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:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT02438618
Eligibility Criteria:
Inclusion Criteria:
* Adult patient, i.e. ≥ 18 years of age
* Eligible for the Ponto system
Exclusion Criteria:
* Known history of immunosuppressive disease
* Use of systemic immunosuppressive medication
* Receiving bilateral bone anchored hearing system
* Relevant dermatological diseases as judged by the investigator
* Not being able to finish the study, for example because of failure to complete the questionnaires
* Participating in another study with medical aids or medication
* When there is no suitable implantation-site for the 4 mm implant during surgery because of insufficient bone quality.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02438618
Study Brief:
Protocol Section:
NCT02438618