Remote Programming for Pediatric Cochlear Implant Users
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the effectiveness of remote programming for young people with cochlear implants. It will also evaluate whether a mobile app for hearing tests provides consistent results over time. The trial seeks participants aged 13 to 20 who have had an Advanced Bionics cochlear implant for at least six months and can hear at least 40% of speech in a quiet setting with it. Participants must be comfortable using an app for remote adjustments and assessments. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance remote care for cochlear implant users.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that remote programming for pediatric cochlear implant users is safe?
Studies have shown that programming cochlear implants remotely is safe for both children and adults. Research has found no unexpected side effects with remote methods. In fact, results for remote programming matched those of in-person fittings, indicating the process is equally safe. Thus, children using the remote method can expect a safe experience similar to traditional methods.12345
Why are researchers excited about this trial?
Researchers are excited about remote programming for pediatric cochlear implant users because it brings the convenience of advanced technology directly to families. Unlike traditional in-person visits to adjust cochlear implants, this method uses the Advanced Bionics Remote Support iOS application to program devices remotely. This means that adjustments can be made more flexibly and potentially more frequently, without the need for travel. Additionally, the use of the experimental Digital Audio Streaming (DAS) application named EVA allows for remote assessment, aiming to improve the auditory experience for young users. These innovations could make cochlear implant management more accessible and efficient for children and their families.
What evidence suggests that remote programming is effective for pediatric cochlear implant users?
Research has shown that programming cochlear implants remotely is as effective as in-person programming for both children and adults. In this trial, participants will receive remote programming and assessment using the Advanced Bionics Remote Support iOS application. One study found that 89.7% of children successfully completed their evaluations remotely. Remote programming offers a practical and effective way to provide cochlear implant services. The ability to recognize speech with remote programming matches that achieved with traditional in-person methods. Overall, remote programming offers a convenient option without sacrificing effectiveness.12678
Who Is on the Research Team?
Ursula M Findlen, PhD
Principal Investigator
Nationwide Children's Hospital
Are You a Good Fit for This Trial?
This trial is for children who use cochlear implants. It's designed to see if doctors can adjust the implants and test hearing remotely, which could make check-ups easier.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Remote cochlear implant programming and self-administered audiological test measures using iOS applications
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Remote Programming
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nationwide Children's Hospital
Lead Sponsor
Advanced Bionics
Industry Sponsor