At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Outcomes in Children With Cochlear Implants and Pre-Operative Residual Hearing: Electric Only and Electric-Acoustic Stimulation
In Brief
A clinical study evaluating Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting and Electric Acoustic Speech Processor: Full-electric stimulation fitting for High Frequency Sensorineural Hearing Impairment and Hearing Disorders in Children. Completed, enrolled 28 participants across 1 site.
Detailed Summary
Purpose: Routine clinical care and pilot study data has shown evidence of postoperative hearing preservation in pediatric cochlear implant (CI) recipients. The primary aim of this study is to investigate speech perception performance in pediatric CI recipients with functional pre-operative hearing. Participants: Two cohorts of CI recipients aged 6 through 17 years who had pre-operative low frequency residual hearing. Subjects in Arm 1 (EAS Arm; electric-acoustic stimulation) will present with a post-operative low frequency pure tone average (125, 250, and 500 Hz) of ≤ 75 dB HL, and those in Arm 2 (FES Arm; full-electric stimulation) will present with a post-operative low frequency pure tone average (LFPTA) that exceeds 75 dB HL. Procedures (methods): Subjects will complete speech perception and quality of life testing during post-operative intervals. Subjects in the EAS Arm will be evaluated with combined electric-acoustic stimulation (EAS). Subjects in FES Arm will be evaluated with FES alone.
Study Details
Timeline
Interventions
Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,
Electric Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or poorer and pre-operative low frequency hearing averages of 75 dB HL or better.