Vibrant Effectiveness and Reliability Study (VERS)
Research type
Research Study
Full title
Evaluating the long-term reliability and performance of the Vibrant Soundbridge and Bonebridge systems
IRAS ID
168330
Contact name
Deborah Vickers
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
This project explores the reliability, medical complications and performance of two hearing devices that are clinically available on the NHS. The first is the Vibrant Soundbridge and the second is the Vibrant Bonebridge. They bi-pass or directly manipulate the bones of the middle ear to provide direct sound transmission to the inner ear. They are designed to help listeners with a moderate to severe, conductive or mixed hearing loss to hear. The main commercially available alternative is the Bone-Anchored Hearing Aid.
These devices are alternatives to conventional hearing aids.The primary aims of this study are to determine:
1. The survival of the Soundbridge (SB) and Bonebridge (BB) and collect information on any post-operative medical complications. The data will be compared to published data for Bone-anchored hearing aids.
2. Post-implantation effectiveness will be evaluated by determining changes in speech perception and quality of life scores compared to pre-implantation.The study will be conducted at multiple sites across the UK who implant either the Bonebridge or Soundbridge implant systems as part of their clinical care. Patients will be recruited for a minimum of 6 months and followed up for a maximum of a year.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0229
Date of REC Opinion
15 May 2015
REC opinion
Further Information Favourable Opinion