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
Location status: Recruiting
NCT Number: NCT06400992
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.
Interested in participating?
Request Info6 year–16 year
All sexes
Interventional
Not applicable
Paris, 75015, France
Location status: Recruiting
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):
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
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:
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).
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
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.
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).
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.
Time frame: 6 months
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
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
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
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
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.
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Acronym: SKY-MARVEL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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