Baha 5 SuperPower Sound Processor & Baha Attract System
Research type
Research Study
Full title
Evaluation of audiological outcomes and subjective benefits of Cochlear Baha 5 SuperPower Sound Processor on the Baha Attract System
IRAS ID
201823
Contact name
Johan Ivarsson Blechert
Contact email
Sponsor organisation
Cochlear Bone Anchored Solutions AB
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
This study is expected to demonstrate that the study device will perform within its intended use and that it is a suitable treatment to restore hearing in subjects with a specific hearing impairment, mixed hearing loss or single-sided sensorineural deafness. The study concerns 21 patients, of which 5 will be studied in the UK.\nThe 5 patients will attend a single ENT department in order to measure their hearing performance with the study device, the Baha 5 SuperPower Sound Processor with the Baha Attract, compared to their unaided hearing performance. The patients will receive the study device as Standard of Care. The Cochlear Baha 5 SuperPower Sound Processor is the first head-worn sound processor within its segment. When used in combination with the Baha Attract System, it will allow more subjects to benefit from the Baha Attract System. The combination Baha Attract System with Baha 5 SuperPower Sound Processor is the most powerful non-skin penetrating bone conduction implant solution available today.\nThe study plan requires patients to attend on 5 occasions over a 12-14 week period; pre-operatively, for surgery, for fitting of the Sound Processor at 4 weeks and for follow-up at 6 and 12 weeks. Hearing performance measures include audiometry (the main measure; pre-operatively (unaided) and at 12 weeks (using the Sound Processor)) and two patient questionnaires, one to evaluate the benefit of using hearing amplification and one to measure hearing disability as this relates to the everyday world.\nThroughout the study, patients will be observed and questioned with regard to adverse events or device deficiencies and at 12 weeks, patients will also be asked about their daily use of the sound processor.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0119
Date of REC Opinion
10 Mar 2016
REC opinion
Further Information Favourable Opinion