One of the biggest barriers to hearing loss treatment is the cost of hearing aids. The Over-the-Counter Hearing Aid Act promises to make hearing aids more affordable and readily available, but isn’t necessarily a good thing for consumers.
Understanding OTC Hearing Aids
What is the Over-the-Counter Hearing Aid Act?
Legislation was introduced by Elizabeth Warren in March of 2017, and signed into federal law just 5 months later. The Over-the-Counter Hearing Aid Act directs the U.S. Food and Drug Administration (FDA) to create and regulate a new category of OTC hearing aids in order to make hearing devices more affordable and readily available. The FDA is working to establish guidelines and is set to release a set of rules and regulations soon.
Who can benefit from off the shelf hearing solutions?
Over-the-counter hearing aids are designed for individuals with mild to moderate hearing loss.
Do you need a prescription for a hearing aid?
At the moment, you can only purchase a hearing aid from a licensed professional after undergoing a series of hearing tests to determine your exact type and degree of loss. Once the guidelines are officially released, consumers will be able to purchase a device on their own without a prescription or medical oversight.
What devices qualify as over-the-counter hearing aids?
In order for hearing aids to be sold directly to consumers, they must do the following:
- Provide reasonable assurances of safety and efficacy
- Establish output limits and labeling requirements
- Describe requirements for the sale of hearing aids in-person, by mail or online, without a prescription
Are OTC hearing aids an affordable solutions?
While the costs may be lower for over-the-counter hearing aids, they are a one-size-fits-all solution. Since you don’t know your degree of hearing loss, there is a chance an OTC will not benefit your specific hearing loss and may even damage your hearing if used incorrectly.
Is an OTC the same as a PSAP?
Personal sound amplification products (PSAP) are currently on the market and vary in quality and price. They provide limited audible improvements in quiet settings and increase speech understanding in non-challenging listening situations.
Provided these PSAPs meet FDA standards, these will likely be rebranded and marketed as over-the-counter hearing aids.
Are OTC hearing aids safe?
U.S Representative David McKinley was staunchly opposed to the Over-the-Counter Hearing Aid Act. He suffered hearing loss damage while attempting to self-treat his hearing loss using an OTC personal amplification device.
Traditional hearing aids only amplify the sounds a patient has trouble hearing. OTC hearing aids amplify all sounds. When a user turns an OTC device up in order to hear better, they can actually damage their hearing further. This hearing health risk can be avoided by scheduling and attending a hearing aid fitting with your local audiologist.
Pros & Cons of OTC Hearing Aids
- Does not require a hearing exam or office visit
- Users don’t need to worry about insurance reimbursement
- Reduced pricing when compared to traditional hearing aids
- Available at local drug and big box stores
- Only designed for one type of user—an individual with mild to moderate sensorineural hearing loss
- Is not an effective treatment option for specific types of hearing loss and is not effectively rated to treat major to severe hearing loss
- Does not involve a physical exam, which can diagnose an underlying condition that requires treatment and may be the root cause of a person’s hearing loss
- Does not include a device fitting in the purchase price, which includes crucial fine tuning and adjustments to treat your unique hearing needs without risking damage
- There is no such thing as a one-size-fits-all solution for hearing loss