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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 13 Years and 20 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.

Recruiting Locations

Nationwide Children's Hospital
Columbus, Ohio 43205
Contact:
Ursula M Findlen, PhD
614-722-6526

More Details

Status
Recruiting
Sponsor
Nationwide Children's Hospital

Study Contact

Ursula M Findlen, PhD
614-722-6526
ursula.findlen@nationwidechildrens.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.