The All-New HiFocus™ Mid-Scala Electrode Designed to Help Protect Cochlea Structures is Now Approved by FDA.
VALENCIA, Calif., May 29, 2013 – Advanced Bionics (AB), the global leader in cochlear implant technology and a company of the Sonova Group, announced today that it received approval in the United States for the HiFocus™ Mid-Scala electrode. Earlier this year, AB announced TÜV and Health Canada approval for distributing the new electrode in Europe and Canada. Now with approval from the Food and Drug Administration, the HiFocus Mid-Scala electrode will soon begin shipping in the United States.
The latest offering in AB’s HiFocus™ electrode family, the HiFocus Mid-Scala is designed to help protect the delicate structures of the cochlea. Studies have shown that patients may retain some of their hearing when cochlea structures are undamaged during electrode insertion.1,2
The new HiFocus Mid-Scala array is the latest innovation in electrode design. Developed through extensive research and using state-of-the-art manufacturing processes, the HiFocus Mid-Scala electrode has been designed for optimal mid-scala placement in the cochlea to protect its delicate structures. It is fully upgradeable for next-generation sound processing and provides recipients with the opportunity to enjoy the best possible hearing now and improved hearing in the future as new technology is introduced.
“We developed a unique design that offers the lowest insertion forces of any of our electrodes and no contact with the delicate structures of the cochlea,” said Hansjuerg Emch, Group Vice President of the Sonova Medical Division within which AB resides. “This patented design also ensures the ideal placement in the cochlea in order to hear the most pitches possible. More pitches mean recipients using our technology have the opportunity to hear speech much better and enjoy music more than ever before.”
Featuring the industry’s smallest pre-curved array, the HiFocus Mid-Scala is the only pre-curved electrode developed for the latest soft surgery approaches, including round window insertion, to suit surgeon preferences and individual recipient needs.
“AB understands the importance of accommodating recipient anatomies and surgical techniques,” said Mark Downing, Director of Product Management and Surgical Support. “This is the market’s only electrode designed for freehand or insertion-tool technique and can be implanted using a round window or cochleostomy approach. No other electrode offers this level of flexibility.”
The new Mid-Scala model, like every electrode array in the HiFocus line, delivers AB’s proprietary current steering technology for hearing that more closely resembles normal hearing.
The HiFocus Mid-Scala electrode, HiRes 90K™ Advantage implant, and current steering are just a few of many industry firsts delivered by AB to provide recipients with better hearing through the most advanced technology. AB has developed unsurpassed sound processing strategies designed to provide the best hearing performance in real-world settings, including ClearVoice™*, HiRes Fidelity 120™*, and AutoSound™. The company introduced Neptune™ last year, the world’s first and only swimmable sound processor, which continues to make a big splash in many countries across the world.
For more information about the HiFocus Mid-Scala electrode, or any Advanced Bionics product, contact a local AB representative or visit AdvancedBionics.com.
About Advanced Bionics
Advanced Bionics is a global leader in developing the most advanced cochlear implant systems in the world. Founded in 1993 and a subsidiary of the Sonova Group since 2009, AB develops cutting-edge cochlear implant technology that allows recipients to hear their best.
AB offers the most sophisticated cochlear implant system on the market, the HiResolution™ Bionic Ear System, with five times more sound resolution than its competitors, designed to help recipients hear in noisy settings and enjoy the full dimensions of music.
With sales in over 50 countries and a proven track record for developing high- performing, state-of-the-art products, AB’s talented group of technologists and professionals from all over the world are driven to succeed, work with integrity and stay firmly committed to quality.
To learn more about AB and its innovative cochlear implant technology, please visit https://www.advancedbionics.com/ or the Advanced Bionics Expo Page on AudiologyOnline.
1. Carlson ML, Driscoll CL, Gifford RH, Service GJ,Tombers NM, Hughes-Borst BJ, Neff BA, Beatty CW. Implications of minimizing trauma during conventional cochlear implantation. Otol Neurotol. 2011 Aug;32(6):962-8.
2. Fraysse B, Macías AR, Sterkers O, Burdo S, Ramsden R, Deguine O, Klenzner T, Lenarz T, Rodriguez MM, Von Wallenberg E, James C. Residual hearing conservation and electroacoustic stimulation with the nucleus 24 contour advance cochlear implant. Otol Neurotol. 2006 Aug;27(5):624-33.
*Not approved for pediatric use in the United States.
