Actively Recruiting

Phase Not Applicable
Age: 7Months - 71Months
All Genders
Healthy Volunteers
ID05775367

Cochlear Implantation in Infants and Toddlers With Single-Sided Deafness

Led by University of North Carolina, Chapel Hill · Updated on 2025-05-29

60

Participants Needed

1

Research Sites

N/A

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

Researchers are investigating the safety and effectiveness of cochlear implants in infants and toddlers with single-sided deafness (SSD). This study aims to determine whether cochlear implants can help young children with SSD hear better and whether the implants are safe for this age group. The study will compare children who receive cochlear implants to those with typical hearing and to children with SSD who do not receive implants. Twenty infants and toddlers under three years old with SSD will receive a cochlear implant. They will be followed until they reach five years of age, during which their implants will be programmed and their hearing development monitored. Two control groups of five-year-olds will also be studied: one with typical hearing and one with SSD but no implant. All groups will undergo hearing tests including localization, hearing in noise, and word recognition. Participants and their families will take part in various evaluations such as hearing tests, speech and language assessments, and educational evaluations. Researchers will measure hearing ability, including signal-to-noise ratio and localization accuracy. Safety will be monitored by tracking any adverse events related to the procedure or device. Participation involves wearing the cochlear implant processor during waking hours and attending scheduled assessments until the child is five years old.

CONDITIONS

Brief Title

Cochlear Implants in Young Children With SSD

Who Can Participate

Age: 7Months - 71Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated parental permission form
  • Unilateral severe-to-profound sensorineural hearing loss, congenital or acquired before age 2, with hearing loss greater than or equal to 70 dB HL in the ear to be implanted
  • Hearing thresholds of 20 dB HL or better in the opposite ear
  • Insufficient functional access to sound with hearing aids or low word recognition scores
  • Age between 7 months and 2 years 11 months at implantation
  • Normal cochlear nerve confirmed by MRI imaging
  • No cochlear malformation
  • No progressive hearing loss in the better-hearing ear
  • Completed hearing aid trial with aided speech intelligibility index above 0.65
  • Realistic parental expectations about benefits and risks
  • Up-to-date meningitis vaccinations as recommended by CDC
  • Normal development and cognition by standardized assessment
  • Parental commitment to follow study schedule, therapy, travel, and encourage implant use during waking hours
Not Eligible

You will not qualify if you...

  • English is not the primary language at home
  • Conductive hearing loss in either ear
  • Cochlear nerve deficiency
  • Cochlear ossification or fibrosis preventing implantation
  • Inability or unwillingness to participate in follow-up visits
  • History of chronic ear infections or conditions preventing anesthesia
  • For control subjects: inability or unwillingness to complete testing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 day

Participants with single-sided deafness receive a cochlear implant through surgery.

1 surgery visit

Surgery and Immediate Post-operative Care

Duration - 6 months

Participants are monitored for safety and any device-related adverse events after cochlear implant surgery.

Multiple follow-up visits during 6 months post-surgery

Long-term Monitoring

Duration - Up to 5 years of age

Participants are followed until they reach 5 years of age to evaluate hearing, language, sensory processing, executive function, fatigue, and cognition.

Periodic visits for testing and assessments until age 5

Trial Site Locations

Total: 1 location

1

The Children's Cochlear Implant Center at UNC

Durham, North Carolina, United States, 27713

Actively Recruiting

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Research Team

L

Lisa Park, AuD

S

Study Coordinator

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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Published Research Related To This Trial

Hearing attention and quality of listening in children with unilateral hearing loss with and without hearing aid.

Francesca Yoshie Russo, Daniele De Seta, Maria Patrizia Orlando...

https://pubmed.ncbi.nlm.nih.gov/35612509

Amplification considerations for children with minimal or mild bilateral hearing loss and unilateral hearing loss.

Sarah McKay, Judith S Gravel, Anne Marie Tharpe

https://pubmed.ncbi.nlm.nih.gov/18270178