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

A change in FDA regulations has cleared the way for over-the-counter (OTC) hearing aids. What does this mean for you if you’re among 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 help explain potential pros and cons.

The basics: Hearing aids versus amplification products

There are various types of hearing aids that largely work in 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 out certain types of noise. “All hearing aids use a combination of signal processing and directional microphones to filter out some unwanted noise and to improve our ability to hear sounds,” says Dr. Naples.

Don’t confuse prescription or OTC hearing aids with personal sound amplification products (PSAPs) sold at most drug stores. Such products merely amplify nearby sounds. They’re not tailored to an individual’s hearing loss, and aren’t regulated by the FDA or intended to treat hearing loss.

“PSAPs are a great alternative for people who only experience difficulties in specific situations, like listening to the TV, says 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 based on 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 less than 25 decibels (dB). Mild to moderate hearing loss is in the 26 dB to 55 dB range. A person with mild hearing loss may hear certain speech sounds, but find softer sounds hard to hear. Someone with moderate hearing loss may have difficulty hearing speech when another person talks at a normal level. Hearing loss related to age or other conditions may affect one or both ears.

OTC hearing aids don’t 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 costs for hearing aids be lower?

Most likely yes, though savings will vary. While Medicare doesn’t cover any hearing aids, some Medicare Advantage plans and other commercial health insurance plans do.

The new FDA regulations mean many people with mild to moderate hearing loss needn’t pay for a hearing exam and fitting. But the most significant savings will be the cost of hearing aids. While costs for brands and types of hearing aids vary, a single prescription hearing aid averages about $2,000 — that’s $4,000 if you need one for each ear, as many people do.

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

The new OTC hearing devices should increase competition among manufacturers and lower average prices over time. Some early estimates suggest the average price could drop to about $1,600 or lower.

Will OTC 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 differ.

Are OTC hearing aids right for me?

Hearing aids are not one-size-fits all. “While OTC devices may help many people with mild or moderate hearing loss, they might not be appropriate for all types of hearing loss,” says Dr. Naples.

Think of drugstore readers, the magnifying glasses useful for reading up close. “Those are designed to correct a specific type of vision problem. Depending on your eyesight, they may only help so much,” says Dr. Naples. “OTC hearing aids may have similar limitations.”

A prescription hearing aid can be individually fine-tuned and fitted; people choosing OTC aids must rely on generic sizes that can’t be altered. And unlike prescription hearing aids, you may not be able to return OTC devices. Right now, it’s unclear how repairs, warranties, and replacements will work.

What else to consider

Self-prescribing an OTC hearing device might result in some people not 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 OTC device, you should see your doctor if you have symptoms like 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 hearing aids can do. “The safest bet is to get a hearing test to confirm your type of hearing loss, to ensure that OTC hearing aids are an option for you,” he says.

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