A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2013
CompletedFirst Posted
Study publicly available on registry
May 21, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedJanuary 24, 2018
January 1, 2018
4 years
May 15, 2013
January 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Up to 1 year post-operatively
Secondary Outcomes (5)
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
Study Arms (2)
Bonebridge
ACTIVE COMPARATORImplantation with a Bonebridge
Bone Anchored Hearing Aid
ACTIVE COMPARATORImplantation with a Bone Anchored Hearing Aid
Interventions
Eligibility Criteria
You may qualify if:
- Conductive Hearing Loss within criteria for Bonebridge
- Adults
You may not qualify if:
- Children
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ninewells Hospital and Medical School
Dundee, DD1 9SY, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen EM Jones
NHS Tayside
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant ENT Surgeon
Study Record Dates
First Submitted
May 15, 2013
First Posted
May 21, 2013
Study Start
January 1, 2014
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
January 24, 2018
Record last verified: 2018-01