Clinical Survey of Oticon Medical Healing Cap
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
32 participants in 1 patient group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal