Investigation of Sky Automatic Technologies in Pediatrics

NCT06400992 | Recruiting

• 2 other identifiers: APHP2301432023-A02351-44
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hearing Loss; cochlear implant; hearing aid; hearing device; hearing system; Simplified French Matrix Test; Noise block; background noise; target cochlear implant; pediatric cochlear implant processor

Outcome Measures

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.

  6 months

Secondary Outcomes (5)

• Speech in noise perception (FraSimat)

  6 months

• Speech in noise perception (FraSimat)

  6 months

• Patient satisfaction - device

  6 months

• Patient satisfaction -listening

  6 months

• Audiologist programming modifications

  6 months

Study Arms (2)

Bilaterally implanted patients

EXPERIMENTAL

patient with two cochlear implant in each ear

Device: Cochlear implant processor Sky CITM M90 (CI-5295); Device: Hearing Aid, including sound processor Phonak: Sky Link M90; Diagnostic Test: French simplified matrix test (FraSimat); Behavioral: Audiologist Fitting Questionnaire; Behavioral: Patient Satisfaction Questionnaire; Behavioral: AutoSens Feedback Discussion Form

Bimodal patients

EXPERIMENTAL

patient with cochlear implant in one ear and fitted with hearing aid audio in the other ear

Device: Hearing Aid, including sound processor Phonak: Sky Link M90; Diagnostic Test: French simplified matrix test (FraSimat); Behavioral: Audiologist Fitting Questionnaire; Behavioral: Patient Satisfaction Questionnaire; Behavioral: AutoSens Feedback Discussion Form

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

Bilaterally implanted patients

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

Bilaterally implanted patients; Bimodal patients

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).

Bilaterally implanted patients; Bimodal patients

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

Bilaterally implanted patients; Bimodal patients

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.

Bilaterally implanted patients; Bimodal patients

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).

Bilaterally implanted patients; Bimodal patients

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Family does not understand French

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Advanced Bionics AG: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (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, 75015, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Study Officials

• Nathalie LOUNDON, MD,PhD

  APHP

  STUDY DIRECTOR

Central Study Contacts

Nathalie LOUNDON, MD, PhD

CONTACT

01 71 39 67 82; natalie.loundon@aphp.fr

Gael PLASTOW

CONTACT

0144381711; gael.plastow@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 6, 2024
• Study Start: December 11, 2024
• Primary Completion (Estimated): December 11, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)