What side effects are associated with this type of intervention?

Common treatments for tinnitus that modulate auditory pathways or neural activity, such as transcranial magnetic stimulation (TMS), generally have mild side effects. These can include lightheadedness, tingling, and tinnitus itself. Other neuromodulation techniques may cause mild device-associated adverse events like a warm sensation, numbness, redness, itching, tingling, muscle spasm, and localized pain. Serious adverse events are rare.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments for tinnitus that focus on the modulation of auditory pathways or neural activity similar to the Tinnitus Implant System. Most treatments for tinnitus are aimed at managing symptoms rather than curing the condition, and they include sound therapy, cognitive behavioral therapy, and medications to address underlying conditions. The Tinnitus Implant System represents a novel approach that is still under investigation for its safety and effectiveness.

What other types of research exist?

Promising, novel alternatives to the Tinnitus Implant System for tinnitus patients include: 1) Transcutaneous supraorbital nerve stimulation, which has shown efficacy in reducing migraine pain and may have potential for tinnitus treatment. 2) Remote electrical neuromodulation, which uses nonpainful electrical skin stimulation and has demonstrated pain relief in migraine patients. 3) Transcranial magnetic stimulation (TMS), which has been effective in treating migraine and may be beneficial for tinnitus by modulating neural activity. 4) Noninvasive vagus nerve stimulation (nVNS), which has shown benefits in migraine treatment and could be explored for tinnitus management.

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Tinnitus Implant for Tinnitus

N/A

Waitlist Available

Led By Matthew L Carlson, MD

Research Sponsored by Matthew L. Carlson, M.D.

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 one year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called the Tinnitus Implant System for people with persistent ringing in their ears. The device is surgically implanted and helps reduce the ringing sound. Participants will need to visit the clinic periodically for adjustments and evaluations.

Who is the study for?

Adults over 18 with severe, persistent tinnitus not helped by usual treatments like hearing aids. They should have had tinnitus for at least 6 months but no more than 3 years, and have a certain level of hearing loss and speech recognition ability.

What is being tested?

The trial is testing the Tinnitus Implant System to see if it's safe and works for treating chronic severe tinnitus. Participants will receive this novel device designed specifically for those who haven't found relief through conventional methods.

What are the potential side effects?

Potential side effects are not detailed in the provided information. However, as with any implant procedure or device, there could be risks such as infection, discomfort at the implant site, or worsening of symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

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

Number of subjects to experience significant improvement from implantation of the device

Number of subjects with treatment-related adverse events

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: Subject with severe tinnitusExperimental Treatment1 Intervention

Subjects diagnosed with severe tinnitus for at least six months, and it has not responded to conventional management will have surgical implantation of the device Tinnitus Implant System.

Do I qualify?Apply below to find out

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 transcranial magnetic stimulation (TMS) and transcutaneous electrical nerve stimulation (TENS), work by modulating neural activity in the auditory pathways. These techniques use magnetic fields or electrical currents to alter brain activity, aiming to disrupt the abnormal neural signals that cause tinnitus. This approach is significant for patients because it targets the root cause of tinnitus symptoms, offering a potential pathway to relief by addressing the underlying neural dysfunction.