The FDA has announced it will be modernizing its 510(k) clearance pathway, which accounts for the majority of devices that the Agency reviews, in what it characterizes as a “generational change.” Specifically, the Agency says it will concentrate on more recent predicates and technological advances in its future decision-making process, and ramp up its post-market surveillance of products.
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Paul R. Kileny, PhD, professor of Otolaryngology and director of Audiology and Electrophysiology at the University of Michigan, talks with Douglas Beck, AuD, about the area of intraoperative neurophysiological monitoring, shares some “war stories” from the operating room, and provides information about his new book, “The Audiologist’s Handbook of Intraoperative Neurophysiological Monitoring.”
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Sensorion announced a letter of intent with Pasteur Institute in Paris to exclusively negotiate a framework agreement to obtain the exclusive licenses to develop and commercialize gene therapy product candidates for restoration, treatment, and prevention of hearing loss disorders. They will collaborate on several lead programs to correct monogenic forms of hereditary hearing loss including, among others, the Usher syndrome type 1 and otoferlin deficiency, according to the announcement.
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The easy-to-use app is said to allow children to recreate their day and talk about how they communicate in different environments—at home, on the playground, or in the classroom–by populating the spaces with friends, family, and the things they enjoy.
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The discovery of this gene (Ikzf2) will help researchers better understand this unique type of cell that is needed for hearing and potentially develop treatments for common age-related hearing loss.
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The data, if collected properly, will help allow a physician to better identify why a patient has episodes of dizziness. Recordings from the application—including video, motion, and pupil tracking—are all said to be automatically uploaded to the DizzyDoctor website. For a fee, this data can be processed for the purpose of diagnosing.
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A clinical expert in tinnitus and audiology, Tyler is a pioneer in the advancement of tinnitus research and treatment, founding the annual International Conference on Management of Tinnitus and Hyperacusis more than 26 years ago.
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Those who had imagined the sounds without experiencing the shocks decreased their fear responses to the real sounds just as well as those who really heard them without experiencing the shocks.
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To maintain consumer safety while dispensing hearing aids and other amplification devices when licensed providers are not involved, a multidisciplinary research team developed the Consumer Ear Disease Risk Assessment (CEDRA) questionnaire, which is designed to identify the risk of diseases with ear and hearing symptoms. Noted researcher Donald Nielsen, PhD, explains its development and how the self-administered test can be used online for free.
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Driven by 20% organic revenue growth in its headset division, GN issued its third quarter corporate report which showed 12% organic revenue growth and an EBITA margin increased to 18.0%. GN’s earnings per share increased by 10% compared to the same period last year.
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Three pediatric audiologists and speech pathologists from Hear and Say are conducting the “first training program” for 30 of China’s professionals, in auditory-verbal therapy for children with hearing loss.
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The conference will be held at the University of Southampton Highfield Campus, and the number of participants is limited to 100. There are also opportunities to participate in portions of the conference remotely via live Internet streaming.
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The Annual Scientific and Technology Conference of the American Auditory Society (AAS) includes translational research presentations, platform papers, special sessions, poster sessions, technology updates, the Carhart Memorial Lecture, and Life Achievement Award.
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In Phase 1, CILcare was reportedly able to correlate electrophysiology, manganese-enhanced magnetic resonance imaging (MEMRI), and behavioral assessments that define a preclinical model for detecting tinnitus. In Phase 2, CILcare will adapt the preclinical model to humans.
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Open to children aged 6-12 years old, the Ideas4Ears contest encourages the youngest generation of inventors to share ideas designed to improve the quality of life for people with hearing loss.
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