Cochlear Limited, the global leader in implantable hearing solutions, announced the U.S. FDA has cleared the Cochlear™ Baha® 5 SuperPower Sound Processor.
Bone conduction systems 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. While a hearing aid tries to push sound through the damaged part of the ear, bone conduction systems bypass the damaged area and send sound directly to the inner ear. They are designed to help those who receive little or no benefit from hearing aids hear and communicate more effectively.
Cochlear is the global leader in implantable hearing solutions with a global workforce of 2,700 people and an annual R&D budget of more than AUS$100 million. Products include hearing systems for cochlear implants, bone conduction and acoustic implants.
The company’s newly cleared Baha 5 SuperPower is designed for children and adults with higher degrees of mixed hearing loss. It is engineered to make difficult listening situations easier and more enjoyable. It is not only the strongest member of the Baha portfolio, it is the first and only super power bone conduction solution with smart, direct-to-device wireless technology for patients with significant hearing loss.
The Baha 5 SuperPower is the first and only behind-the-ear sound processor that works for patients with a type and degree of hearing loss that means they 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body-worn solution to help improve their hearing experience, but still have difficulty due to insufficient features and outdated audio processing technology.
To date, more than 50 people have been fit with the device in Europe and the United States. Commercial availability in the United States is estimated for summer 2016.
“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 the people 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.”
“Patient response has been extremely positive,” said Mats Dotevall, Director of Design & Development, Cochlear Bone Anchored Solutions AB. “Early results from European clinics show great satisfaction in terms of loudness, speech understanding and sound quality.”
Source: PR Newswire