Ponto Implantation Using a Minimally Invasive Surgical Technique

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.

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.

Implant survival will be assessed by the investigator by means of a Yes/No question: Implant in place [Yes/No]

Clinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable [Yes/No]

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.

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.

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.

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.

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.

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.

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.

Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject.

Assessment of presence of patient-perceived numbness by means of a Yes/No question to the patient.

Length of surgery measured in minutes.

Average sound processor usage time.

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.