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OpenTrials
Completed

NCT Number: NCT03742089

Evaluation of the BHX Implant in Children with a BAHS

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.

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Key information

Conditions

Hearing Loss, Conductive Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The James Cook University Hospital

Middlesbrough, TS4 3BE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients who cannot attend follow up visits.
  • Patients with single side deafness (SSD).
  • In surgeon's opinion, any other disorder and condition that may deem the patient unfit to participate in the study.
  • Patients who receive other implant than the Ponto BHX.

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Treatment and study plan

Bone Anchored Hearing Surgery

Device

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.

Primary outcomes

  1. Implant stability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Nov 15, 2018
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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