Evaluation of Pétale® (Small Hearing Test Equipment for Children) for the Screening of Hearing Disorders in Children From 9 Months to 3 Years Old by the General Practitioner or Pediatrician

Study Overview
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Brief Summary
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The aim of this study is to confirm the value of this new version of Pétale® ((small equipment for testing the child's hearing) in the daily practice of general practitioners or pediatricians for the screening of hearing disorders in very young children.

Detailed Description
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The research procedure is auditory stimulation using Pétale® (small equipment for testing the child's hearing) based on the orientation reflex (Ewing test): the child is seated on the companion's knees between the two enclosures and the investigator observes whether or not he is attracted to a familiar calibrated noise coming from one side or the other.

Official Title
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Evaluation of Pétale® (Small Hearing Test Equipment for Children) for the Screening of Hearing Disorders in Children From 9 Months to 3 Years Old by the General Practitioner or Pediatrician

Conditions
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Petale, Hearing Disorders, Child Development

Intervention / Treatment
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* Device: Petale


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chil, girl or boy between 9 months and 3 years-old Child seen in consultation by a general practitioner or a pediatrician whatever the reason for consultation Child attached to a beneficiary of a social security scheme Signature of informed consent by parents. Exclusion Criteria: Age greater than 3 years and less than 9 months Refusal of one or more parents during the consultation State of the child which does not allow the screening test to be carried out

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: children at the general practitioner or pediatrician<br>Children between 9 months and 3 years-old coming to their doctor for any consultation | Device: Petale<br>* The child sits on the companion's lap between the two enclosures, and the investigator observes whether or not he is attracted to a familiar calibrated noise coming from one side or the other.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Proportion of children with a hearing impairment assessed by the investigator knowing that they were also assessed with a hearing impairment by ENT specialist. | 2 weeks | 
| Specificity | Proportion of children without hearing impairment assessed by the investigator knowing that they were also assessed without hearing impairment by ENT. | 2 weeks | 
| Positive Predictive Value (PPV): | Proportion of children with hearing impairment assessed by both investigator and ENT among children with hearing impairment assessed by ENT. | 2 weeks | 
| Negative Predictive Value (NPV) | Proportion of children without hearing impairment assessed by both investigator and ENT among children without hearing impairment assessed by ENT. | 2 weeks |