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NCT Number: NCT07035873

Pediatric Cochlear Implant Remote Programming and Assessment

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.

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Key information

Age range

13 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location status: Recruiting

Location contact

Ursula M Findlen, PhD

CONTACT

614-722-6526

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote Programming

Behavioral

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

Diagnostic Test

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

Primary outcomes

  1. Efficacy and User Satisfaction- Participant

    Time frame: From enrollment to end of treatment at 6 months

    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.

  2. Efficacy and User Satisfaction- Parent

    Time frame: From enrollment to end of treatment at 6 months

    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.

Secondary outcomes

  1. DAS Speech Perception- Single Word Recognition

    Time frame: From enrollment to end of treatment at 6 months

    Speech perception performance measured via digital audio streaming (DAS) task via iOS application. Single word recognition is measured by typing the word heard and measured in percent correct.

  2. DAS Speech Perception- Oldenburg Matrix Task

    Time frame: From enrollment to end of treatment at 6 months

    Speech perception performance measured via digital audio streaming (DAS) task via iOS application. The Oldenburg Matrix Task is a closed-set sentence in noise task in which the listener selects the five words heard in the sentence presented. Performance is measured in percent correct, speech recognition threshold (in dB), and signal-to-noise ratio slope.

  3. DAS Speech Perception- Digits In Noise Task

    Time frame: From enrollment to end of treatment at 6 months

    Speech perception performance measured via digital audio streaming (DAS) task via iOS application. The Digits in Noise Task is a closed-set word in noise task in which the listener selects the three digits (numbers) heard. Performance is measured in percent correct and speech recognition threshold (in dB).

  4. DAS Speech Perception- Soft Sound Detection

    Time frame: From enrollment to end of treatment at 6 months

    Speech perception performance measured via digital audio streaming (DAS) task via iOS application. The soft sound detection task is a threshold seeking tasks where the listener adjusts the level of a warble tone presented in noise until they deem it to be just barely noticeable. Performance is measured in dB level for frequencies 250, 500, 1000, 2000, 3000, 4000, and 6000 Hz.

Study contacts

Contact information is provided by the study sponsor or research team.

Nationwide Children's Hospital- Audiology Department

CONTACT

[email protected]

614-722-3951

Ursula M Findlen, PhD

CONTACT

[email protected]

614-722-6526

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Collaborators

  • Advanced Bionics

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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