NCT01858246

A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Ninewells Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hearing Loss, Conductive
• Bone Conduction Deafness

Interventions

Type	Name	Description
DEVICE	Bonebridge
DEVICE	Bone Anchored Hearing Aid

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2013-05-21
• Last updated: 2018-01-24

Locations

1 site across 1 country: United Kingdom