Validation of the French Version of the Hearing Aid Benefit Measurement COSI and IOI-HA Questionnaires (AUDI-FR)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Reproducibility, Internal Consistency, Relevance and Discriminatory Performance of the Tests
• Intervention / Treatment: Other: Administration of the French version of the COSI and IOI-HA questionnaires

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Hôpital Fondation Adolphe de Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

100 patients seen for consultation, with unilateral or bilateral hearing aids

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MDL_2023_7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No