Remote Evaluation of the Naída CI M90 (Marvel) Sound Processor

Study Overview
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Brief Summary
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Within-subject comparison. Remotely Evaluating latest Advanced Bionics Marvel Sound Processor for cochlear implants, from two adult groups.

Detailed Description
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Within-subject comparison, standard of care CE marked Advanced Bionics device. Remote Evaluation of new CI Naida M sound processor through speech understanding in quiet and noise using standard clinical tests, subjective feedback on sound quality for a set of listening situations reflecting everyday use and a ease of use questionnaire. Two adult groups, one CI users and the other bimodal users. All tests completed remotely.

Official Title
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Remote Evaluation of the Naída CI M90 (Marvel) Sound Processor

Conditions
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Cochlear Hearing Loss, Hearing Loss

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CI users with a CI, HiRes90K (Advantage) or HiRes Ultra cochlear implant system Unilaterally implanted recipients using only a Naída Q sound processor Bimodal users: additionally using hearing aid on their contralateral ear Minimum of 18 years of age Minimum of five years' experience with their Naída Q sound processor Minimum of six months experience with their contralateral hearing aid (if applicable) Ability to give feedback on sound quality Speech intelligibility with the BKB sentence test in noise at a +10 dB SNR > 10% as obtained during previous visits in the clinical routine or BKB >50% in quiet conditions if noise has previously not been tested Fluent in English language Exclusion Criteria: Difficulties additional to hearing impairment that would interfere with the study procedures Concurrent participation in any other clinical hearing study Not due to have their sound processor upgraded in line with normal clinical procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate difference in speech perception in noise with Naida M (Marvel) and Naida Q hearing devices | Understanding speech in presence of completing noise and quiet testing remotely through use of Gorilla software. This will be done through a percentage score calculated within the Gorilla software. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in sound clarity and comfort with Naida M (Marvel) device when listening to speech | Assessment in quiet, background, speech babble, household noises, traffic noise, cafeteria noise and louder alarm signals.This will be done through a measurement of specific questionnaires. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cochlear implant, Advanced Bionics Marvel Processor