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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year (12 months) post implantation
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My hearing in the non-implanted ear is normal or almost normal.
Select...
I am 65 years old or older.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through one year (12 months) post implantation.
Secondary outcome measures
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.
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Study ProcedureExperimental Treatment1 Intervention
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Who is running the clinical trial?
Med-El CorporationLead Sponsor
23 Previous Clinical Trials
998 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have previously used a specific type of hearing aid as recommended by the investigator.You have already used a hearing aid that suits your needs, as recommended by the researcher. You are able to speak and understand English fluently.Your ability to recognize words in the ear that will receive an implant is 5% or less in a quiet environment.I have an infection in my outer or middle ear.You have a specific type of hearing loss in the ear where the device will be implanted.My hearing in the non-implanted ear is normal or almost normal.I have a severe inner ear abnormality.I am 65 years old or older.I have a health condition that makes surgery or anesthesia risky for me.You are suspected to have problems with thinking or memory.You have very severe hearing loss in one ear.I have had severe hearing loss for 10 years or more.I experienced sudden hearing loss within 6 months after getting an implant.You have a type of hearing loss that affects the nerve or area behind the ear.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the enrollment period for this clinical trial remain open?
"Affirmative. According to information on clinicaltrials.gov, this experiment is presently recruiting participants and was initially posted on June 27th 2022. The research team seeks 15 test subjects from three locations to observed the trial's results."
Answered by AI
How many participants have enlisted in this research?
"Affirmative, clinicaltrials.gov data reveals that this trial is actively recruiting patients at this time. This experiment was initially posted on June 27th 2022 and the same date marks its most recent update. A total of 15 participants will be recruited across 3 sites."
Answered by AI
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