Today, the US Food and Drug Administration (FDA) published its proposed rules for a new category of over-the-counter (OTC) hearing aids in the Federal Register. Designed to make hearing aids more affordable and accessible for people with mild-to-moderate hearing loss, the new proposed regulations are more extensive than expected—essentially breaking hearing aids up into two categories for the purpose of labeling: “OTC hearing aids” and “prescription hearing aids” (professionally dispensed aids). The regulations are crafted to create a new OTC class of hearing aids that could be sold directly to consumers in stores or online without a medical exam or fitting by a hearing care professional (HCP). Mandated by the FDA Reauthorization Act of 2017 (FDARA), the FDA says it also wishes to increase competition in the market while ensuring the safety and effectiveness of both OTC and prescription hearing aids.

The 114-page rules document, “Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids,” covers most aspects related to OTC hearing aid manufacturing, electroacoustic requirements, packaging and labeling, returns, and conditions for sale. In an effort to promote more consistency in the regulations and enforcement of hearing aid manufacturing and distribution, the FDA is also proposing several important changes that would affect the industry and state-wide hearing aid dispensing. In fact, it appears that the FDA is proposing to remove professionally dispensed hearing aids from its restricted device category. It states:
This rulemaking also affects other existing regulations that apply to hearing aids. FDA has established device restrictions for hearing aids that include labeling requirements as well as conditions for sale. We are proposing to remove these device restrictions for hearing aids, and establish a new regulation for prescription hearing aid labeling. Further, FDA has by regulation granted or denied exemptions from Federal preemption for State requirements pertaining to hearing aids. The removal of the device restrictions on hearing aids, as well as certain provisions of FDARA, impact most of these previous exemption decisions, for example, by altering their scope. We are proposing to remove the regulations codifying these decisions and establish other regulations clarifying some of the effects of statutory preemption under FDARA.
In the document, FDA refers repeatedly to recommendations made by the President’s Council of Advisors for Science and Technology (PCAST) and the Committee on Accessible and Affordable Hearing Health Care for Adults, a part of the National Academies of Sciences and Medicine (NASEM). However, at least when it comes to the extremely important issue of output levels which largely determines the hearing loss severity range treatable by OTC devices, the Agency sided with positions advocated by the Consumer Technology Association (CTA) instead of those promulgated by the OTC Hearing Aid Consensus Statement published by AAA, ADA, IHS, and ASHA (for a summary, see Oct 2018 Hearing Review, pgs 8-9) and endorsed by the Hearing Industries Association (HIA). With up to a 120 dB SPL output limit proposed for the new OTC devices, a closed-fit OTC hearing aid could creep into the severe hearing loss range.
Additionally, FDA refers to the new device category as “OTC hearing aids” whereas it had been recommended by the consensus statement they be called “self-fit over-the-counter hearing devices” so as not to cause any further confusion among consumers.
OTC hearing aid manufacturers would be given a pass by FDA when it comes to product returns if the new regulations go unchanged; however, state or local requirements for returns would continue to apply provided they don’t conflict with the FDA’s final rulemaking. Additionally, the manufacturer would need to describe their return policy (or lack thereof) on the product packaging.
For a good deal of the other issues—ranging from product labeling to electroacoustic specifications— the new rules for OTC hearing aids hew fairly close to the consensus statement positions advocated by the professional organizations. At several places within the rules, there is emphasis that OTC hearing aids are intended for use by adults ages 18 and older with mild-to-moderate losses.
Importantly, the OTC Hearing Aid regulations, in accordance with the FDARA of 2017, would preempt any state or local requirements specifically related to hearing products that “would restrict or interfere with commercial activity involving OTC hearing aids, including any state or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access OTC hearing aids,” according to the document. In other words, non-professionals and professionals alike can dispense OTC hearing aid products; however, the regulations are not meant to interfere with or pre-empt state requirements regulating professional services of audiologists, hearing aid specialists, or speech pathologists.
Consolidating Hearing Device Categories
Over the years, FDA has created different regulations for the variety of hearing devices as technology and use-cases evolved. FDA would now like to re-align and categorize its hearing aid regulations by “sound-conduction mode.” It proposes combining wireless and non-wireless (“legacy”) hearing aids, as well as self-fit hearing aids (eg, Bose Self-fitting Hearing Aid), into an “air conduction hearing aid” class, including OTC hearing aids as a separate subset. It would also retain the separate classification regulation for bone-conduction devices. FDA says this realignment would not affect the device class or premarket notification exemption status (ie, 510k filing requirements) of any existing device. Additionally, for the sake of consistency, some special controls for wireless hearing aids would be removed and replaced by the proposed labeling requirements for both OTC and prescription hearing aids.
As shown above, FDA is calling for something of a “clean slate” when it comes to the agency’s previous decisions about state and local exemptions on conditions for sale of hearing aids. Over the past four decades, FDA has granted or denied hundreds of state exemptions pertaining to hearing aids, with some exemptions pre-empting others in confusing ways. It is proposing removal of these decisions and establishment of other regulations, along with a more transparent system that would better clarify the rules in each state for all stakeholders. (This is perhaps one of the most complicated pieces of the regulatory puzzle, and will be addressed in later articles.)
A Deeper Dive into Some Specifics in the Proposed OTC Regulations
The above withstanding, here are some of the high-points of the newly proposed OTC regulations:
Loudness limits. Perhaps the most important debate topic for OTC hearing aids revolves around safe volume levels for consumers. In the FDARA of 2017, Congress mandated that the new OTC classification be for mild-to-moderate hearing losses, typically defined from 20-55 dBHL. The proposed rule might be seen as very liberal in its allowance of output, with a maximum OSPL90 of 120 dB SPL for an OTC hearing aid that implements input-controlled compression and a user-adjustable device volume control (VC), and a 115 dB SPL for those that do not. “This is because a user adjustable volume control allows the user to reduce the output below the maximum, in effect, further reducing the device’s limit,” states the agency. “Input-controlled compression is an automatic function that dynamically reduces the output of frequency ranges based on the input. Both of these design features thus reduce the likelihood that a user will experience high acoustic outputs, at the device’s limit, at any given moment.”    
However, these proposed 115-120 dB SPL limits substantially exceed those recommended by the OTC Hearing Aid Consensus Statement, and could push a closed-fit OTC hearing aid into the severe hearing loss category. In the consensus paper, the four national hearing care organizations recommended OTC devices to be intended only for mild-to-moderate hearing losses of 26-55 dB HL with a 110 dB max output (26 dB max HFA-FOG), while offering input compression and volume controls. In the July 2020 edition of Hearing Review, three audiologists from the hearing industry published data that showed how, based on the audiograms of over 28,000 adults, commercially available hearing aids programmed according to parameters typical of people with mild-to-moderate hearing loss yield output and gain levels well within the consensus-recommended limits of 110 dB SPL output and 25 dB gain. 
The agency is proposing not to restrict loudness levels for OTC hearing aids based on gain because it believes the proposed maximum output limit, along with the other requirements, provides “reasonable assurance of safety and effectiveness without limiting the device gain also.” It points out that gain characteristics can depend on the implementation of the amplification circuit design (eg, linear vs WDRC), and wishes to allow for more technological innovations for the upcoming device class.
Electroacoustic requirements. The proposed regulations also include a subset of tests and specifications adopted from the ANSI/CTA-2051 voluntary standard for amplification devices. The FDA believes the following provide “reasonable assurance of safety and effectiveness, as well as set an objective baseline for device performance”:

• Distortion control limits;
  
• Self-generated noise limits;
  
• Latency limit;
  
• Frequency response bandwidth, and
  
• Frequency response smoothness limits.
  

• Maximum insertion depth;
  
• Eartips made from atraumatic materials;
  
• Proper physical fit, and
  
• Tools, tests, or software allowing the lay user to control the device and customize it to the user’s hearing needs.
  

• A conspicuous warning that the device is not for users younger than 18 years old;
  
• Symptoms of perceived mild-to-moderate hearing loss (with examples);
  
• Considerations for seeking a consultation with a hearing healthcare professional, and
  
• Red flag conditions.
  

• Warnings, cautions, and notes, including a conspicuous statement warning against the use of the OTC hearing aid in people younger than 18 years old, as well as a warning regarding “red flag” medical conditions to prompt consumers to consult with a licensed physician and a note about how to report adverse events to FDA;
  
• Illustrations about the controls, user adjustments, and the battery compartment;
  
• A description of any accessory that accompanies the OTC hearing aid;
  
• Adequate directions for use of the product, including details for sizing and inserting the eartip as well as the tools, tests, or software that allow the user to control and customize the OTC hearing aid to the user’s hearing needs (eg, to self-select, self-fit, and self-check the performance of the device);
  
• Technical specifications to allow users, prospective users, and others to evaluate and compare the performance of OTC hearing aids;
  
• Description of commonly occurring, avoidable events that could adversely affect or damage the OTC hearing aid;
  
• Identification of known physiological side effects associated with using the OTC hearing aid that may warrant consultation with a physician, including but not limited to skin irritation and accelerated build-up of ear wax (cerumen accumulation);
  
• Information on repair services; and
  
• Information from clinical and non-clinical studies pertaining to the product.
  

原标题：AI＋区块链，能否颠覆百亿美元的助听器产业？

引用:小海按：在老年人的众多痛点中，老年性听力损失常常被忽略，根据AgeClub调研了解的数据，许多助听器品牌的用户中，70%以上均为中老年人群，一些品牌的中老年用户占比甚至接近100%，而随着经济条件和时代变化，老人的思想也在改变，这也给予了银发经济赛道新的机遇。

• 最便宜的经济型助听器双耳价格基本在1000元以内，这类助听器一般不具备定制化功能，且使用的并非当前的主流技术；
  

• 高端助听器则主要指国际助听器品牌，由于技术含量较高且为国际品牌所垄断，大多价格昂贵，单只价格多在1万元以上。
  

• 助听器网点的覆盖多集中在高线城市或者低线城市的市中心，在更加广阔的下沉市场比如县城、乡镇以及农村地区，网点较少，增加了老人线下验配的难度；
  

• 现有的助听器网点验配水平大多参差不齐，老人在验配时同样存在不够准确或者舒适度不够的情况。
  

• 一类是以瑞士峰力、丹麦奥迪康、丹麦瑞声达等六大国外巨头为代表的品牌。 他们凭借品牌和技术优势，几乎垄断了国内的助听器市场，占据了接近90%的市场份额，双耳价格基本在两万元以上；
  

• 另一类是以欧仕达、新声、惠耳、爱可声等为代表的国产助听器品牌。 与国外品牌相比，国内助听器企业规模普遍较小，整体研发创新能力不足，产品竞争力较弱，占据了接近10%的市场份额，大多走的是性价比路线，双耳价格基本在万元以下。
  

• ① 一些其他行业的巨头或者定位智能养生的消费医疗品牌 开始布局这一行业，比如宝岛眼镜、九安、苹果等品牌；
  

• ② 一些新兴初创企业的进场 ，他们大多具有复合背景，关注用户需求，以创新的产品或商业模式，切入某个细分领域，比如又为智能、聆通科技等。
  

• 去年10月，美国初创品牌Whisper拿到Quiet Capital 领投的3500 万美元 B 轮融资；
  

• 前不久，由国内团队创立的助听器品牌又为智能完成近500万美元A轮融资，由Atypical Ventures领投；
  

• 美国另一个新兴助听器品牌Eargo去年更是成功在纳斯达克上市，目前市值近20亿美元，进一步拓宽了助听器市场的想象空间。
  

• 蓝牙技术联盟（Bluetooth SIG）在CES 2020上宣布推出LE Audio低功耗音频，能够显著增强音质，提供更丰富的助听和不同场景的音频服务；
  

• 苹果推出的AirPods Pro能够支持主动降噪，增强外界声音，实现辅助听音的效果；
  

• 三星推出Galaxy Buds Pro无线耳机，也具有辅听功能。
  

• 一类由用户线上提交听力图或进行在线听力测试，之后专业助听器验配师根据听力状况调试助听器，再通过线上发货的方式寄给用户；
  

• 另一类是用户在线上浏览商品，用较低的价格购买线下门店专享券，再去往就近门店进行验配。CBNData联合阿里健康发布的《健康趋势白皮书》显示，2019年，这一模式助推助听器线下服务的销量实现飞跃；
  

• 还有一类则是品牌通过开发相应的电脑和手机测听APP，用户可以自己操作检测听力损失程度，再自行调校舒适的音量。
  

• 较为普遍的是免息分期和超长售后模式 ，比如6期免息分期，7天无理由退换，试戴30天、45天甚至100天不满意均可以退，长达两年的保修期等等，降低用户的心理负担；
  

• 新声创始人余仕湖在创立新声助听器以前，曾在一家丹麦助听器公司工作了11年；
  

• 又为智能核心创始团队在硬件设计、算法开发、听损市场研究以及消费电子类供应链领域均有着丰富经验；
  

• 以色列辅听品牌唯安耳的母公司Alango Technologies是以色列知名的致力于数字声音处理和增强技术的科技公司。
  

• Eargo在产品外形上做了极大的革新，其助听器拥有轻盈的机身，同时从飞鱼身上获得设计灵感，通过“鬃毛”设计（小儿轻柔的医用级硅胶材质），做到了超隐形和超透气；
  

• 聆通科技则开发出一款智能助听APP，用户只需要在手机上下载应用，配合普通耳机即可使用；
  

• 前面提到的Whisper，其推出的月度租赁计划，也是一种极为新颖的商业模式。
  

[font=宋体]辅具情报研究第四期 我国助听器市场现状分析及建议[/font]

例如，要求他们立即请求比较市场分析，或者只是访问、喜欢或评论您的社交媒体网站。创建号召性用语或 CTA 时，请使用动作动词。例如，“立即下载您的免费电子书”比只显示“电子书”的按钮更具吸引力。 确保您希望他们做什么是显而易见的：用粗体链接、比特币电子邮件信息 颜色鲜艳的按钮甚至箭头来吸引他们的注意力，以帮助他们将目光引向您的 CTA。 说实话。有足够多的点击诱饵在网络上流传。如果您的 CTA 只是点击诱饵，它可能会显得虚伪并关闭它们。诚实是值得的。（感谢 Stepps 团队）


回答这两个问题很重要，因此请通过比特币电子邮件信息与他们保持联系，以促使他们采取行动。 你的最终目标是亲自会见你的客户，深入讨论他们的需求，所以所有的 比特币电子邮件信息 都应该促使 CTA 参加会议，或者至少是一个电话。 这一点至关重要，因为 70% 的房屋销售商在签订合同前只采访了一名经纪人，而其中只有 4% 的人通过网站与该经纪人取得联系。这是可以完成工作的简单比特币电子邮件信息： 从人群中脱颖而出并建立这种关系取决于面对面的会议，因此在进行家庭评估后提供对他们家的比较市场分析。 最好的房地产营销理念之一是该代理商在比特币电子邮件信息底部所做的事情，包括提供免费指南的 CTA，帮助客户为他们的房屋获得更多资金。


这里额外的警告是不要过度使用列表比特币电子邮件信息策略，除非读者是活跃的买家或卖家（艾玛） 5. 带回死者 - 特别照顾前客户以促进潜在客户的产生 推荐是房地产经纪人业务的支柱。NAR 指出，40% 的买家和 38% 的房屋卖家选择由邻居、朋友或亲戚推荐给他们的房地产经纪人。 在向以前的客户营销时，您需要仔细计划。他们可能知道他们需要了解的有关当前房地产市场的所有信息，因此请加入专注于家庭和花园技巧或当地事件的时事通讯。 另一种方法是放弃时事通讯并发送不那么频繁的个性化比特币电子邮件信息 您可以利用他们搬家的周年纪念日与他们建立联系或发送节日问候，让他们记住您的名字。个人问候也让他们知道您重视与他们的关系。

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0~14岁人口占17.95%；15~59岁人口占比63.35%；60岁及以上人口占18.7%，（其中，65岁及以上人口占13.5%。）

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来源： 思宇智库

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