A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge

Overview

The Bonebridge is a new bone conducting implantable hearing aid. The investigators plan to randomize patients to receive either the Bonebridge or a conventional bone conducting hearing device. The investigators will then compare the surgical and audiological outcomes of the two groups.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2017

Detailed Description

The new Bonebridge fully implanted, except for an external sound processor. It does not have any percutaneous parts like the Bone Anchored Hearing Aid. The investigators believe that this may improve wound healing and reduce problems with wound infection and skin overgrowth seen in Bone Anchored Hearing Aids. There may also be audiological improvements by the use of the Bonebridge as the physical separation of the vibrating part from the sound processor should reduce feedback. The company also claims other audiological improvements in the Bonebridge. The investigators wish to demonstrate whether this is actually the case by performing a study directly comparing the outcomes of the two groups.

Interventions

  • Device: Bonebridge
  • Device: Bone Anchored Hearing Aid

Arms, Groups and Cohorts

  • Active Comparator: Bonebridge
    • Implantation with a Bonebridge
  • Active Comparator: Bone Anchored Hearing Aid
    • Implantation with a Bone Anchored Hearing Aid

Clinical Trial Outcome Measures

Primary Measures

  • Speech audiogram result at 6 months after switch on at 60 dBA in quiet using AB word lists
    • Time Frame: Up to 1 year post-operatively
    • We will record and compare the standard speech audiometry results at a specific sound level in order to make a direct comparison of devices

Secondary Measures

  • Speech audiogram result at 60 dB A in noise using AB word lists
    • Time Frame: Up to 1 year after implantation
    • The speech audiogram will also be carried out in noise to demonstrate whether one device gives an appreciable advantage over another with respect to understanding in noise compared to silence.
  • Patient reported outcome data
    • Time Frame: Up to 1 year following implantation
    • Patients will be asked to complete the Glasgow Benefit Inventory (GBI) and Hearing Device Satisfaction Scale (HDSS) questionnaires
  • Time from surgery to device switch-on
    • Time Frame: Up to 3 months
    • The time (measured in days) will be recorded from the date of implantation to the date of its switch-on.
  • Number of patient episodes required during study period
    • Time Frame: 1 year from implantation
  • Time to complete wound healing
    • Time Frame: Up to 3 months from implantation
    • Measured in days, as judged subjectively by ENT medical and nursing staff

Participating in This Clinical Trial

Inclusion Criteria

  • Conductive Hearing Loss within criteria for Bonebridge – Adults Exclusion Criteria:

  • Children – Pregnancy

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ninewells Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stephen Jones, Consultant ENT Surgeon – Ninewells Hospital
  • Overall Official(s)
    • Stephen EM Jones, Principal Investigator, NHS Tayside

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