Cochlear Implantation in Children With Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial

This is a two-phase study that compares performance growth pre-implant with current hearing aid (HA) technology versus post-implant with a cochlear implant (CI) in children with either asymmetric hearing loss (AHL) or single-sided deafness (SSD). Post-implant performance with a CI alone is expected to outperform pre-implant performance with a HA. The study also evaluates the effectiveness of bimodal hearing defined as a CI in the poor ear and a HA in the better ear for AHL or a CI in the poor ear and normal hearing in the better ear for SSD compared to pre-implant performance. The study examines factors contributing to CI outcomes.

Study Overview

• Status: Recruiting
• Conditions: Unilateral Deafness; Asymmetric Hearing Loss; Single-sided Deafness
• Intervention / Treatment: Device: Cochlear Implant

Detailed Description

The study is conducted as a multicenter, prospective, two-phase clinical trial, evaluating the efficacy and safety of cochlear implantation in children with asymmetric hearing loss (AHL) or single-sided deafness (SSD). A hearing aid (HA) phase occurs over a minimum of 4 mos prior to obtaining a cochlear implant (CI). A CI phase occurs over the 15-month period after initial activation of the CI. The AHL/SSD groups are tested for change in performance pre- to post-implant. Investigators also collect longitudinal data over 12 months (matching the 3 to 15 month post-implant timeframe) from normal hearing (NH) participants to provide additional information about outcome trajectory due to development alone. The NH participants are matched to AHL/SSD participants on age, gender and parent education. Post-implant performance with a CI alone is expected to outperform pre-implant performance with a HA. The study evaluates the effectiveness of bimodal hearing defined as a CI in the poor ear and a HA in the better ear for AHL or a CI in the poor ear and normal hearing in the better ear for SSD compared to pre-implant performance. The study examines factors contributing to CI outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noel Dwyer, AuD; Phone Number: 314-362-7245; Email: NDwyer@wustl.edu
• Study Contact Backup: Name: Laura Holden, AuD; Phone Number: 314-362-7245; Email: laurakholden@wustl.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Keck School of Medicine of the University of Southern California
      • Contact: Laurie S Eisenberg, PhD; Phone Number: 213-764-2826; Email: laurie.eisenberg@med.usc.edu
      • Contact: Karen C Johnson, PhD; Phone Number: 213-764-2909; Email: karen.johnson@med.usc.edu
      • Principal Investigator: Laurie S Eisenberg, PhD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • Recruiting
      • Fairview Health Services
      • Contact: Margaret Koeritzer, AuD; Phone Number: 612-365-8307; Email: Margaret.Koeritzer@fairview.org
      • Contact: Jennifer Ward, AuD; Phone Number: 612-365-8311; Email: jward3@fairview.org
      • Principal Investigator: Margaret Koeritzer, AuD
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine/St Louis Children's Hospital
      • Contact: Jamie Cadieux, AuD; Phone Number: 314-454-2201; Email: CadiuxJH@wustl.edu
      • Principal Investigator: Jill B Firszt, PhD
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Recruiting
      • Hearts for Hearing
      • Contact: Sara Neumann, AuD; Phone Number: 405-548-4300; Email: Sara.Neumann@heartsforhearing.org
      • Principal Investigator: Sara Neumann, AuD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia - Buerger Center
      • Principal Investigator: John Germiller, MD
      • Contact: Carmen Hayman, AuD; Phone Number: 215-590-7461; Email: hayman@email.chop.edu
      • Contact: Joy Peterson, AuD; Phone Number: 215-590-7620; Email: petersonj@email.chop.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• At least 4 ys of age and up to 14 yrs, 11 mos of age and able to complete all investigational procedures.
• Parents and child fluent in English. Parents desire bilateral hearing for their child, are willing to comply with study requirements, including the pre-implant HA phase, and are able to provide informed consent.
• Poor ear (AHL/SSD): PTA at .5, 1, 2 kHz > 70 dB HL; Aided CNC word recognition score at 60 dB SPL < 40%; SPHL duration ≥ 6 mos and ≤ 10 yrs at time of CI surgery; If > 5 yrs of age, evidence of non-congenital SPHL onset (e.g., passed newborn hearing screening); If ≤ 5 yrs of age, no restrictions on SPHL onset.
• Better ear
• AHL: PTA at .5, 1, 2, 4 kHz > 25 and ≤ 60 dB HL; Aided CNC word score at 60 dB SPL ≥ 55%; Currently using a HA; Stable hearing for the past 6-mo period. "Stable" is defined as thresholds that have not declined by more than 20 dB at three or more octave-interval audiometric frequencies.
• SSD: PTA at .5, 1, 2, 4 kHz ≤ 25 dB HL; CNC word score at 60 dB SPL ≥ 70%; Stable hearing for the past 6-mo period.
• Both ears of NH participants: PTA at .5, 1, 2, 4 kHz ≤ 25 dB HL.
• To continue with cochlear implantation and into the CI phase of the study: Indication, via imaging, of a normal cochlear nerve and of cochlear anatomy in the ear to be implanted that allows full insertion of the electrode array. Imaging modality is at the discretion of the surgeon. In addition, better ear hearing must be stable throughout the HA phase.

Exclusion Criteria for AHL/SSD Participants:

• Medical condition that contraindicates surgery; Actively using an implantable device in the ear to be implanted; Inability to complete study procedures; Unrealistic expectations related to the benefits and limitations of implantation; Unwillingness or inability to comply with all investigational requirements.
• Exclusions for cochlear implantation and the CI phase of the study: Cochlear malformation or obstruction that would preclude full insertion of the electrode array in the ear to be implanted; Abnormal cochlear nerve in the ear to be implanted; Hearing loss of neural or central origin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AHL/SSD; Children with asymmetric hearing loss or single-sided deafness	Device: Cochlear Implant; Cochlear implantation of a device from one of the three manufacturers available in the US.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Poor ear alone word recognition in quiet from Pre-Implant to 12 months post-implant	Poor ear alone CNC monosyllabic word recognition in quiet with the CI alone compared to pre-implant with a HA.	Pre-Implant and 12 months post-implant
Change in Bimodal speech understanding in noise from Pre-Implant to 15 months post-implant	Speech reception thresholds (SRTs) for understanding words in noise in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) post-implant compared to the pre-implant best aided condition.	Pre-implant and 15 months post-implant
Post-implant bimodal vs better ear alone speech understanding in noise	Post-implant speech reception thresholds (SRTs) for understanding words in noise in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) compared to the better ear alone condition.	15 months post-implant
Change in pre-implant trajectory of Bimodal speech understanding in noise over time to post-implant trajectory over time	The trajectory of speech reception thresholds (SRT) for understanding noise throughout the CI Phase (5 visits post-implant) in the bimodal condition is compared to the trajectory throughout the HA Phase (5 visits pre-implant) in the best aided condition.	5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Poor ear alone audibility from Pre-Implant to 12 months post-implant	FM tone sound field threshold levels in the poor ear alone with a CI compared to pre-implant threshold levels with a HA	Pre-implant and 12 months post-implant
Change in Bimodal sound localization from Pre-Implant to 15 months post-implant	RMS error scores for a sound localization task in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) post-implant compared to the pre-implant best aided condition.	Pre-implant and 15 months post-implant
Change in Bimodal soft speech understanding from Pre-Implant to 12 months post-implant	CNC monosyllabic word recognition at a soft level in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) post-implant compared to the pre-implant best aided condition.	Pre-implant and 12 months post-implant
Change in PedsQL-MFS ratings from Pre-Implant to 15 months post-implant	Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings.	Pre-implant and 15 months post-implant
Change in SSQ ratings from Pre-Implant to 15 months post-implant	Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings.	Pre-implant and 15 months post-implant
Change in HEAR-QL ratings from Pre-Implant to 15 months post-implant	Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings.	Pre-implant and 15 months post-implant
Post-implant bimodal vs better ear alone sound localization	Post-implant RMS error scores for the sound localization task are compared in the bimodal condition to the better ear alone condition.	15 months post-implant
Post-implant bimodal vs better ear alone soft speech understanding	Post-implant word recognition scores at soft levels are compared in the bimodal condition to the better ear alone condition.	12 months post-implant

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Children's Hospital of Philadelphia; University of Southern California; University of Minnesota; St. Louis Children's Hospital; Hearts for Hearing
• Investigators: Principal Investigator: Jill B Firszt, PhD, Washington University School of Medicine in St Louis

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: cochlear implant; hearing loss
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Unilateral
• Other Study ID Numbers: 202007142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared through presentations at relevant scientific meetings and through publication(s) in peer-reviewed journals. As required by the NIH Public Access Policy, an electronic version of final manuscripts resulting from this study will be submitted to the NIH National Library of Medicine PubMed Central (PMC) upon acceptance for publication. The few numbers of children at each study site who meet the inclusion criteria and receive a cochlear implant puts participant's privacy at risk if individual data are shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes