A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01858246|
Recruitment Status : Completed
First Posted : May 21, 2013
Last Update Posted : January 24, 2018
|Condition or disease||Intervention/treatment|
|Hearing Loss, Conductive Bone Conduction Deafness||Device: Bonebridge 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge|
|Study Start Date :||January 2014|
|Primary Completion Date :||December 31, 2017|
|Study Completion Date :||December 31, 2017|
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|
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858246
|Ninewells Hospital and Medical School|
|Dundee, United Kingdom, DD1 9SY|
|Principal Investigator:||Stephen EM Jones||NHS Tayside|