Evaluation of the BHX Implant in Children with a BAHS

Completed

• Conditions: Hearing Loss, Conductive
• Interventions: Device: Bone Anchored Hearing Surgery

• Registration Number: NCT03742089
• Lead Sponsor: Oticon Medical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-22
• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-11-12
• Study First Posted: 2018-11-15
• Primary Completion: 2023-06-14
• Study Completion: 2024-09-22
• 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

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Implant stability	6 months post surgery	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.

Trial Locations

Locations (1)

The James Cook University Hospital; 🇬🇧 Middlesbrough, United Kingdom