Evaluation of the BHX Implant in Children With a BAHS

Hearing Loss, Conductive Clinical Trial

Official title:

Evaluation of Implant Stability and Audiological Benefit of Oticon Medicals BHX Implant in Children Undergoing Surgery for a Percutaneous Bone Anchored Hearing System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03742089
• Other study ID #: C52
• Status: Active, not recruiting
• Start date: May 22, 2018
• Est. completion date: August 30, 2024

Study information

• Verified date: October 2023
• 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: August 30, 2024
• Est. primary completion date: June 14, 2023
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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.

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Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Conductive

Intervention

Device:
• Bone Anchored Hearing Surgery
This is a observational study of pediatric patients undergoing bone anchored hearing surgery. The collected will be used to assess the implant stability development of the Ponto BHX implant during up to 24 months after implantation in a pediatric population undergoing BAHS. The study will also monitor the Ponto BHX implant safety and survival throughout the study period.

Locations

Country	Name	City	State
United Kingdom	The James Cook University Hospital	Middlesbrough

Sponsors (1)

Lead Sponsor	Collaborator
Oticon Medical

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant stability	Implant stability will be assessed using resonance frequency analysis (RFA). This is a non-invasive technique using a SmartPeg (no 55) introduced into the abutment top. A probe is directed to the SmartPeg measuring the vibrations as a test for the stability of the interface between the fixture and the bone (osseointegration). The measurement renders Implant Stability Quotient (ISQ) 'numerical values from 1 to 100'; the higher the ISQ value, the higher the stability. Two perpendicular measurements will be performed at each site. The highest and lowest ISQ value obtained at each time point aree recorded. The Osstell ISQ instrument and SmartPegs from Osstell (Gothenburg, Sweden) will be used. Difference in mean of ISQ low at 6 months compared to surgery.	6 months post surgery