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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03723161
• Other study ID #: C64
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Atresia
• Conductive Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Conductive

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