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On October 17, 2022, the FDA’s Over-the-Counter hearing aids regulation went into effect. You can now buy and use medical devices without a doctor’s consultation, prescription, or professional adjustment.
This decision changed a lot of things in hearing care. On the one hand, sophisticated medical devices have become more affordable for Americans. But on the other hand, a lack of professional help can lead to frustration and further hearing loss.
Why does it matter?
Millions of Americans are facing hearing loss. Despite all public health measures, the problem continues to spread. Modern lifestyles, especially in large cities, negatively affect our health, including our hearing organs which are fragile and can be easily damaged. Unlike other body systems, hearing organs do not regenerate fully. You won’t naturally restore your hearing if you damage it.
City noise, stress, and bad habits increase the chances of hearing problems. How often should you check your hearing? You may not even remember the last time you saw the audiologist. However, doctors recommend checking your hearing at least once a year. If your work involves noise (musicians, construction workers, etc.), this period is reduced to once every six months. How many Americans follow the recommendations of audiologists to prevent hearing problems? Only a small percentage of the population!
As a result, millions of Americans have some form of hearing loss. According to statistics, nearly 25% of Americans over 65 have hearing loss, which negatively affects daily life! That’s a huge number! Unfortunately, the unpleasant rate continues to grow. At the same time, the study shows that the prevalence of hearing loss increases with each age decade.
Hearing care doctors know how to bring people back to normal lives. Using hearing aids for hearing loss is the best solution to the problem. However, misconceptions about these electronic devices are widespread. Americans believe that hearing aids are expensive and do not help. That’s wrong!
So 2/3 of adults over 70 have some kind of problem. These are big figures. However, only 20% of them use hearing aids daily. The rest prefer to ignore difficulties, even if it seriously interferes with their lives!
Hearing aids have proven to be effective. These electronic devices, especially modern ones, may surprise you with their functionality. Hearing aids provide crystal-clear sound in any acoustic environment. Prescription hearing aids have different models, styles, and features.
Price is the main factor for many Americans when choosing hearing aids. We all want modern devices with extra features and top-notch performance. However, the cost of such electronic devices is high. Is it possible to find an inexpensive hearing aid? Yes! You can find great and not expensive models on the market. However, for some Americans, even such devices are still unaffordable. This problem prompted the FDA to make changes and allow the purchase of Over-the-Counter hearing aids. This difficult decision makes medical devices more affordable for Americans. Now, more people can get the help they need to hear the wonderful world of sounds and the voices of their loved ones!
What are over-the-counter hearing aids?
As of October 17, 2022, you can buy over-the-counter hearing aids. The FDA finally approved OTC hearing aids for patients with mild to moderate hearing loss who are 18 years of age or older. OTC’s are medical devices that restore audibility. However, OTC hearing aids are classified separately from prescription devices. In fact, they are the same hearing aids but have a separate classification and fewer additional features. However, they do fulfill their purpose. They can be of a standard type, construction, and design. You can even use rechargeable OTC hearing aids.
OTC and prescription hearing aids
The FDA regulates all OTC and prescription hearing aids. They both have the same purpose, but each type has its pros and cons. Dr. Stella Fulman notes that the main advantage of OTC hearing aids is the lower cost which makes them available to citizens who previously could not afford hearing aids . That’s great! More and more people will be able to wear hearing aids and get back to a happy life!
However, don’t forget that OTC hearing aids are a budget option. You won’t find many features here. In addition, you can buy OTC devices without consulting a doctor and without customization! This is the downside of the FDA’s decision. A hearing aid fitting is often the most important step in making a device sound good. Without it, you risk not getting the results you want. Take your choice of medical devices seriously!
OTC hearing aids and hearing amplifiers
These devices are easier to compare . Personal sound amplification products (PSAPs, hearing amplifiers, or sound amplifiers) are not medical devices. People use them in some acoustic environments where a person with normal hearing cannot hear well because of the surroundings. For example, many students use sound amplifiers when listening to lectures in large classrooms. A PSAP amplifies all of the sounds around you. Now you know the difference.
OTC hearing aids are medical devices. Their job is to restore your ability to hear. They amplify some sounds and muffle out others, creating clear sound. Do you have hearing loss? Then only hearing aids can help you, not other devices!
Who can use OTC hearing aids?
Over-the-Counter hearing aids are intended for patients over 18 years of age with mild to moderate hearing loss. However, they are not suitable for everyone. They are a low-cost option without the additional features and capabilities that prescription hearing aids have. Do you have trouble hearing even in quiet acoustic environments? Do you find it difficult to talk in noisy places? In that case, OTC hearing aids are not the best solution.
Instead, it is better to make an appointment with your doctor. A hearing care professional will make a diagnosis and help you choose hearing aids, including OTC ones. Remember that hearing is not something you should skimp on!
About Dr Stella Fulman
Dr. Stella Fulman, AU.D., CCC-A received her Bachelors and Masters degrees in Audiology from Brooklyn College in 2004 and her Doctorate of Audiology from Salus University in 2008. [ Learn More ]