A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge
Primary Purpose
Hearing Loss, Conductive, Bone Conduction Deafness
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Bonebridge
Bone Anchored Hearing Aid
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Conductive focused on measuring Hearing Loss, Conductive, Bone Conduction, bone conduction thresholds better than 45 dBHL
Eligibility Criteria
Inclusion Criteria:
- Conductive Hearing Loss within criteria for Bonebridge
- Adults
Exclusion Criteria:
- Children
- Pregnancy
Sites / Locations
- Ninewells Hospital and Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bonebridge
Bone Anchored Hearing Aid
Arm Description
Implantation with a Bonebridge
Implantation with a Bone Anchored Hearing Aid
Outcomes
Primary Outcome Measures
Speech audiogram result at 6 months after switch on at 60 dBA in quiet using AB word lists
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 Outcome Measures
Speech audiogram result at 60 dB A in noise using AB word lists
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
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
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 to complete wound healing
Measured in days, as judged subjectively by ENT medical and nursing staff
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01858246
Brief Title
A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge
Official Title
A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ninewells Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Conductive, Bone Conduction Deafness
Keywords
Hearing Loss, Conductive, Bone Conduction, bone conduction thresholds better than 45 dBHL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bonebridge
Arm Type
Active Comparator
Arm Description
Implantation with a Bonebridge
Arm Title
Bone Anchored Hearing Aid
Arm Type
Active Comparator
Arm Description
Implantation with a Bone Anchored Hearing Aid
Intervention Type
Device
Intervention Name(s)
Bonebridge
Intervention Type
Device
Intervention Name(s)
Bone Anchored Hearing Aid
Primary Outcome Measure Information:
Title
Speech audiogram result at 6 months after switch on at 60 dBA in quiet using AB word lists
Description
We will record and compare the standard speech audiometry results at a specific sound level in order to make a direct comparison of devices
Time Frame
Up to 1 year post-operatively
Secondary Outcome Measure Information:
Title
Speech audiogram result at 60 dB A in noise using AB word lists
Description
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.
Time Frame
Up to 1 year after implantation
Title
Patient reported outcome data
Description
Patients will be asked to complete the Glasgow Benefit Inventory (GBI) and Hearing Device Satisfaction Scale (HDSS) questionnaires
Time Frame
Up to 1 year following implantation
Title
Time from surgery to device switch-on
Description
The time (measured in days) will be recorded from the date of implantation to the date of its switch-on.
Time Frame
Up to 3 months
Title
Number of patient episodes required during study period
Time Frame
1 year from implantation
Title
Time to complete wound healing
Description
Measured in days, as judged subjectively by ENT medical and nursing staff
Time Frame
Up to 3 months from implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Conductive Hearing Loss within criteria for Bonebridge
Adults
Exclusion Criteria:
Children
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen EM Jones
Organizational Affiliation
NHS Tayside
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ninewells Hospital and Medical School
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
12. IPD Sharing Statement
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A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge
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