今天的爆炸性新闻：FDA takes steps to improve hearing aid accessibility【FDA采取步骤改善助听器的可获得性】For Immediate Release
December 7, 2016
Release
TheU.S. Food and Drug Administration today announced important steps to bettersupport consumer access to hearing aids. The agency issued a guidance documentexplaining that it does not intend to enforce the requirement that individuals18 and up receive a medical evaluation or sign a waiver prior to purchasing mosthearing aids. 【不强迫18岁以上的个人在购买助听器之前接受医学评估或者签署放弃声明】This guidanceis effective immediately. 【该指导意见立即生效】Today, the FDA isalso announcing its commitment to consider creating a category ofover-the-counter (OTC) hearing aids that could deliver new, innovative andlower-cost products to millions of consumers.
“Today’sactions are an example of the FDA considering flexible approaches to regulationthat encourage innovation in areas of rapid scientific progress,” 【FDA考虑采取灵活的管理方式，鼓励在科技进步领域的创新】said FDA Commissioner Robert Califf, M.D. “The guidance will supportconsumer access to most hearing aids while the FDA takes the steps necessary topropose to modify our regulations to create a category of OTC hearing aids【FDA采取必要措施修改相关规定并创立一个OTC助听器类别】 that could help many Americans improve their quality of lifethrough better hearing.”
TheFDA has cited that hearing loss affects some 30 million people in the UnitedStates and can have a significant impact on communication, social participationand overall health and quality of life. Despite the high prevalence and publichealth impact of hearing loss, only about one-fifth of people who could benefitfrom a hearing aid seek intervention.
InOctober 2015, the President's Council of Advisors on Science and Technology(PCAST) issued recommendations intended to facilitate hearing aiddevice innovation, and improve affordability and patient access. Additionally,the FDA and other federal agencies and a consumer advocacy group sponsored a study published by the National Academies ofSciences, Engineering and Medicine (NAS) in June 2016.
BothPCAST and NAS cited FDA regulations regarding conditions forsale as a potentialbarrier to availability and accessibility of hearing aids, and concluded thatthe regulation was providing little to no meaningful benefit to patients. PCASTnoted that, at present, hearing aids often cost more than $2,000 a piece, andsuch barriers to distribution channels may limit new entrants who could achievetechnological breakthroughs that could offer a greater variety of lower-costhearing aid options to those suffering from hearing loss. The regulationrequires that all prospective hearing aid users have a medical evaluation by alicensed physician to determine the cause of hearing loss and whether medicalor surgical treatments would be more appropriate. Individuals 18 and up maywaive the requirement for a medical evaluation by signing a waiverstatement.
Forthe guidance document issued today, the FDA considered recommendations from thePCAST and NAS reports and public comments received on a draft guidance issued in 2013, as well as commentsreceived at an April 2016 FDA workshop.
Underthe new guidance, the FDA will continue to enforce the medical evaluationrequirement for prospective hearing aid users under 18. 【对18岁以下助听器个人使用者，FDA将继续强制其接受医学评估】Under the FDA’s hearing aidregulations, hearing aid labeling must include information about medicalconditions that should be evaluated by a licensed physician. In addition, theFDA requires that information and instructions about hearing aids be providedto consumers before any purchase from a licensed hearing aid dispenser【执业助听器验配师在消费者购买助听器之前，必须为消费者提供助听器产品信息及说明】.
Theguidance is “Immediately in Effect,” which means it is implemented withoutprior public comment because it presents a less burdensome policy that isconsistent with public health. The public can still comment on the guidance,and the FDA will consider all comments received and revise the guidancedocument as appropriate【指导意见“立即生效”表明它没有事先征询公众意见，因为它所代表的减轻消费者负担的政策符合公共健康的利益。FDA将根据收到的公众意见对指导意见做适当的修正。】.
TheFDA intends to consider and address PCAST and NAS recommendations regarding aregulatory framework for over-the-counter hearing aids without the requirementfor consultation with a credentialed dispenser. The agency is committed toseeking additional public input before proposing such an approach.
TheFDA, an agency within the U.S. Department of Health and Human Services,protects the public health by assuring the safety, effectiveness, security ofhuman and veterinary drugs, vaccines and other biological products for humanuse, and medical devices. The agency is also responsible for the safety andsecurity of our nation’s food supply, cosmetics, dietary supplements, productsthat give off electronic radiation, and for regulating tobacco products.
以上转自今天美国FDA官网http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm532005.htm