Hearing aids: the long-repressed demand of 3000 million patients in the United States

There are more than 3000 million people in the United States who suffer from various degrees of hearing problems, and the hearing aids they need most cannot currently be bought from general pharmacies, that is, they are not OTC (Over-The-Counter) devices and require a doctor’s prescription to buy them. .The United States Act of the 20s stipulated that Medicare does not includeHearing aidBecause the impact of hearing loss on human health was not realized at that time, insurance companies have continued to use it.All countries on the planet are facing the problem of aging society. There are more elderly people, and the number of hearing patients is still increasing rapidly.

而且由于美国绝大多数的医疗保险是不包括听力检查和助听器费用的,所以即便是买了助听器的患者,他们有不少人是硬熬了几年,实在熬不住才去买的。一个极端的例子是,由于费用昂贵,有个叫Ms.Holland的美国患者,先买了一只,5年后再买第二只。只能通过处方获取就意味着垄断和高价,目前美国助听器市场被不到12家医疗器械公司把持。听力患者获取助听器的平均成本接近5000美金一副。高企的价格导致的直接后果,就是只有不到1/3的患者能负担得起。

An article in the Wall Street Times reported yesterday [Article 3] that this huge monopolized market is very likely to be opened up, and huge new business opportunities will follow.

文章3:《Should Hearing Aids Be Sold Over-the-Counter》,WSJ, 05/01/2017

Under the impetus of all parties, the U.S. Congress is currently enacting legislation, preparing to apply to mild and moderate hearing lossHearing aid(mild to moderate hearing loss), classified into a new OTC non-prescription drug equipment category.In this way, patients can easily buy hearing aids in local pharmacies just like buying reading glasses, without the need to go to see a doctor, then get a prescription, and finally find an audiologist to equip the equipment.

(OTC non-prescription drugs, buy as you go)

This report has several implications for our cross-border e-commerce:

1. A previously monopolized market, its door is likely to be opened, bringing huge business opportunities to cross-border e-commerce.China is a major producer of medical devices, with advantages in cost and technology.The U.S. OTC household equipment market is huge, and those with resources in this area may wish to pay attention to it.Note that the demand for tens of millions of patients has been suppressed by high prices for decades. Once released, the capacity of the factory may become a bottleneck.

2. Before the legislation was passed, smart manufacturers were already playing the sideball.For example, the Here One wireless bluetooth headset company, its declared product features include: stream music, take phone calls, control real-world sound, and amplify speech.Pay attention to the function of Amplify speech, it actually acts as a hearing aid, amplifying the voice of the dialogue.However, according to the law, Here One cannot advertise that its products have hearing aid functions, and can only cryptically mention amplify.Some patients who can’t afford hearing aids for $5000, should be able to understand this word. Here One, a pair of headphones for $300 can help them.Smart cross-border friends, what have you learned?

The Hermès Bose in the earphones also aimed at the hearing impaired people, and released a earphone, which uses the word “conversation-enhancing headphone”.(The effect of sound amplification can be adjusted through the mobile APP)

(If you don’t use such a tall word as Conversation-enhancing, can you see that it has a hearing aid function?)

3. Once Congress passes legislation, products like Here One can be immediately registered with the FDA (U.S. Food and Drug Administration) to become OTC, and then enter various sales channels.By that time, product manufacturers don’t need to be evasive, and can justly promote themselves as “hearing aids.”

Just a few more words. Similar to reading glasses and sunglasses, hearing aids through air conduction belong to FDA Class I medical products, and they need to apply for FDA registration and obtain a serial number when they are exported to the United States.According to Forrest, the registration period is about 3-4 working days. FDA registration is also something that can be prepared in advance.

(FDA three types of control)

Before the product is exported, it may need to pass some related tests. For example, reading glasses need to pass the impact test. Hearing aids are temporarily unclear.It should be noted that hearing aids conducted through bones belong to the FDA

Class II medical products must pass the 510k evaluation before being marketed.Therefore, in the early stage, the development of air conduction hearing aids should be the best choice.

Link:      Hearing aids: the long-repressed demand of 3000 million patients in the United States

REF: Hearing aids ChinaBluetooth Hearing AidsITE hearing aids
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