Traditional Hearing Aids VS PSAPS

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

Pros

• 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

Cons

• 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