A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hearing Loss, Conductive
- Sponsor
- Ninewells Hospital
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Speech audiogram result at 6 months after switch on at 60 dBA in quiet using AB word lists
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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 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.
Investigators
Stephen Jones
Consultant ENT Surgeon
Ninewells Hospital
Eligibility Criteria
Inclusion Criteria
- •Conductive Hearing Loss within criteria for Bonebridge
Exclusion Criteria
- •Pregnancy
Outcomes
Primary Outcomes
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 Outcomes
- Speech audiogram result at 60 dB A in noise using AB word lists(Up to 1 year after implantation)
- Patient reported outcome data(Up to 1 year following implantation)
- Time from surgery to device switch-on(Up to 3 months)
- Number of patient episodes required during study period(1 year from implantation)
- Time to complete wound healing(Up to 3 months from implantation)