A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Vibrant Bonebridge

This study is not yet open for participant recruitment.
Verified May 2013 by Ninewells Hospital
Sponsor:
Information provided by (Responsible Party):
Stephen Jones, Ninewells Hospital
ClinicalTrials.gov Identifier:
NCT01858246
First received: May 15, 2013
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

The Vibrant 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.


Condition Intervention
Hearing Loss, Conductive
Bone Conduction Deafness
Device: Vibrant Bonebridge
Device: Bone Anchored Hearing Aid

Study Type: Interventional
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 Vibrant Bonebridge

Resource links provided by NLM:


Further study details as provided by Ninewells Hospital:

Primary Outcome Measures:
  • Surgical wound complications [ Time Frame: Up to 1 year post-operatively ] [ Designated as safety issue: Yes ]

    The investigators will record time to full healing, number of visits to clinic, time to switch on of device and any frank infection requiring antibiotics.

    Any device failures or removals will also be recorded.



Secondary Outcome Measures:
  • Speech audiometry [ Time Frame: Up to 1 year after implantation ] [ Designated as safety issue: No ]

    Speech audiometry will be carried out pre-operatively with and without conventional hearing aids.

    Speech audiometry will also be carried out using a bone conducting hearing device on a soft headband to demonstrate improvements achievable.

    Post-operatively at switch-on, 6 months and 12 months speech audiometry will also be carried out using the selected implant to demonstrate what hearing improvement was achieved.


  • Patient reported outcome data [ Time Frame: Up to 1 year following implantation ] [ Designated as safety issue: No ]

    Patients will be asked to complete the Health Utilities Index questionnaire pre-operatively and at 6 months and 12 months following implantation.

    Patients will also be asked to complete the Glasgow Benefit Inventory questionnaire at 6 months and 12 months post-operatively.


  • Pure Tone Audiometry [ Time Frame: Up to 1 year after implantation ] [ Designated as safety issue: No ]

    Pure tone audiometry will be carried out pre-operatively with and without conventional hearing aids.

    Pre-operatively pure tone audiometry will also be carried out using a bone conducting hearing device on a soft headband to demonstrate improvements achievable.

    Post-operatively at switch-on, 6 months and 12 months pure-tone audiometry will also be carried out using the selected implant to demonstrate what hearing improvement was achieved.



Estimated Enrollment: 60
Study Start Date: August 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vibrant Bonebridge
Implantation with a Vibrant Bonebridge
Device: Vibrant Bonebridge
Active Comparator: Bone Anchored Hearing Aid
Implantation with a Bone Anchored Hearing Aid
Device: Bone Anchored Hearing Aid

Detailed Description:

The new Vibrant 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 Vibrant 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.

  Eligibility

Ages Eligible for Study:   16 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Conductive Hearing Loss within criteria for Vibrant Bonebridge
  • Adults

Exclusion Criteria:

  • Children
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01858246

Locations
United Kingdom
Ninewells Hospital and Medical School Not yet recruiting
Dundee, United Kingdom, DD1 9SY
Contact: Stephen EM Jones, MBBS, FRCS    +44 (0) 1382 660111 ext 32162    stephenemjones@nhs.net   
Principal Investigator: Stephen EM Jones, MBBS, FRCS         
Sub-Investigator: Patrick M Spielmann         
Sub-Investigator: Musheer Hussain         
Sub-Investigator: Samantha Batty         
Sponsors and Collaborators
Ninewells Hospital
Investigators
Principal Investigator: Stephen EM Jones NHS Tayside
  More Information

No publications provided

Responsible Party: Stephen Jones, Consultant ENT Surgeon, Ninewells Hospital
ClinicalTrials.gov Identifier: NCT01858246     History of Changes
Other Study ID Numbers: SJPSMH01
Study First Received: May 15, 2013
Last Updated: May 20, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Ninewells Hospital:
Hearing Loss, Conductive
Bone Conduction
bone conduction thresholds better than 45 dBHL

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Loss, Conductive
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014