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Cochlear Implant

Cochlear Implants for Unilateral 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 or near-normal hearing in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 30 dB or less

65 years of age or older at the time of implantation

Must not have

External or middle ear infection

Evidence of severe cochlear malformation (i.e., common cavity or ossification)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year (12 months) post implantation

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether cochlear implants are safe and effective for seniors.

Who is the study for?

This trial is for adults over 65 with single-sided deafness who have tried other hearing aids without success. They must have profound hearing loss in one ear and normal or near-normal hearing in the other, not have had long-term deafness, no recent sudden hearing loss, and no issues that would make surgery risky.

What is being tested?

The study tests the safety and effectiveness of the MED-EL Cochlear Implant System in older adults with unilateral hearing loss. It aims to see if this implant can improve their ability to hear when traditional devices haven't worked well.

What are the potential side effects?

Potential side effects may include risks associated with surgery such as infection, issues related to anesthesia, inflammation around the implant site, changes in taste sensation due to nerve disturbance during implantation.

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 almost normal.

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an infection in my outer or middle ear.

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I have a severe inner ear abnormality.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year (12 months) post implantation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year (12 months) post implantation

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year (12 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

Performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through one year (12 months) post implantation.

Secondary study objectives

Performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through one year (12 months ) post implantation.

Performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through one year (12 months) post implantation.

Safety will be evaluated for all study subjects through one year (12 months) post implantation.

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