On Friday, August 18, President Donald Trump signed into law today the Food and Drug Administration Reauthorization Act of 2017, legislation that includes the Over the Counter Hearing Aid Act designed to provide greater public accessibility and affordability with over-the-counter (OTC) hearing aids. FDA will now be charged with creating and regulating a new class of OTC hearing aids.
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The online survey was conducted between August 1 and August 8, 2017, reportedly for the purpose of exploring the views of audiologists on the subject of over-the-counter (OTC) hearing aids. A total of 566 US-based audiologists completed the survey.
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William Demant—parent company of Oticon, Sonic, and Bernafon—said it would start producing over-the-counter hearing aids if customer demand increases after passage of the Over-the-Counter Hearing Aid Act.
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The US Senate passed the FDA Reauthorization Act of 2017—which includes the Over-the-Counter (OTC) Hearing Aid Act of 2017—by a vote of 94-1, on August 3.
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Larry Humes, PhD, responds to the July 2017 Hearing Review article by John Tecca, which addressed Dr Humes recent article about OTC hearing aids in the American Journal of Audiology and a summary article in the May 2017 Hearing Review.
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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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In the article, Sawalich says, “Like a thumb print, every ear and hearing loss is unique,” and stresses the vital role that hearing care professionals play in the diagnosis and evaluation of hearing loss.
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There is much to be learned from the recent IU study on OTC hearing aids. However, as its authors state, the findings are specific to that study and should not be generalized to the population of hearing-impaired individuals at large. A comparison is offered here to an audiology clinic using best practices. Results indicate that removing the professional from the fitting and follow-up process yields significantly lower levels of benefit, satisfaction, and use. If OTC hearing aids become a reality, this should be clearly stated on advertising and packaging; consumers should be informed that research has shown 45% of individuals returned hearing aids that were self-fit. Improving accessibility and affordability is only worthwhile if use and satisfaction are not sacrificed in the process.
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The new logo and standard will help consumers in the future, distinguish high-quality hearing enhancement devices for mild to moderate hearing loss from what the CTA says are “ineffective” personal amplifiers commonly found today.
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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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Gary Shapiro of the Consumer Technology Association (CTA) praised the House Energy and Commerce Committee for approving the Medical Device User Fee Amendments (MDUFA) user fee package that included the over-the-counter (OTC) hearing aid provision.
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Those of us who have chosen to earn a living serving those who have difficulty hearing also have an obligation: a duty to do what is right for the patient.
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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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