What is this study trying to find out about single-sided deafness in young children?

This study is evaluating whether cochlear implants are a safe and effective treatment for infants and toddlers with single-sided deafness. Researchers want to understand if early implantation helps improve hearing and development compared to children with typical hearing or those with deafness who do not receive implants. The University of North Carolina, Chapel Hill is leading this research.

Who may be eligible for this single-sided deafness clinical trial?

Children between 7 months and 2 years 11 months old with severe hearing loss in one ear and normal hearing in the other may be eligible. Participants must have tried hearing aids and have normal development and cognition. The study includes children of any gender. Please review eligibility criteria for more details.

Is there any cost to participate in this single-sided deafness clinical trial?

Study-related care, including the cochlear implant device and all trial visits, is provided at no cost. However, personal travel expenses to attend appointments may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 7Months - 71Months

All Genders

Healthy Volunteers

ID05775367

Safety and Effectiveness of Cochlear Implants in Infants and Toddlers With Single-Sided Deafness

Led by University of North Carolina, Chapel Hill · Updated on 2026-06-26

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety and effectiveness of cochlear implants in infants and toddlers with single-sided deafness SSD. This study aims to determine if cochlear implants can provide a beneficial treatment for young children with SSD, a condition where one ear has severe-to-profound hearing loss while the other ear hears normally. The trial compares children who receive implants to those with typical hearing and those with SSD who do not receive an implant, to better understand the impact of early implantation on hearing and development. Twenty infants and toddlers under three years old with SSD will receive a cochlear implant device surgically placed in the ear with hearing loss. These participants will be followed until they reach five years old. Two control groups will be included one with typically hearing five-year-olds and another with five-year-olds with SSD without implants. The study will involve ongoing programming of the cochlear implants and evaluations at various intervals. Participants will attend hearing tests including localization, hearing in noise, and word recognition assessments, as well as speech, language, and educational evaluations. Researchers will monitor auditory development and safety outcomes such as procedural and device-related adverse events. The main outcomes measured at five years of age focus on hearing ability in noise and sound localization. The study lasts until participants reach five years old, with continuous monitoring and evaluations throughout this period.

CONDITIONS

Brief Title

Cochlear Implants in Young Children With SSD

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Cochlear Implant Group	SSD Control Group	Typical Hearing Control Group
What it is	Surgically implanted electronic device provided to infants and young children with single-sided deafness to deliver sound signals to the auditory nerve of the deaf ear.	Children with single-sided deafness who do not receive a cochlear implant and continue without surgical or device intervention.	Children with normal hearing in both ears, observed as a reference group in the same age range.
Role in trial	Investigational intervention group receiving a cochlear implant for SSD.	Comparator group with SSD not undergoing cochlear implantation.	Reference group with typical hearing, providing normative developmental data.
Primary use / purpose	To assess whether cochlear implantation improves hearing performance, speech recognition in noisy environments, and sound localization in young children with SSD.	To measure hearing, speech, and localization outcomes in children with SSD who do not receive a cochlear implant.	To provide age-matched normative data for auditory performance in children with normal hearing.
How it is given or performed	Cochlear implant surgery is performed under general anesthesia. The electronic device is implanted into the cochlea of the deaf ear, and children are followed for device activation and ongoing evaluation.	No device is implanted; participants continue with their usual care and education but receive regular follow-up assessments as part of the study.	No intervention is performed. Children attend study visits for hearing and speech assessments.
Evidence status	Evidence from systematic reviews and guidelines suggests that cochlear implant candidates with SSD may benefit in sound localization and speech perception, though published studies primarily evaluate children age 5 and above; long-term outcomes in infants and toddlers are being studied.	Children with SSD who do not undergo cochlear implantation are at increased risk for difficulties with spatial hearing and speech understanding in noise, as well as potential developmental and academic challenges compared to peers with typical hearing.	Children with typical hearing generally achieve age-appropriate language, academic, and social development, with optimal spatial hearing and speech understanding in competing noise.
Important limitations	Not all children with SSD are candidates for or benefit from cochlear implantation; surgery carries procedural risks and long-term device use requires ongoing support. Longitudinal outcomes in those implanted before age 3 remain under investigation.	No intervention may result in persistent functional disadvantages related to sound localization, speech-in-noise performance, and academic risk; spontaneous improvement in these domains is uncommon without intervention.	No clinical or hearing difficulties related to the study's measured outcomes are expected in this group.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 7Months - 71Months

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Signed and dated parental permission is required
Unilateral severe-to-profound sensorineural hearing loss diagnosed before 2 years of age
Hearing loss in the affected ear with a pure tone average of 70 dB or greater
Normal hearing in the other ear with pure tone average of 20 dB or less
Hearing thresholds measured appropriately using recommended methods
Insufficient benefit from hearing aids based on parent questionnaires or word recognition tests
Age between 7 months and 2 years 11 months at implantation
Normal cochlear nerve confirmed by MRI brain/internal auditory canal imaging
No cochlear malformations
No progressive hearing loss in the better-hearing ear
Willingness to try hearing aids with recommended fitting methods
Realistic parental expectations about implant outcomes
Willingness to obtain recommended meningitis vaccinations
Normal development and cognition as measured by standardized assessments
Parental commitment to study involvement including evaluations, therapy, travel, and encouraging implant use during waking hours
For control groups: children with typical hearing or single-sided deafness at 5 years old meeting similar cognitive and hearing criteria

You will not qualify if you...

English is not the primary language spoken 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 or testing
History of chronic otitis media or conditions contraindicating anesthesia
For control subjects, inability or unwillingness to participate in testing

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment and Follow-up

Duration - Until participants reach 5 years of age

Children with single-sided deafness will receive a cochlear implant and wear the processor during waking hours. All participants, including control groups, will attend scheduled hearing tests and developmental evaluations to monitor auditory and cognitive progress.

Regular visits for hearing assessments and evaluations