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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Cochlear implantation of a device from one of the three manufacturers available in the US.
Keck School of Medicine of the University of Southern California
Los Angeles, California, United States
Fairview Health Services
Minneapolis, Minnesota, United States
Washington University School of Medicine/St Louis Children's Hospital
St Louis, Missouri, United States
Hearts for Hearing
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia - Buerger Center
Philadelphia, Pennsylvania, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months post-implant
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