Pediatric Cochlear Implant Remote Programming and Assessment
ConditionCochlear Implant Listeners
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-20
SponsorNationwide Children's Hospital
About this trial
This is a prospective, interventional study to evaluate efficacy and end user satisfaction of remote cochlear implant programming in the pediatric population. Additionally, this study will evaluate the long-term replicability of digital audio streaming (DAS) self-assessment speech perception measures via iOS mobile application.
Eligibility criteria
Qualifiers
Cochlear implantation with an Advanced Bionics cochlear implant in at least one ear.
At least 6 months post-implantation listening experience and at least 2 weeks of listening experience with Marvel cochlear implant external processor.
Speech perception performance of at least 40% correct on standard of care speech perception measures in quiet for the ear to be used in the study
Ages 13 years to 20 years, inclusive
Disqualifiers
Children under the age of 13
Speech perception performance < 40% on SOC speech perception measures
Cognitive or language deficits that preclude ability and willingness to participate in remote programming sessions and self-administered assessment measures, as identified by eMR diagnoses and the participant's primary clinical audiologist judgement.
Trial design
Treatments tested in this trial
- Remote Programming
- Remote Speech Perception
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Nationwide Children's Hospital
Lead sponsor
Advanced Bionics
Collaborator
Source ClinicalTrials.gov