Investigation of Sky Automatic Technologies in Pediatrics

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 11, 2024

Primary Completion Date

December 11, 2026

Study Completion Date

June 30, 2027

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).

Trial Locations (1)

75015

RECRUITING

"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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Advanced Bionics AG

INDUSTRY

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT06400992 - Investigation of Sky Automatic Technologies in Pediatrics | Biotech Hunter | Biotech Hunter