Investigation of Sky Automatic Technologies in Pediatrics

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
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).
RECRUITING
Paris
Contact Information
Primary
Nathalie LOUNDON, MD, PhD
natalie.loundon@aphp.fr
01 71 39 67 82
Backup
Gael PLASTOW
gael.plastow@aphp.fr
0144381711
Time Frame
Start Date: 2024-12-11
Estimated Completion Date: 2027-06
Participants
Target number of participants: 20
Treatments
Experimental: Bilaterally implanted patients
patient with two cochlear implant in each ear
Experimental: Bimodal patients
patient with cochlear implant in one ear and fitted with hearing aid audio in the other ear
Related Therapeutic Areas
Sponsors
Collaborators: Advanced Bionics AG
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov