Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant

2015-05-05 17:08:23 | BioPortfolio


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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment




Bone anchored hearing implant


University Medical Center St Radboud


Active, not recruiting


Oticon Medical

Results (where available)

View Results


Published on BioPortfolio: 2015-05-05T17:08:23-0400

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Sensorineural hearing loss which develops suddenly over a period of hours or a few days. It varies in severity from mild to total deafness. Sudden deafness can be due to head trauma, vascular diseases, infections, or can appear without obvious cause or warning.

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