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Cochlear Implants in Young Children With SSD

NCT05775367 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-29

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Med-El Corporation

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Lisa Park, AuD · University of North Carolina, Chapel Hill

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Months
Max Age
71 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-07
Primary Completion
2030-05-30
Completion
2030-05-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05775367 on ClinicalTrials.gov