Investigation of Sky Automatic Technologies in Pediatrics

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT06400992
Status
Recruiting
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Conditions

  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
6 Years - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • Cochlear implant processor Sky CITM M90 (CI-5295) — DEVICE
    The Sky CI available to included patients (no procedures added) offers the AutoSense Sky OS technology with the three following programming conditions possible. This three condition are fitting and evaluated in noise 6 months after inclusion: 1. Omnidirectional mode : no sound treatment 2. AS Target : Autosense is active and no modifications are made by clinician 3. AS Clinique : Autosense is active and modified by the clinician
  • Hearing Aid, including sound processor Phonak: Sky Link M90 — DEVICE
    The device is fitting and programmed for home especially for the purpose research at inclusion. The Clinical map parameters will be verified according to clinical routine. The Sky Link offers the AutoSense Sky OS technology with the three following programming conditions possible. This three condition are fitting and evaluated in noise 6 months after inclusion: 1. Omnidirectional mode : no sound treatment 2. AS Target : Autosense is active and no modifications are made by clinician 3. AS Clinique : Autosense is active and modified by the clinician
  • French simplified matrix test (FraSimat) — DIAGNOSTIC_TEST
    The FraSimat speech in noise test will be tested, 6 months before inclusion in the three different fitting configurations: omni, AS clinic, AS Target. The speech will be presented from the front, noise from 180°. Noise will be presented at a fixed level of 65 dB SPL while the speech signal will be adapted to find the 50% speech reception threshold (SRT).
  • Audiologist Fitting Questionnaire — BEHAVIORAL
    After the fitting of Hearing Aid at inclusion, the audiologist will complete a questionnaire describing the fitting and justifying fitting decisions and will collect the demographic information
  • Patient Satisfaction Questionnaire — BEHAVIORAL
    The patient will be giving a Patient satisfaction Questionnaire, with questions regarding device and accessory use. The audiologist will go over the instructions for filling out the questionnaire at inclusion. Patients will be asked to complete the questionnaire and return it at the next visit, 6 months after inclusion.
  • AutoSens Feedback Discussion Form — BEHAVIORAL
    6 months after inclusion and fitting, the audiologist discusses the use of AS clinic with the subject and completes the AS questionnaire (questionnaire on the experience of using the processor in different listening situations).

Study Details

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 Dates

First listed
May 6, 2024
Start date
Dec 11, 2024
Status verified
Mar 2026
Primary completion
Dec 11, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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

Primary Outcome Measure

Speech in noise perception (FraSimat) [ Time Frame: 6 months ]

Central Contacts

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