Actively Recruiting

Phase Not Applicable
Age: 6Years - 16Years
All Genders
NCT06400992

Investigation of Sky Automatic Technologies in Pediatrics

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-03

20

Participants Needed

1

Research Sites

128 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

A

Advanced Bionics AG

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Investigation of Sky Automatic Technologies in Pediatrics

Who Can Participate

Age: 6Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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, 75015

Actively Recruiting

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Research Team

N

Nathalie LOUNDON, MD, PhD

CONTACT

G

Gael PLASTOW

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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