2018年7月24日，美国食品药品管理局(FDA)突然向全球各大助听器厂商致函，要求在FDA有关“非处方助听器(OTC)”相关管理法规出台前，不得向市场宣传或作为非处方助听器(OTC)销售。据FDA发布的公开函件称，目前，非处方助听器的类别还不存在，在建立之前，没有任何产品可以称之为是非处方助听器(OTC)。助听器设备仍受到FDA原有法规限制，销售必须符合各地区要求。
受此函影响，欧洲及美国部分州的家乐福和沃尔玛超市连夜下架已在超市销售的OTC助听器。
美国FDA是全球助听器厂商的“大考及监管”机构，由于FDA建立了听力行业内最为系统的行业标准及法规制度，所有大品牌的助听器都需在FDA获得批准，并按照FDA基本法规在全球销售。
OTC助听器被称之为“无需验配的助听器”，主要用于轻度听力损失的干预，过去20年来，美国一些听力学家发现轻度听力损失人群的助听器佩戴率极低，并认为是过于复杂的听力服务流程，购买渠道和高昂的价格导致的。便提出了轻度听力损失的解决方案，这种方案仅针对轻微听力损失人群，在药店、超市、便利店或加油站销售。这种助听器大多属于非智能型线性放大设备，由于放大输出很小，原则上不会对听力产生负面影响，且能提供部分频率增益的听力。
2017年，美国国会授权FDA定义OTC助听器，允许FDA建立非处方助听器类别，且在2020年前立法非处方助听器相关法规、技术标准及销售程序(该授权已获得美国总统特朗普签署)。
“此次负责发函的FDA首席医务官WilliamMaisel,MD当天前往美国国会参加质询，他表示，FDA预计将于2020年8月18日前制定新的OTC助听器法规，并依据法规制定相关技术标准，而后才能建立非处方助听器类别并监管，在监管试行期内(180天内)，消费者、专业人士和行业机构都可对FDA提出更改建议。
美国食品药品监督管理局(FDA)应该如何在截止期前定义、确定技术标准和监管这些设备呢?这是一个难题。
2018年8月14日，美国听力学会(American Academy of Audiology,AAA)、美国听力学医师学会(Academy of Doctors of Audiology,ADA)、美国演讲语言听力协会(American Speech-Language-Hearing Association,ASHA)、美国国际听力学会(International Hearing Society,IHS)四大组织发布针对OTC助听器的联合共识声明。
该共识声明共35页，内容主要分为5项，由四大组织联合起草，用于向FDA作出听力学专业建议，以帮助FDA起草OTC助听器法案和建立类别。该共识不具备法律效益和行业约束，属于美国听力学界共识性和建议性声明。该声明也获得美国联邦贸易委员会(FTC)和听力产业协会(Hearing Industries Association,HIA)支持。
声明概要如下：OTC助听器适应证范围应为26-55 dB HL的轻度至中度听力损失，仅供成人使用并仅限于非定制耳模，采用输入压缩和音量控制(其他技术参数请详见附件)，包装内外都应有明显且清晰易懂的标签(包括警告标识和不适用条件标识，列表见附件)、用户手册和听力机构联系方式，并应当建立客户档案，以确保设备基本安全性和有效性。新的OTC设备仍需归类为I类或II类医疗设备，并且需要获得FDA上市前授权。OTC助听器应与个人声音放大产品(PSAP)分别创建类别和行业标准，并建立规范化售后体系，在消费者提出索赔时，应有相应的消费者保护方案。
附件
共识声明资料：
The consensus paper is divided into five key recommendations:
1) Establish product requirements appropriate for OTC hearing devices targeting mild‐to‐moderate adult hearing impairment. Easily one of the most contentious issues in the OTC hearing aid debate is the amount of hearing loss and corresponding safe output limits for which the devices should be intended. The consensus paper uses the ASHA definition of mild-to-moderate hearing loss from 26-55 dB HL (a 30 dB range) which would easily cover the majority of people with hearing loss. It also recommends a high-frequency average full-on gain limit (HFA-FOG) of 25 dB (2cc coupler), with an input level of 50 dB SPL. Additionally, it recommends OTC devices use a signal processing scheme that reduces gain as input level increases, and as a minimal standard, employs input compression and a volume control. In order to prevent long-term over-exposure to sound, the peak (or maximum) 2cc-coupler OSPL90 should not exceed 110 dB SPL, states the working group. It’s worthwhile to note that this exceeds the upper limits of some of the standards currently being employed in the EU.
For obvious safety reasons, the consensus paper recommends OTC products be limited only to instant-fit eartips (ie, custom earmold fabrication should be limited to licensed hearing care professionals). Due to the majority of Americans—including seniors—now using cell phones, the devices should use the ANSI Standard RF immunity rating system and meet the M2/T2 standard (if a T-coil is available), which is the current minimal standard for today’s hearing aids.
2) Out-of-the-box labeling with “Red Flag” warnings and a strong recommendation to consult with a licensed hearing care professional. Two other major contentious issues surrounding an OTC hearing device center on those consumers with life-threatening medical issues (eg, an acoustic neuroma) or the possibility that consumers might be dissuaded from seeking professional assistance if their device does not work for them or give up if their unique hearing loss is not satisfactorily resolved. Additionally, several hearing care professionals and organizations are concerned that an OTC device will be used for a child instead of providing them with the necessary care associated with pediatric hearing loss. With that in mind, the consensus statement recommends out-of-the-box labeling that states:
“This device is intended for use only by adults (minimum age 18) with mild-to-moderate hearing loss, who have difficulties hearing conversational speech. This device is not intended for use by children. Benefits from this device may vary from individual to individual. If you have any questions, concerns or need further assistance with regards to your ability to hear it is recommended that you consult with a hearing healthcare professional before purchasing this device.”
Concerning “red flag” conditions, the Working Group also recommends the following outside-the-box labeling:
Important notice for the prospective users: Hearing loss is a medical condition best addressed in consultation with a licensed hearing healthcare professional. If you experience any of the following conditions, do not purchase this product and consult a hearing care professional before proceeding:
Visible deformities of the ear since birth or from injury
Fluid, pus, or blood coming out of the ear within the previous three months
Sudden, quickly worsening, or fluctuating hearing loss within the previous three months
Dizziness or periodic vertigo associated with hearing loss
Hearing loss in only one ear or a large difference in hearing between ears
Ear wax build up or feeling that something is in the ear canal
Pain or discomfort in the ear
Tinnitus or ringing in one or both of your ears.
3) Inside-of-the-box labeling. In addition to the User Instructional Brochure, the consensus paper urges emphasizing that the device is not intended for children, that it should not be worn for more than 12 hours a day if the sound level causes discomfort, and provides numerous examples when to stop using the device and/or seek professional care from a licensed practitioner. Details regarding the technical data about the device (eg, Max OSPL90, HFA-FOG, Battery type, etc) should also be included inside the packaging.
4) Define new OTC category as “Self-fit OTC Hearing Devices” and use risk class requirements for safety and effectiveness. Confusion by consumers about the difference between a hearing aid and personal sound amplification product (PSAP) have been an ongoing concern, and the creation of an OTC device category threatens to exacerbate the problem. The consensus paper recommends defining the new category as “Self-Fit Over-the-Counter Hearing Devices” to clearly distinguish them from hearing aids and PSAPs. According to the Working Group, all device classification should be based on intended use, conditions for sale, and risk classification. Therefore, it follows that the new OTC devices be classified with traditional hearing aids as Class I and Class II devices and be required to undergo a first-time FDA premarket authorization (ie, 510(k) clearance). Those devices receiving 510(k) would then be applicable for premarket clearance exemptions.
5) Adequate provisions for consumer protection and oversight by FTC. The reputation of hearing healthcare has suffered in the past due to unscrupulous companies, and the FDA and Federal Trade Commission (FTC) have provided strong federal guidance, along with the states, in protecting consumers. Currently, 32 states have return and refund policies for hearing aids, but the OTC Hearing Aid Act may pre-empt these protections. The Working Group’s recommendation is that FDA, in coordination with the FTC, establish strong consumer protection regulations, and strongly recommends that return and refund policies be defined for this new category. It also recommends that specific attention be called to marketing claims for this new category, and that FDA and FTC create a process to ensure that all product claims are substantiated by data, scientific evidence, and/or clinical studies.
