Cochlear Implants for Young Children with Single-Sided Deafness
This study is looking into how safe and effective cochlear implants are for infants and toddlers who have single-sided deafness (hearing loss in one ear). A cochlear implant is a device surgically placed to help people hear when hearing aids aren't enough. The study aims to see if these implants help young children with single-sided deafness hear better and locate sounds. Children aged 7 months to 71 months with severe-to-profound hearing loss in one ear, present from birth or before age two, may be able to join. The study will compare the hearing abilities of children who receive an implant with those who have single-sided deafness but no implant, and with children who have typical hearing. The goal is to understand if early implantation is beneficial for these children.
- Study design
- This is an interventional study planning to enroll 60 participants. It will compare three groups of children at age five: those who received a cochlear implant, those with single-sided deafness who did not, and those with typical hearing.
- What's involved
- If you join, your child will undergo cochlear implantation and will need to wear their cochlear implant processor whenever they are awake.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed until they are five years old to monitor their auditory development.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Cochlear Implants in Young Children With SSD
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Lisa Park, AuD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill
Who to contact
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What this trial measures
- Mean Difference in the Signal-to-Noise Ratio 50 (SNR-50) between the Study Group and SSD Control Group as Measured with the BKB-SIN at 5 Years of Age5 years of age
Two ½ lists of the Bamford-Kowal-Bench Speech in Noise Test (BKB-SIN) will be presented in a single condition: speech in front and masker directed 90 degrees to the normal ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better. All participants will be 5 years old at the time of testing. The study group will use their cochlear implant in conjunction with the normal hearing ear. The SSD control group will use their normal hearing ear alone.
- Mean Difference in Localization Error Between the Study Group and the SSD Control group Measured at 5 Years of Age5 years of age
Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. All participants will be 5 years old at the time of testing. The study group will use their cochlear implant in conjunction with the normal hearing ear. The SSD control group will use their normal hearing ear alone.