NL-OMON44599
Completed
Phase 3
Minimally invasive surgery for Ponto bone anchored hearing implants - C50
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- deafness
- Sponsor
- Oticon Medical AB
- Enrollment
- 62
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patient, i.e. \>\= 18 years of age
- •Eligible for the Ponto system
- •Signed informed consent
Exclusion Criteria
- •A potential subject who meets the inclusion criteria for Ponto surgery, is willing to participate in the trial and meets any of the following criteria will be excluded from participation in this study.
- •\- 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.
Outcomes
Primary Outcomes
Not specified
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