Overseen ByMatthew L Carlson, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Matthew L. Carlson, M.D.
No Placebo Group
Trial Summary
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.
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.
You must be 18 years old or older.
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%).
+6 more
Exclusion Criteria
History of brain or major ear surgery
You have a normal CT scan of your temporal bone.
Age: <18 years of age
+11 more
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?
Matthew L. Carlson, M.D.Lead Sponsor