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Cochlear Implant

MED-EL SYNCHRONY PIN Cochlear Implant for Sensorineural Hearing Loss

Q: What is the geographic breadth of this trial's implementation?

<p>Ann &#x26; Robert H. Lurie Children's Hospital of Chicago in Chicago, <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a>, ENT for Children in Coppell, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> and Medical College of <a href="https://www.withpower.com/clinical-trials/wisconsin">Wisconsin</a> in Milwaukee, Wisconsin are among the many sites currently enrolling participants into this clinical trial. An additional 8 locations have also been identified as recruiting centres.</p>

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 month post-activation for reporting.

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Med-El CorporationLead Sponsor

23 Previous Clinical Trials

766 Total Patients Enrolled

Media Library

MED-EL SYNCHRONY PIN Cochlear Implant (Cochlear Implant) Clinical Trial Eligibility Overview. Trial Name: NCT03900897 — N/A

Sensorineural Hearing Loss Research Study Groups: Retrospective, Prospective

Sensorineural Hearing Loss Clinical Trial 2023: MED-EL SYNCHRONY PIN Cochlear Implant Highlights & Side Effects. Trial Name: NCT03900897 — N/A

MED-EL SYNCHRONY PIN Cochlear Implant (Cochlear Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03900897 — N/A

Frequently Asked Questions

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

Am I eligible to join this research endeavor?

"This clinical trial has 60 slots for children between the ages of 7 months and 6 years who suffer from severe to profound bilateral sensorineural hearing loss. The requirements are that a parent/guardian must be able to communicate in one of the available languages, patients have insufficient access to sound with fitted amplification and habilitation, as well as meeting all other criteria outlined in the LEAQ."

Answered by AI

Does this medical trial have an age restriction, and if so, what is it?

"As mandated by the recruitment criteria, patients must be between 7 Months and 6 years old in order to participate."

Answered by AI

What is the geographic breadth of this trial's implementation?

"Ann & Robert H. Lurie Children's Hospital of Chicago in Chicago, Illinois, ENT for Children in Coppell, Texas and Medical College of Wisconsin in Milwaukee, Wisconsin are among the many sites currently enrolling participants into this clinical trial. An additional 8 locations have also been identified as recruiting centres."

Answered by AI

Does this research offer opportunities to participate for any current patients?

"According to information provided on clinicaltrials.gov, this medical trial is not actively recruiting candidates at the present time; it was initiated June 17th 2019 and last updated November 7th 2022. Alternatively, there are 157 other ongoing trials that are in need of participants currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Expanded Indications in the MED-EL Pediatric Cochlear Implant Population

2019. "Expanded Indications in the MED-EL Pediatric Cochlear Implant Population". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03900897.