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Trial record 1 of 1 for:    NCT01858246
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A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge

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ClinicalTrials.gov Identifier: NCT01858246
Recruitment Status : Completed
First Posted : May 21, 2013
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Stephen Jones, Ninewells Hospital

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.

Condition or disease Intervention/treatment
Hearing Loss, Conductive Bone Conduction Deafness Device: Bonebridge Device: Bone Anchored Hearing Aid

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  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. Number of patient episodes required during study period [ Time Frame: 1 year from implantation ]
  5. 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



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Ages Eligible for Study:   16 Years to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Conductive Hearing Loss within criteria for Bonebridge
  • Adults

Exclusion Criteria:

  • Children
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858246


Locations
United Kingdom
Ninewells Hospital and Medical School
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
Ninewells Hospital
Investigators
Principal Investigator: Stephen EM Jones NHS Tayside

Responsible Party: Stephen Jones, Consultant ENT Surgeon, Ninewells Hospital
ClinicalTrials.gov Identifier: NCT01858246     History of Changes
Other Study ID Numbers: SJPSMH01
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

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

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