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1. www.fda.gov › news-events › press-announcementsFDA Issues Landmark Proposal to Improve Access to Hearing ...

   www.fda.gov › news-events › press-announcements

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   2021年10月19日 · October 19, 2021. Español 简体中文. Today, the U.S. Food and Drug Administration issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of...

2. www.fda.gov › medical-devices › hearing-aidsOTC Hearing Aids: What You Should Know | FDA

   www.fda.gov › medical-devices › hearing-aids

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   A hearing aid is a medical device that is intended to help with hearing loss and is worn behind or within the ear canal. The FDA regulates all hearing aids to ensure safety and effectiveness...

3. 其他人也問了

   Will a new category of over-the-counter hearing aids be introduced?

   • Español 简体中文 Today, the U.S. Food and Drug Administration issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of Americans. The agency proposed a rule to establish a new category of over-the-counter (OTC) hearing aids.

   FDA Issues Landmark Proposal to Improve Access to Hearing Aid

   www.fda.gov/news-events/press-announcements/fda-issues-landmark-proposal-improve-access-hearing-aid-technology-millions-americans

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   Will FDA make hearing aids more affordable?

   • “Today’s move by FDA takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss.” Approximately 15% of American adults (37.5 million) age 18 and over report some trouble hearing.

   FDA Issues Landmark Proposal to Improve Access to Hearing Aid

   www.fda.gov/news-events/press-announcements/fda-issues-landmark-proposal-improve-access-hearing-aid-technology-millions-americans

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   How do I tell the FDA about OTC hearing aids?

   • Tell the FDA about any injuries, malfunctions, or other adverse events related to medical devices, including OTC hearing aids, through the online MedWatch form or by calling 1-800-FDA-1088. Submit the information to the FDA as soon as possible after the event.

   OTC Hearing Aids: What You Should Know | FDA

   www.fda.gov/medical-devices/hearing-aids/otc-hearing-aids-what-you-should-know

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   Can you buy a hearing aid online without a doctor?

   • The FDA recently established a new category of over the counter (OTC) hearing aids so people 18 years of age and older with perceived mild to moderate hearing loss can buy one in the store or online without seeing an ear-nose-throat (ENT) doctor, or a licensed hearing health care professional (an audiologist).

   How to Get Hearing Aids | FDA - U.S. Food and Drug Administration

   www.fda.gov/medical-devices/hearing-aids/how-get-hearing-aids

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4. www.fda.gov › medical-devices › hearing-aidsHow to Get Hearing Aids | FDA - U.S. Food and Drug Administration

   www.fda.gov › medical-devices › hearing-aids

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   The FDA recently established a new category of over the counter (OTC) hearing aids so people 18 years of age and older with perceived mild to moderate hearing loss can buy one in the store or...

5. www.fda.gov › medical-devices › consumer-productsHearing Aids | FDA - U.S. Food and Drug Administration

   www.fda.gov › medical-devices › consumer-products

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   2023年5月3日 · This site provides general information on hearing aids including benefit and safety information, types and styles, how to get and buy a hearing aid, and use with cell phones.

6. www.fda.gov › consumers › consumer-updatesHearing Aids and Personal Sound Amplification Products: What ...

   www.fda.gov › consumers › consumer-updates

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   • Air-Conduction vs. Bone-Conduction Hearing Aids
   • Medical Evaluation For Children
   • Over-The-Counter (OTC) Hearing Aids
   • Hearing Aids vs. Personal Sound Amplification Products

   Most hearing aids work through air conduction. They bring amplified sound into the ear canal. Sound then moves through the eardrum and three tiny bones in the middle ear to reach the inner ear, where it’s processed and sent to the brain. For people who have problems with their outer or middle ear, those areas can be bypassed with bone-conduction he...

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   While hearing loss in adults is often caused by aging or noise exposure, the reasons for hearing loss in children are more varied and may be associated with other medical conditions that should be medically evaluated before prescribing hearing aids. OTC hearing aids are not intended for and must not be sold to people younger than 18 years of age. H...

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   To broaden access to hearing aids, the FDA established a new category of OTC hearing aids so you will be able to buy one in the store or online without seeing a physician for an exam or an audiologist for help with fitting. The new FDA regulation, which implements a law from Congress, also aims to stimulate competition, providing consumers with imp...

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   You may have seen products in stores or online that are known as personal sound amplification products (PSAPs). These are not alternatives to hearing aids. While hearing aids and PSAPs both amplify sound for the user, the products have different intended uses. Hearing aids are intended to make up for impaired hearing. PSAPs, in contrast, are intend...

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7. www.fda.gov › regulatory-information › search-fda-guidanceRegulatory Requirements for Hearing Aid Devices and Personal ...

   www.fda.gov › regulatory-information › search-fda-guidance

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   2022年10月17日 · Guidance Issuing Office. Center for Devices and Radiological Health. This guidance document identifies applicable legal requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)...

8. www.fda.gov › consumers › consumer-updates助听器和 个人扩音产品：消费者须知 | FDA簡

   www.fda.gov › consumers › consumer-updates

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   助听器及其工作原理. 一个人可能生来就有听力损失，或在以后的生活中出现听力损失，其原因通常是因为内耳可能会随着年龄的增长而“磨损”，或者因多年暴露在嘈杂的环境中而受损。 在某些情况下，听力损失是暂时的，可以通过医疗帮助来得到恢复；在另一些情况下，听力损失是永久性的，但可以通过佩戴助听器来得到改善。 助听器属于医疗设备 ，佩戴在使用者的耳朵后面或插入耳道内。...