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Should you get a hearing aid over the counter?

What your ears and wallet can expect from the new hearing aid options.

Over the counter (OTC) hearing aids are now legal thanks to a change in FDA regulations. What does this mean for you if you are one of the 48 million Americans who have some degree of hearing loss? Dr. James Naples, assistant professor of otolaryngology/head and neck surgery at Harvard-affiliated Beth Israel Deaconess Medical Center, was kind enough to explain the potential benefits and drawbacks.

The fundamentals: hearing aids vs. amplification devices
Hearing aids come in a variety of styles, but they all function in the same way. They amplify sounds to make them louder, whether they are worn behind the ear or in the ear canal. They also aid in the filtering of certain types of noise. Dr. Naples says, "All hearing aids filter out some unwanted noise and improve our ability to hear sounds by using a combination of signal processing and directional microphones."


Contrast prescription or over-the-counter hearing aids with personal sound amplification products (PSAPs) available at most drug stores. These products simply amplify nearby sounds. They are not tailored to a person's hearing loss, are not regulated by the FDA, and are not intended to treat hearing loss.

According to Dr. Naples, PSAPs are an excellent option for people who experience hearing loss only in specific situations, such as watching television.

Will an OTC hearing aid require a hearing test?
People's hearing has traditionally been tested by a certified audiologist, who is trained to configure hearing aids based on a person's specific hearing loss. The procedure is similar to that of obtaining prescription glasses.

Hearing tests determine how loud a sound must be in order for you to hear it clearly. People with normal hearing can detect sounds that are less than 25 decibels in volume (dB). Mild to moderate hearing loss ranges from 26 dB to 55 dB. A person with mild hearing loss can hear certain speech sounds but struggles to hear softer sounds. When another person speaks normally, someone with moderate hearing loss may have difficulty hearing the speech. Hearing loss caused by ageing or other factors can affect one or both ears.

A hearing test by an audiologist is not required for OTC hearing aids. These devices, however, can only treat mild to moderate hearing loss. "Even if you have severe or profound hearing loss, you should still see an audiologist for a full exam," Dr. Naples says.

Will the cost of hearing aids be reduced?
Yes, most likely, though savings will vary. Although Medicare does not cover hearing aids, some Medicare Advantage and other commercial health insurance plans do.

Because of new FDA regulations, many people with mild to moderate hearing loss no longer have to pay for a hearing exam and fitting. The cost of hearing aids, however, will represent the most significant savings. While prices vary depending on the brand and type of hearing aid, a single prescription hearing aid costs around $2,000—$4,000 if you need one for each ear, which many people do.

The majority of prescription hearing aids for the US market are manufactured by a few companies. High prices are exacerbated by a lack of competition.

The new OTC hearing devices should increase manufacturer competition and lower average prices over time. According to preliminary estimates, the average price could fall to around $1,600 or lower.

Will over-the-counter hearing aids be as good as prescription hearing aids?
The FDA will regulate the quality of OTC hearing aids in the same way that prescription hearing aids are regulated. Appearance, styles, and characteristics may vary.

Are OTC hearing aids appropriate for me?
Hearing aids do not come in a one-size-fits-all format. "While over-the-counter devices may benefit many people with mild to moderate hearing loss, they may not be appropriate for all types of hearing loss," Dr. Naples says.

Consider drugstore readers, which are magnifying glasses that are useful for reading up close. "These are intended to correct a specific type of vision issue. Depending on your vision, they may only be of limited assistance," said Dr. Naples says "over-the-counter hearing aids may have similar limitations."

Prescription hearing aids can be fine-tuned and fitted individually, whereas OTC aids must rely on generic sizes that cannot be altered. In addition, unlike prescription hearing aids, OTC devices may not be returnable. It is currently unknown how repairs, warranties, and replacements will be handled.

What else should you think about?
Some people may not receive a proper diagnosis of their hearing loss if they self-prescribe an OTC hearing device.

"Their hearing loss could be a sign of an underlying condition that needs to be evaluated." "Hearing loss can be caused by a variety of conditions, and many people are unable to determine the cause without an evaluation. Dr. Naples says: "Thus, even if you benefit from an over-the-counter device, you should see your doctor if you experience symptoms such as ear pain, dizziness, vertigo, hearing loss in only one ear, or ringing in the ears, which could indicate a condition other than simple hearing loss."

It is also critical to have realistic expectations about what hearing aids can accomplish. "The best bet is to get a hearing test to confirm your type of hearing loss and to ensure that over-the-counter hearing aids are an option for you," he says.

Author: Matthew Solan, Executive Editor, Harvard Men's Health Watch

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