Cochlear Ltd. Announces FDA Clearance of the Baha(R) 4 Attract System
Dec 3 13
Cochlear Ltd. announced that the US Food and Drug Administration (FDA) cleared the Cochlear(TM) Baha(R) 4 Attract System for use in the United States. Cochlear is the only company to now offer patients a choice of either a magnetic or a direct bone conduction hearing solution. The new Baha 4 Attract System uses magnets to connect the sound processor to the titanium implant. The sound processor simply attaches to the external magnet which transmits the sound to the internal magnet hidden under the skin. The single-point of transmission through the osseointegrated implant and Cochlear's advanced sound processor technology enables efficient conduction of sound.
FDA Advisory Panel Votes Favorably on Cochlear Nucleus Hybrid L24 Implant System
Nov 11 13
Cochlear Limited announced that an advisory committee to the US Food and Drug Administration (FDA) voted favorably on the Cochlear(TM) Nucleus(R) Hybrid(TM) L24 Implant System. This is a first of its kind system designed for the treatment of adults with severe to profound sensorineural hearing loss in the high frequencies and normal to only mild hearing loss in the low frequencies, often referred to as 'ski-slope' hearing loss. The panel, comprised of physicians and researchers, voted in favor of the new Hybrid device based on substantial clinical evidence demonstrating the safety and efficacy of the Nucleus Hybrid System in patients who met the candidacy criteria. The FDA is not bound by the recommendations of its advisory committees, but will consider the guidance during the final review of the new Hybrid device. The Nucleus Hybrid System combines the natural hearing via acoustic amplification of low frequencies with the electrical stimulation of a cochlear implant for high frequencies in one device. It is designed to deliver patients superior quality and clarity of sound in even the most difficult hearing situations, especially hearing in noisy environments.
Cochlear Limited Announces Launch of Nucleus(R) 6 in India
Oct 31 13
Cochlear Limited has announced the launch of Nucleus(R) 6 in India, its next generation cochlear implant sound processor. Nucleus 6 delivers industry first innovations designed to provide superior outcomes in a way that makes hearing a lot easier for the recipient - in the smallest sound processor on the market. Built on a completely new microchip platform with five times the processing power of the market-leading Nucleus 5 sound processor, Nucleus 6 delivers: - SmartSound iQ advanced sound processing to optimise performance in every hearing situation. True automation with industry's only scene classifier, which analyses the sound environment and automatically applies the best sound processing technology. - Direct wireless connectivity to the sound processor linking customers to a wide range of Bluetooth and audio devices. - Fully integrated hearing aid functionality in every sound processor to boost residual hearing through acoustic stimulation. - Comprehensive data logging capability providing a rich source of information for the clinician to help optimise individual performance. - Smallest sound processor on the market Optimising hearing performance in every hearing situation. With Nucleus 6, Cochlear introduces its third generation of input processing - SmartSound iQ. Different listening situations require specifically designed sound processing technologies to optimise hearing performance. SmartSound iQ delivers the broadest range of input processing capabilities available including new background noise and wind noise solutions. Nucleus 6 introduces the industry's first scene classifier, SCAN, which analyses the sound environment then applies the best sound processing solutions to optimise hearing performance. In the past, recipients had to manually change programs for different sound environments. With Nucleus 6 this happens automatically, so they don't have to think about it. Truly wireless connectivity: Nucleus 6 delivers truly wireless capabilities. Unlike other wireless solutions, sound can be streamed directly to the sound processor wirelessly from a wide range of Bluetooth and audio sources without the need for intermediary body worn devices. A range of new Cochlear wireless audio accessories including a TV streamer, remote microphone and phone clip will follow shortly after launch. Bimodal wireless connectivity: The Cochlear wireless accessories can also simultaneously stream sound from Bluetooth and audio devices direct to GN ReSound hearing aids (which include ReSound, Beltone and Interton brands) as well as the Nucleus 6 sound processor. This provides an integrated, bimodal solution for those people who have both a cochlear implant and GN ReSound hearing aid. Hybrid capability to enrich residual hearing: For customers who have residual hearing in their implanted ear, their hearing experience may be significantly improved if this residual hearing can also be amplified. Unique to Nucleus 6, every sound processor has the capability to operate as an all-in-one hearing aid plus cochlear implant sound processor, which delivers both electrical and acoustic stimulation simultaneously. The Nucleus 6 System also includes a range of new innovations specifically designed for the clinician. Of major benefit is the industry's only comprehensive data logging capability, which monitors and records how the sound processor is being used and the types of sound environments experienced. Data logging provides rich information for the clinician to help them have better discussions with their patients to enable even better hearing outcomes. The Nucleus 6 System has been built on the same principles that have seen Cochlear remain the company of choice for implantable hearing solutions for over thirty years. When choosing a cochlear implant, seven out of ten people globally choose Nucleus from Cochlear due to its leading technology, superior reliability and lifetime commitment to customers.