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

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

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

Inclusion Criteria:

• 18 years or older
• Patient indicated for an ear level bone anchored sound processor
• Bone thickness at the implant site of at least 4 mm

Exclusion Criteria:

• Longer abutment (>6mm) required
• Inability to participate in follow-up
• Psychiatric disease in the medical history
• Mental disability
• Presumed doubt, for any reason, that the patient will be able to show up on all follow ups
• Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.