Your Guide to the Over the Counter Hearing Aid Act of 2017
The OTC Hearing Aids Bill
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.
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:
- Provide reasonable safety assurances.
- Establish labeling requirements and output limits for devices.
- Set up sale requirements for hearing aids without a prescription in-person, by mail and online.
The FDA has 3-years to develop guidelines and for the changes to be enacted. According to the bill’s 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 user’s needs by the consumer.
Why did they pass the bill?
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.
How will this change the hearing industry?
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. Everyone’s 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.
Why you shouldn’t wait around for OTC hearing aids to come to market.
Don’t 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.
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.