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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three years (36 months) post implantation
Awards & highlights

Study 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 below
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three years (36 months) post implantation
This trial's timeline: 3 weeks for screening, Varies for treatment, and three years (36 months) post implantation for reporting.

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 more

Trial 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

MED-EL Cochlear Implant System (Cochlear Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04506853 — N/A
Unilateral Hearing Loss Research Study Groups: Study Procedure
Unilateral Hearing Loss Clinical Trial 2023: MED-EL Cochlear Implant System Highlights & Side Effects. Trial Name: NCT04506853 — N/A
MED-EL Cochlear Implant System (Cochlear Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04506853 — N/A
~26 spots leftby Sep 2026