Investigation of Sky Automatic Technologies in Pediatrics
ConditionHearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-16
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- 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
- AutoSens Feedback Discussion Form
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Advanced Bionics AG
Collaborator
URC-CIC Paris Descartes Necker Cochin
Collaborator
Source ClinicalTrials.gov