Cochlear CBAS5477
Research type
Research Study
Full title
Post-market clinical follow-up of a magnetic bone conduction implant (Cochlear™ Baha® Attract System)
IRAS ID
142228
Contact name
Kevin Green
Contact email
Sponsor organisation
Cochlear Bone Anchored Solutions AB
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 2 days
Research summary
Subjects with mixed or conductive hearing loss or single-sided sensorineural deafness may benefit from implantable hearing aid systems. Subjects may refuse to undergo surgery for aesthetic concerns. The Baha Attract System was developed to improve cosmetic outcomes and minimal aftercare. It is allowed to be sold on the market in the EU and US.
The Baha Attract System consists of several parts. A circularly shaped implant magnet comprising an implantable hermetically sealed titanium casing including two magnets (north and south pole) is implanted subcutaneously via a titanium screw into the bone just behind the ear. This magnet serves as a docking station for a second magnet that is placed on top of the skin. The Baha Sound Processor attaches to the external magnet via snap-coupling. The transducer of the sound processor transforms sounds into vibrations which are conducted through the soft tissues and via the titanium implant to the skull and onwards to the cochlea.
This study aims to evaluate the safety, usability and performance of the Baha Attract System. The investigation will also provide input to future product developments in the area of transcutaneous bone conduction hearing.
Fifty-two adult subjects with conductive or mixed hearing loss or single-sided sensorineural deafness, who have sufficient bone quality and quantity to support successful implant placement are candidate to receive the Baha Attract System. Subjects will be enrolled at five hospitals in the Netherlands, Switzerland, UK and US.
Subjects will be followed for 24 months after implantation and will be asked to return to the hospital for 7 times after surgery: 10 days (to remove sutures), 4 weeks (fitting of the sound processor), 6 weeks, 12 weeks, 6 months, 12 months and 24 months. During these follow-up visits, subjects will be checked for the functionality and quality of their Baha Attract System and for adverse events and subsequent treatment that they experienced. In addition, during the 6 and 24 months visits, the subjects are asked to complete 3 questionnaires regarding their general health, communication, speech and hearing.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
14/NW/0063
Date of REC Opinion
15 Apr 2014
REC opinion
Further Information Favourable Opinion