Hi guys. Rachel Cook,
Doctor of Audiology at Applied Hearing Solutions in Phoenix, Arizona,
and in this video I'm going to review the four key differences between OTC
hearing aids and prescription hearing aids.
It's been a long road for hearing aids since the OTC Act was signed into
law back in 2017 by then President Donald Trump. Finally,
five years later, on August 17th, 2022,
the FDA released their 200 page final guidelines establishing new
categories of OTC hearing aids and prescription hearing aids.
Now that an OTC hearing aid category exists,
you might be asking yourself what makes an OTC hearing aid different from
a prescription hearing aid?
That is why today I'll be discussing the four key differences between OTC
hearing aids and prescription hearing aids so that you can make an informed
decision about which one is right for you. But before I do that,
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Now let's jump into our first key difference between OTC hearing aids and
prescription hearing aids,
which is who these different devices are designed for.
The intended user of an OTC hearing aid is described by the FDA as
individuals over the age of 18 with perceived mild to moderate hearing loss.
OTC hearing aids also warn of several red flag conditions that disqualify a
consumer from using them, such as active pain or drainage from the ears,
tinnitus in asymmetrical hearing loss,
or a sudden change in hearing tinnitus or vertigo.
Prescription hearing aids are intended for users of all ages with all types
and severities of hearing losses,
along with the assistance of a professional like an audiologist or a hearing
instrument specialist.
If you are someone who understands technology has a perceived mild to moderate
hearing loss and does not have any of the ear related medical conditions,
then OTC is an option for you. However, if you are not tech savvy,
have more than a mild hearing difficulty or have one of the FDA red
flag conditions,
then you will still need to see a hearing healthcare professional.
The second key difference between OTC hearing aids and prescription hearing aids
is accessibility.
OTC hearing aids are intended to be more accessible to the general public by
removing the involvement of a hearing healthcare professional and by making them
available online and through other retail establishments.
This new legislation defines design function and safety requirements
to allow these products to be available over the counter like medications and
health devices that you can purchase today without barriers to access.
This allows OTC products to end up in the hands of consumers who may live in
rural areas with limited access to healthcare professionals who may not have the
finances to obtain prescription level hearing aids or who may have a mild
hearing impairment and feel comfortable setting up and learning how to use their
own devices. Alternatively,
prescription level hearing aids are considered medical devices by the fda,
and as such,
have a high level of mandatory regulations to ensure safety and
effectiveness.
Because prescription hearing aids are intended to treat a wide variety of
hearing losses with a varying degree of complexity,
it requires additional expertise to ensure that the hearing loss is being
treated appropriately by a hearing care professional.
This need for a specific device and in-office,
professional assistance make prescription hearing aids less accessible even with
the proliferation of remote care services,
allowing for some at-home follow-up care.
This brings me to the third key difference between OTC hearing aids and
prescription hearing aids, which is affordability. Now,
it's no surprise that if you remove a hearing care professional from the hearing
aid delivery model, that this would reduce the cost of an OTC hearing aid.
Prescription hearing aid manufacturers spend hundreds of millions of dollars on
research and development and require a hearing care professional for programming
verification and validation and for ongoing long-term audiologic
support. While compliance with these new FDA guidelines will make OTC hearing
aids more costly to manufacture and sell initially,
they will still cost less to manufacturer than prescription hearing aids.
OTC manufacturers also will not incur the additional costs
associated with providing ongoing support.
Most OTC hearing aids are expected to range between a few hundred dollars and a
few thousand dollars,
and it'll depend on the technology capabilities that they contain and their
build quality.
There will still be some prescription hearing aids fit with professional
assistance that will be at or below the price point of over the counter hearing
aids. However,
overall OTC hearing aids are anticipated to cost less and
therefore be more affordable.
The fourth and final key difference between OTC hearing aids and prescription
hearing aids is the level of consumer support.
Individuals who obtain an OTC hearing aid will now be responsible for selecting
the brand, the style and acoustic coupling of the hearing aid,
as well as self fitting the hearing aid through the use of their smart device.
They will also be responsible for familiarizing themselves with the devices,
including insertion and removal of the hearing aid care,
maintenance of the devices, and all associated troubleshooting.
While the FDA is finalizing the ruling regarding returns and refunds,
they did not include any requirements about the ongoing support of the devices
themselves.
Meaning some companies may not have ways to assist consumers who purchase the
product and are struggling with using it when pursuing the prescriptive route.
The primary role of a hearing care professional is to identify the hearing loss,
prescribe the appropriate hearing aids,
fit the hearing aids to your hearing loss prescription,
and provide ongoing in-person support.
These appointments allow professionals who follow best practices to verify and
validate your performance with the hearing aids to ensure you're obtaining the
maximum amount of benefit from your devices.
Adjusting to amplification can be difficult for some first time hearing aid
users and hearing healthcare professionals can help provide guidance through
this process. Also,
there's generally a structured follow up schedule put in place as well to
perform repairs and preventative maintenance of the devices to ensure the
devices are mechanically functioning properly and to monitor your hearing loss
over time, making any necessary changes to hearing aid programming.
While more differences between OTC hearing aids and prescription hearing aids
will become more apparent over time,
these four key differences will be very apparent right from the start.
If you do elect to go the OTC route, just remember that performance may vary,
and if you're not getting the benefit that you expected from your OTC hearing
aid,
reach out to your local audiology clinic for additional assistance because they
would be happy to help you with your OTC devices.
If you elect to go the prescriptive route,
just make sure you find a professional that follows best practices,
and if you don't know what best practices are,
I recommend you check out our video that I will link in the description.
Overall, it was about time that the FDA released these final guidelines.
Now we just have to wait and see what these OTC hearing aids are capable of.
That's it for this video. If you have any questions,
please be sure to drop 'em in the comments below. And if you liked this video,
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this one.