A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge
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.
Hearing Loss, Conductive
Bone Conduction Deafness
Device: Bone Anchored Hearing Aid
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge|
- 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 ] [ Designated as safety issue: No ]We will record and compare the standard speech audiometry results at a specific sound level in order to make a direct comparison of devices
- Speech audiogram result at 60 dB A in noise using AB word lists [ Time Frame: Up to 1 year after implantation ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Time to complete wound healing [ Time Frame: Up to 3 months from implantation ] [ Designated as safety issue: No ]Measured in days, as judged subjectively by ENT medical and nursing staff
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Bonebridge
Implantation with a Bonebridge
Active Comparator: Bone Anchored Hearing Aid
Implantation with a Bone Anchored Hearing Aid
|Device: Bone Anchored Hearing Aid|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01858246
|Ninewells Hospital and Medical School||Recruiting|
|Dundee, United Kingdom, DD1 9SY|
|Contact: Stephen EM Jones, MBBS, FRCS +44 (0) 1382 660111 ext 32162 firstname.lastname@example.org|
|Principal Investigator: Stephen EM Jones, MBBS, FRCS|
|Sub-Investigator: Patrick M Spielmann|
|Sub-Investigator: Musheer Hussain|
|Sub-Investigator: Samantha Batty|
|Principal Investigator:||Stephen EM Jones||NHS Tayside|