Should you get an over-the-counter hearing aid?

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What new hearing aid options mean for your ears and your wallet.

A change in FDA regulations paved the way for over-the-counter (OTC) hearing aids. What does this mean to you if you are one of the approximately 48 million Americans with some degree of hearing loss? We asked Dr. James Naples, assistant professor of otolaryngology/head and neck surgery at Harvard-affiliated Beth Israel Deaconess Medical Center to walk us through the potential pros and cons.

The Basics: Hearing Aids vs. Amplification Products

There are different types of hearing aids that work in much the same way. Whether the style is behind the ear or in the ear canal, they amplify sounds to make them louder. They also help filter certain types of noise. “All hearing aids use a combination of signal processing and directional microphones to filter out some unwanted noise and improve our ability to hear sounds,” says Dr. Naples.

Don’t confuse prescription or over-the-counter hearing aids with personal sound amplification products (PSAPs) sold at most drugstores. These products only amplify surrounding sounds. They are not tailored to an individual’s hearing loss and are not FDA regulated or intended to treat hearing loss.

“PSAPs are an excellent alternative for people who only have difficulty in specific situations, such as watching television, explains Dr. Naples.”

Will I need a hearing test to get an OTC hearing aid?

Traditionally, people have their hearing tested by a certified audiologist trained to configure hearing aids for a person’s specific hearing loss. The process is similar to getting prescription glasses.

Hearing tests measure how loud a sound needs to be for you to hear it clearly. People with normal hearing can identify sounds below 25 decibels (dB). Mild to moderate hearing loss is between 26 dB and 55 dB. A person with mild hearing loss may hear some speech sounds, but find quieter sounds difficult to hear. A person with moderate hearing loss may have difficulty hearing speech when another person is talking at a normal level. Hearing loss related to age or other conditions can affect one or both ears.

OTC hearing aids do not require a hearing test by an audiologist. However, these devices can only treat mild to moderate hearing loss. “If you have severe or profound hearing loss, you still need to see an audiologist for a full exam,” says Dr. Naples.

Will hearing aid costs be lower?

Most likely yes, although savings vary. Although Medicare does not cover hearing aids, some Medicare Advantage plans and other commercial health insurance plans do.

New FDA regulations mean that many people with mild to moderate hearing loss don’t need to pay for a hearing test and fitting. But the biggest savings will be the cost of hearing aids. Although the costs of brands and types of hearing aids vary, a single prescription hearing aid costs on average around $2,000 – that’s $4,000 if you need one for each ear, like many people do.

For the US market, a handful of companies produce most prescription hearing aids. Lack of competition contributes to high prices.

New OTC hearing aids are expected to increase competition between manufacturers and lower average prices over time. Some early estimates suggest the average price could drop to around $1,600 or lower.

Will over-the-counter hearing aids be the same quality as prescription hearing aids?

OTC hearing aids will be regulated by the FDA for product quality, just like prescription hearing aids. Appearance, styles and features may vary.

Are OTC hearing aids right for me?

Hearing aids are not universal. “While over-the-counter devices can help many people with mild to moderate hearing loss, they may not be suitable for all types of hearing loss,” says Dr. Naples.

Think of drugstore readers, useful magnifying glasses for reading closely. “These are designed to correct a specific type of vision problem. Depending on your eyesight, they may not be very helpful,” says Dr. Naples. “OTC hearing aids can have similar limitations.”

A prescription hearing aid can be fitted and adjusted individually; people who choose over-the-counter aids must rely on generic sizes that cannot be changed. And unlike prescription hearing aids, you may not be able to return OTC devices. At this time, it’s unclear how repairs, warranties, and replacements will work.

What else to consider

Self-prescribing an over-the-counter hearing aid can prevent some people from getting a proper diagnosis of their hearing loss.

“Their hearing loss could be a symptom of an underlying condition that requires evaluation. A number of different conditions can cause hearing loss, and often people cannot differentiate the cause without an evaluation,” says Dr. Naples. “So 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 ear, which could represent a condition other than just simple hearing loss.”

It’s also important to have realistic expectations about what the hearing aids can do. “The safest bet is to take a hearing test to confirm your type of hearing loss, to ensure over-the-counter hearing aids are an option for you,” he says.

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