Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation

Study Overview
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Brief Summary
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A bone anchored hearing system is used to improve hearing for patients with e.g. conductive/mixed hearing loss or single sided deafness. With this type of system, a titanium implant is installed in the temporal bone, where it osseointegrates, i.e. integrates with the bone. An abutment (also in titanium) is attached to the implants and penetrates the skin. The sound processor (hearing aid) is then connected to the abutment, and can be attached and removed by the patient via a snap-coupling. This type of system has been successfully implanted in more than 100.000 patients. Recently, a simplified surgical procedure, where no skin thinning around the abutment is made, was approved. The results after using this installation technique, here called soft tissue preservation, are the focus of this study. The objective of the study is to compare the outcomes after a surgical procedure with soft tissue preservation (test) and a surgery with soft tissue reduction (control) for placing Oticon Medical Ponto implants and abutments. The main hypothesis is that patient numbness around the implant is less in the test group compared to the control group.

Official Title
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Clinical Survey of Oticon Medical Ponto Implants and a Surgical Technique With Tissue Preservation

Conditions
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Conductive Hearing Loss, Mixed Hearing Loss, Single Sided Deafness

Participation Criteria
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Eligibility Criteria
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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: 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. Patients with natural skin height of >10 mm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tissue preservation<br>Ponto implant installed using a tissue preservation surgical technique | |
| Tissue reduction<br>Ponto implant installed using a classical technique with skin thinning | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbness around implant, specifically mean Total sensibility |  | 36 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of surgery |  | At surgery | 
| Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient |  | 0-6 months | 
| Mild/Adverse skin reaction | Adverse skin reaction is defined as a Holgers score ≥ 2 at least one follow-up visit, including unplanned visits, during the analysis period Holgers score is a standardized score of skin reactions around a bone anchored hearing implant. | 0-6 months | 
| Skin condition according to Holgers | Holgers score is a standardized score of skin reactions around a bone anchored hearing implant. | 7 days after surgery | 
| Postoperative complications | Including Bleeding or hematoma Flap necrosis Wound dehiscence Other (description) | 7 days to 6 months | 
| Proportion of patients with complete wound healing at first surgical visit |  | 7 days | 
| Glasgow Benefit Inventory (GBI) scores |  | 3 months | 
| Glasgow Health Status Inventory (GHSI) scores |  | Baseline (before surgery) | 
| Abbreviated profile of hearing aid benefit (APHAB) scores |  | Baseline (before surgery) | 
| Mean hours of use of the sound processor |  | 0-6 months | 
| Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient |  | 0-12 months | 
| Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient |  | 0-36 months | 
| Bone conduction (BC) in-situ audiometric thresholds |  | 6 months | 
| Bone conduction (BC) audiometric threshold | Measured with B-71 | 6 months | 
| Mean total sensibility around implant |  | Baseline (before surgery) | 
| Implant stability quotient (ISQ) |  | At surgery | 
| Time to implant loss |  | 0-36 months | 
| Patient and Observer scar assessment score |  | 21 days post surgery | 
| Mild/Adverse skin reaction | Adverse skin reaction is defined as a Holgers score ≥ 2 at least one follow-up visit, including unplanned visits, during the analysis period | 0-12 months | 
| Mild/Adverse skin reaction | Adverse skin reaction is defined as a Holgers score ≥ 2 at least one follow-up visit, including unplanned visits, during the analysis period | 0-36 months | 
| Skin condition according to Holgers |  | 21 days | 
| Skin condition according to Holgers |  | 12 weeks | 
| Skin condition according to Holgers |  | 6 months | 
| Skin condition according to Holgers |  | 1 year | 
| Skin condition according to Holgers |  | 2 years | 
| Skin condition according to Holgers |  | 3 years after surgery | 
| Postoperative complications | Including Bleeding or hematoma Flap necrosis Wound dehiscence Other (description) | 7 days to 12 months | 
| Postoperative complications | Including Bleeding or hematoma Flap necrosis Wound dehiscence Other (description) | 7 days to 36 months | 
| Glasgow Benefit Inventory (GBI) scores |  | 12 months | 
| Glasgow Health Status Inventory (GHSI) scores |  | 6 months | 
| Glasgow Health Status Inventory (GHSI) scores |  | 36 months | 
| Abbreviated profile of hearing aid benefit (APHAB) scores |  | 6 months | 
| Abbreviated profile of hearing aid benefit (APHAB) scores |  | 36 months | 
| Mean hours of use of the sound processor |  | 0-36 months | 
| Mean total sensibility around implant |  | 21 days | 
| Mean total sensibility around implant |  | 6 months | 
| Mean total sensibility around implant |  | 12 months | 
| Mean total sensibility around implant |  | 36 months | 
| Implant stability quotient (ISQ) |  | 7 days post surgery | 
| Implant stability quotient (ISQ) |  | 21 days post surgery | 
| Implant stability quotient (ISQ) |  | 12 weeks post surgery | 
| Implant stability quotient (ISQ) |  | 6 months post surgery | 
| Implant stability quotient (ISQ) |  | 12 months post surgery | 
| Implant stability quotient (ISQ) |  | 24 months post surgery | 
| Implant stability quotient (ISQ) |  | 36 months post surgery | 
| Patient and Observer scar assessment score |  | 6 months | 
| Patient and Observer scar assessment score |  | 12 months | 
| Patient and Observer scar assessment score |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone anchored hearing implant, Bone anchored hearing device