Multi-Centre Study on the Performance of the Ponto BHX Implant System (in Adult Patients)
- Conditions
- Hearing Loss
- Interventions
- Other: Abbreviated Profile of Hearing Aid Benefit (APHAB)Other: Glasgow Benefit Inventory (GBI)Other: Additional follow-up visits after surgery
- Registration Number
- NCT04310202
- Lead Sponsor
- Oticon Medical
- Brief Summary
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). 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. A total of 50 patients will be included in the study.
The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Biohelix (BHX) Implant system.
- Detailed Description
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). 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. A total of 50 patients will be included in the study.
The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto BHX Implant system. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 18 years of age or older
- Patients indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines
- Adequate bone quality to allow for a Ponto BHX implant insertion, as judged by the investigator, and an expected bone thickness above 3 mm, where no complications during surgery are expected
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Single-arm Abbreviated Profile of Hearing Aid Benefit (APHAB) In this single-arm study, the only interventions compared to routine clinical practice are the completion of two patient questionnaires (APHAB and GBI) and additional follow-up visits after surgery. Single-arm Glasgow Benefit Inventory (GBI) In this single-arm study, the only interventions compared to routine clinical practice are the completion of two patient questionnaires (APHAB and GBI) and additional follow-up visits after surgery. Single-arm Additional follow-up visits after surgery In this single-arm study, the only interventions compared to routine clinical practice are the completion of two patient questionnaires (APHAB and GBI) and additional follow-up visits after surgery.
- Primary Outcome Measures
Name Time Method Implant/abutment complex capability to provide a reliable Anchorage for a sound processor 3 months after implant surgery 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.
- Secondary Outcome Measures
Name Time Method Implant/abutment complex capability to provide reliable anchorage for sound processor 12 months after implant surgery 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.
Patient-perceived magnitude of pain around implant/abutment 12 months after implant surgery 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
Skin/soft tissue overgrowth 12 months after implant surgery Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question
IPS (Inflammation, Pain, Skin height) scores 12 months after implant surgery 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
Patient-perceived presence of pain around implant/abutment 12 months after implant surgery Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject
Patient-perceived magnitude of numbness around implant/abutment 12 months after implant surgery 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
Implant survival 12 months after implant surgery Implant survival will be assessed by the investigator by means of a Yes/No question: Implant/abutment complex in place \[Yes/No\]
Implant stability 12 months after implant surgery Clinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable \[Yes/No\]
Duration of surgery At implant surgery Length of surgery measured in minutes
Wound healing time 12 months after implant surgery Average healing time \[days\] from surgery when the wound is considered healed
Patient-perceived presence of numbness around implant/abutment 12 months after implant surgery Assessment of presence of patient-perceived numbness by means of a Yes/No question to the subject
Wound dehiscence 12 months after implant surgery Prevalence of wound dehiscence measured as millimeters of dehiscence
Holgers score ratings 12 months after implant surgery Distribution of Holgers score ratings (scale 0-4) where a higher score corresponds to a poorer outcome, assigned by investigator
Implant/abutment usage 12 months after implant surgery Mean hours of use of a sound processor on the implant/abutment
Subjective benefit after implant surgery 12 months after implant 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
Trial Locations
- Locations (6)
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Rigshospitalet
🇩🇰Copenhagen, Denmark
Hospital Universitario de Donostia
🇪🇸San Sebastián, Gipuzkoa, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom