Cochlear Implants in Young Children With SSD
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
| Condition(s) | Single Sided Deafness, Unilateral Deafness, Hearing Loss, Unilateral, Hearing Loss, Congenital Hearing Loss, Deafness One Ear |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 * Partic |
| Who can participate | To be eligible to participate in this trial as a study subject, an individual must meet all of the following criteria: 1. Provision of signed and dated parental permission form 2. Unilateral severe-to-profound sensorineural hearing loss, congenital or acquired prior to the age of 2 years, defined as: 1. Unaided residual hearing thresholds that yield a 3 frequency pure tone average (PTA; average at 500, 1000, and 2000 Hz) of ≥70 dB hearing loss (HL) in the ear to be implanted 2. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz). i. Thresholds should be measured using inserts wherever possible, or in the sound field to record the better-hearing ear alone. Required thresholds will include 250, 500, 1000, 2000, and 4000 Hz for air conduction. |
| Ages | 7 Months to 71 Months |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of North Carolina, Chapel Hill |
| Locations | Durham, North Carolina, United States |
| Start date | 2023-07-07 |
| NCT ID | NCT05775367 |
| Official listing | https://clinicaltrials.gov/study/NCT05775367 |