What side effects are associated with this type of intervention?

The most common treatments for tinnitus involving electrical and acoustic stimulation can have several side effects. Electrical stimulation methods, such as cochlear implants, electrodes in the ear canal, and needles through the ear drum, may cause discomfort, pain, or infection at the site of stimulation. Other potential side effects include dizziness, hearing changes, and, in rare cases, seizures. Acoustic stimulation typically has fewer side effects but may cause temporary changes in hearing sensitivity or discomfort from prolonged exposure to sound. Overall, while these treatments show promise, they are not without risks, and patients should discuss potential side effects with their healthcare provider.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for tinnitus that have proven to be effective. Current research is exploring the potential of electrical and acoustic stimulation of the inner ear as possible treatments. These methods aim to modulate neural activity to reduce or eliminate the perception of tinnitus, but they are still under investigation and not yet available as approved therapies.

What other types of research exist?

Promising alternatives to electrical and acoustic stimulation for tinnitus treatment include transcutaneous electrical nerve stimulation (TENS) and transcranial magnetic stimulation (TMS). TENS has been effective in reducing chronic pain and neuropathic pain, which may translate to tinnitus relief. TMS, particularly repetitive TMS, has shown efficacy in reducing functional disability in migraine and may offer similar benefits for tinnitus patients.

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Acoustic + Electrical Stimulation for Tinnitus

N/A

Recruiting

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

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

Must have

18 years or older

Tinnitus present for 6 months or more

Must not have

Abnormalities of the ear canal or ear drum

Chronic middle ear disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up outcome will be measured during each participant visit through study completion which can be an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if playing sounds through headphones or using small electrical currents in the ear can help people with tinnitus. It targets those whose tinnitus significantly affects their quality of life. The treatment works by trying to interfere with the ringing noise, making it quieter or stopping it. Using small electrical currents has been explored in various studies as a potential treatment for tinnitus, showing mixed results in terms of effectiveness.

Who is the study for?

This trial is for adults who have had tinnitus, or ringing in the ears, for at least six months. Participants must speak English well enough to describe their experiences and complete surveys. Those with cochlear implants can join the electrical stimulation part of the study. Excluded are individuals under 18, pregnant or breastfeeding women, those on certain medications like aspirin that cause tinnitus, with ear abnormalities or treatable causes of tinnitus.

What is being tested?

The study investigates acoustic and electrical stimulation as treatments for tinnitus. Acoustic tests involve listening to sounds through headphones and rating tinnitus loudness. Electrical tests use a cochlear implant or electrodes placed in/on the ear to assess changes in tinnitus perception.

What are the potential side effects?

Potential side effects may include discomfort from wearing headphones during acoustic testing or from electrode placement during electrical stimulation. There might also be temporary changes in hearing levels after procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have had ringing in my ears for over 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have issues with my ear canal or ear drum.

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I have a long-term ear infection.

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My tinnitus can be treated.

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I am not taking aspirin, ibuprofen, or naproxen that I cannot stop.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ outcome will be measured during each participant visit through study completion which can be an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~outcome will be measured during each participant visit through study completion which can be an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and outcome will be measured during each participant visit through study completion which can be an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Audiogram

Medical Outcomes Study Questionnaire Short Form 36 (SF-36) Health Survey Quality of life metrics.

Otoacoustic Emissions (OAE)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Electrical/ Acoustic stimulationExperimental Treatment2 Interventions

0 / 7Eligibility criteria met

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, such as electrical and acoustic stimulation, work by modulating neural activity in the inner ear. Electrical stimulation, delivered via cochlear implants, ear canal electrodes, or needles through the eardrum, alters auditory pathway signals to reduce tinnitus perception. Acoustic stimulation uses specific sounds to induce residual inhibition, temporarily reducing tinnitus. These mechanisms are important for patients as they offer potential relief by directly targeting the neural processes responsible for tinnitus.