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

NCT ID: NCT06108609

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-16

Study Completion Date

2024-08-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hearing Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hopital Fondation Adolphe de Rothschild

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MDL_2023_7

Identifier Type: -

Identifier Source: org_study_id