Evaluation of the BHX Implant in Children with a BAHS

Oticon Medical

Status: Completed

Conditions: Hearing Loss, Conductive

Treatments: Device: Bone Anchored Hearing Surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT03742089

C52

Details and patient eligibility

About

The purpose of this study is to in a proactive manner collect high quality data from pediatric patients who have undergone a bone anchored hearing surgery, using the Ponto BHX implant, in clinical practice. This to further increase the knowledge of bone anchored hearing systems in the pediatric population.

Enrollment: 15 patients

Sex: All

Ages: 5 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who have decided to undergo a Bone Anchored Hearing Surgery and receive a Ponto system.
2. Signed informed consent.
3. Patients between 5 - 16 years of age.
4. Patients eligible for one stage surgery.
5. Patients who have been using Ponto sound processor on a soft band for at least 2 weeks.

Exclusion criteria

1. Patients who cannot attend follow up visits.

2. Patients with single side deafness (SSD).

3. In surgeon's opinion, any other disorder and condition that may deem the patient unfit to participate in the study.

4. Patients who receive other implant than the Ponto BHX.

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 Anchored Hearing Surgery