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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Bilaterally implanted patientsExperimental treatment 6 interventions
Group B: Bimodal patientsExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Speech in noise perception (FraSimat)

Difference in the FraSimat score obtained with the Sky HS programmed in Omni versus the score obtained in AS Target. The scores vary from -15,0 to +15,0, the higher the score is, better is the patient's hearing comprehension.

Time frame
6 months

Secondary outcomes

1

Speech in noise perception (FraSimat)

Difference in the FraSimat score obtained with the Sky HS programmed in AS Clinic versus the score obtained in Omni. The scores vary from -15,0 to +15,0, the higher the score is, better is the patient's hearing comprehension.

Time frame
6 months
2

Speech in noise perception (FraSimat)

Difference in the FraSimat score obtained with the Sky HS programmed in AS Clinic versus the score obtained in AS Target. The scores vary from -15,0 to +15,0, the higher the score is, better is the patient's hearing comprehension.

Time frame
6 months
3

Patient satisfaction - device

A patient questionnaire will be used to determine patient satisfaction with the devices. The scores vary from 0 to 10, the higher the score is better is the patient's satisfaction.

Time frame
6 months
4

Patient satisfaction -listening

With the help of the audiologist, patients will discuss and rate listening quality in different listening situations. The scores vary from 1 to 5, the higher the score is better is the patient's listening quality.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Advanced Bionics AG

Collaborator

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov
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