Do you have hearing loss but feel like the cost is holding you back from getting hearing aids? You're not alone: The price is a barrier for many, which is why Congress passed a law in 2017 to authorize over-the-counter hearing aids for adults with mild-to-moderate hearing loss.
On Oct. 19, 2021, the FDA issued their long-awaited draft guidance that (when finalized) would allow hearing aids "to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist," the FDA news release stated. The goal is to increase competition in the hearing aid market and ultimately make them more affordable.
Other details of the FDA's proposed OTC hearing aid rule
The proposed rule would apply to hearing aids for adults 18 and older with "perceived" mild to moderate hearing loss. Hearing aids in children would still be prescription devices.
According to the FDA's draft guidance, under the proposed rule:
- hearing aids would be sold over the counter "in more traditional brick-and-mortar retail stores or online (rather than doctors’ offices or specialty retail outlets) and will likely be less expensive than those currently sold"
- state regulations of hearing aids will change to reflect the federal changes
- OTC devices will include limits to prevent injuries from hearing device volume being set too high and also adjusts requirements for device performance and design
The FDA also issued draft guidance to clarify the difference between personal sound amplification devices (PSAPs) and OTC hearing aids, to help better inform consumers that PSAPs are not for hearing loss.
The proposed rule still needs to be finalized, which can take months to years. The next step is for the public to comment on the proposed guidance in the Federal Register.
Am I a candidate for an OTC hearing aid?
If you have mild hearing loss and are holding back because of the cost of hearing aids, OTC hearing aids will be low-cost and will give you a taste of the advantages of better hearing.
An OTC hearing aid will help you if you notice hearing issues only now and again—usually, in noisy places, groups or when you can’t see who is talking.
Often your family and friends will notice your hearing loss first. They might complain that they need to repeat themselves, you don’t hear them shouting from the other room, or you turn the TV volume up high. Learn about these and other early warning signs of hearing loss.
Who is not a candidate for an OTC hearing aid?
If you have trouble hearing conversations even in quiet settings or miss loud sounds like cars honking when you drive or announcements in public buildings, your hearing loss is more severe than OTC hearing aids are designed to address, notes the National Institutes of Health. Learn more about the degrees of hearing loss and hearing aids for profound to severe hearing loss.
You need to see a doctor quickly if you have a sudden hearing loss, sudden plunge in your hearing (even if it improves), a big difference between one ear and the other, or tinnitus (ringing) in only one ear. These are possible signs of a medical problem. After it is evaluated and treated, you will know what kind of hearing aid will help you.
What are my chances of being satisfied with an OTC hearing aid?
A recent study showed that "premium" hearing aids have the highest user satisfaction. This preference stemmed from factors related to comfort, specifically how the hearing aids processed background noise and how well the study participants could hear speech in a group setting. Because of the cost of the technology to develop these features, OTC hearing aids are unlikely to be as sophisticated.
Other research indicates that people who've tried out OTC hearing aids greatly benefit from the help of a knowledgeable hearing care provider. This small 2017 trial provides some clues. It tested the outcome when adults aged 55 to 79 years with mild-to-moderate hearing loss chose among three pre-programmed hearing aids on their own for both ears. These were high-end digital mini-behind-the-ear aids, one of several common hearing aid styles.
As Catherine Palmer, AuD, director of Audiology at the University of Pittsburgh, notes, a large majority—90 percent of participants—tried more than one hearing aid. But close to three-quarters picked the wrong aids based on their audiograms. In addition, although they saw a video and received handouts, 20 percent asked for extra help using the aids.
The volunteers paid for their aids upfront and could get their money back if they chose to return their aids. The results: 55 percent wanted to keep them.
Ongoing hearing care is key
Your chances of satisfaction are higher if you receive a hearing aid fitted by a hearing instrument specialists or audiologist: In the study, a comparison group were fitted by audiologists and 81 percent of the volunteers wanted to keep their aids.
An additional wrinkle: The researchers gave everyone who didn’t want their aids a chance to work with an audiologist and wear the results over the next month. Of 10 people who had chosen among pre-programmed aids on their own who took that option, six did decide to keep their aids after working with an audiologist.
We don’t know yet what our options will be when buying OTC aids in real life. This study suggests that for a better-than-even chance of satisfaction you will need the option to try different aids and help using your aids. Even so, your chances of getting hearing devices truly appropriate for your hearing loss are small, much lower than they would be if you work with an audiologist.
In addition, a full-service audiologist can advise you about a variety of other devices that stream audio. If you have age-related vision loss, the choices are fairly simple: you can pick glasses and adjust the magnification and lighting on electronic devices. For hearing loss when you're older, there are many other options, including hearing aids, cochlear implants and assistive listening devices.
Even where hearing aids are free, many people don't wear them
Price may not be the real reason you haven’t bought an aid. In Australia, Iceland and Germany public funding makes hearing aids free for many—yet many eligible people with significant hearing loss don’t wear hearing aids.
When asked why they don’t wear hearing aids, people tend to say that the aids aren’t comfortable or didn’t give them natural hearing.
(Note from author: As someone who has worn hearing aids for decades, I see those reasons as a sign you didn’t give hearing aids a chance. They aren’t comfortable–if you’re not used to them. There is an adjustment period. They also don’t give you “natural” hearing—but good natural hearing is beyond my reach. My choices are bad hearing or slightly artificial-sounding better hearing.)
Things to keep in mind
- Is your spouse or an adult child bugging you to get a hearing aid (or wear the one you have)? Close family members can be hurt and angry that you don’t value conversations with them enough to solve the problem. When you choose bad hearing—while other people are complaining—don’t be surprised if they think you’re selfish. On the other hand, if you demonstrate you care, you might be surprised by their gratitude.
- Do you find your grandkids squeaky and impossible to understand? You’d have more fun in their company if you could chat with them if you treat your high-frequency hearing loss.
- Are you unable to participate in business meetings? Parties? Dinners at a long table?
Those are all strong reasons to take action before your hearing declines further. If cost is truly the issue, watch the news: OTC hearing aids could be in-between step, or a life-changer, on your path to healthy hearing.
What about cheap hearing aids I'm finding online?
If you've browsed online shopping sites, you've likely come across hearing aids that cost little more than a meal at a fancy restaurant. Be warned that these are likely not true hearing aids, but are "hearing amplifiers," also known as PSAPs, and they are not intended for use by people with hearing loss, which the FDA plans to address.
Need help now?
Beyond helping you hear better, hearing aids are also linked to health benefits including reduced rates of depression and delayed onset of cognitive decline. The longer you wait, the harder it will be to treat your hearing loss. As many hearing providers say, "use it or lose it."
If you're ready to take action, browse our directory of hearing aid clinics near you to make an appointment.
