A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge

Hearing Loss, Conductive Clinical Trial

Official title:

A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858246
• Other study ID #: SJPSMH01
• Status: Completed
• Phase: N/A
• First received: May 15, 2013
• Last updated: January 23, 2018
• Start date: January 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2018
• Source: Ninewells Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 85 Years

Eligibility

Inclusion Criteria:

• Conductive Hearing Loss within criteria for Bonebridge

• Adults

Exclusion Criteria:

• Children

• Pregnancy

Related Conditions & MeSH terms

• Bone Conduction Deafness
• Deafness
• Hearing Loss
• Hearing Loss, Conductive

Intervention

Device:
• Bonebridge

• Bone Anchored Hearing Aid

Locations

Country	Name	City	State
United Kingdom	Ninewells Hospital and Medical School	Dundee

Sponsors (1)

Lead Sponsor	Collaborator
Ninewells Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech audiogram result at 6 months after switch on at 60 dBA in quiet using AB word lists	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	Speech audiogram result at 60 dB A in noise using AB word lists	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
Secondary	Patient reported outcome data	Patients will be asked to complete the Glasgow Benefit Inventory (GBI) and Hearing Device Satisfaction Scale (HDSS) questionnaires	Up to 1 year following implantation
Secondary	Time from surgery to device switch-on	The time (measured in days) will be recorded from the date of implantation to the date of its switch-on.	Up to 3 months
Secondary	Number of patient episodes required during study period		1 year from implantation
Secondary	Time to complete wound healing	Measured in days, as judged subjectively by ENT medical and nursing staff	Up to 3 months from implantation