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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

No Placebo-Only Group

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.

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.

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

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My hearing in the non-implanted ear is normal or has mild to moderate loss.

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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:

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I have hearing loss not caused by ear damage.

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I have an ear infection.

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I have had severe hearing loss for 10 years or more.

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I have a health condition that makes surgery or anesthesia risky for me.

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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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

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