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

NCT04793412 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 202007142
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Asymmetric Hearing Loss; Single-sided Deafness; Unilateral Deafness

Keywords

hearing loss; cochlear implant

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Change in Poor ear alone audibility from Pre-Implant to 12 months post-implant

  Pre-implant and 12 months post-implant

• Change in Bimodal sound localization from Pre-Implant to 15 months post-implant

  Pre-implant and 15 months post-implant

• Change in Bimodal soft speech understanding from Pre-Implant to 12 months post-implant

  Pre-implant and 12 months post-implant

• Change in PedsQL-MFS ratings from Pre-Implant to 15 months post-implant

  Pre-implant and 15 months post-implant

• Change in SSQ ratings from Pre-Implant to 15 months post-implant

  Pre-implant and 15 months post-implant

Study Arms (1)

AHL/SSD

EXPERIMENTAL

Children with asymmetric hearing loss or single-sided deafness

Device: Cochlear Implant

Interventions

Cochlear Implant DEVICE

Cochlear implantation of a device from one of the three manufacturers available in the US.

AHL/SSD

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• St. Louis Children's Hospital: collaborator
• University of Southern California: collaborator
• Children's Hospital of Philadelphia: collaborator
• Hearts for Hearing: collaborator
• University of Minnesota: collaborator

Study Sites (5)

Keck School of Medicine of the University of Southern California

Los Angeles, California, 90033, United States

Location

Fairview Health Services

Minneapolis, Minnesota, 55454, United States

Location

Washington University School of Medicine/St Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Hearts for Hearing

Oklahoma City, Oklahoma, 73120, United States

Location

Children's Hospital of Philadelphia - Buerger Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Hearing Loss, Unilateral; Hearing Loss

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

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

• Jill B Firszt, PhD

  Washington University School of Medicine in St Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 11, 2021
• Study Start: September 20, 2021
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)