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Investigation of Sky Automatic Technologies in Pediatrics

RecruitingNAAges 6 Years - 16 YearsAllAssistance Publique - Hôpitaux de Paris
NCT06400992 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The hypothesis of this research is that the AS Target setting provides the best estimate of the settings required to optimize listening in noise. As such, it is expected that speech in noise performance will be best in the AS Target condition, followed by the AS Clinic condition, and the Omni condition will be the least favourable for speech in noise performance.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Be between 6 and 16 years of age at the time of inclusion * Use spoken French as their primary mode of communication * Ability to perform the Simplified French Matrix test in Noise * Bimodal group: use the Sky CI processor or be eligible for a Sky CI processor upgrade on one side and use a contralateral hearing aid * Bilaterally implanted group: use two Sky CI processors or be eligible for an upgrade to two Sky CI processors * Obtain signed consent from legal guardian(s) * Be enrolled in a health insurance plan or eligible for coverage Exclusion Criteria: * Severe neurological pathology identified prior to inclusion identified by MRI + /- neuro-pediatric workup * Severe cognitive, psychiatric, or developmental disabilities identified prior to inclusion * Family does not understand French
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What it tests

  • Cochlear implant processor Sky CITM M90 (CI-5295)
  • Hearing Aid, including sound processor Phonak: Sky Link M90
  • French simplified matrix test (FraSimat)
  • Audiologist Fitting Questionnaire
  • Patient Satisfaction Questionnaire
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Where

1 site
Audiophonology Unit of the Ear, Nose and Throat (ENT) Department ("Oto-rhino-laryngologie (ORL) et chirurgie cervico-faciale") at the Necker-Enfants Malades hospital (AP-HP).
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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