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

NCT06108609 | Completed

• 1 other identifier: MDL_2023_7
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Impairment

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Administration of the French version of the COSI and IOI-HA questionnaires OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hopital Fondation Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: May 16, 2023
• Primary Completion: August 8, 2024
• Study Completion: August 8, 2024
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)