A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge

January 23, 2018 updated by: Stephen Jones, Ninewells Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 81 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Conductive Hearing Loss within criteria for Bonebridge
  • Adults

Exclusion Criteria:

  • Children
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bonebridge
Implantation with a Bonebridge
Device: Bonebridge
Active Comparator: Bone Anchored Hearing Aid
Implantation with a Bone Anchored Hearing Aid
Device: Bone Anchored Hearing Aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 1 year post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 1 year after implantation
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
Up to 1 year following implantation
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.
Up to 3 months
Number of patient episodes required during study period
Time Frame: 1 year from implantation
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
Up to 3 months from implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ninewells Hospital

Investigators

  • Principal Investigator: Stephen EM Jones, NHS Tayside

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

May 15, 2013

First Submitted That Met QC Criteria

May 20, 2013

First Posted (Estimate)

May 21, 2013

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJPSMH01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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