A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge

Not Applicable

Completed

• Conditions: Hearing Loss, Conductive; Bone Conduction Deafness
• Interventions: Device: Bone Anchored Hearing Aid; Device: Bonebridge

• Registration Number: NCT01858246
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2013-05-15
• Study First Submitted QC: 2013-05-20
• Study First Posted: 2013-05-21
• Study Start: 2014-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Conductive Hearing Loss within criteria for Bonebridge
• Adults

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Exclusion Criteria

• Children
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bone Anchored Hearing Aid	Bone Anchored Hearing Aid	Implantation with a Bone Anchored Hearing Aid
Bonebridge	Bonebridge	Implantation with a Bonebridge

Primary Outcome Measures

Name	Time	Method
Speech audiogram result at 6 months after switch on at 60 dBA in quiet using AB word lists	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

Name	Time	Method
Speech audiogram result at 60 dB A in noise using AB word lists	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.
Patient reported outcome data	Up to 1 year following implantation	Patients will be asked to complete the Glasgow Benefit Inventory (GBI) and Hearing Device Satisfaction Scale (HDSS) questionnaires
Time from surgery to device switch-on	Up to 3 months	The time (measured in days) will be recorded from the date of implantation to the date of its switch-on.
Number of patient episodes required during study period	1 year from implantation
Time to complete wound healing	Up to 3 months from implantation	Measured in days, as judged subjectively by ENT medical and nursing staff

Trial Locations

Locations (1)

Ninewells Hospital and Medical School; 🇬🇧 Dundee, United Kingdom