deafness hearing loss
Conditions
Interventions
The surgical placement (conventional versus the investigational surgical
technique) of the Ponto-system
Sponsors
Oticon Medical AB
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Adult patient, i.e. >= 18 years of age • Eligible for the Ponto system • Signed informed consent
Exclusion criteria
Exclusion criteria: A potential subject who meets the inclusion criteria for Ponto surgery, is willing to participate in the trial and meets any of the following criteria will be excluded from participation in this study. - Known history of immunosuppressive disease - Use of systemic immunosuppressive medication - Receiving bilateral bone anchored hearing system - Relevant dermatological diseases as judged by the investigator - Not being able to finish the study, for example because of failure to complete the questionnaires - Participating in another study with medical aids or medication - When there is no suitable implantation-site for the 4 mm implant during surgery because of insufficient bone quality.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the incidence of inflammation. Incidence of inflammation is calculated as the sum of patients with one or more observations of Holgers index of 2 or higher between surgery and 3 months post-surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| After 3 months post-surgery - Presence of dehiscence after surgery - VAS pain scale >6 - Loss of sensibility - Soft tissue overgrowth - Extrusion rate - ISQ measurments - Skin position - Dynamic skin motion - Surgical time - Wound healing time After 24 months post-surgery - Holgers index of two or higher at any timepoint - Presence of dehiscence after surgery - VAS pain scale >6 - Loss of sensibility - Soft tissue overgrowth - Extrusion rate - ISQ measuremnts - Cosmetic result | — |
Countries
Netherlands
Outcome results
None listed