This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands). In total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique.
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands). In total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique. 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 three months after implantation/surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
The subjects will be implanted with a bone anchored hearing system using a minimally invasive surgery.
A quality of life-questionnaire is to be completed by the subjects at one occasion.
There are 1-3 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics).
Aalborg University Hospital
Aalborg, Denmark
Univerisity Medical Center Groningen
Groningen, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Sahlgrenska University Hospital
Gothenburg, Sweden
Number of Implants With Reliable Anchorage for a Sound Processor
The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin overgrowth 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, skin overgrowth or pain preventing usage of the sound processor.
Time frame: 3 months after implant surgery
Number of Implants With Reliable Anchorage for a Sound Processor
The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin overgrowth and pain preventing use of the sound processor. For a positive outcome (reliable anchorage), the implant should be in place and stable without any adverse skin reactions, skin overgrowth or pain preventing usage of the sound processor.
Time frame: 12 months after implant surgery
Implant Survival
Implant survival will be assessed by the investigator by means of a Yes/No question: Implant in place \[Yes/No\]
Time frame: 12 months after implant surgery
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
Holgers Score Distribution
Distribution of Holgers score ratings assigned by investigator across all study visits. The Holgers score is used to grade skin reactions around the skin-penetrating abutment on a scale from 0 to 4, where 0 indicates a reaction-free area whereas 4 indicates a severe infection often requiring removal of the implant. The results are presented based on Holgers score distribution across all study visits, as well as separate for each study visit and for unplanned visits.
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University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Time frame: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits
Max Holgers Score
Max Holgers score rating per patient across study visits. The Holgers score is used to grade skin reactions around the skin-penetrating abutment on a scale from 0 to 4, where 0 indicates a reaction-free area whereas 4 indicates a severe infection often requiring removal of the implant.
Time frame: 12 months after implant surgery
Mild/Adverse Skin Reaction
Mild/Adverse skin reaction per patient across study visits, where adverse skin reaction is defined as Holgers ≥ 2 on at least one follow-up visit. The Holgers score is used to grade skin reactions around the skin-penetrating abutment on a scale from 0 to 4, where 0 indicates a reaction-free area whereas 4 indicates a severe infection often requiring removal of the implant.
Time frame: 12 months after implant surgery
IPS (Inflammation, Pain, Skin Height) Scores
Distribution of IPS scores assigned by investigator across all study visits. The IPS scale is used to assess soft tissue status including inflammation (I), pain (P), and skin height (S) for a skin-penetrating implant, with scores ranging from 0 to 4 for the I-scale, and from 0 to 2 for the P- and S-scales. The IPS score is presented as \[Ix Px Sx\] with x being the individual score for each parameter. A higher score reflects a more severe complication. The results are presented based on IPS score distribution across all study visits, as well as separate for each study visit and unplanned visits.
Time frame: 9 days, 5 weeks, 3-, 6- and 12 months after implant surgery, and unplanned visits
Wound Healing
Investigator assessment of wound being completely healed by means of a Yes/No question. The results are presented for each study visit and for unplanned visits.
Time frame: 9 days, 5 weeks and 3 months after implant surgery, and unplanned visits
Skin Overgrowth
Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question. The results are presented for each study visit and for unplanned visits.
Time frame: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits
Post-operative Events Around Abutment
Assessment of post-operative events by investigator into five different categories: None, Bleeding and/or hematoma, Hair in-growth, Skin dehiscence around abutment, and Other. The results are presented based on post-operative event distribution across all study visits, as well as separate for each study visit and unplanned visits.
Time frame: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits
Patient-perceived Presence of Pain Around Abutment
Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject.
Time frame: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits
Patient-perceived Presence of Numbness Around Abutment
Assessment of presence of patient-perceived numbness by means of a Yes/No question to the patient.
Time frame: 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits
Duration of Surgery
Length of surgery measured in minutes.
Time frame: 3 months after implant surgery
Sound Processor Usage
Average sound processor usage time.
Time frame: 12 months after implant surgery
Subjective Benefit After Surgery
The Glasgow Benefit Inventory (GBI) is a validated, 18-item patient-reported questionnaire that assesses changes in health-related quality-of-life following otorhinolaryngological (ENT) interventions. The questionnaire evaluates the perceived benefit after a procedure and generates a Total Score and three subscale scores: General (12 items), Social Support (3 items), and Physical Health (3 items). Each score ranges from -100 to +100, where positive values indicate improvement, negative values indicate deterioration, and zero reflects no change. The Total Score is calculated as the mean of all item scores (not a sum of subscale scores), while each subscale score is calculated as the mean of the items belonging to that subscale.
Time frame: 3 months after surgery