Cochlear Implants in Young Children With SSD

May 22, 2025 updated by: University of North Carolina, Chapel Hill

Cochlear Implantation in Infants and Toddlers With Single-Sided Deafness

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Recruiting
        • The Children's Cochlear Implant Center at UNC
        • Principal Investigator:
          • Kevin Brown, MD, PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lisa Park, AuD
        • Sub-Investigator:
          • Erika Gagnon, AuD
        • Sub-Investigator:
          • Jennifer Woodard, AuD
        • Sub-Investigator:
          • Lillian Henderson, MSP
        • Sub-Investigator:
          • Sandra Hancock, MS
        • Sub-Investigator:
          • Carlton Zdanski, MD
        • Sub-Investigator:
          • Margaret Richter, AuD
        • Sub-Investigator:
          • Lauren Leeper, MD
        • Sub-Investigator:
          • Matthew Dedmon, MD, PhD
        • Sub-Investigator:
          • A. Morgan Selleck, MD
        • Sub-Investigator:
          • Dakota Sharp, AuD
        • Sub-Investigator:
          • Melissa Anderson, AuD
        • Sub-Investigator:
          • Caitlin Sapp, AuD, PhD
        • Sub-Investigator:
          • Meredith Rooth, AuD
        • Sub-Investigator:
          • Sarah Spencer, MS
        • Sub-Investigator:
          • Erin Thompson, MS
        • Sub-Investigator:
          • Samantha Scharf, AuD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 5 years (Child)

Accepts Healthy Volunteers

Yes

Description

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. All other octave frequencies should be attempted. Bone conduction thresholds should be obtained at 500, 1000, 2000, and 4000 Hz. Masking should be attempted where appropriate. As participants are very young and masking is difficult for this population, suspected shadow audiograms will be sufficient if objective testing has confirmed a severe-to-profound unilateral hearing loss. Testing should confirm a severe-to-profound hearing loss, defined as a 3-frequency PTA (500, 1000, and 2000) >70 dB HL in one ear and ≤20 dB HL in the contralateral ear. The Primary Investigator and Lead Diagnostic Audiologist must agree on this diagnosis for enrollment.

  3. Insufficient functional access to sound with appropriately fit amplification and aural habilitation (based on best practices and standard of care) defined as:

    1. PEACH + parent questionnaire scores below the expected value for children who lack the requisite language to complete open-set word recognition testing or
    2. Recorded Multisyllabic Lexical Neighborhood Test (MLNT) scores ≤ 30% in the ear to be implanted for children with the requisite language to complete open-set word recognition testing.
  4. Between 7 months and 2 years, 11 months of age at implantation
  5. Normal cochlear nerve as evaluated by imaging, required imaging by MRI brain/Internal auditory canal (IAC) without contrast with heavily weighted T2 images. CT optional at the physician's discretion.
  6. No malformation of the cochlea
  7. No evidence of progressive hearing loss of the contralateral ear
  8. Willing to/has undergone hearing aid trial as warranted based on achieving an aided speech intelligibility index (SII) of > .65 when fitted via Desired Sensation Level (DSL) methods.
  9. Realistic parental expectations: a verbal acknowledgment of the potential benefits and risks, and postoperative variation in performance. For instance, cochlear implantation will not restore normal hearing
  10. Willing to obtain recommended meningitis vaccinations per Centers for Disease Control (CDC) recommendations
  11. Development and cognition within the normal range as measured by the Developmental Assessment of Young Children (DAYC-2).
  12. Parental commitment to study parameters including being able and willing to participate in the evaluation schedule, involvement in prescribed therapy, and travel to the investigational site and study-related activities. Parents must be willing to encourage wearing implant during waking hours.

To participate as an SSD control subject, an individual must meet all the following criteria:

  1. Provision of signed and dated parental permission form

  2. Unilateral severe-to-profound hearing loss - congenital or acquired prior to 2 years of age.

    1. Unaided residual hearing thresholds that yield a 3 frequency PTA (500, 1000, and 2000 Hz) of ≥70 dB HL in the affected ear.
    2. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz)
    3. Unable to use or benefit from traditional amplification
  3. Five years of age at the time of testing
  4. Development and cognition within the normal range as measured by the Early Stanford Binet 2 (SB2).

To participate as a TH control subject, an individual must meet all the following criteria:

  1. Provision of signed and dated parental permission form
  2. Bilateral hearing thresholds that yield a PTA of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz).
  3. Five years of age at the time of testing
  4. Development and cognition within the normal range as measured by the Early SB2.

An individual who meets any of the following criteria will be excluded from participation in this study as a study subject:

  1. English is not primary language of the home

    1. Speech perception materials are presented in English
    2. Parental questionnaires are administered in English
  2. Conductive hearing loss in either ear
  3. Cochlear nerve deficiency
  4. Ossification/Fibrosis of the cochlea precluding implantation
  5. Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)
  6. History of refractory chronic otitis media or condition that contraindicates anesthesia

An individual who meets any of the following criteria will be excluded from participation in this study as a control subject:

  1. English is not primary language of the home

    1. Speech perception materials are presented in English
    2. Parental questionnaires are administered in English
  2. Inability to participate in testing (i.e., unwillingness)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
This group of children with single-sided deafness will receive a cochlear implant.
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.
Other Names:
  • MED-EL SYNCHRONY 2 Cochlear Implant
No Intervention: Typical Hearing Control Group (THCG)
This group of five-year-old children will have typical hearing in both ears.
No Intervention: Single-Sided Deafness Control Group (SSDCG)
This group of five-year-old children will have single-sided deafness and no cochlear implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Age
Time Frame: 5 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.
5 years of age
Mean Difference in Localization Error Between the Study Group and the SSD Control group Measured at 5 Years of Age
Time Frame: 5 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.
5 years of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Procedural Related Adverse Events 6 months after Surgery
Time Frame: 6 months after surgery
Procedural adverse events will be collected and reported as the proportion of subjects experiencing them.
6 months after surgery
Proportion of Device-Related Adverse Events 6 Months after Surgery
Time Frame: 6 months after surgery
Device related adverse events will be collected and reported as the proportion of subjects experiencing them.
6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Med-El Corporation

Investigators

  • Principal Investigator: Lisa Park, AuD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2023

Primary Completion (Estimated)

May 30, 2030

Study Completion (Estimated)

May 30, 2030

Study Registration Dates

First Submitted

March 7, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-0862

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-Identified raw data will be archived at Open Science Framework

IPD Sharing Time Frame

At the time of the first publication following study closure

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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