Oticon Medical announced that the US Food and Drug Administration (FDA) has granted premarket approval (PMA) to the company’s Neuro System to treat individuals 18 years or older, with bilateral severe-to-profound sensorineural hearing loss, who obtain limited benefit from appropriately fitted hearing aid(s).
Cooling the sensitive tissues of the inner ear before and during a cochlear implant surgery may lead to better hearing outcomes, according to a University of Miami Health System and College of Engineering researcher who is leading a collaborative team developing this therapeutic approach.
The TICI contains all the internal and external components of a cochlear implant system in one device placed underneath the skin, including the audio processor, microphone, and power supply.
“This paper outlines the first global consensus on how we can optimize care for adults with severe to profound hearing loss. The recommendations for surgeons, audiology experts, and healthcare providers are crystal clear,” said Dr Craig Buchman.
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The company says that new MED-EL recipients can swap out an unopened RONDO 2 Audio Processor for a RONDO 3 Audio Processor through the RONDO Swap Program.
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NYU Langone clinicians combined local anesthesia and conscious sedation (LA-CS) in cochlear implantation for the first time in 2006. The team has regularly performed the procedure ever since, establishing a mounting body of evidence of the approach’s efficacy and safety.
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Precision surgical implantation of electrodes for the electric-acoustic stimulation of the inner ear can stabilize the long-term residual hearing of severely hearing-impaired people and significantly improve their speech recognition.
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American Cochlear Implant (ACI) Alliance announced that it was awarded a grant by Oberkotter Foundation to update the seminal Project HOPE study published in 2000 by Mohr, et al.
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The July operation at Barnes-Jewish Hospital marked the first use of the MED-EL Auditory Nerve Test System (ANTS) in North America, allowing simultaneous removal of a vestibular schwannoma and placement of a cochlear implant.
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Hear the World Foundation reports that the success of the CI project in Vietnam is largely owed to its project partner: The Global Foundation For Children With Hearing Loss.
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The latest cochlear implant from MED-EL incorporates a “revolutionary design change” that allows the special internal magnet to rotate with the magnetic force from the MRI, making surgical removal of the magnet or a head wrap unnecessary.
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The approval of the Cochlear Nucleus Kanso 2 Sound Processor, Nucleus 7 Sound Processor for Nucleus 22 Implant recipients, and Custom Sound Pro fitting software reflects Cochlear’s “ongoing commitment to innovation in hearing technology, providing access to smartphone connectivity and helping to improve hearing performance, and enhancing the cochlear implant fitting experience for hearing health professionals.”
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If approved by the FDA, the Acclaim would be the “first-of-its-kind cochlear implant without any external components to offer unique benefits to users and hopefully increase cochlear implant adoption and user compliance across the globe.”
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According to Plural’s announcement, these updates bring new features including fully rewritten chapters and up-to-date research on cochlear implant devices and assessment “that will benefit students and clinicians alike.”
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These models will ultimately enable development of next-generation programming strategies that rely on these computational simulations of implant performance to find programming settings that greatly improve sound quality for cochlear implant users compared to the traditional programming approach.
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HRF President Geoff Plant announced that the organization is one of 130 local nonprofits to receive grants of $100,000 to $500,000 each through the Cummings Foundation’s $20 Million Grant Program. The Woburn-based organization was chosen from a total of 738 applicants during a competitive review process.
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The research and support in practice by trained hearing health professionals provided the foundation to approve the indication be lowered to 9 months, along with the considerable developments in technology and evolving speech coding strategies in modern day cochlear implant devices.
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The article estimates that Cochlear’s costs, including legal fees and interest, could exceed $750 million.
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