Actively Recruiting
Cochlear Implants in Young Children With SSD
Led by University of North Carolina, Chapel Hill · Updated on 2025-05-29
60
Participants Needed
1
Research Sites
359 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
M
Med-El Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to investigate the safety and effectiveness of cochlear implantation in infants and toddlers with single-sided deafness. The main questions it aims to answer are: * Are cochlear implants an effective treatment of single-sided deafness in infants and toddlers? * Are cochlear implants a safe treatment for single-sided deafness in infants and toddlers? Participants will receive a cochlear implant and be followed until they are five years old. During those five years, the investigators will program the device and monitor auditory development. Children will be asked to: * Undergo cochlear implantation * Wear their cochlear implant processor whenever they are awake. * Participate in traditional hearing tests * Participate in traditional hearing testing * Participate in localization testing * Participate in hearing in noise testing * Participate in word recognition testing * Participate in speech, language, and educational evaluations The researchers will compare results to children with typical hearing in both ears and children with single-sided deafness who have not received an implant to observe any differences between the groups.
CONDITIONS
Official Title
Cochlear Implants in Young Children With SSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated parental permission form
- Unilateral severe-to-profound sensorineural hearing loss, congenital or acquired before age 2
- Hearing loss defined as 3-frequency average ≥70 dB HL in the ear to be implanted and ≤20 dB HL in the other ear
- Insufficient hearing benefit from amplification based on PEACH questionnaire or word recognition scores ≤30%
- Age between 7 months and 2 years 11 months at implantation
- Normal cochlear nerve as shown by MRI brain/Internal auditory canal without contrast
- No cochlear malformation
- No progressive hearing loss in the better ear
- Willingness to undergo hearing aid trial and achieve aided speech intelligibility index >0.65
- Verbal parental acknowledgment of potential benefits and risks
- Willingness to obtain recommended meningitis vaccinations
- Development and cognition within normal range by DAYC-2 assessment
- Parental commitment to study participation including evaluation schedule and encouraging implant use during waking hours
You will not qualify if you...
- English not the primary language of the home
- Conductive hearing loss in either ear
- Cochlear nerve deficiency
- Cochlear ossification or fibrosis preventing implantation
- Inability or unwillingness to participate in follow-up procedures
- History of refractory chronic otitis media or anesthesia contraindications
- For control subjects: inability or unwillingness to participate in testing
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Children's Cochlear Implant Center at UNC
Durham, North Carolina, United States, 27713
Actively Recruiting
Research Team
L
Lisa Park, AuD
CONTACT
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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