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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03723161
Other study ID # C64
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 4, 2018
Est. completion date January 31, 2024

Study information

Verified date April 2024
Source Oticon Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date January 31, 2024
Est. primary completion date January 10, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Months to 18 Years
Eligibility 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

Study Design


Intervention

Device:
Bone Achored Hearing surgery
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.

Locations

Country Name City State
Sweden Karolinska University Hospital Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Oticon Medical Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Stability 24 months Difference in mean of ISQ low at 24 months compared to surgery 24 months post surgery
Secondary Implant survival rate Implant survival rate in percent compared to litterature 24 months post surgery
Secondary 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
Secondary 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
Secondary Performance speech intelligibility Difference between abutment-aided and softband-aided speech intelligibility in SNR in preoperative condition and at fitting. 1 month post surgery
Secondary Functional assessment Functional assessment as measured by change in Pediatric Evaluation of Aural/Oral Performance of Children (PEACH) 12 months, 24 months
Secondary 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
Secondary 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
Secondary Sustainability of audibility PTA4 performance Difference between abutment aided sound field PTA 4 over time 1 month, 12 months, 24 months post surgey
Secondary 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
Secondary Sustainability of speech intelligibility performance Difference between abutment aided speech intelligibility over time 1 month, 12 months, 24 months post surgey
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