Cochlear Implant ListenersNCT07035873
Pediatric Cochlear Implant Remote Programming and Assessment
A study testing Remote Programming and Remote Speech Perception in people with Cochlear Implant Listeners, run by Nationwide Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 20 years
- Conditions the study is for
- Cochlear Implant Listeners
- What is being tested?
- Remote Programming and Remote Speech Perception
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nationwide Children's Hospital- Audiology Department contact
United States1 site, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Ursula M Findlen, PhD, 614-722-6526
About this study
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.
Read the 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.
- Conditions
- Cochlear Implant Listeners
- Being tested
- Remote Programming, Remote Speech Perception
- Keywords
- pediatric, cochlear implant, remote programming, telehealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ProgrammingBehavioural
Use of the Advanced Bionics Target CI remote programming software to complete behavioral measurements of cochlear implant function and programming via telehealth.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Remote Programming; Diagnostic Test: Remote Speech Perception |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to end of treatment at 6 months
Secondary outcomes (4)
DAS Speech Perception- Single Word Recognition
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.
Measured: From enrollment to end of treatment at 6 months
DAS Speech Perception- Oldenburg Matrix Task
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.
Measured: From enrollment to end of treatment at 6 months
DAS Speech Perception- Digits In Noise Task
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).
Measured: From enrollment to end of treatment at 6 months
DAS Speech Perception- Soft Sound Detection
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.
Measured: From enrollment to end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start15 Jan 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear Implant ListenersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Bionics
- Responsible party
- Principal investigator, Ursula Findlen, Nationwide Children's Hospital
- Investigators
- Ursula M Findlen, PhD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035873
- Sponsor's protocol ID
- STUDY00004526
- Status last verified
- Apr 2026
- First submitted
- 22 May 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Cochlear Implant Remote Programming and Assessment
- ClinicalTrials.gov ID
- NCT07035873
- Acronym / sponsor ID
- STUDY00004526
- Conditions
- Cochlear Implant Listeners
- Keywords
- pediatric, cochlear implant, remote programming, telehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Advanced Bionics
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote Programming & Assessment | Experimental | Behavioral: Remote Programming, Diagnostic Test: Remote Speech PerceptionRemote 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. |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ProgrammingUse of the Advanced Bionics Target CI remote programming software to complete behavioral measurements of cochlear implant function and programming via telehealth. | Behavioural | Remote Programming & Assessment |
| Remote Speech PerceptionUse of digital audio streaming (DAS) through a proprietary platform to complete remote speech perception testing of performance with cochlear implants via telehealth. | Diagnostic test | Remote Programming & Assessment |
Primary outcome
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.
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.
4 secondary outcomes
DAS Speech Perception- Single Word Recognition
Time frame: From enrollment to end of treatment at 6 months
DAS Speech Perception- Oldenburg Matrix Task
Time frame: From enrollment to end of treatment at 6 months
DAS Speech Perception- Digits In Noise Task
Time frame: From enrollment to end of treatment at 6 months
DAS Speech Perception- Soft Sound Detection
Time frame: From enrollment to end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nationwide Children's Hospital- Audiology Department contact
Ursula M Findlen, PhD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Programming and Remote Speech Perception in people with Cochlear Implant Listeners, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ursula M Findlen, PhD (614-722-6526, ursula.findlen@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy and User Satisfaction- Participant (time frame: From enrollment to end of treatment at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.