Eligibility Module

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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 @ 10:58 PM
Ignite Modification Date: 2025-12-24 @ 10:58 PM
NCT ID: NCT05733169
Eligibility Criteria: Inclusion Criteria: * Experienced hearing aid user (minimum use duration 1 year) * Adult (minimum age: 18 years), * Experience with frequency lowering, * Hearing thresholds with N5-N7, S1, S2, S3 hearing loss * Symmetrical hearing loss (difference between ears \<= 10 dB for 1kHz-6kHz) , * Sensorineural hearing loss, * Air Conduction - bone conduction gap \<= 10 dB, * Written and spoken German, * Ability to understand instruction, * Ability to describe listening experiences, * Ability to attend to the appointments, * Ability to fill in a questionnaire conscientiously * Healthy outer ear (without previous surgical procedures) * Hearing loss within the fitting ranges of the investigational product, * Informed consent as documented by signature. Exclusion Criteria: * Clinical contraindications deformity of the ear (closed ear canal * or absence of pinna), * Not willing to wear the hearing aid, * Fluctuating hearing that could influence the results, * Contraindications to the MD in this study, e.g. known hypersen-sitivity or allergy to the investigational product, * Limited mobility and not in the position to attend all appoint-ments, * Limited ability to describe listening impressions/experiences and the use of the hearing aid, * Inability to produce a reliable hearing test result, * Massively limited dexterity, * Known psychological problems, * Known central hearing disorders.
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT05733169
Study Brief:
Protocol Section: NCT05733169