Tinnitus Implant for Tinnitus

Overseen By Nicole M Tombers, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Matthew L. Carlson, M.D.

Must not be taking: Antidepressants, Anxiolytics, Antipsychotics

Disqualifiers: Pregnancy, Brain surgery, Major head trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 22

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Tinnitus Implant System, to determine its safety and effectiveness in treating tinnitus, a persistent ringing in the ears. Participants will have severe tinnitus that has not improved with standard treatments like hearing aids. This trial may suit those who have experienced disruptive tinnitus in one ear for at least six months but no more than three years. As an unphased trial, it offers a unique opportunity to explore a novel treatment option for tinnitus not addressed by conventional methods.

Will I have to stop taking my current medications?

The trial requires that participants are not currently taking antidepressants, anxiolytics (medications for anxiety), or antipsychotics. If you are on these medications, you may need to stop taking them to participate.

What prior data suggests that the Tinnitus Implant System is safe for treating tinnitus?

Research shows that cochlear implants, such as the Tinnitus Implant System, can pose some risks. One possible side effect is the loss of any remaining hearing in the implanted ear. This means the implant might eliminate any residual hearing in that ear. Another concern is the potential for effects that are not yet fully understood.

Some individuals have experienced significant side effects from similar devices, leading them to withdraw from studies. While these risks are important to consider, they provide insight into potential outcomes with the Tinnitus Implant System. As this device is still under testing, its safety is not yet fully known. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Tinnitus Implant System is unique because it offers a surgical solution for severe tinnitus, a condition often treated with sound therapy, cognitive behavioral therapy, or medication. Unlike these standard options, which mainly focus on managing symptoms, this implant aims to directly target and modulate the neural pathways responsible for tinnitus. Researchers are excited about this treatment because it represents a potential breakthrough for patients whose tinnitus hasn't responded to conventional management, offering the hope of more effective and lasting relief.

What evidence suggests that the Tinnitus Implant System is effective for tinnitus?

Research shows that the Tinnitus Implant System, which participants in this trial will receive, might help reduce tinnitus symptoms. One study found that people experienced a 58% decrease in the loudness of their tinnitus after using a similar implant for 24 months. This suggests the device could significantly lessen the bothersome ringing in the ears. Although more information about this specific device is needed, the early results are encouraging for those with severe tinnitus. ^{6 7 8 9 10}

Who Is on the Research Team?

Matthew L Carlson, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You experience tinnitus in only one ear or the sound is louder in one ear compared to the other.

Your hearing loss is not severe (less than or equal to 70 decibels) and you can understand speech well (word recognition score of at least 75%).

You have had tinnitus for at least 6 months but not longer than 3 years.

Exclusion Criteria

History of brain or major ear surgery

You have a normal CT scan of your temporal bone.

Your score on the PHQ-8 test is higher than 9, which means you may have significant depression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Implantation

Participants undergo outpatient surgery for the implantation of the Tinnitus Implant System

1 day

1 visit (in-person)

Device Programming and Testing

Participants attend visits for device programming and audiometric testing

1 year

At least 21 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Tinnitus Implant System

Trial Overview 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.

How Is the Trial Designed?

Group I: Subject with severe tinnitus Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Matthew L. Carlson, M.D.

Lead Sponsor

Trials

1

Recruited

9+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03988699

Novel Tinnitus Implant System for the Treatment of Chronic ... Researchers are gathering information on the safety and effectiveness of a novel device called the Tinnitus Implant System for the treatment of tinnitus.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11659473/

A prospective cohort study of cochlear implantation as ... Here we show that after 24 month implant usage, the tinnitus cohort experience 58% reduction in tinnitus loudness (on a 0–10 scale from 4.3 ...

3. nature.com nature.com/articles/s43856-025-00837-3

Retrospective chart review demonstrating effectiveness of ... Directly asking patients if they benefitted from the Lenire treatment also led to a high success rate of 89.2%. In terms of safety, there were ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0196070925001103

Evidence synthesis of tinnitus treatment methods Summary data showed that CBT was effective in the treatment of tinnitus [OR = 3.61,95 %CI (2.16,6.02), I2 = 0 %] [22], and the difference was ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0302790

Protocol for a prospective quasi-experimental study | PLOS One This study will systematically collect data on tinnitus and tinnitus-related outcomes from patients at multiple points during the cochlear implant pathway.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P970051S205B.pdf

Summary of Safety and Effectiveness Data (SSED) Below is a list of potential adverse effects (e.g., complications) associated with the implantation and use of the Nucleus 24 Cochlear Implant ...

7. fda.gov fda.gov/medical-devices/cochlear-implants/benefits-and-risks-cochlear-implants

Benefits and Risks of Cochlear Implants May lose residual hearing. The implant may destroy any remaining hearing in the implanted ear. May have unknown and uncertain effects. The ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/99/NCT03988699/ICF_000.pdf

Novel Tinnitus Implant System for the Treatment of Chronic ... One example of why you might consider withdrawing from the study would be if you experienced significant side-effects while using the device ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11528090/

The Current State of Tinnitus Diagnosis and Treatment In this review, we summarize the current state of knowledge about tinnitus management with a particular focus on the translation into clinical practice.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT06641999

Study Details | NCT06641999 | Evaluating How a Tinnitus ... This study will test an experimental Tinnitus Implant System that consists of a cochlear implant, sound processor and programming software.