Multi-Center Study on Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (in Adult Patients)

Study Overview
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Brief Summary
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This prospective, multi-center study funded by Oticon Medical AB will be conducted at six clinical sites in North America. Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. The total number of participants included in the study will be 64. The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Implant system using the surgical technique Minimally Invasive Ponto Surgery (MIPS).

Detailed Description
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This prospective, multi-centre study funded by Oticon Medical AB will be conducted at six clinical sites in North America. Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. The total number of participants included in the study will be 64. Patients who are withdrawn from the study prior to completion will not be replaced. The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Implant system using the surgical technique Minimally Invasive Ponto Surgery (MIPS). The implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. The primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor, 3 months after implantation/surgery.

Official Title
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A Prospective Multi-Center Study on the Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (MIPS)

Conditions
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Hearing Loss

Intervention / Treatment
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* Other: Abbreviated Profile Hearing Aid Benefit (APHAB)
* Other: Glasgow Benefit Inventory (GBI)
* Other: Additional follow-up visit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Patient indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines. Normal bone quality and bone thickness above 3 mm, where no complications during surgery are expected. Skin thickness of 12mm or less at the implant site Exclusion Criteria: Patients undergoing re-implantation Patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales. Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus Known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator. Any other known condition that the investigator determines could interfere with compliance or study assessments.

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 |
| --- | --- |
| Single-arm<br>In this single-arm study, the only interventions compared to routine clinical practice are the completion of two patient questionnaires (APHAB and GBI) and an additional follow-up visit after surgery. | Other: Abbreviated Profile Hearing Aid Benefit (APHAB)<br>* An intervention in this study which is outside the routine clinical practice of the clinics is the APHAB questionnaire that will be completed by the subjects on 2 occasions.<br>Other: Glasgow Benefit Inventory (GBI)<br>* An intervention in this study which is outside the routine clinical practice of the clinics is the GBI questionnaire that will be completed by the subjects on 2 occasions.<br>Other: Additional follow-up visit<br>* There is an additional follow-up visit after surgery (compared to the routine clinical practice of the surgeons/clinics).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant/abutment complex capability to provide reliable anchorage for sound processor | The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin over-growth and pain preventing use of the sound processor. For a positive outcome of the primary endpoint (reliable anchorage), the implant should be in place and stable. without any adverse skin reactions or skin over-growth and pain preventing usage of the sound processor. | 3 months after implant surgery (MIPS) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant/abutment complex capability to provide reliable anchorage for sound processor | The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin over-growth and pain preventing use of the sound processor. For a positive outcome of the primary endpoint (reliable anchorage), the implant should be in place and stable without any adverse skin reactions or skin over-growth and pain preventing usage of the sound processor. | 12 months after implant surgery (MIPS) | 
| Implant survival | Implant survival will be assessed by the investigator by means of a Yes/No question: Implant/abutment complex in place [Yes/No] | 12 months after implant surgery (MIPS) | 
| Implant stability | Clinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable [Yes/No] | 12 months after implant surgery (MIPS) | 
| Holgers score ratings | Distribution of Holgers score ratings (scale 0-4) where a higher score corresponds to a poorer outcome, assigned by investigator | 12 months after implant surgery (MIPS) | 
| IPS scores | Distribution of IPS (Inflammation [total score 0-4], Pain [score 0-2], Skin height [score 0-2]) scores assigned by investigator. The IPS score is presented as [Ix Px Sx] with x being the individual score for each parameter. A higher score corresponds to a poorer outcome | 12 months after implant surgery (MIPS) | 
| Patient-perceived presence of pain around implant/abutment | Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject | 12 months after implant surgery (MIPS) | 
| Patient-perceived magnitude of pain around implant/abutment | Assessment of magnitude of patient-perceived pain using a numerical rating scale (NRS) (range 0-10) where a higher rating corresponds to a poorer outcome | 12 months after implant surgery (MIPS) | 
| Patient-perceived presence of numbness around implant/abutment | Assessment of presence of patient-perceived numbness by means of a Yes/No question to the subject | 12 months after implant surgery (MIPS) | 
| Patient-perceived magnitude of numbness around implant/abutment | Assessment of magnitude of patient-perceived numbness using a numerical rating scale (NRS) (range 0-10) where a higher rating corresponds to a poorer outcome | 12 months after implant surgery (MIPS) | 
| Skin/soft tissue overgrowth | Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question | 12 months after implant surgery (MIPS) | 
| Duration of surgery | Length of surgery measured in minutes | At implant surgery (MIPS) | 
| Wound dehiscence | Prevalence of wound dehiscence measured as millimeters of dehiscence | 12 months after implant surgery (MIPS) | 
| Wound healing time | Average healing time [days] from surgery when the wound is considered healed | 12 months after implant surgery (MIPS) | 
| Implant/abutment usage | Mean hours of use of a sound processor on the implant/abutment | 12 months after implant surgery (MIPS) | 
| Subjective benefit after MIPS surgery | Abbreviated Profile Hearing Aid Benefit (APHAB) questionnaire score (1-99) where a global higher score corresponds to a poorer outcome | At screening visit (visit before surgery) | 
| Subjective benefit after MIPS surgery | Abbreviated Profile Hearing Aid Benefit (APHAB) questionnaire score (1-99) where a higher global score corresponds to a poorer outcome | 6 months after implant surgery (MIPS) | 
| Subjective benefit after MIPS surgery | Glasgow Benefit Inventory (GBI) questionnaire score (-100 to +100) where [-100] means maximum adverse effect, [0] means no effect, and [+100] means maximum positive effect | 3 months after implant surgery (MIPS) | 
| Subjective benefit after MIPS surgery | Glasgow Benefit Inventory (GBI) questionnaire score (-100 to +100) where [-100] means maximum adverse effect, [0] means no effect, and [+100] means maximum positive effect | 12 months after implant surgery (MIPS) |