Over the Counter Hearing Aids

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According to recently passed law as well as FDA guidance, over-the-counter hearing aids will be available to those in the United States for the first time. This landmark legislation may help millions of Americans dealing with some degree of hearing loss. 

However, as with all new things, consumers have a lot of questions. To help you understand what OTC hearing aids may mean for you, we’ve created an FAQ below that should answer your questions and point you in the right direction for more information.

What Are Over the Counter Hearing Aids?

Previously, purchasing hearing aids could be a long, drawn-out experience. You would need to schedule an appointment with a doctor who would examine you. In many cases, you would need to follow up with a specialist to confirm the issue. Then, if there was a medical need for hearing aids, you would receive a prescription that allowed you to purchase hearing aids from a medical device distributor. 

HOWEVER, an OTC hearing aid would be available in your local drug store, pharmacy, or other retail space. You’d be able to walk in, pick one off the counter, and pay for it without needing any examination or prescription. 

Who Are OTC Hearing Aids For?

As currently written, OTC hearings aids would be available for those at least 18 years of age. That is, those younger than 18 years old would still need a prescription to receive hearing aids. 

For adults, OTC hearing aids would be available like any other medical device available at retail stores, such as a thermometer or band-aids. This could reduce the amount of time most people wait, from noticing hearing loss to seeking out hearing aids. Currently, most people wait around 15 years from the time they’re aware of their hearing loss to purchase their first hearing aid device. 

Why Are Some Hearing Aids Becoming Available Without a Prescription?

The FDA estimates that there are 38 million people with hearing loss in the United States. Yet, only around one out of every six people with hearing loss will ever even attempt to use a hearing aid to rectify the issue. 

The cumbersome experience of seeking out hearing aids, as mentioned above, could be a major factor in these statistics. Lowering the barrier to purchasing hearing aids could help people regain their hearing even if they lack the time or finances to see a doctor or hearing specialist. 

When Will OTC Hearing Aids Be Available?

The FDA released its rules on OTC hearing aids in October 2021. However, there is a lengthy public commenting and review period before the rules can be officially “issued” as regulations. That means it may still take several months before the OTC hearing aids are available to the public. Most estimates indicate consumers should purchase these devices sometime in mid-2022. 

Are OTC Hearing Aids Safe?

Generally, OTC hearing aids should be safe. The FDA’s proposed rules contain several passages that should help keep these medical devices safe for consumer use, including limiting their maximum volume output and requiring FDA approval for certain types of self-fitting hearing aids. 

However, some manufacturers are taking advantage of the multiple delays and confusion around the rules to try and take advantage of consumers. For instance, some manufacturers have already started to market their devices as OTC despite a lack of clearance to do so. Others call their hearing devices “personal sound amplification products” and market them as a treatment for hearing loss. This allows them to skate by FDA regulation and offer a product that’s marketed illegally and potentially unsafe. 

Until the FDA’s rules are officially issued as regulation, consumers should be wary about purchasing any hearing aid device that’s sold over the counter.  

Should You Purchase OTC Hearing Aids?

While OTC hearing aids may be beneficial to those with moderate hearing loss or worse, you may still benefit from seeing a doctor before making any purchases. An audiological expert or a doctor who specializes in hearing may be able to diagnose an underlying issue causing the hearing loss. These issues can range from something as minor as ear wax build-up to something as serious as a tumor. 

Where Can You Find More Information About Hearing Loss and Hearing Aids?

At Memorial Hearing in Houston, Texas, we offer our patients a wide range of hearing services. From a hearing check-up to hearing aid evaluations to tinnitus therapy, we’re eager to help you understand why you’re experiencing hearing loss and work with you to find ways to effectively improve your hearing. 

 If you’re in the Houston area and experiencing moderate or severe hearing loss, schedule an appointment today!

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