Cochlear Implants in Young Children With SSD

NCT05775367 | Recruiting FDA Device

• 1 other identifier: 22-0862
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cochlear implant; uhl; ssd; children; hearing loss; deafness

Outcome Measures

Primary Outcomes (2)

• 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.

  5 years of age

• 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.

  5 years of age

Secondary Outcomes (2)

• Proportion of Procedural Related Adverse Events 6 months after Surgery

  6 months after surgery

• Proportion of Device-Related Adverse Events 6 Months after Surgery

  6 months after surgery

Study Arms (3)

Study Group

EXPERIMENTAL

This group of children with single-sided deafness will receive a cochlear implant.

Device: Cochlear Implant

Typical Hearing Control Group (THCG)

NO INTERVENTION

This group of five-year-old children will have typical hearing in both ears.

Single-Sided Deafness Control Group (SSDCG)

NO INTERVENTION

This group of five-year-old children will have single-sided deafness and no cochlear implant.

Interventions

Cochlear Implant DEVICE

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.

Also known as: MED-EL SYNCHRONY 2 Cochlear Implant

Study Group

Eligibility Criteria

• Age: 7 Months - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Med-El Corporation: collaborator

Study Sites (1)

The Children's Cochlear Implant Center at UNC

Durham, North Carolina, 27713, United States

RECRUITING

Related Publications (20)

• 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.

  PMID: 3512353 BACKGROUND

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

  PMID: 6462820 BACKGROUND

• 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.

  PMID: 34609204 BACKGROUND

• 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.

  PMID: 28828919 BACKGROUND

• 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.

  PMID: 29651362 BACKGROUND

• 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.

  PMID: 26452077 BACKGROUND

• 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.

  PMID: 36004776 BACKGROUND

• 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.

  PMID: 35612509 BACKGROUND

• 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.

  PMID: 18270178 BACKGROUND

• 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.

  PMID: 24035639 BACKGROUND

• 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.

  PMID: 35213890 BACKGROUND

• 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.

  PMID: 34542181 BACKGROUND

• 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.

  PMID: 33769866 BACKGROUND

• 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.

  PMID: 33761831 BACKGROUND

• 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.

  PMID: 31836889 BACKGROUND

• Bess FH, Davis H, Camarata S, Hornsby BWY. Listening-Related Fatigue in Children With Unilateral Hearing Loss. Lang Speech Hear Serv Sch. 2020 Jan 8;51(1):84-97. doi: 10.1044/2019_LSHSS-OCHL-19-0017. Epub 2020 Jan 8.

  PMID: 31913803 BACKGROUND

• Hoff S, Ryan M, Thomas D, Tournis E, Kenny H, Hajduk J, Young NM. Safety and Effectiveness of Cochlear Implantation of Young Children, Including Those With Complicating Conditions. Otol Neurotol. 2019 Apr;40(4):454-463. doi: 10.1097/MAO.0000000000002156.

  PMID: 30870355 BACKGROUND

• Deep NL, Purcell PL, Gordon KA, Papsin BC, Roland JT Jr, Waltzman SB. Cochlear Implantation in Infants: Evidence of Safety. Trends Hear. 2021 Jan-Dec;25:23312165211014695. doi: 10.1177/23312165211014695.

  PMID: 34028328 BACKGROUND

• Chweya CM, May MM, DeJong MD, Baas BS, Lohse CM, Driscoll CLW, Carlson ML. Language and Audiological Outcomes Among Infants Implanted Before 9 and 12 Months of Age Versus Older Children: A Continuum of Benefit Associated With Cochlear Implantation at Successively Younger Ages. Otol Neurotol. 2021 Jun 1;42(5):686-693. doi: 10.1097/MAO.0000000000003011.

  PMID: 33710159 BACKGROUND

• Benchetrit L, Ronner EA, Anne S, Cohen MS. Cochlear Implantation in Children With Single-Sided Deafness: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2021 Jan 1;147(1):58-69. doi: 10.1001/jamaoto.2020.3852.

  PMID: 33151295 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Unilateral; Hearing Loss; Articulation Disorders; Deafness

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Study Officials

• Lisa Park, AuD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Park, AuD

CONTACT

9842152871; lisa_park@med.unc.edu

Study Coordinator

CONTACT

919-966-5251; CIResearch@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: July 7, 2023
• Primary Completion (Estimated): May 30, 2030
• Study Completion (Estimated): May 30, 2030
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: At the time of the first publication following study closure

Locations

US (1)