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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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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According to HIA statistics, the US hearing aid market has experienced sales gains of 5.9% and may exceed 4 million hearing aid units dispensed by the end of 2018. Here’s a summary of the US hearing industry statistics through the third quarter of this year, including a look at the most-common styles of hearing aids sold.
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For the 2018 third quarter, the company reported net sales of $30.1 million, up 20.2% from $25.1 million in the prior-year period. According to the announcement, the increase was primarily due to year-over-year revenue gains from IntriCon’s largest medical customer and growth in its value-based hearing healthcare business.
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On October 5, the FDA granted De Novo status to Bose Corporation for a self-fitting hearing aid for mild-to-moderate hearing loss.
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Shennib brings over 30 years of experience in healthcare innovations, starting his career in implantable cardiac pacing, and later taking leading roles with several hearing aid manufacturers including ReSound and InSound Medical, where he invented and developed the Lyric™ hearing device.
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The 2018 Academy of Doctors of Audiology (ADA) Convention had the theme, “Bolder than Ever,” and lived up to it with 3 days of excellent seminars and events in Orlando, Fla, on October 22-24.
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The Zounds product portfolio featured on Walmart.com includes the Vizara, a 16-Channel digital rechargeable hearing system; the Prezia, a 16-Channel premium digital hearing aid, and the Hearing in a Box digital RIC hearing aid.
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Before jumping to the conclusion that any PSAP and/or future OTC hearing device would be suitable for the many different types of hearing losses, we need to look at their coupler and real-ear performance data. This study by Adam Voss, Kristi Oeding, AU Bankaitis, John Pumford, and Michael Valente suggests current PSAPs are suitable for mild losses only.
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The FDA has concluded that the Bose Hearing Aid should be classified as a Class II device under the generic name “self-fitting air-conduction hearing aid,” according to an October 5 letter from the Agency. Accordingly, Bose is free to market the device immediately subject to general provisions and special controls required by FDA. Subsequent applications for a self-fitting hearing aid will need to undergo premarket notification requirements, according to the Agency.
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Shares of three large hearing aid companies—GN Store Nord A/S, William Demant Holding A/S, and Sonova Holding AG—dropped significantly on Monday, according to an article on ‘Bloomberg.’
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Shares of three large hearing aid companies—GN Store Nord A/S, William Demant Holding A/S, and Sonova Holding AG—dropped significantly on Monday, according to an article on ‘Bloomberg.’
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The FDA’s recent granting of de novo status for the self-fit Bose Hearing Aid may open the door to a new era of hearing aid technology and dispensing. Unlike an “OTC hearing device,” there will likely be a “self-fitting category” within the current FDA Class I and Class II hearing aid classifications.
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The FDA has approved the Bose Hearing Aid as the first self-fit hearing aid under the Agency’s De Novo premarket review pathway used for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.
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The typical image of a musician with hearing loss is someone like Beethoven, who lost his hearing long after spending a lifetime learning, playing, or composing aural music. What is lost in this image is the fact that there are individuals like myself, who acquire significant hearing loss shortly after birth or in early adolescence, yet fall in love with aural music during this same period in their lives.
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