Cochlear: US FDA clearance for first smart bone conduction solution
FDA
The new device is designed for people with significant mixed hearing loss and was developed to make hearing easier and more enjoyable in difficult listening situations, PRNewswire reports.
Cochlear Limited, global leader in implantable hearing devices, recently announced that the US Food and Drug Administration (FDA) has approved the Cochlear™ Baha® 5 SuperPower Sound Processor for sale in the United States. This new addition to the bone-anchored hearing aid (baha) range is the first and only super power bone conduction solution with smart, direct-to-device wireless technology. Users can stream audio directly from various smart devices using Bluetooth® Smart and Made for iPhone®.
The Baha 5 SuperPower is the first and only behind-the-ear sound processor that has a fitting range up to 65 dB sensorineural hearing loss (SNHL). “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 surgery required to fit the device is based on the same well-proven implant technology used in more than 125,000 patients over the last 35 years, the company reported. “Patient response has been extremely positive,” said Mats Dotevall, Director of Design and Development, Cochlear Bone-Anchored Solutions AB. “Early results from European clinics show great satisfaction in terms of loudness, speech understanding, and sound quality.” The Baha 5 SuperPower will be available in the US by summer 2016.
Source: PRNewswire
