NCT07035873

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Jan 2025Mar 2027

Study Start

First participant enrolled

January 15, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

May 22, 2025

Last Update Submit

April 7, 2026

Conditions

Cochlear Implant Listeners

Keywords

pediatriccochlear implantremote programmingtelehealth

Outcome Measures

Primary Outcomes (2)

  • Efficacy and User Satisfaction- Participant

    End user satisfaction as measured by survey of remote cochlear implant programming in the pediatric population. A variety of questions will be asked with Likert scale ratings, Scale = 1 (strongly disagree) to 5 (strongly agree), multiple choice, or open-ended questions.

    From enrollment to end of treatment at 6 months

  • Efficacy and User Satisfaction- Parent

    End user satisfaction as measured by survey of remote cochlear implant programming in the pediatric population. A variety of questions will be asked with Likert scale ratings, Scale = 1 (strongly disagree) to 5 (strongly agree), multiple choice, or open-ended questions.

    From enrollment to end of treatment at 6 months

Secondary Outcomes (4)

  • DAS Speech Perception- Single Word Recognition

    From enrollment to end of treatment at 6 months

  • DAS Speech Perception- Oldenburg Matrix Task

    From enrollment to end of treatment at 6 months

  • DAS Speech Perception- Digits In Noise Task

    From enrollment to end of treatment at 6 months

  • DAS Speech Perception- Soft Sound Detection

    From enrollment to end of treatment at 6 months

Study Arms (1)

Remote Programming & Assessment

EXPERIMENTAL

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.

Behavioral: Remote ProgrammingDiagnostic Test: Remote Speech Perception

Interventions

Remote ProgrammingBEHAVIORAL

Use of the Advanced Bionics Target CI remote programming software to complete behavioral measurements of cochlear implant function and programming via telehealth.

Remote Programming & Assessment
Remote Speech PerceptionDIAGNOSTIC_TEST

Use of digital audio streaming (DAS) through a proprietary platform to complete remote speech perception testing of performance with cochlear implants via telehealth.

Remote Programming & Assessment

Eligibility Criteria

Age13 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Study Officials

  • Ursula M Findlen, PhD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ursula M Findlen, PhD

CONTACT

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

Nationwide Children's Hospital- Audiology Department

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Audiology Research

Study Record Dates

First Submitted

May 22, 2025

First Posted

June 25, 2025

Study Start

January 15, 2025

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

US(1)