ong-term stability and survival rates of a novel Oticon Medical bone conduction device implant
Completed
- Conditions
- implant stabilitylocal skin reactions100192431004078510019190
- Registration Number
- NL-OMON37464
- Lead Sponsor
- Oticon Medical AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
The subject is/has:
1. 18 years or older;
2. given written informed consent to participate in the study;
3. eligible for the BCD system;
4. eligible for implantation with a BCD implant (bone thickness at implant site at least 4mm).
Exclusion Criteria
The subject is/has:
1. age below 18 years;
2. longer abutment (>6mm) required;
3. inability to participate in follow-up;
4. psychiatric disease in the medical history;
5. mental disability;
6. presumed doubt, for any reason, that the patient will be able to show up on all follow ups;
7. disease or treatment known to compromise the bone quality at the implant site: radiotherapy, osteoporosis, diabetes mellitus.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method