Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2025-12-24 @ 12:50 PM
NCT ID:
NCT02589561
Eligibility Criteria:
Inclusion Criteria:
* Age limits ≥ 18 et \< 85 years
* User of two hearing aids for more than a year
* Carriers of adjustable digital hearing aids by means of a software of the usable manufacturer on Windows® PC (in stand-alone or as plug-in in the software NOAH®) to be integrated into the platform AudioProConnect. It is the case of almost all the current hearing aids (Phonak, Starkey, Siemens, Unitron, etc.)
* Subject able to understand the nature, the aim and the methodology of the study.
* Affiliation or recipient with the mode of social security.
* Collection of the informed consent
Exclusion Criteria:
* Fluctuations in the tonal audiometry, defined as variations furthermore of 10 dB of the average hearing loss (Average arithmetic of thresholds in 500, 1000, 2000 et 4000 Hz) Between the last 2 tonal audiometries realized over the previous 2 years
* Cognitive disorders or severe phasic hampering the understanding of the language or the repetition of the speech (Subject not being capable of participating in a vocal audiometry during the last regulation of its hearing aids)
* Incapacitated to move in a laboratory of audioprosthesis
* Fickle bearing of the hearing aid (\<6h /day ou \< 5day/7)
* Tip not adapted little finger
* Presence of plugs of earwax at the time of the tests
* Patient minor(miner) or protected adults or in the incapacity to give its consent according to the article L1121-8 Of the Public Code of the Health (CSP)
* Pregnant or breast-feeding women according to the article L1121-5 du CSP.
* Vulnerable people according to the article L1121-6 du CSP.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
84 Years
Study:
NCT02589561
Study Brief:
Protocol Section:
NCT02589561