Pediatric Cochlear Implant Remote Programming and Assessment

Nationwide Children's Hospital

Status: Enrolling

Conditions: Cochlear Implant Listeners

Treatments: Behavioral: Remote Programming; Diagnostic Test: Remote Speech Perception

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07035873

STUDY00004526

Details and patient eligibility

About

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.

Full description

The objectives of this study are to evaluate the efficacy and end user satisfaction of mobile application based (1) remote cochlear implant programming and 2) self-administered audiological test measures in older children (13 to 20 year olds). Based on existing data, we hypothesize that remote programming is efficacious, and provides positive end user satisfaction. Additionally, while our prior work has shown that application-based speech perception outcomes are replicable when measured within one session, repeated testing over time may show learning effects.

Enrollment: 15 estimated patients

Sex: All

Ages: 13 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Ability and willingness to participate in remote programming sessions and self-administered assessment measures

Exclusion criteria

• 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

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Remote Programming & Assessment

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Remote Speech Perception

Behavioral: Remote Programming