Pediatric Cochlear Implant Remote Programming and Assessment
NCT ID: NCT07035873
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2025-01-15
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Remote Programming & Assessment
Remote cochlear implant programming will be completed via the Advanced Bionics Remote Support iOS application. Remote assessment will be completed using the Advanced Bionics experimental Digital Audio Streaming (DAS) iOS application named EVA.
Remote Programming
Use of the Advanced Bionics Target CI remote programming software to complete behavioral measurements of cochlear implant function and programming via telehealth.
Remote Speech Perception
Use of digital audio streaming (DAS) through a proprietary platform to complete remote speech perception testing of performance with cochlear implants via telehealth.
Interventions
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Remote Programming
Use of the Advanced Bionics Target CI remote programming software to complete behavioral measurements of cochlear implant function and programming via telehealth.
Remote Speech Perception
Use of digital audio streaming (DAS) through a proprietary platform to complete remote speech perception testing of performance with cochlear implants via telehealth.
Eligibility Criteria
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Inclusion Criteria
* 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
* Ability and willingness to participate in remote programming sessions and self-administered assessment measures
Exclusion Criteria
* 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.
13 Years
20 Years
ALL
No
Sponsors
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Advanced Bionics
INDUSTRY
Nationwide Children's Hospital
OTHER
Responsible Party
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Ursula Findlen
Director of Audiology Research
Principal Investigators
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Ursula M Findlen, PhD
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Locations
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Nationwide Children's Hospital
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Ursula M Findlen, PhD
Role: primary
Other Identifiers
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STUDY00004526
Identifier Type: -
Identifier Source: org_study_id
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