Trials / Completed
CompletedNCT01738490
Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 59 (actual)
- Sponsor
- Oticon Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The overall aim of the study is to investigate the Ponto wide implant considering; initial implant stability, stability over time, skin reaction and long term success when loaded at 3 weeks post surgery. Patients' quality of life improvements following implantation will also be surveyed. More specifically the primary objective of this clinical study is to test the hypothesis * The new Ponto wide diameter implant offers increased implant stability measured as ISQ (implant stability quotient) compared to the previous generation Ponto implant. And the secondary objective is to * Investigate when in time implant stability is the lowest as the initial mechanical stability is gradually replaced by biological stability
Conditions
- Deafness
- Hearing Loss
- Hearing Loss, Conductive
- Hearing Disorders
- Ear Diseases
- Otorhinolaryngologic Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Bone anchored hearing implant |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2014-06-01
- Completion
- 2016-12-01
- First posted
- 2012-11-30
- Last updated
- 2017-11-27
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01738490. Inclusion in this directory is not an endorsement.