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

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Mar 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how well children with asymmetric hearing loss (AHL) or single-sided deafness (SSD) perform with cochlear implants (CIs) compared to their current hearing aids (HAs). The main goal is to see if using a cochlear implant can help children hear better than they do with their hearing aids. The study will also look at what happens when a child uses both a cochlear implant in their poorer hearing ear and a hearing aid in their better ear, to determine if this combination improves hearing even more.

To participate in the trial, children need to be between 4 and 14 years old and have specific types of hearing loss. They should be able to understand and follow the study rules, and their parents must agree to the process. During the trial, participants will first use their hearing aids before getting a cochlear implant, and researchers will carefully track their hearing improvements. It’s important for families to understand that this study aims to gather valuable information to help improve hearing solutions for children with these types of hearing loss.

Gender

ALL

Eligibility criteria

• 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.