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

Oticon Medical1 site in 1 country15 target enrollmentSeptember 4, 2018

ConditionsHearing Loss Conductive Hearing Loss Atresia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hearing Loss
Sponsor: Oticon Medical
Enrollment: 15
Locations: 1
Primary Endpoint: Stability 12 months
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 4, 2018

End Date

January 31, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Oticon Medical

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Stability 12 months

Time Frame: 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 Outcomes

Implant survival rate(24 months post surgery)
Performance audibility PTA4(1 month post surgery)
Functional assessment(12 months, 24 months)
Skin conditions Holger(7-10 days,12 months, 24 months post surgery)
Stability 24 months(24 months post surgery)
Performance speech intelligibility(1 month post surgery)
Skin conditions IPS evaluation(7-10 days,12 months, 24 months post surgery)
Performance audibility(1 month post surgery)
Sustainability of audibility performance(1 month, 12 months, 24 months post surgey)
Sustainability of audibility PTA4 performance(1 month, 12 months, 24 months post surgey)
Sustainability of speech intelligibility performance(1 month, 12 months, 24 months post surgey)