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.
Study Type
OBSERVATIONAL
Enrollment
15
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.
Karolinska University Hospital
Stockholm, Sweden
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.
Time frame: 12 months post surgery
Stability 24 months
Difference in mean of ISQ low at 24 months compared to surgery
Time frame: 24 months post surgery
Implant survival rate
Implant survival rate in percent compared to litterature
Time frame: 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.
Time frame: 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
Time frame: 1 month post surgery
Performance speech intelligibility
Difference between abutment-aided and softband-aided speech intelligibility in SNR in preoperative condition and at fitting.
Time frame: 1 month post surgery
Functional assessment
Functional assessment as measured by change in Pediatric Evaluation of Aural/Oral Performance of Children (PEACH)
Time frame: 12 months, 24 months
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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.
Time frame: 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
Time frame: 7-10 days,12 months, 24 months post surgery
Sustainability of audibility PTA4 performance
Difference between abutment aided sound field PTA 4 over time
Time frame: 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
Time frame: 1 month, 12 months, 24 months post surgey
Sustainability of speech intelligibility performance
Difference between abutment aided speech intelligibility over time
Time frame: 1 month, 12 months, 24 months post surgey