The Over the Counter Hearing Aid Act (HR 1652), which was bundled as part of the Medical Device User Fee Amendments (MDUFA) package and the FDA Reauthorization Act, was passed yesterday by the US House of Representatives as anticipated.
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GV (formerly Google Ventures) has announced an investment into Decibel Therapeutics, which reportedly combines the companies’ respective expertise to apply advanced big data sciences and analytics in the field of hearing. In conjunction with its equity investment, GV will contribute its significant technical expertise to Decibel. The amount of the investment was not disclosed.
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Brandon Sawalich has been appointed as the new president of Starkey Hearing Technologies. Sawalich began his career at Starkey Hearing Technologies in 1994 at age 19 in the company’s hearing aid repair lab and held several roles within the company before being named senior vice president in 2010. In addition to his work at Starkey Hearing Technologies, he is chairman of the Hearing Industries Association (HIA) and has long-time involvement in several charitable organizations.
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Oticon has joined forces with the rock band Styx for a live concert broadcast exclusively for fans wearing Oticon Opn™ Internet-connected hearing aids. The broadcast—scheduled as part of the band’s nationwide summer tour—is said to be the first time a live performance is delivered directly to hearing aid wearers, enabling them to stream the Styx classic gold hits “Renegade,” “Come Sail Away,” and more directly to their Opn hearing aids.
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Oticon will again join Homes for Our Troops to support the national non-profit organization’s work of building mortgage-free homes for severely injured veterans. This is the second year that Oticon has designated a $5000 donation to support construction of a specially adapted home for an injured veteran.
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Phonak has launched of a new dedicated platform on Family-Centered Care (FCC), an approach to hearing healthcare that recognizes the vital role the family plays in the treatment process. Based on this insight, an expert circle brought together by Phonak and chaired by Professor Louise Hickson, PhD, developed specific recommendations for hearing care professionals on how to implement FCC in daily clinical practice.
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A panel discussion at Starkey Hearing Technologies included the Dalai Lama, Forest Whitaker, and Bill Austin who discussed a range of topics, including compassion, giving, and leadership.
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The Academy of Doctors of Audiology will host a 3-part online Audiology Hackathon series to bring audiologists, students, consumers, and other experts together virtually, for the purpose of addressing specific issues and to foster greater awareness and action around hearing health as a public health concern. The series starts on July 23.
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The argument that a new FDA class of OTC hearing aids will dramatically expand the hearing healthcare market by making hearing aids more affordable is often taken as a “given.” However, research into what economists call “price elasticity”—or how much growth occurs in terms of market penetration when the cost of a product is reduced/increased—tend to suggest otherwise when it comes to hearing aids.
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The June 9 Dissemination Meeting featured a wide menu of possible regulations for a new OTC category of hearing devices, and the meeting concentrated on safety and quality control, as well as packaging and labeling requirements. The NASEM meeting’s proposals are not part of the FDA’s formal rule-making process, but they could serve as a starting point for considerations by FDA and discussions with stakeholders in hearing hearing healthcare when formulating a possible new OTC hearing device category.
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The AudiologyNOW! 2017 convention theme, “Connect, Reconnect, and Innovate in INDY!” reflected the Academy’s desire for its members to forge new relationships, strengthen existing ties, and learn about new technology during the 4-day conference in Indianapolis. However, talk about over-the-counter hearing aids and potential changes in hearing healthcare dominated discussion at the event.
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According to industry sources, the June 9 dissemination meeting of the National Academies of Sciences, Engineering, and Medicine (NASEM) is expected to include a “strawman” proposal that could serve as a starting point for discussions that lead to an OTC hearing aid category by the FDA.
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Many recent studies have linked hearing loss to disabling conditions, such as cognitive decline, depression, diabetes, falls, heart disease, and many more. This webinar—presented by Harvey Abrams, PhD, and sponsored by Hamilton CapTel—reviews several of the most eye-opening of these studies and summarizes their findings so that hearing care professionals can use them for better patient counseling—as well as to help educate doctors and primary care physicians for more patient referrals.
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The Hearing Industries Association (HIA) has issued a position paper in response to what the organization sees as several inaccurate statements made at the recent April 18 FTC Workshop titled, “Now Hear This.”
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The Over the Counter Hearing Aid Act of 2017 is expected to pass through the Senate Health, Education, Labor & Pensions (HELP) Committee as part of the much larger Medical Device User Fee Amendments (MDUFA) package. Although the current bill continues to allow OTC devices to apply to “mild-to-moderate” hearing losses, the severity of hearing loss remains a primary sticking point for the bill.
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