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).
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 Patients who are withdrawn from the study prior to completion will not be replaced.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.
Study Type
OBSERVATIONAL
Enrollment
64
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.
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.
There is an additional follow-up visit after surgery (compared to the routine clinical practice of the surgeons/clinics).
Silverstein Institute
Sarasota, Florida, United States
Otolaryngology Associates
Indianapolis, Indiana, United States
New York Eye and Ear Infirmary
New York, New York, United States
Northwest Ear Institute
Portland, Oregon, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
The Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
Hospital Universitario de Donostia
San Sebastián, Gipuzkoa, Spain
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.
Time frame: 3 months after implant surgery (MIPS)
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.
Time frame: 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 \[Yes/No\]
Time frame: 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 \[Yes/No\]
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months after implant surgery (MIPS)
Duration of surgery
Length of surgery measured in minutes
Time frame: At implant surgery (MIPS)
Wound dehiscence
Prevalence of wound dehiscence measured as millimeters of dehiscence
Time frame: 12 months after implant surgery (MIPS)
Wound healing time
Average healing time \[days\] from surgery when the wound is considered healed
Time frame: 12 months after implant surgery (MIPS)
Implant/abutment usage
Mean hours of use of a sound processor on the implant/abutment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months after implant surgery (MIPS)
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