Remote programming and app-based hearing tests for kids and young adults with cochlear implants

Pediatric Cochlear Implant Remote Programming and Assessment

This will test whether remote programming and an iOS app for speech tests work well for teens and young adults (ages 13–20) who use Advanced Bionics cochlear implants.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 13 Years to 20 Years
• Sex: All
• Sponsor: Nationwide Children's Hospital (other)
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT07035873 on ClinicalTrials.gov

What this trial studies

This prospective interventional protocol uses a mobile iOS application to deliver remote cochlear implant programming sessions and self-administered speech perception tests in participants aged 13–20. Participants must have at least one Advanced Bionics implant, a minimum of six months post-implant listening experience, at least two weeks with the Marvel external processor, and ≥40% correct on standard speech-in-quiet measures for the tested ear. The study measures clinical outcomes, end-user satisfaction with remote programming, and the long-term reproducibility of digital audio streaming (DAS) speech-perception measures over repeated testing. Sessions are coordinated through Nationwide Children's Hospital with collaboration from Advanced Bionics, and data will be compared to standard-of-care benchmarks to identify learning effects over time.

Who should consider this trial

Good fit: Ideal candidates are ages 13–20 with at least one Advanced Bionics cochlear implant, ≥6 months post-implant listening experience, ≥2 weeks with a Marvel processor, ≥40% correct on standard speech-in-quiet tests for the study ear, and willingness/ability to use an iOS device for remote sessions.

Not a fit: Patients under 13, those with speech perception <40% on standard measures, those with cognitive or language impairments that prevent reliable remote testing, or those without an Advanced Bionics device are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could let eligible young cochlear implant users receive convenient remote tuning and monitoring, reducing clinic visits and improving access to follow-up care.

How similar studies have performed: Prior work has shown remote programming and app-based speech tests can be feasible and produce replicable within-session results, but long-term reproducibility and potential learning effects across repeated tests are less well established.

Eligibility criteria

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.

Where this trial is running

Columbus, Ohio

• Nationwide Children's Hospital — Columbus, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Ursula M Findlen, PhD — Nationwide Children's Hospital
• Study coordinator: Ursula M Findlen, PhD

Conditions: Cochlear Implant Listeners, pediatric, cochlear implant, remote programming, telehealth