非处方助听器:实施与机遇

King Chung, Fan-Gang Zeng
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引用次数: 0

摘要

经过包括政府机构、患者权益组织和专业组织在内的股东们数十年的努力,美国食品和药物管理局(FDA)于 2022 年 10 月 17 日为非处方(OTC)助听器设立了一个新的医疗设备类别。美国食品和药物管理局的这一规定允许 18 岁或以上、有轻度至中度听力损失的成年人购买非处方助听器,无需处方,甚至无需听力测试。其目的是提高助听器的可及性,从而改善听力,提高生活质量。在对美国食品及药物管理局(FDA)机构注册和设备列表数据库的分析中,我们发现目前的非处方助听器市场仍由传统助听器制造商主导,来自大型消费电子产品和初创公司的干扰有限。我们的技术分析表明,相对较高的输出规格没有增益限制,即使是重度到永久性听力损失患者也能获得足够的放大效果。此外,借鉴人工耳蜗的映射策略,我们提出了无需听力图即可验配 OTC 助听器的新型放大算法。我们认为,智能手机和真无线立体声耳塞在功能上可以充当非处方助听器,从而进一步提高可及性和可负担性,同时减少与助听器相关的耻辱感,尤其是在中低收入国家。与传统的处方助听器相比,非处方助听器能在更年轻的时候治疗更多的人,减少他们的听力损失,因此,非处方助听器有可能产生听力保健以外的重大影响,如延缓或预防老年人认知能力的衰退。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Over-the-counter hearing aids: implementations and opportunities
After decades of effort by shareholders, including government agencies, patient advocacy groups, and professional organizations, the U.S. Food and Drug Administration (FDA) established a new medical device category for over-the-counter (OTC) hearing aids on October 17, 2022. This FDA regulation allows adults aged 18 years or older with perceived mild-to-moderate hearing loss to purchase OTC hearing aids without a prescription or even a hearing test. The goal is to increase hearing aid accessibility, potentially leading to improved hearing and a better quality of life. In our analysis of the FDA Establishment Registration & Device Listing database, we found that the current OTC hearing aid market is still dominated by traditional hearing aid manufacturers, with limited disruptor from major consumer electronics and startup companies. Our technological analyses showed that the relatively high-level output specification without gain limitation allows sufficient amplification even for people with severe-to-profound hearing loss. Additionally, borrowing from the cochlear implant mapping strategy, we propose novel amplification algorithms for fitting OTC hearing aids without an audiogram. We argue that smartphones and true-wireless-stereo earbuds can functionally serve as OTC hearing aids, further increasing accessibility and affordability while reducing the stigma associated with hearing aids, especially in low- and mid-income countries. By treating more people at a younger age with less hearing loss than traditional prescription hearing aids, OTC hearing aids can potentially have a significant impact beyond hearing care, such as delaying or preventing cognitive decline in the elderly.
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