NCT07035873

Pediatric Cochlear Implant Remote Programming and Assessment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 13 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Cochlear Implant Listeners

Interventions

Type	Name	Description
BEHAVIORAL	Remote Programming	Use of the Advanced Bionics Target CI remote programming software to complete behavioral measurements of cochlear implant function and programming via telehealth.
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2025-01-15
• Primary completion: 2027-01-15
• Completion: 2027-03-31
• First posted: 2025-06-25
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study