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| Name | Class |
|---|---|
| Advanced Bionics | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From enrollment to end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to end of treatment at 6 months |
| DAS Speech Perception- Oldenburg Matrix Task |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ursula M Findlen, PhD | Contact | 614-722-6526 | ursula.findlen@nationwidechildrens.org | |
| Nationwide Children's Hospital- Audiology Department | Contact | 614-722-3951 | ursula.findlen@nationwidechildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Ursula M Findlen, PhD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43205 | United States |
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| 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. |
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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. |
| 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). | 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. | From enrollment to end of treatment at 6 months |