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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT03281967
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older.
* Patient indicated for an ear level bone anchored sound processor.
* Healthy bone quality to allow for 4mm implant insertion.
Exclusion Criteria:
* Intraoperative switch to an alternative surgical technique
* Patients undergoing re-implantation (on the side being included in the study)
* Previous participation in the C47 study.
* Inability to participate in follow-up.
* Psychiatric disease in the medical history.
* Mental disability.
* Presumed doubt, for any reason, that the patient will be able to show up on all follow-ups.
* Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
* Patients with natural skin height of \>12mm (as there will be additional skin reduction needed)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03281967
Study Brief:
Protocol Section:
NCT03281967