Other

Tinnitus Implant System 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
Tinnitus present for at least 6 months, but not longer than 3 years
Tinnitus that is disruptive
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upone year
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new implant to see if it's safe and effective in treating tinnitus.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have experienced ringing in your ears for at least 6 months but no longer than 3 years.
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You have a ringing in your ears that is bothersome and affects your daily activities.
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You have a constant ringing in your ears that cannot be improved with a hearing aid or other treatments.
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You have ringing in one ear that only you can hear.
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You have severe tinnitus, rated as 50 or higher on a scale of 0 to 100.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.

Find a site

Who is running the clinical trial?

Matthew L. Carlson, M.D.Lead Sponsor
Matthew L Carlson, MDPrincipal Investigator
Mayo Clinic
3 Previous Clinical Trials
67 Total Patients Enrolled

Media Library

Tinnitus Implant System (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03988699 — N/A
Tinnitus Research Study Groups: Subject with severe tinnitus
Tinnitus Clinical Trial 2023: Tinnitus Implant System Highlights & Side Effects. Trial Name: NCT03988699 — N/A
Tinnitus Implant System (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03988699 — N/A
Tinnitus Patient Testimony for trial: Trial Name: NCT03988699 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still able to apply for participation in this research?

"The clinical trial registry hosted on clinicaltrials.gov shows that patient recruitment for this particular medical study has ended, with the initial posting of August 23rd 2021 and the most recent update occuring July 14th 2022. Despite this, 45 other trials are still actively recruiting participants."

Answered by AI

Who else is applying?

What state do they live in?
Florida
California
Minnesota
Other
How old are they?
65+
18 - 65
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
1
0

Why did patients apply to this trial?

I’m very motivated to work for a solution to. Tendinitis interferes with my quality of life.
Patient
i become really creazy from this sound in my ear/brain! I have been bothered for years, it is effecting my work and home life, constantly having to ask people to repeat what they have said.
Patient
I have tinnitus and UNMC is dragging their feet trying to offer me relief. Maybe since I don’t qualify for a cochlear implant, that this could work.
Patient

What questions have other patients asked about this trial?

what are they doing in this trial? When will you be starting the study? How long does thisvtake? How many visits are necessary ?
Patient
Can you put an implant on an ear that has already been cut open in 1995?
Patient

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Mayo Clinic in Rochester: < 48 hours
Typically responds via
Email
~0 spots leftby Dec 2023