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Single Sided DeafnessLittle SSDNCT05775367

Cochlear Implants in Young Children With SSD

A study testing Cochlear Implant in people with Single Sided Deafness and Unilateral Deafness, run by University of North Carolina, Chapel Hill at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 7 to 71 monthsHealthy volunteers can take part
What is being tested?
Cochlear Implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
7 Jul 2023to 30 May 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 71 months
  • All sexes
  • Healthy volunteers accepted
  • Child

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:
  3. 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
  4. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz).
  5. 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.
  6. Insufficient functional access to sound with appropriately fit amplification and aural habilitation (based on best practices and standard of care) defined as:
  7. PEACH + parent questionnaire scores below the expected value for children who lack the requisite language to complete open-set word recognition testing or
  8. 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.
  9. Between 7 months and 2 years, 11 months of age at implantation
  10. 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.
  11. No malformation of the cochlea
  12. No evidence of progressive hearing loss of the contralateral ear
  13. 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.
  14. 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
  15. Willing to obtain recommended meningitis vaccinations per Centers for Disease Control (CDC) recommendations
  16. Development and cognition within the normal range as measured by the Developmental Assessment of Young Children (DAYC-2).
  17. 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.
  3. Unaided residual hearing thresholds that yield a 3 frequency PTA (500, 1000, and 2000 Hz) of ≥70 dB HL in the affected ear.
  4. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz)
  5. Unable to use or benefit from traditional amplification
  6. Five years of age at the time of testing
  7. 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
  2. Speech perception materials are presented in English
  3. Parental questionnaires are administered in English
  4. Conductive hearing loss in either ear
  5. Cochlear nerve deficiency
  6. Ossification/Fibrosis of the cochlea precluding implantation
  7. Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)
  8. 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
  2. Speech perception materials are presented in English
  3. Parental questionnaires are administered in English
  4. Inability to participate in testing (i.e., unwillingness)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lisa Park, AuD contact

9842152871

lisa_park@med.unc.edu

Study Coordinator contact

919-966-5251

CIResearch@unc.edu

United States1 site, 1 recruiting

  • The Children's Cochlear Implant Center at UNC

    Durham, North Carolina, 27713

    Lisa Park, AuD, 984-215-2871, lisa_park@med.unc.edu

    CI Research, CIResearch@unc.edu

    Recruiting

Other trials in United States

About this study

Official title: 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:

Read more
  • 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.

Read the 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.

Being tested
Cochlear Implant
Keywords
cochlear implant, uhl, ssd, children, hearing loss, deafness
Medical subject headings
Hearing Loss, Unilateral, Hearing Loss, Articulation Disorders, Deafness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cochlear ImplantDevice

    Also called MED-EL SYNCHRONY 2 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.

Study groups in NCT05775367
Study groupRoleWhat they receive
Study GroupExperimentalThis group of children with single-sided deafness will receive a cochlear implant.
Receives: Device: Cochlear Implant
Typical Hearing Control Group (THCG)No interventionThis group of five-year-old children will have typical hearing in both ears.
Single-Sided Deafness Control Group (SSDCG)No interventionThis group of five-year-old children will have single-sided deafness and no cochlear implant.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: 5 years of age

  2. Mean Difference in Localization Error Between the Study Group and the SSD Control group Measured at 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.

    Measured: 5 years of age

Secondary outcomes (2)

  1. Proportion of Procedural Related Adverse Events 6 months after Surgery

    Procedural adverse events will be collected and reported as the proportion of subjects experiencing them.

    Measured: 6 months after surgery

  2. Proportion of Device-Related Adverse Events 6 Months after Surgery

    Device related adverse events will be collected and reported as the proportion of subjects experiencing them.

    Measured: 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2023
  2. Study start7 Jul 2023
  3. Primary completion30 May 2030 (estimated)
  4. Study completion30 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The study group will receive a cochlear implant under the age of three and be tested at the age of five. Two control groups, both five years old, will be tested as well. The control groups will consist of children with typical hearing in both ears and children with single-sided deafness who have not received a cochlear implant.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05775367
Sponsor's protocol ID
22-0862
Acronym
Little SSD
Status last verified
Jun 2026
First submitted
7 Mar 2023
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: De-Identified raw data will be archived at Open Science Framework

Publications

  • Bess FH, Tharpe AM. An introduction to unilateral sensorineural hearing loss in children. Ear Hear. 1986 Feb;7(1):3-13. doi: 10.1097/00003446-198602000-00003.

    PubMed 3512353

  • Bess FH, Tharpe AM. Unilateral hearing impairment in children. Pediatrics. 1984 Aug;74(2):206-16.

    PubMed 6462820

  • Corbin NE, Buss E, Leibold LJ. Spatial Hearing and Functional Auditory Skills in Children With Unilateral Hearing Loss. J Speech Lang Hear Res. 2021 Nov 8;64(11):4495-4512. doi: 10.1044/2021_JSLHR-20-00081. Epub 2021 Oct 5.

    PubMed 34609204

  • Anne S, Lieu JEC, Cohen MS. Speech and Language Consequences of Unilateral Hearing Loss: A Systematic Review. Otolaryngol Head Neck Surg. 2017 Oct;157(4):572-579. doi: 10.1177/0194599817726326. Epub 2017 Aug 22.

    PubMed 28828919

  • Lieu JEC. Permanent Unilateral Hearing Loss (UHL) and Childhood Development. Curr Otorhinolaryngol Rep. 2018;6(1):74-81. doi: 10.1007/s40136-018-0185-5. Epub 2018 Feb 15.

    PubMed 29651362

  • Purcell PL, Shinn JR, Davis GE, Sie KC. Children with unilateral hearing loss may have lower intelligence quotient scores: A meta-analysis. Laryngoscope. 2016 Mar;126(3):746-54. doi: 10.1002/lary.25524. Epub 2015 Oct 9.

    PubMed 26452077

  • Bell R, Mouzourakis M, Wise SR. Impact of unilateral hearing loss in early development. Curr Opin Otolaryngol Head Neck Surg. 2022 Oct 1;30(5):344-350. doi: 10.1097/MOO.0000000000000848. Epub 2022 Aug 24.

    PubMed 36004776

  • Russo FY, De Seta D, Orlando MP, Ralli M, Cammeresi MG, Greco A, de Vincentiis M, Ruoppolo G, Mancini P, Turchetta R. Hearing attention and quality of listening in children with unilateral hearing loss with and without hearing aid. Acta Otorhinolaryngol Ital. 2022 Apr;42(2):169-175. doi: 10.14639/0392-100X-N1746.

    PubMed 35612509

  • McKay S, Gravel JS, Tharpe AM. Amplification considerations for children with minimal or mild bilateral hearing loss and unilateral hearing loss. Trends Amplif. 2008 Mar;12(1):43-54. doi: 10.1177/1084713807313570.

    PubMed 18270178

  • Ead B, Hale S, DeAlwis D, Lieu JE. Pilot study of cognition in children with unilateral hearing loss. Int J Pediatr Otorhinolaryngol. 2013 Nov;77(11):1856-60. doi: 10.1016/j.ijporl.2013.08.028. Epub 2013 Sep 6.

    PubMed 24035639

  • Park LR, Griffin AM, Sladen DP, Neumann S, Young NM. American Cochlear Implant Alliance Task Force Guidelines for Clinical Assessment and Management of Cochlear Implantation in Children With Single-Sided Deafness. Ear Hear. 2022 Mar/Apr;43(2):255-267. doi: 10.1097/AUD.0000000000001204.

    PubMed 35213890

  • Brown KD, Dillon MT, Park LR. Benefits of Cochlear Implantation in Childhood Unilateral Hearing Loss (CUHL Trial). Laryngoscope. 2022 Mar;132 Suppl 6(Suppl 6):S1-S18. doi: 10.1002/lary.29853. Epub 2021 Sep 20.

    PubMed 34542181

  • Park LR, Dillon MT, Buss E, O'Connell BP, Brown KD. Spatial Release From Masking in Pediatric Cochlear Implant Recipients With Single-Sided Deafness. Am J Audiol. 2021 Jun 14;30(2):443-451. doi: 10.1044/2020_AJA-20-00119. Epub 2021 Mar 26.

    PubMed 33769866

  • Park LR, Preston E, Noxon AS, Dillon MT. Comparison of test methods to assess the implanted ear alone for pediatric cochlear implant recipients with single-sided deafness. Cochlear Implants Int. 2021 Sep;22(5):283-290. doi: 10.1080/14670100.2021.1903715. Epub 2021 Mar 24.

    PubMed 33761831

  • Nassrallah F, Tang K, Whittingham J, Sun H, Fitzpatrick EM. Auditory, Social, and Behavioral Skills of Children With Unilateral/Mild Hearing Loss. J Deaf Stud Deaf Educ. 2020 Apr 5;25(2):167-177. doi: 10.1093/deafed/enz041.

    PubMed 31836889

Questions about this trial

What is this clinical trial studying?

A study testing Cochlear Implant in people with Single Sided Deafness and Unilateral Deafness, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lisa Park, AuD (9842152871, lisa_park@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05775367, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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