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Cochlear Implant
Cochlear Implant for Hearing Loss
N/A
Recruiting
Research Sponsored by Med-El Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal hearing or mild to moderate hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 55 dB or less
Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz and a diagnosed pathology of the outer or middle ear
Must not have
Other retrocochlear hearing loss
External or middle ear infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three years (36 months) post implantation
Awards & highlights
Summary
This trial will test the safety and effectiveness of cochlear implants for those with single-sided deafness or asymmetric hearing loss.
Who is the study for?
This trial is for adults and children aged 5 or older with single-sided profound hearing loss, who have tried other hearing aids without success. They must have very poor word recognition in the affected ear and normal to moderate hearing in the other ear. People can't join if they've been profoundly deaf for over 10 years, have developmental issues, surgical risks, cochlear nerve problems, or severe inner ear abnormalities.Check my eligibility
What is being tested?
The study tests the long-term safety and effectiveness of MED-EL Cochlear Implant System in individuals with single-sided deafness or asymmetric hearing loss. It aims to see how well this implant works for those who haven't benefited from traditional or bone conduction hearing aids.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of cochlear implants may include discomfort at the implant site, ringing in the ears (tinnitus), dizziness, taste disturbances due to nerve injury during surgery, and device failure requiring reimplantation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My hearing in the non-implanted ear is normal or has mild to moderate loss.
Select...
I have hearing loss in one ear without major issues in the outer or middle ear.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have hearing loss not caused by ear damage.
Select...
I have an ear infection.
Select...
I have had severe hearing loss for 10 years or more.
Select...
I have a health condition that makes surgery or anesthesia risky for me.
Select...
My inner ear or hearing nerve does not work properly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three years (36 months) post implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three years (36 months) post implantation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Long-term performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through three years (36 months) post implantation
Secondary outcome measures
Long term performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through three (36 months) post implantation
Long term performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through three years (36 months) post implantation
Long term safety will be evaluated for all study subjects through three (36 months) years post implantation
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Study ProcedureExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Med-El CorporationLead Sponsor
23 Previous Clinical Trials
949 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hearing in the non-implanted ear is normal or has mild to moderate loss.I have hearing loss not caused by ear damage.I have hearing loss in one ear without major issues in the outer or middle ear.You have a severe problem with the structure of your inner ear.I have an ear infection.You have severe hearing loss in one ear, with a specific measure of 90 decibels or more at certain frequencies.I am at least 5 years old.I have used a specific type of hearing aid before, as recommended by a doctor.I have had severe hearing loss for 10 years or more.There are worries about your learning or thinking abilities.I have a health condition that makes surgery or anesthesia risky for me.Your ability to understand words with the ear that will be implanted is 5% or less in a quiet environment.My inner ear or hearing nerve does not work properly.
Research Study Groups:
This trial has the following groups:- Group 1: Study Procedure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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