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Cochlear Implant Settings for Childhood Hearing Loss
N/A
Waitlist Available
Led By Lisa Park, AuD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Spoken English as the primary language (speech perception testing conducted in English)
Aged 5 through 17 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-stimulation
Awards & highlights
Study Summary
This trial is investigating whether speech perception is better in pediatric cochlear implant (CI) recipients with functional pre-operative hearing when they use the hearing aid alone or combined electric-acoustic stimulation. Two cohorts of CI recipients aged 6 through 17 years will be evaluated.
Who is the study for?
This trial is for children aged 5-17 with certain types of hearing loss who speak English and have realistic expectations. They must be able to participate in tests, have adequate language skills, and received a specific cochlear implant. Those with oral motor delays, cochlear nerve issues, or cognitive impairments that prevent testing are excluded.Check my eligibility
What is being tested?
The study compares speech perception in kids with pre-operative low frequency hearing using two methods: one group uses a hearing aid alone (HA-alone), the other combines this with electric-acoustic stimulation (EAS). The goal is to see which method better supports speech understanding.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort from wearing devices, possible changes in residual hearing levels due to device use or surgery-related complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I primarily speak and understand English.
Select...
I am between 5 and 17 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post-stimulation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-stimulation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean BKB-SIN SNR-50 scores, comparing EAS and CI-alone conditions at 12 months post stimulation (Arm 1 to Arm 2).
Mean CNC word scores, comparing EAS and CI-alone conditions at 12 months post stimulation (Arm 1 to Arm 2).
Secondary outcome measures
Change in percent correct in single word scores in quiet, comparing pre- and post-stimulation scores in both groups
Speech
Mean Pediatric SSQ scores, comparing Pre-operative and 12 month post stimulation scores in both groups.
Other outcome measures
Percent correct in prosodic identification scores, comparing EAS to CI-Alone conditions in Arm 1 participants
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment1 Intervention
Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of > 75 dB HL.
Electric Acoustic Speech Processor: Electric only fitting They will be evaluated in the traditional fully electric condition only.
Group II: Arm 1Experimental Treatment1 Intervention
Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL.
Electric Acoustic Speech Processor: EAS fitting. They will be evaluated in the EAS condition and the hearing aid (HA) alone condition.
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,520 Previous Clinical Trials
4,196,540 Total Patients Enrolled
Med-El CorporationIndustry Sponsor
23 Previous Clinical Trials
973 Total Patients Enrolled
Lisa Park, AuDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
60 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I struggle to understand speech because of difficulty moving my mouth.I primarily speak and understand English.My surgery was adjusted due to specific physical conditions.I have a problem with the nerve that connects my ear to my brain.You have received a MED-EL SYNCHRONY Cochlear Implant device.You have hearing loss in one or both ears that is severe enough to affect your ability to hear well.I am between 5 and 17 years old.Parents and patients have reasonable expectations.I cannot complete certain tests due to behavioral or thinking problems.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 2
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.
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