Your session is about to expire
← Back to Search
Cochlear Implant
MED-EL SYNCHRONY PIN Cochlear Implant for Sensorineural Hearing Loss
N/A
Waitlist Available
Research Sponsored by Med-El Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 month post-activation
Awards & highlights
Study Summary
This trial is to show that MED-EL cochlear implants are safe and effective for children aged 7 months to 5 years and 11 months who cannot access sound well enough with hearing aids, despite training.
Eligible Conditions
- Sensorineural Hearing Loss
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 month post-activation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 month post-activation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number and proportion of subjects experiencing device- and/or procedure-related adverse events.
Percent correct on Multisyllabic Lexical Neighborhood Test (MLNT)/Lexical Neighborhood Test (LNT)
Secondary outcome measures
Speech recognition testing in the implanted ear(s)
Total Score on Auditory Skills Checklist (ASC)
Total Score on LittlEARS Auditory Questionnaire (LEAQ)
Trial Design
2Treatment groups
Experimental Treatment
Group I: RetrospectiveExperimental Treatment1 Intervention
Study identification, sponsor/collaborators, oversight, purpose, indications, and primary endpoints for the retrospective, observational study arm align with the prospective study arm. The retrospective arm will be enrolling by invitation for chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020. The specific devices and outcome measures will vary slightly for retrospective subjects, based on what was clinically available and used at the time of implantation.
Group II: ProspectiveExperimental Treatment1 Intervention
Detailed interventions and outcome measures refer to the prospective, experimental study arm. The prospective arm is active but not enrolling.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MED-EL SYNCHRONY PIN Cochlear Implant
2019
N/A
~250
Find a Location
Who is running the clinical trial?
Med-El CorporationLead Sponsor
23 Previous Clinical Trials
766 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You or your parents have expectations that are not realistic for the study.You have a type of hearing loss that can be treated.You have a permanent hearing loss that affects your ability to hear sounds.You have a skin or scalp condition that makes it impossible to use an external audio processor.You have suspected memory or thinking problems that could affect your ability to participate in the study.You have previously had a hearing implant.You have a condition called common cavity.You currently have meningitis or have had it in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Retrospective
- Group 2: Prospective
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.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger