A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge

• Sponsor: Ninewells Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01858246
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss, Conductive; Bone Conduction Deafness	Device: Bonebridge; Device: Bone Anchored Hearing Aid	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Dec 31, 2017
• Actual Study Completion Date: Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bonebridge Implantation with a Bonebridge	Device: Bonebridge
Active Comparator: Bone Anchored Hearing Aid Implantation with a Bone Anchored Hearing Aid	Device: Bone Anchored Hearing Aid

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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

3. 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.

4. Number of patient episodes required during study period [1 year from implantation]

5. Time to complete wound healing [Up to 3 months from implantation]

   Measured in days, as judged subjectively by ENT medical and nursing staff

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Conductive Hearing Loss within criteria for Bonebridge

• Adults

Exclusion Criteria:

• Children

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ninewells Hospital and Medical School	Dundee		United Kingdom	DD1 9SY

Sponsors and Collaborators

• Ninewells Hospital

Investigators

• Principal Investigator: Stephen EM Jones, NHS Tayside

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stephen Jones, Consultant ENT Surgeon, Ninewells Hospital
• ClinicalTrials.gov Identifier: NCT01858246
• Other Study ID Numbers: SJPSMH01
• First Posted: May 21, 2013
• Last Update Posted: Jan 24, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by Stephen Jones, Consultant ENT Surgeon, Ninewells Hospital: Hearing Loss, Conductive; Bone Conduction; bone conduction thresholds better than 45 dBHL
• Additional relevant MeSH terms: Hearing Loss; Deafness; Hearing Loss, Conductive

Study Results

No Results Posted as of Jan 24, 2018