Recruiting

Cochlear Implant Programming

Sponsor:

Nationwide Children's Hospital

Code:

NCT07035873

Conditions

Cochlear Implant Listeners

Eligibility Criteria

Sex: All

Age: 13 - 20

Healthy Volunteers: Not accepted

Interventions

Remote Programming

Remote Speech Perception

Study Details

Brief 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.

Conditions

Cochlear Implant Listeners

Study ID

NCT07035873

Start date

Jan 15, 2025

Status verified date

Apr, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 20

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Efficacy and User Satisfaction- Participant [ Time Frame: From enrollment to end of treatment at 6 months ]
  • Efficacy and User Satisfaction- Parent [ Time Frame: From enrollment to end of treatment at 6 months ]

Central Contacts and Locations

Central contacts

Ursula M Findlen, PhD

614-722-6526ursula.findlen@nationwidechildrens.org

Nationwide Children's Hospital- Audiology Department

614-722-3951ursula.findlen@nationwidechildrens.org

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Ursula M Findlen, PhD

614-722-6526

More Information

Sponsor

Nationwide Children's Hospital

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • pediatric
  • cochlear implant
  • remote programming
  • telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nationwide Children's Hospital on 2026-04-13.