Validation of the French Version of the Hearing Aid Benefit Measurement COSI and IOI-HA Questionnaires

Active, not recruiting

• Conditions: Hearing Impairment

• Registration Number: NCT06108609
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

Estimating patient satisfaction is essential in modern day-to-day medical practice. This is particularly true in the field of audiology where evaluating the benefit of patients' devices makes it possible to improve settings and increase patient satisfaction and therefore compliance. Questionnaires measuring hearing aid benefit such as the IOI-HA (International Outcome Inventory for Hearing Aids) and the COSI (Client Oriented Scale of Improvement) are used in everyday practice and promote cooperation between researchers by providing comparable data. Unlike other countries, these questionnaires have never been validated in French by psychometric studies. The objective of this study is to validate the translation of the IOI-HA questionnaire already used in the clinic and to adapt the COSI into French and statistically validate its translation.

Detailed Description

Recruitment of cases via the otological consultation of the ENT department, among patients consulting for hearing aids. Inclusion will be suspended once 100 tests and at least 35 re-tests have been completed.

Inclusion (D0):

* Audiometry (as part of treatment)

* Clinical evaluation (as part of treatment)

* Passing the French version of the COSI and IOI-HA questionnaires Visit 1 (D0 +3±1 week): only for 35 patients Second administration of the French version of the COSI and IOI-HA questionnaires either by telephone, or during a second consultation or hospitalization, if this occurs within a compatible time frame.

Study Timeline

• Study Start: 2023-10-25
• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients > 18 years old
• Diagnosis of deafness with unilateral or bilateral hearing aid
• Informed consent to participate in the study
• Good understanding of French
• Non-opposition to participation in the study

Exclusion Criteria

• Comorbidity that may hamper the interpretation of results (e.g. disabling cognitive disorder)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Statistical validation of the French version of the IOI-HA and COSI questionnaires: Reproducibility, internal consistency, relevance and discriminatory performance of the tests	3 +/- 1 week

Trial Locations

Locations (1)

Hopital Fondation Adolphe de Rothschild; 🇫🇷 Paris, France