matters for tinnitus patients as it offers a non-invasive method to modulate auditory input and may provide relief from the persistent and often distressing symptoms of tinnitus.

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Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor

137 Previous Clinical Trials

10,967 Total Patients Enrolled

Harvard UniversityOTHER

233 Previous Clinical Trials

475,022 Total Patients Enrolled

~17 spots leftby Sep 2025

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