Hearing Loss
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREMinimally invasive surgery
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).
Sponsors
Oticon Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Patient indicated for surgical intervention with a bone anchored hearing system * Signed informed consent * Adequate bone quality to allow for a Ponto implant insertion, as judged by the investigator, and an expected bone thickness above 5 mm, where no complications during surgery are expected * Skin thickness of 12 mm or less at the implant site
Exclusion criteria
* Patient undergoing re-implantation * Patient who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales * Known condition or previous treatment that could jeopardize skin condition and wound healing over time as judged by the investigator (e.g. uncontrolled diabetes, previous radiotherapy in the area of interest) * Known medical condition that contraindicate surgery as judged by the investigator * Known and/or planned pregnancy at time of surgery * Any other known condition that the investigator determines could interfere with compliance or investigation assessments * Simultaneous participation in another clinical investigation with pharmaceutical and/or medical device which might cause interference with investigation participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Implants With 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Implants With Reliable Anchorage for a 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 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 | 12 months after implant surgery | Implant survival will be assessed by the investigator by means of a Yes/No question: Implant 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 \[Yes/No\] |
| Holgers Score Distribution | 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits | 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 | 12 months after implant surgery | 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 | 12 months after implant surgery | 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. |
| IPS (Inflammation, Pain, Skin Height) Scores | 9 days, 5 weeks, 3-, 6- and 12 months after implant surgery, and unplanned visits | 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. |
| Wound Healing | 9 days, 5 weeks and 3 months after implant surgery, 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 | 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and 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. |
| Post-operative Events Around Abutment | 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and 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. |
| Patient-perceived Presence of Pain Around Abutment | 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits | Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject. |
| Patient-perceived Presence of Numbness Around Abutment | 9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits | Assessment of presence of patient-perceived numbness by means of a Yes/No question to the patient. |
| Duration of Surgery | 3 months after implant surgery | Length of surgery measured in minutes. |
| Sound Processor Usage | 12 months after implant surgery | Average sound processor usage time. |
| Subjective Benefit After Surgery | 3 months 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. |
Countries
Denmark, Netherlands, Sweden, United Kingdom
Contacts
PRINCIPAL_INVESTIGATORHarry Powell, MD
Guy's and St Thomas' NHS Foundation Trust
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age, Continuous | 56.2 years STANDARD_DEVIATION 15.6 |
| BMI | 27.0 kg/m2 STANDARD_DEVIATION 4.2 |
| Hearing loss indication Conductive hearing loss | 15 Participants |
| Hearing loss indication Mixed hearing loss | 25 Participants |
| Hearing loss indication Sensorineural hearing loss | 3 Participants |
| Hearing loss indication Single sided deafness | 8 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 46 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Region of Enrollment Denmark | 6 participants |
| Region of Enrollment Netherlands | 14 participants |
| Region of Enrollment Sweden | 6 participants |
| Region of Enrollment United Kingdom | 25 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 26 Participants |
| Smoking Current smoker | 8 Participants |
| Smoking History of smoking | 21 Participants |
| Smoking No smoking | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 16 / 51 |
| serious Total, serious adverse events | 1 / 51 |
Outcome results
None listed