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FDA Releases New OTC Hearing Act Aims To Provide More Accessible Hearing Aids

Written by OrkaDec 03, 2021 - 5 min read


What exactly is the proposal about?

The Food and Drug Administration (FDA) recently released a proposal addressing the regulation of Over-The-Counter (OTC) hearing aids. This will allow for people over the age of 18 with mild to moderate hearing loss to purchase hearing aids directly online or from retail stores without the assistance of audiologists. However, those with severe hearing loss or under the age of 18 are still required to choose hearing devices under the supervision of professional doctors.

FDA specifically emphasizes the importance of hearing aids safety to users in the proposal as well as standardized marketing of hearing aids will be established. The sale of OTC hearing aids is strictly forbidden to or for people younger than 18. FDA would also define OTC hearing aids as misbranding unless its labeling bears adequate directions for use.

Why did FDA eventually pass the OTC hearing aids act?

It is estimated 30 million people in the USA, approximately 13 percent of the national population, are suffering from hearing loss. Despite this incredible number, only one-fifth of them have access to certain hearing loss treatments. Those who are unable to receive proper treatment often struggle with daily communication, mental health, and different types of discrimination. Different reasons including the high cost of hearing devices, the stigma of being considered as old are all responsible for preventing people to seek hearing loss treatment.

By establishing a category of OTC hearing aids, FDA can provide more accessible hearing aids with considerably lower prices. Consumers with mild or moderate hearing loss can now purchase hearing aids without jumping through hoops by different services and procedures. FDA also believes that proposal would eventually bring positive economic impact and health effects once it is finalized.

How would it benefit hearing aids users?

According to data, the average cost of a pair of hearing aids is more than $5000 and they are usually not under the healthcare insurance coverage. OTC hearing aids’ prices however, are significantly lower. FDA hopes that this will stimulate innovation of hearing technology and introduce more manufactures into a competitive market that was originally dominated by “The Big Six”. The act might also affect the traditional way of selling hearing aids bundled with professional services by encouraging firms to use online sales that directly deliver devices to customers.

On the other end of the spectrum, many manufacturers argue that OTC hearing aids are not the ultimate solution to hearing health issues. The encouragement of OTC hearing aids might give chances to those substandard devices that eventually disappoint consumers. But generally, most experts believe that the new act will have positive impacts by reducing the overall health care costs and making hearing aids more accessible and affordable to tens of millions of Americans. As for the safety issue, FDA plans to simultaneously enact relevant regulations to monitor the OTC hearing aids market and to protect hearing aids users.

Although OTC hearing aids are currently not available, there is still another category called direct-to-customer (DTC) hearing aids that can be purchased online and then delivered directly to your house. The cost of DTC hearing aids is also significantly lower compared to traditional hearing aids. Companies like Orka now offers FDA-cleared, medical grade hearing aids at only 30% of the cost also with the latest features. Advanced functions such as background noise reduction, Bluetooth® connection allows for phone calls and unlimited streaming, and rechargeable battery are all available.


All content and information on this website is for informal and educational purposes only, nothing contained herein shall constitute medical advice, and does not establish any patient-client relationship by your use and access of this blog.
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