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 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT04310202
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Patients indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines
* Adequate bone quality to allow for a Ponto BHX implant insertion, as judged by the investigator, and an expected bone thickness above 3 mm, where no complications during surgery are expected
Exclusion Criteria:
* Patients undergoing re-implantation
* Patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales.
* Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus
* Known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator
* Any other known condition that the investigator determines could interfere with compliance or study assessments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04310202
Study Brief:
Protocol Section:
NCT04310202