Cochlear Limited (Centennial, CO) has received FDA 510(k) clearance for the Cochlear Baha 4 Attract system. With this FDA approval, Cochlear now offers both a magnetic as well as a direct bone conduction hearing solution in the US. The Baha 4 Attract system consists of a titanium implant, magnets, and a sound processor that work together to create a pathway for bone conduction hearing without the need for a skin penetrating abutment as in the case of the sister product Baha 4 Connect System, as well as most other cochlear hearing devices.
In the Baha 4 Attract, the titanium implant is placed in the bone behind the ear and allows for transmission of sound vibrations to the inner ear. Titanium is the metal of choice due to to its ability to bond to bone, biocompatibility, and the fact that it’s non-ferrous. The titanium implant is connected to the advanced Baha 4 sound processor using a magnet. The sound processor, which is attached to the external magnet, uses a front microphone to pick up sounds facing the user and a secondary microphone to filter surrounding noise. The vibrations from the sound processor and external magnet are transmitted to the internal magnet which rests under the skin. The internal magnet then transmits the vibrations to the titanium implant that is placed in the bone, which in turn transmits the sound waves to the inner ear. The Baha 4 sound processor, which features 2.4 GHz wireless connectivity, uses the Ardium platform that is three times faster and has eight times more memory than previous generation processors.
Press release: Cochlear Announces the FDA Clearance of the Baha® 4 Attract System, the First Magnetic Baha Bone Conduction Hearing Device