Cochlear Announces FDA Clearance of the First Smart Bone Conduction Solution for People with Significant Mixed Hearing Loss

March 9, 2016
Media Contact
Renee Oehlerking
Cochlear Americas

The Cochlear™ Baha® 5 SuperPower Sound Processor provides those who struggle more than most the ability to hear better and connect wirelessly to a variety of electronic devices

Centennial, Colo., (March 9, 2016) — Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announced the U.S. Food and Drug Administration (FDA) cleared the Cochlear™ Baha® 5 SuperPower Sound Processor for use in the United States.


Designed for children and adults with higher degrees of mixed hearing loss, the Baha 5 SuperPower 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.

Building off of the award-winning Baha 5 Sound Processor, the Baha 5 SuperPower is designed to provide an unparalleled hearing experience. Features like Bluetooth® Smart and Made for iPhone® allow users to stream audio directly from 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 the first and only 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body-worn solution to help improve their hearing experience, but still have difficulty due to insufficient features and outdated audio processing technology.

“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.”

The Baha 5 SuperPower combines two proven Cochlear technologies in one device, harnessing Baha bone conduction technology with that of the widely-used Nucleus® System (a cochlear implant system). The surgery is based on the same well-proven 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 device in Europe and the United States.

“Patient response has been extremely positive,” says 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.”

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

About Bone Conduction Implants

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.

About Cochlear Limited (ASX: COH)

Cochlear is the global leader in implantable hearing solutions. The company has a global workforce of 2,700 people and invests more than AUS$100 million a year in research and development. Products include hearing systems for cochlear implants, bone conduction and acoustic implants.

Over 400,000 people of all ages, across more than 100 countries, now hear because of Cochlear.

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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. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Cochlear is under license. iPhone, iPad and iPod touch are registered trademarks of Apple Inc. ©Cochlear Limited 2016. All rights reserved. Hear now. And always and other trademarks and registered trademarks are the property of Cochlear Limited or Cochlear Bone Anchored Solutions AB. The names of actual companies and products mentioned herein may be the trademarks of their respective owners.