Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population

Study Overview
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Brief Summary
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The purpose of this study is to in a proactive manner collect high quality data from a pediatric patients who have undergone a bone anchored hearing solution, using the Ponto BHX implant, in clinical practice. This to further increase the knowledge of using the system.

Official Title
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Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population

Conditions
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Hearing Loss, Conductive Hearing Loss, Atresia

Intervention / Treatment
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* Device: Bone Achored Hearing surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have decided to undergo a Bone Anchored Hearing Surgery Diagnosed with atresia Signed informed consent Patients between 2,5 - 18 years of age Patients eligible for one stage surgery Exclusion Criteria: Not fluent in Swedish or English; subject and/or legal guardian Unwillingness to participate in follow up visits

Ages Eligible for Study
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Minimum Age: 30 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment<br>Bone Anchored Hearing surgery using a BHX implant manufactured by Oticon Medical | Device: Bone Achored Hearing surgery<br>* This is a observational study of pediatric patients undergoing bone anchored hearing surgery. The collected data will be used to assess the implant stability development of the Ponto BHX implant during up tp 24 months after implantation in a pediatric population undergoing bone anchored hearing surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability 12 months | The development of implant stability during the first 12 months after implantation; as measured by difference in mean of (Implant Stability Quotient) ISQ low 12 months compared to surgery. | 12 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability 24 months | Difference in mean of ISQ low at 24 months compared to surgery | 24 months post surgery | 
| Implant survival rate | Implant survival rate in percent compared to litterature | 24 months post surgery | 
| Performance audibility PTA4 | The difference between abutment-aided and softband-aided sound field Pure Tone Average of thresholds at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4) in preoperative condition and at fitting. | 1 month post surgery | 
| Performance audibility | Difference between abutment-aided and softband-aided sound field Pure Tone thresholds at frequencies 500, 1000, 2000, 4000, 6000 and 8000 Hz) in preoperative condition and at fitting | 1 month post surgery | 
| Performance speech intelligibility | Difference between abutment-aided and softband-aided speech intelligibility in SNR in preoperative condition and at fitting. | 1 month post surgery | 
| Functional assessment | Functional assessment as measured by change in Pediatric Evaluation of Aural/Oral Performance of Children (PEACH) | 12 months, 24 months | 
| Skin conditions Holger | Skin assessment as assessed with maximum Holgers score per patient. Maximum score 4. 0= no adverse skin reaction, 4=maximum adverse skin reaction. | 7-10 days,12 months, 24 months post surgery | 
| Skin conditions IPS evaluation | Skin condition as assessed by (Inflammation, Pain, Skin height/numbness (IPS) score. I scale randing from 0-4, Pain scale ranging from 0-2, Height scale ranging from 0-2. Total score 8, 0=no adverse skin reaction, 8=maximum adverse skin reaction | 7-10 days,12 months, 24 months post surgery | 
| Sustainability of audibility PTA4 performance | Difference between abutment aided sound field PTA 4 over time | 1 month, 12 months, 24 months post surgey | 
| Sustainability of audibility performance | Difference between abutment aided sound field Pure Tone thresholds at frequencies 500, 1000, 2000, 4000, 6000 and 8000 Hz over time | 1 month, 12 months, 24 months post surgey | 
| Sustainability of speech intelligibility performance | Difference between abutment aided speech intelligibility over time | 1 month, 12 months, 24 months post surgey |