← Back to Search

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 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

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Med-El CorporationLead Sponsor

23 Previous Clinical Trials

948 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

Frequently Asked Questions

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

What is the peak capacity of participants in this experimental trial?

"The Med-El Corporation, who is sponsoring this trial, needs a total of 65 individuals meeting the inclusion criteria to fulfill their research objectives. They will be conducting the study from various sites such as Ann & Robert H. Lurie Children's Hospital of Chicago in Illinois and University of North carolina in Chapel Hill."

Answered by AI

Are there a plentiful number of research centers currently running this experiment in Canada?

"At present, 7 medical centres are taking part in the trial. These sites have been established across Chicago, Chapel Hill and Iowa City as well as several other cities, allowing patients to select a location nearby them which will reduce travelling demands should they decide to participate."

Answered by AI

Are researchers still gathering participants for this clinical trial?

"Affirmative, the information on clinicaltrials.gov implies that this research is enlisting participants as of now. Initially posted on February 22nd 2021 and amended lastly on January 24th 2022, 65 volunteers are being sought from 7 different facilities."

Answered by AI