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Completed

NCT Number: NCT01858246

A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge

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.

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Key information

Conditions

Hearing Loss, Conductive Bone Conduction Deafness Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

16 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ninewells Hospital and Medical School

Dundee, DD1 9SY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Conductive Hearing Loss within criteria for Bonebridge
  • Adults

Exclusion criteria

  • Children
  • Pregnancy

Treatment and study plan

Bonebridge

Device

Bone anchored hearing aid

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ninewells Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 21, 2013
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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