文章出處：http://hearinglab.com/your-guide-to-the-otc-hearing-aids-act-of-2017/

這是一家美國助聽器製造公司 (Hearing Lab) 提供的資訊，難免會有立場上的考量。

Your Guide to the OTC Hearing Aids Act of 2017

Jan 12, 2018

Your Guide to the Over the Counter Hearing Aid Act of 2017 (The OTC Hearing Aids Bill)

中譯如有錯誤，會隨時修改

Both the House and Senate introduced OTC Hearing Aid bills regarding the categorization of hearing aids in March of 2017. In May the language was included in a larger bill called the FDA Reauthorization Act of 2017. This bill passed both the House and Senate and was signed into law by President Trump in August of 2017.

眾議院和參議院都在2017年3月推出了關於助聽器分類的OTC助聽器法案。今年5月，該法案被納入了一項名為「2017年FDA再授權法案」的大型法案。該法案通過了眾議院和參議院，並且特朗普總統於2017年8月已簽署成為法律。

The bill was designed to loosen FDA requirements on hearing aids in order to establish an over-the-counter category. The language in the bill states that the new regulations must do the following three things:

該法案旨在放寬FDA對助聽器的要求，以建立一個非處方類別。 法案中的語言指出，新規定必須做以下三件事：

1. Provide reasonable safety assurances.

提供合理的安全保證。

2. Establish labeling requirements and output limits for devices.

規定助聽器如何標示和生產製造上的限制。

3. Set up sale requirements for hearing aids without a prescription in-person, by mail and online.

在沒有記名處方簽的情況下通過郵件和線上購買方式，助聽器銷售時的規定。

Summary 摘要

The FDA has 3-years to develop guidelines and for the changes to be enacted. According to the bills definition, an over-the-counter hearing aid must have the same fundamental technology as an air conduction hearing aid, must be used by adults 18 years and older to address a mild to moderate hearing loss and must be able to be customized to the users needs by the consumer.

FDA須在3年內制定指導方針及對現行助聽器銷售方式的變更方案。 根據該法案的定義，非處方助聽器必須具有與氣導助聽器相同的基本技術，只適用於18歲及以上的成年人，以適應輕度至中度聽力損失，並且必須能夠適應使用者需求。

Why did they pass the bill?

為什麼通過這項法案？

According to the Hearing Loss Association of America, 86% of people who could benefit from hearing aids choose not to get them because of cost. The goal of the OTC Hearing Aid Act is to increase competition in the industry, creating more variety and driving down costs.

根據[美國聽力損失協會]的統計，有86％可以從助聽器中受益的聽損人士因為售價太高而沒有購用助聽器。 OTC助聽器法案的目標是增加行業競爭，提供更多品種上的選擇並降低成本。

How will this change the hearing industry?

這將如何改變聽力行業？

The jury is out! On one hand, we love the idea of increasing access to hearing aids, by offering lower cost options. On the other hand, we worry that this will keep people from getting the help they need. We may sell hearing aids, but what we really pride ourselves on is our service. Everyones hearing loss is unique and often times finding the right hearing aid and getting it adjusted to the nuances of your particular hearing loss can take time and expertise. When someone buys an OTC hearing aid they will be selecting it and choosing the settings on their own. They may end up frustrated and give up on addressing their hearing loss altogether. There is a difference between knowing your hearing is decline and understanding the cause and appropriate treatment options.

陪審團出局了！ 一方面，我們歡迎通過提供更低成本的選擇來普及助聽器的使用。但是另一方面，我們擔心這會使人們無法獲得所需的服務。 雖然我們可以只出售助聽器本身，可是我們真正感到自豪的是我們的服務。 每個人的聽力損失都是獨一無二的，通常會找到合適的助聽器，並根據您特定聽力損失的細微差別進行調整，這需要時間和專業知識。 當有人購買OTC助聽器時，他們會選擇它並自行選擇自行設定。 他們可能最終會感到沮喪，並完全放棄解決他們的聽力損失問題。 了解您的聽力下降與了解原因和適當的治療方案，這兩者之間存在差異。

Why you shouldnt wait around for OTC hearing aids to come to market.

為什麼你不應該等待OTC助聽器上市。

Dont Wait – If you suspect you have a hearing loss now, you should not wait 3 years for the FDA to enact changes to address it. Every day you live with hearing loss you are putting yourself at risk for other health issues like falls, dementia, depression, anxiety, and isolation. It is in your best interest to treat your hearing loss as soon as possible. Learn more about how hearing loss impacts your health here. 

不要等待 - 如果您懷疑自己現在有聽力損失，那麼您不應該等待3年時間讓FDA做出改變來解決它。 每天，因為聽力損失，您將面臨其他健康問題的風險，如跌倒，癡呆，抑鬱，焦慮和孤立。 盡快治療您的聽力損失符合您的最佳利益。 詳細了解聽力損失如何影響您的健康。

Not for everyone – OTC hearing aids will not help everyone. They are specifically assigned to treat mild to moderate hearing loss. If you have a moderate loss you generally have trouble following conversations. In person and on the phone you frequently have to ask people to repeat themselves. This type of loss is easily dismissed by telling yourself everyone else just mumbles. So by the time you choose to address your hearing loss it has advanced past the mild/moderate level.

不是適用於所有的人 -  OTC助聽器不會幫助到每一個聽損者。 它們只針對輕度(25--40 dB)至中度(41--55 dB)聽力損失。 如果您有中度的損失，通常無法聽清楚一般的對話。 在面對面或電話中，你經常要求別人再說一次。 這種類型的損失很容易被忽略而不加以處置，只安慰自己--聽不清楚是因為別人在是喃喃自語。 因此，等到您決定不得不處理您聽不清楚的問題時，它的嚴重度已經超過了輕度/中度的聽損值。