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

Completed

• Conditions: Conductive Hearing Loss; Hearing Loss; Atresia
• Interventions: Device: Bone Achored Hearing surgery

• Registration Number: NCT03723161
• Lead Sponsor: Oticon Medical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-04
• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-26
• Study First Posted: 2018-10-29
• Primary Completion: 2023-01-10
• Study Completion: 2024-01-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	Bone Achored Hearing surgery	Bone Anchored Hearing surgery using a BHX implant manufactured by Oticon Medical

Primary Outcome Measures

Name	Time	Method
Stability 12 months	12 months post surgery	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden