NCT05775367

Cochlear Implants in Young Children With SSD

Cochlear Implantation in Infants and Toddlers With Single-Sided Deafness

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 7 Months – 71 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Cochlear implantation is an FDA-approved option for children with single-sided deafness (SSD) who are over the age of five years. It has been well established that early implantation is advantageous for children with bilateral hearing loss as it takes advantage of the narrow window of neural plasticity. Research has yet to show the ideal age for implantation in children with SSD but considering the known impacts of age at implantation and duration of deafness on cochlear implant (CI) outcomes, five years is likely a late age for implantation in a child with congenital SSD. The purpose of this prospective clinical trial is to evaluate the safety and effectiveness of cochlear implantation in infants and toddlers with SSD. Twenty (20) infants and Toddlers with SSD who are under the age of three will receive a cochlear implant. They will be followed until they reach the age of five. A group of typically hearing five-year-olds (n=20) and a group of five-year-olds with congenital or early onset SSD who have not received a cochlear implant (n=20) will also be recruited. All three groups of five-year-olds will be tested on measures of hearing in quiet, localizing, and hearing in spatially separated noise for comparison. Scores from the study group and the SSD control group will be compared to evaluate effectiveness. The study will also explore the potential effects of SSD and early implantation on language, sensory processing, executive function, fatigue, and cognition.

Conditions

• Single Sided Deafness
• Unilateral Deafness
• Hearing Loss, Unilateral
• Hearing Loss
• Congenital Hearing Loss
• Deafness One Ear

Interventions

Type	Name	Description
DEVICE	Cochlear Implant	A cochlear implant is a surgically implanted device that provides access to sound in people cannot get enough access to sound for communication with traditional hearing aids.

Timeline

• Start date: 2023-07-07
• Primary completion: 2030-05-30
• Completion: 2030-05-30
• First posted: 2023-03-20
• Last updated: 2025-05-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study