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

Oticon Medical

Status: Completed

Conditions: Atresia; Hearing Loss; Conductive Hearing Loss

Treatments: Device: Bone Achored Hearing surgery

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03723161

C64

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 30 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

Treatment

Description:

Bone Anchored Hearing surgery using a BHX implant manufactured by Oticon Medical

Treatment:

Device: Bone Achored Hearing surgery