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A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge

N

Ninewells Hospital

Status

Completed

Conditions

Hearing Loss, Conductive
Bone Conduction Deafness

Treatments

Device: Bonebridge
Device: Bone Anchored Hearing Aid

Study type

Interventional

Funder types

Other

Identifiers

NCT01858246
SJPSMH01

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

16 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Conductive Hearing Loss within criteria for Bonebridge
  • Adults

Exclusion criteria

  • Children
  • Pregnancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

3 participants in 2 patient groups

Bonebridge
Active Comparator group
Description:
Implantation with a Bonebridge
Treatment:
Device: Bonebridge
Bone Anchored Hearing Aid
Active Comparator group
Description:
Implantation with a Bone Anchored Hearing Aid
Treatment:
Device: Bone Anchored Hearing Aid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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