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

9 Participants Needed

Trial Summary

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 data supports the effectiveness of the Tinnitus Implant System treatment for tinnitus?

Research shows that cochlear implants, which are similar to the Tinnitus Implant System, can significantly reduce tinnitus in many patients. In one study, five out of six patients experienced tinnitus suppression with cochlear implants, suggesting that electrical stimulation devices like the Tinnitus Implant System may help reduce tinnitus symptoms. ^{1 2 3 4 5}

Is the Tinnitus Implant System safe for humans?

The Tinnelec Implant, a type of tinnitus implant, was tested in a small study and showed some benefits for tinnitus relief. However, one patient needed a device replacement due to unrelated hearing loss, and others switched to different implants for additional hearing benefits. This suggests the implant is generally safe, but more studies are needed to confirm its safety in a larger group. ^{6 7 8 9 10}

How does the Tinnitus Implant System treatment differ from other tinnitus treatments?

The Tinnitus Implant System is unique because it uses a non-penetrating electrode to electrically stimulate the auditory nerve, aiming to suppress or mask tinnitus without affecting normal hearing. This approach allows for treatment in patients with normal hearing and can be adapted to address progressive hearing loss by switching to a penetrating electrode if needed. ^{5 8 10 11 12}

What is the purpose of this trial?

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.

Research Team

Matthew L Carlson, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Tinnitus suppression by cochlear implants. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Patient-based outcomes in patients with primary tinnitus undergoing tinnitus retraining therapy. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

[Hearing aids, implantable hearing aids and cochlear implants in chronic tinnitus therapy]. [2021]

4. Canada pubmed.ncbi.nlm.nih.gov

A matched-pair comparison of two cochlear implant systems. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Cochlear implant for tinnitus. Case reports. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Post Market Clinical Follow up Results of the Steady State Coherent Bio-modulator Patch for tinnitus. [2021]

7. Italy pubmed.ncbi.nlm.nih.gov

Tinnitus suppression with electrical stimulation in adults: long-term follow-up. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Non-penetrating round window electrode stimulation for tinnitus therapy followed by cochlear implantation. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

A Randomized, Placebo-Controlled, Double-Blind, Parallel Groups Study Evaluating the Performance and Safety of a Steady State Coherent Biomodulator Patch in the Treatment of Subjective Tinnitus. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Tinnitus management with percutaneous osseointegrated auditory implants for unilateral sensorineural hearing loss. [2015]

11. Japan pubmed.ncbi.nlm.nih.gov

[A tinnitus case with an implanted electrical tinnitus suppressor]. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Current Device-based Clinical Treatments for Tinnitus. [2021]