Clinical Trial: A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Ninewells Hospital

Current Primary Outcome: 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


Original Primary Outcome: Surgical wound complications [ Time Frame: Up to 1 year post-operatively ]

The investigators will record time to full healing, number of visits to clinic, time to switch on of device and any frank infection requiring antibiotics.

Any device failures or removals will also be recorded.



Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • Speech audiometry [ Time Frame: Up to 1 year after implantation ]

    Speech audiometry will be carried out pre-operatively with and without conventional hearing aids.

    Speech audiometry will also be carried out using a bone conducting hearing device on a soft headband to demonstrate improvements achievable.

    Post-operatively at switch-on, 6 months and 12 months speech audiometry will also be carried out using the selected implant to demonstrate what hearing improvement was achieved.

  • Patient reported outcome data [ Time Frame: Up to 1 year following implantation ]

    Patients will be asked to complete the Health Utilities Index questionnaire pre-operatively and at 6 months and 12 months following implantation.

    Patients will also be asked to complete the Glasgow Benefit Inventory questionnaire at 6 months and 12 months post-operatively.

  • Pure Tone Audiometry [ Time Frame: Up to 1 year after implantation ]

    Pure tone audiometry will be carried out pre-operatively with and without conventional hearing aids.

    Pre-operatively pure tone audiometry will also be carried out using a bone conducting hearing device on a soft headband to demonstrate improvements achievable.

    Post-operatively at switch-on, 6 months and 12 months pure-tone audiometry will also be carried out using the selected implant to demonstrate what hearing improvement was achieved.



Information By: Ninewells Hospital

Dates:
Date Received: May 15, 2013
Date Started: January 2014
Date Completion: December 2017
Last Updated: March 29, 2017
Last Verified: March 2017