15 Participants Needed

Remote Programming for Pediatric Cochlear Implant Users

NC
UM
Overseen ByUrsula M Findlen, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Nationwide Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

UM

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

Cochlear implantation with an Advanced Bionics cochlear implant in at least one ear
I am between 13 and 20 years old.
I can and will join remote sessions and do self-checks as required.
See 2 more

Exclusion Criteria

Speech perception performance less than 40% on standard of care speech perception measures
I do not have cognitive or language issues that prevent me from joining in remote sessions or self-assessments.
I am under 13 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Remote cochlear implant programming and self-administered audiological test measures using iOS applications

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Remote Programming
Trial Overview The study tests remote programming of cochlear implants and assessing speech perception through a mobile app. It aims to find out how well these methods work and if they're satisfying for users.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Remote Programming & AssessmentExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials
354
Recruited
5,228,000+

Advanced Bionics

Industry Sponsor

Trials
17
Recruited
500+

Citations

Remote Programming of Adult and Pediatric Cochlear Implant ...Most responses from audiologists indicated that they achieved outcomes similar to those of in-person sessions. This suggests that remote ...
Study Details | NCT07035873 | Pediatric Cochlear Implant ...This is a prospective, interventional study to evaluate efficacy and end user satisfaction of remote cochlear implant programming in the pediatric population.
Evaluation of remote check in children with cochlear implantsRemote assessments were beneficial, with 89.7 % of participants successfully completing RC. Aided threshold tests (ATT) were completed in 73.2 % of ...
Remote Programming a Viable Option for the Adult and ...Remote programming is a feasible and effective service delivery model for the adult and pediatric CI population.
Speech Perception Outcomes in Cochlear Implant Users ...This study reviews the literature comparing speech recognition outcomes between remote versus in-person CI programming.
Remote Programming of Cochlear Implants - PMCThe results from this multicenter study demonstrate that remote programming of cochlear implants via telecommunication is safe, yields similar ...
Evaluation of remote programming of cochlear implants ...2 It has been found to be safe and effective in both pediatric and adult users, yielding similar results to in-person fitting for parameters such as ...
Remote Programming of Adult and Pediatric Cochlear ...The primary safety endpoint was the absence of unanticipated adverse device effects related to remote programming. Study design and setting ...
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