C51 - Clinical Survey of Oticon Medical Healing Cap
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Oticon Medical
- Enrollment
- 32
- Locations
- 4
- Primary Endpoint
- Skin reactions according to Holgers
Study Overview
Brief Summary
This study investigates the use of a new healing cap which, through altered design and choice of material, has been improved when it comes to minimizing the risk of it falling off as well as increasing patient comfort.
Detailed Description
This study will primarily investigate the use of a new healing cap, Healing cap II. The new healing cap has the same function as previous healing caps, but it soft instead of hard. Due to this, the healing cap is anticipated to not fall off as easily, but at the same time does not risk transferring larger forces than previously to the implant. Secondly, the patients will start using the sound processor 1-2 weeks after surgery. The implant stability will be monitored before and after loading by the use of resonance frequency analysis, an established method to evaluate and monitor osseointegrated implants.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients eligible for treatment with a bone anchored hearing aid
- •18 years or older
Exclusion Criteria
- •Inability to participate in follow-up
- •Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
Arms & Interventions
Use of Healing cap II
Single arm study using a new healing cap as intervention
Intervention: Healing cap II (Device)
Outcomes
Primary Outcomes
Skin reactions according to Holgers
Time Frame: At time of sugical follow up visit (visit window of 7-14 days after surgery)
Focus is on healing, post-operative complications and skin reactions after the first 7-14 days after surgery.
Secondary Outcomes
- Fitting of sound processor at surgical follow-up visit(At time of surgical follow up visit (visit window of 7-14 days after surgery))