Investigation of Sky Automatic Technologies in Pediatrics

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.

Conditions

• Hearing Loss

Interventions

DEVICE

Cochlear implant processor Sky CITM M90 (CI-5295)

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

DEVICE

Hearing Aid, including sound processor Phonak: Sky Link M90

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

DIAGNOSTIC_TEST

French simplified matrix test (FraSimat)

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).

BEHAVIORAL

Audiologist Fitting Questionnaire

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

BEHAVIORAL

Patient Satisfaction Questionnaire

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.

BEHAVIORAL

AutoSens Feedback Discussion Form

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).

Sponsors & Collaborators

• Advanced Bionics AG

  collaborator INDUSTRY

• URC-CIC Paris Descartes Necker Cochin

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Nathalie LOUNDON, MD,PhD · APHP

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-11

Primary Completion

2026-12-11

Completion

2027-06-30

Countries

• France

Study Locations