FDA 授权首款非处方助听器软件

美国食品和药物管理局 (FDA) 已批准首款非处方 (OTC) 助听器软件，名为“助听器功能”，可与兼容的 Apple AirPods Pro 配合使用。 18 岁及以上患有轻度至中度听力障碍的成年人可以使用该技术。经过安装和个性化调谐以适应个人听力要求后，AirPods Pro 变身为 OTC 助听器。听力损失影响着大约 3000 万美国公民，通常是由于年龄、噪音暴露、疾病或其他原因造成的。它会影响老年人的沟通能力、人际关系、工作表现、情绪健康，如果不及时治疗，甚至会引发认知能力下降、抑郁和进一步的健康问题。作为回应，FDA 于 2022 年 10 月 27 日出台了新规定，允许有听力困难的人直接从商店或在线平台购买助听器，无需处方或预约医生。随着今天的批准，FDA 继续致力于提供方便、创新和安全的听力解决方案。 “助听器功能”是一款专为iPhone和iPad等iOS设备设计的移动应用程序，它通过自我调节机制进行调整，使用户能够根据自己的听力偏好进行更改，而无需听力专家。此功能在设置过程中使用来自 iOS HealthKit 的数据来相应地进行自我调整。 FDA 在分析该应用程序在一项试验中的表现后做出了这一决定，该试验涉及美国各地的 118 名被认为患有轻度至中度听力障碍的参与者。研究结果显示，参与者在利用自我装配技术时获得了与专业装配设备相当的益处。此外，测试分数表明该应用程序在嘈杂的环境中提供了一致的声音增强效果和语音理解能力的提高。 FDA 向苹果公司授予“助听器功能”的营销授权。本新闻稿代表 FDA 致力于促进医疗保健平等和扩大获得造福公民的基本技术的机会。

The United States Food and Drug Administration (FDA) has approved the first over-the-counter (OTC) hearing aid software named "Hearing Aid Feature" that works alongside compatible Apple AirPods Pro. Adults aged 18 and above with perceived mild to moderate hearing impairments can utilize this technology. After installation and personalized tuning to accommodate individual hearing requirements, the AirPods Pro transforms into an OTC hearing aid. Hearing loss impacts around 30 million US citizens, often resulting from age, loud noise exposure, diseases, or other causes. It affects communication abilities, relationships, job performance, emotional health, and even triggers cognitive decline, depression, and further health issues in seniors when left untreated. In response, the FDA introduced new rules in October 27th, 2022, allowing people with such hearing difficulties to acquire hearing aids straight from stores or online platforms without prescriptions or doctor appointments. With today's approval, the FDA continues its dedication towards offering accessible, innovative, and safe hearing solutions. The "Hearing Aid Feature" is a mobile app designed for iOS devices like iPhones and iPads, which adapts through a self-adjustable mechanism enabling users to make changes according to their own hearing preferences without needing a hearing expert. This feature uses data from the iOS HealthKit during setup to tailor itself accordingly. The FDA based the decision after analyzing the app's performance in a trial involving 118 participants with perceived mild to moderate hearing challenges across various locations in the USA. Study outcomes revealed that participants achieved benefits equivalent to professionally fitted devices while utilizing the self-fit technique. Additionally, test scores indicated that the app provided consistent sound boosting effects and speech comprehension improvements in noisy environments. The FDA granted marketing authorization to Apple Inc. for the "Hearing Aid Feature". This press release represents the FDA's ongoing pursuit of promoting healthcare equality and expanding access to essential technologies benefiting citizens.

For Immediate Release:: September 12, 2024

Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro headphones. Once installed and customized to the user’s hearing needs, the Hearing Aid Feature enables compatible versions of the AirPods Pro to serve as an OTC hearing aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment.

“Hearing loss is a significant public health issue impacting millions of Americans,” said Michelle Tarver, M.D., Ph.D., acting director of the FDA's Center for Devices and Radiological Health. “Today’s marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”

More than 30 million American adults report some degree of hearing loss. Hearing loss can be caused by aging, exposure to loud noises, certain medical conditions, and other factors. Hearing loss can have a negative effect on communication, relationships, school or work performance and emotional well-being. Using hearing aids has been linked to reductions in the frequency or severity of cognitive decline, depression and other health problems in older adults.

The FDA’s OTC hearing aid regulations established in October 2022 represented a significant step toward helping ensure that adults with mild to moderate hearing loss have improved access to more safe and effective product options. The rule enabled consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or seeing an audiologist. Today’s authorization exemplifies the FDA’s continued commitment to provide safe and effective solutions for those with hearing loss, while also fostering innovation and convenience.

The Hearing Aid Feature (HAF) is a software-only mobile medical application that is intended to be used with compatible versions of the AirPods Pro. The HAF utilizes a self-fitting strategy, and users may adjust it to meet their hearing needs without the assistance of a hearing professional. The HAF is set up using an iOS device (e.g., iPhone, iPad), and the user’s hearing levels are accessed from the iOS HealthKit to customize the HAF. Users can refine the volume, tone and balance settings after setting up the HAF.

The HAF was evaluated in a clinical study with 118 subjects with perceived mild to moderate hearing loss, at multiple U.S. sites. The results demonstrated that subjects who used the HAF self-fitting strategy achieved similar perceived benefit as subjects who received professional fitting of the same device. Results also showed comparable performance for tests measuring levels of amplification in the ear canal, as well as a measure of speech understanding in noise. No adverse events related to the device were observed in this study.

This application was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.

As part of the Center for Devices and Radiological Health’s strategic priority to advance health equity, the Center will continue to support innovation that expands access to important technologies and brings health care directly to patients.

The FDA granted marketing authorization of the Hearing Aid Feature to Apple Inc.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

FDA 授权首款非处方助听器软件 FDA Authorizes First Over-the-Counter Hearing Aid Software

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