FDA Approves Hearing Device from Cochlear Limited

Centennial, Colo.-based Cochlear Limited has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Cochlear Baha 4 Attract system. The approval gives Cochlear both a magnetic and direct bone conduction hearing solution in the United States.

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 its sister product, the Baha 4 Connect System, as well as with 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, according to the company.

“The Baha 4 Attract System sets new standards in simplicity, comfort and hearing performance for magnetic bone conduction implant systems,” said Chris Smith, president of Cochlear Americas. “We are pleased to be bringing this new hearing option to patients who want to enjoy the benefits of the Baha System without a skin penetrating abutment.”

Titanium is ideal for use in implants due to to its bone-bonding ability, biocompatibility, and its non-ferrous makeup. 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.

The first Baha 4 Attract System surgeries in the United States began last fall. Approximately 100 people worldwide have received the system.

Cochlear designs and develops implantable hearing solutions.