Home / Blog / FDA Clears Cochlear™ Smart Bone Conduction Sound Processor


  • FDA Clears Cochlear™ Smart Bone Conduction Sound Processor
    11 Mar , 2016








    Cochlear Limited, a global provider of implantable hearing solutions, announced that the US Food and Drug Administration (FDA) cleared the Cochlear™ Baha® 5 SuperPower Sound Processor for use in the United States.


    According to the company, the Baha 5 SuperPower is designed for children and adults with higher degrees of mixed hearing loss, and is engineered to make difficult listening situations easier and more enjoyable. Cochlear Limited describes it as the strongest member of the Baha portfolio, and the first super power bone conduction solution with smart, direct-to-device wireless technology for patients with significant hearing loss.


    The new SuperPower sound processor is an advance on its predecessor, the Baha 5 Sound Processor. Features like Bluetooth, Smart, and Made for iPhone allow users to stream audio directly from an iPhone, iPad, and iPod touch. With access to Cochlear True Wireless technology, users will also benefit from a range of accessories that are designed to further improve hearing performance and overall hearing experience.


    The Baha 5 SuperPower is a behind-the-ear sound processor with a fitting range up to 65 dB SNHL. Patients with this type and degree of hearing loss often struggle more than most to hear and understand speech, especially in noisy situations. Many of these patients currently use a body-worn solution to help improve their hearing experience, but still have difficulty due to insufficient features and outdated audio processing technology, according to Cochlear.


    “The FDA clearance of the Baha 5 SuperPower Sound Processor is a very important milestone for the industry and patients,” said Tony Manna, president of Cochlear Americas. “It means that people with mixed hearing loss, who need it most, can now benefit from a device that not only provides the amplification they need, but the ability to connect wirelessly to their favorite electronic devices, including smartphones and TVs.”


    The Baha 5 SuperPower combines two Cochlear technologies in one device, blending Baha bone conduction technology with that of the company’s Nucleus System (a cochlear implant system). The surgery is based on the same implant technology used in more than 125,000 patients over the last 35 years. It is a flexible option that can be used on both an abutment system (Baha Connect System) and a magnetic system (Baha Attract System).


    To date, more than 50 people have been fit with the Baha 5 SuperPower device in Europe and the United States, and the company reports that patient response has been very positive, with early results showing satisfaction in terms of loudness, speech understanding, and sound quality.


    Commercial availability in the United States is estimated for summer 2016.


    Cochlear Baha 5 sound processors are compatible with iPhone 6s Plus, iPhone 6s, iPhone 6 Plus, iPhone 6, iPhone 5s, iPhone 5c, iPhone 5, iPad Air 2, iPad Air, iPad (4th generation), iPad mini with retina display, iPad mini and iPod touch (5th generation) running iOS 7.X or later.


    Source: Cochlear Limited, Cochlear Americas

    Image credit: Cochlear Limited, Cochlear Americas