Investigation of Sky Automatic Technologies in Pediatrics

Recruiting now · Not applicable

Conditions studied: Hearing Loss

In brief

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.

Key facts

Study ID

NCT06400992

Run by

Assistance Publique - Hôpitaux de Paris

People needed

20

Starts

2024-12-11

Expected to finish

2027-06-01

Last updated by the study team

2026-04-03

Who can join

Age: 6 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 (enrolling)

Full record on ClinicalTrials.gov

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