FDA Approves Cochlear Americas Baha 3 Power Processor

May 2011

Cochlear Americas announced today that the U.S. Food and Drug Administration (FDA) has cleared the Cochlear(tm) Baha(r) 3 Power Sound Processor, the industry's most powerful programmable bone conduction hearing solution. The Baha 3 Power is an excellent choice for many children and adults with conductive hearing loss, mixed hearing loss or single-sided sensorineural deafness.

The Baha 3 Power improves upon previous systems by offering users the industry's first power bone- anchored hearing solution with advanced automatic digital signal processing and a directional microphone. The automatic signal processing functions automatically adapt to the user's sound environment, helping to provide greater audibility and listening comfort across different listening environments. Adults are now able to transition easily to different listening environments without degradation in hearing performance. Parents enjoy greater peace of mind knowing that their child can participate all day in various daily activities, without interruption, and with greater access to speech and sounds.

"The Baha 3 Power is the most advanced implantable bone conduction solution available, representing a major technological innovation in sound processor utility and design. It's engineered to deliver better hearing performance than ever before," said Chris Smith, President of Cochlear Americas. "Users who cannot benefit from hearing aids now have the best opportunity to connect to sound and effectively communicate."

The Baha 3 Power joins the Baha 3 Sound Processor in an innovative product line which was redesigned based on feedback from recipients, parents, and clinicians, resulting in devices that are sophisticated yet easy to use. These processors incorporate features especially designed for children including tamper-resistant battery doors, a key lock function, and a universal connector for FM systems for increased connectivity in the classroom. The Baha 3 devices are designed to be more water protected than ever before, allowing children and adults to live full, active lives. For clinicians, the Cochlear Fitting Software includes a unique prescription formula designed specifically for bone-conduction devices as well as BC Direct measurements which provide unparalleled customization for every individual patient.

"As an audiologist, I appreciate the advancements in technology that have been made in the osseointegrated implant industry over the past few years," says Colleen Ryan-Bane, MS, CCCA, Clinical Director of Audiology at The Johns Hopkins Hospital. "Patients are requesting both improved sound quality and better performance in background noise. The introduction of digital technology in bone conduction sound processors has allowed greater access to successful outcomes for both the patient and the audiologist. We now have greater flexibility through programming and fine-tuning of the sound processors and better opportunity for meeting the needs of the patients. I hope continued development in osseointegrated technology provides patients greater access for improvements in their quality of life."

About Bone Anchored Hearing Solutions

Bone-anchored hearing solutions are a proven medical option for adults and children with conductive hearing loss, mixed hearing loss, and single-sided sensorineural deafness meeting the candidacy criteria. The Baha(r) system sends external sounds to the inner ear through the bone by passing the outer and middle ear. Bone anchored hearing solutions are designed to provide audibility and to improve the communication abilities of those who receive little or no benefit from hearing aids.

About Cochlear Americas

Cochlear Americas is the world's leader in advanced hearing technologies. Since launching the first multichannel cochlear implant system more than 25 years ago, Cochlear Limited and its U.S. headquarters have brought the miracle of sound to more than 220,000 people with hearing loss across the globe. Cochlear Americas markets the Baha implantable bone-anchored hearing device for treatment of conductive and mixed hearing loss, as well as single-sided sensorineural deafness. Cochlear Americas' state-of-the-art cochlear implant technology, based on extensive research and development at preeminent academic institutions, provides the ability to hear sound and to better understand speech, enhancing both learning capabilities and quality of life for those with severe to profound sensorineural hearing loss. For more information about Cochlear Americas' products, visit www.cochlearamericas.com.