Hearing LossSKY-MARVELNCT06400992
Investigation of Sky Automatic Technologies in Pediatrics
A study testing Cochlear implant processor Sky CITM M90 (CI-5295), Hearing Aid, including sound processor Phonak: Sky Link M90 and French simplified matrix test (FraSimat) in people with Hearing Loss, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Cochlear implant processor Sky CITM M90 (CI-5295), Hearing Aid, including sound processor Phonak: Sky Link M90 and French simplified matrix test (FraSimat)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- 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, 75015
Melissa MACSKILL, 01 87 89 29 14 ext. +33, melissa.macaskill-ext@aphp.fr
Nathalie LOUNDON, MD,PhD
About this study
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.
Read the detailed description
The ability to hear speech in noise is particularly important for children, as they are often in complex listening situations like classrooms or playgrounds. In children with hearing loss, the ability to understand speech in noise is further degraded not only by decreased audibility of speech sounds, but also additionally by the distortion spectral and temporal processing cues, and reduced binaural processing abilities. Cochlear implant manufacturers have introduced a number of technologies designed to improve speech recognition in background noise. Sound processing algorithms use a variety of strategies to facilitate listening in noise, and research has shown that these advances do lead to improved performance.
AutoSense Sky OS 3.0 (AutoSense Sky OS, AS) is an automatic auditory scene classification system specifically designed for children's typical listening situations, like classrooms and playgrounds. This technology is available in the new Sky CI M90 (Sky CI), which is the latest generation of sound processor (SP) from Advanced Bionics, designed for children.
This algorithm is also available in the Sky Link M90 hearing aid (Sky Link). This means that bimodal patients, using one Sky Link and one Sky CI can benefit from AutoSense Sky OS in addition to children with two Sky CI. The combination of the two hearing devices (HD) tested in this research, whether it be two Sky CI or one Sky CI and one Sky Link, will be referred to as the Sky Hearing System (Sky HS).
As usual in standard care, children with Sky HS can have their hearing system programmed in three ways (at the discretion of the clinician):
- Omnidirectional mode, in which the AutoSense Sky OS is deactivated and no modifications are made by the clinician (no sound treatment)
- AS Target, in which the AutoSense Sky OS is active and programmed with the parameters suggested by the programming software (Target) and no modifications are made by the clinician
- AS clinic, in which the AutoSense Sky OS is active, and settings have been modified by the clinician (mixed setting).
The goal of this research is to compare speech in noise perception in each of those three possible programming conditions used in the standard care. 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.
- Conditions
- Hearing Loss
- Being tested
- Cochlear implant processor Sky CITM M90 (CI-5295), Hearing Aid, including sound processor Phonak: Sky Link M90, French simplified matrix test (FraSimat), Audiologist Fitting Questionnaire, Patient Satisfaction Questionnaire
- 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
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- Omnidirectional mode : no sound treatment
- AS Target : Autosense is active and no modifications are made by clinician
- AS Clinique : Autosense is active and modified by the clinician
Hearing Aid, including sound processor Phonak: Sky Link M90Device
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:
- Omnidirectional mode : no sound treatment
- AS Target : Autosense is active and no modifications are made by clinician
- 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 QuestionnaireBehavioural
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 QuestionnaireBehavioural
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 FormBehavioural
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 group | Role | What they receive |
|---|---|---|
| Bilaterally implanted patients | Experimental | patient with two cochlear implant in each ear Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Audiologist programming modifications
An audiologist questionnaire will be used to determine the programming modifications and decisions made by the audiologist for each individual patient. The questionnaire doesn't involve any scoring.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start11 Dec 2024
- Primary completion11 Dec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Bionics AG, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Nathalie LOUNDON, MD,PhD, Study director, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400992
- Sponsor's protocol ID
- APHP230143
- Other IDs
- 2023-A02351-44
- Acronym
- SKY-MARVEL
- Status last verified
- Mar 2026
- First submitted
- 2 May 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Sky Automatic Technologies in Pediatrics
- ClinicalTrials.gov ID
- NCT06400992
- Acronym / sponsor ID
- SKY-MARVEL / APHP230143
- Conditions
- Hearing Loss
- Keywords
- Hearing Loss, cochlear implant, hearing aid, hearing device, hearing system, Simplified French Matrix Test, Noise block, background noise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Advanced Bionics AG, URC-CIC Paris Descartes Necker Cochin
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 11 Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The ability to hear speech in noise is particularly important for children, as they are often in complex listening situations like classrooms or playgrounds. In children with hearing loss, the ability to understand speech in noise is further degraded not only by decreased audibility of speech sounds, but also additionally by the distortion spectral and temporal processing cues, and reduced binaural processing abilities. Cochlear implant manufacturers have introduced a number of technologies designed to improve speech recognition in background noise. Sound processing algorithms use a variety of strategies to facilitate listening in noise, and research has shown that these advances do lead to improved performance.
AutoSense Sky OS 3.0 (AutoSense Sky OS, AS) is an automatic auditory scene classification system specifically designed for children's typical listening situations, like classrooms and playgrounds. This technology is available in the new Sky CI M90 (Sky CI), which is the latest generation of sound processor (SP) from Advanced Bionics, designed for children.
This algorithm is also available in the Sky Link M90 hearing aid (Sky Link). This means that bimodal patients, using one Sky Link and one Sky CI can benefit from AutoSense Sky OS in addition to children with two Sky CI. The combination of the two hearing devices (HD) tested in this research, whether it be two Sky CI or one Sky CI and one Sky Link, will be referred to as the Sky Hearing System (Sky HS).
As usual in standard care, children with Sky HS can have their hearing system programmed in three ways (at the discretion of the clinician):
- Omnidirectional mode, in which the AutoSense Sky OS is deactivated and no modifications are made by the clinician (no sound treatment)
- AS Target, in which the AutoSense Sky OS is active and programmed with the parameters suggested by the programming software (Target) and no modifications are made by the clinician
- AS clinic, in which the AutoSense Sky OS is active, and settings have been modified by the clinician (mixed setting).
The goal of this research is to compare speech in noise perception in each of those three possible programming conditions used in the standard care. 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilaterally implanted patients | Experimental | 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 Formpatient with two cochlear implant in each ear |
| Bimodal patients | Experimental | 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 Formpatient with cochlear implant in one ear and fitted with hearing aid audio in the other ear |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
- Bilaterally implanted group: use two Sky CI processors or be eligible for an upgrade to two Sky CI processors
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Bilaterally implanted patients |
| Hearing Aid, including sound processor Phonak: Sky Link M90The 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 | Device | Bilaterally implanted patients, Bimodal patients |
| 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). | Diagnostic test | Bilaterally implanted patients, Bimodal patients |
| Audiologist Fitting QuestionnaireAfter 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 | Behavioural | Bilaterally implanted patients, Bimodal patients |
| Patient Satisfaction QuestionnaireThe 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. | Behavioural | Bilaterally implanted patients, Bimodal patients |
| AutoSens Feedback Discussion Form6 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). | Behavioural | Bilaterally implanted patients, Bimodal patients |
Primary outcome
Speech in noise perception (FraSimat)
Time frame: 6 months
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.
5 secondary outcomes
Speech in noise perception (FraSimat)
Time frame: 6 months
Speech in noise perception (FraSimat)
Time frame: 6 months
Patient satisfaction - device
Time frame: 6 months
Patient satisfaction -listening
Time frame: 6 months
Audiologist programming modifications
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathalie LOUNDON, MD,PhD study director
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear implant processor Sky CITM M90 (CI-5295), Hearing Aid, including sound processor Phonak: Sky Link M90 and French simplified matrix test (FraSimat) in people with Hearing Loss, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathalie LOUNDON, MD, PhD (01 71 39 67 82 ext. +33, natalie.loundon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech in noise perception (FraSimat) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.