This trial is a monocentric, prospective and controlled study of the pupil response to detect hearing threshold and comfortable loudness of normal-hearing (NH) and CI-subjects.
The purpose of the clinical investigation is to explore the pupil dilation response of subjects with a cochlear implant and to provide proof of concept that it is possible to perform the adaptation of a cochlear implant using pupillometry. The population of this study is divided in 2 group: * A control group with normal-hearing listeners. * An Cl group with subjects with bilateral, severe-to-profound sensorineural hearing loss, with at least one cochlear implant for more than 6 months. Mainly used in audiology to evaluate listening effort, pupillometry is an objective measure that could also be used for fittings. Studies have shown that sound intensity influence pupil dilation. indeed, normal hearing and hearing aids subjects exhibit larger pupil responses with increasing intensity/loudness. The purpose of this study is to explore the pupil dilation response of cochlear implant subjects and to provide a proof of concept that we can perform cochlear implant fitting using pupillometry. Implanted subjects (Cl group) will undergo up to 3 visits: 1. Visit 1 or V1(inclusion) on day 1, 2. Visit 2 or V2 (Experiment 1-+2+3 or Experiment 1+2 or Experiment 3 )\* up to 1 month after V1 3. Visit 3 or V3 (Experiment 1+2 or Experiment 3, optional)\* up to 1 month after V2 \*lt is up to investigator decision to conduct experiment 1+2 and experiment 3 the same day or in on independent visit (no matter in which order) Normal-hearing listeners (control group) will undergo up to 2 visits: 1. Visit 1 or Va (inclusion) on day 1, 2. Visit 2 or V2 (experiment) up to 1 month after V1
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
13
Pupillometry measurements are carried out by a dedicated device (eye tracker), which includes cameras allowing the measurement of pupillary dilation. The subject stands in front of a screen and fixes a point in the center of the screen, the cameras placed on the screen allowing a measurement of the pupillary dilation in a non-invasive way. These eye-tracking measurements are performed simultaneously with an auditory task and allow to study the pupil's response to different stimuli.
Centre de Recherche en Audiologie adulte GH Pitié-Salpêtrière, APHP Sorbonne Université, Unité Fonctionnelle Implants auditifs et Explorations Fonctionnelles, 52 Bd Vincent Auriol, 75013 Paris, France
Paris, France
Measurement of the pupil dilation response to a range of auditory stimuli (acoustic and electric).
Pupil dilation response for each intensity and frequency \[Mean pupil dilatation in milimeters\]
Time frame: At Visit 2 (Month 1)
Evaluation of the loudness perception of the subjects regarding the different auditory stimuli (acoustic and electric) to correlate the results to the pupil dilation response.
Loudness score corresponding to each pupil dilation response. \[Using Oticon Medical Loudness scale: scale from 0 to 10 following the ISO 16832. 0 (zero) corresponding to inaudible level and 10 to extremely loud (intolerable) sounds.\]
Time frame: At Visit 2 (Month 1) and Visit 3 (Month 2)* [* if done]
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