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This month, the Food and Drug Administration finalized a decision this opens the door for tech companies to sell hearing aids over the counter, without a visit to the audiologist. Not only will this create more competition and lower prices, but it will also remove some of the stigma surrounding hearing loss. If a person can buy aids online, anonymously, the feeling of insecurity when visiting a doctor is not a problem.
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In fact, if they were to buy a in the ear audience assistance online, even their loved ones may not know they have a hearing loss. And let’s not forget that there are many elderly and/or disabled people for whom visits to the audiologist remain a major obstacle. Now people with perceived mild to moderate hearing loss may be able to avoid seeing a hearing care professional altogether.
While there are plenty of positives in the new rule, it’s important to remember that hearing aids contain complex technology, and having one fitted and calibrated at home requires some technical know-how. For techies, working with an audiologist can always yield the best results.
But for those of us who welcome the idea of ordering our pajamas and tweaking the audio settings the way we like them, it’s an exciting time. The hearing aid market is poised for explosive growth, which is why some hearing aid manufacturers already have their hearing aids available for purchase.
Without FDA approval, a company cannot classify its product as a “hearing aid.” Instead, they are called “listening devices” or “personal amplifying devices” (PSAPs). We note which of them are FDA approved or registered, and which are not.
Here are some companies that make hearing aids and PSAPs that you can buy over-the-counter and online right now:
1. Lexie B2 Bose hearing aids
Bose has become synonymous with exceptional sound, which is why the company’s recent partnership with Lexie Hearing is something we’re excited about. This collaboration has resulted in two generations of hearing aids, the most recent being the Lexie B2. Our reviewer was immediately impressed with these aids, and he particularly liked the ability to adjust the bass and treble settings in the Lexie app. Although these hearing aids do not stream media, they perform extremely well and have features comparable to the (much more expensive) prescription hearing aids he has tried.
While many hearing aids sit behind the ear and deliver sound to the ear canal via a tube that wraps around the ear, other designs, such as ear, fit completely inside the ear, making them virtually invisible. Eargo offers a free online hearing assessment, lifetime support, and will even send you a non-working sample so you can see how the hearing aids feel when worn.
Lively offers three different hearing aids: the Lstrongly 2 Pro, the Lively 2 Plus and the Lively 2 Lite. They range from $1,195 to $1,695 per pair. Although this is a significant change, it is still only a fraction of the cost of prescription hearing aids. If you buy through Lively, you can get a 100-day trial, three years of support from a team of audiologists, and a three-year warranty against loss and damage.
Atom Pro, features wireless charging, 45-day money back guarantee and 1-year warranty. All of this, and it rings for just $99.
It offers a wireless charging station and reviewers like how discreet these aids are thanks to their small size. As you would expect for this price, you don’t get a ton of bells and whistles. But if you just need to amplify the sounds, it’s worth trying them. They are not FDA approved and are technically a Personal Sound Amplification Device (PSAP), not a hearing aid.
Not registered or cleared by the FDA
Audicus is another option for budget-conscious buyers. The company offers several models, some of which are as expensive as prescription hearing aids, but the cost is a little easier to swallow since you have the option of paying monthly.
They come with a 45-day money-back trial and unlimited support. If you received an audiogram from an audiologist, you can even send those results to Audicus to get your new hearing aids set up perfectly. or you can buy them on Amazon and let the seller send you a hearing test kit, which you then return and they send your pre-programmed aids based on your results.
6. MD Hearing
Volt Maxis compatible with smartphones.
As with so many other over-the-counter hearing aids, you’ll have 45 days with these to try them risk-free. The warranty, however, is only 90 days from receipt of your order, so be sure to work hard during your 45-day trial period.
IQBwe2 Max; a TV broadcast box; aand a Bluetooth transmitter. The TV the streaming box does exactly what you think: it transmits stereo sound fromTVthe output of your IQBou.
BluetoothyouThe ransmitter can be plugged into any audio device with a3.5 millimeters Iack and thentransmits this signal to your hearing aids. Many modern hearing aids incorporate Bluetooth, which would make this equipment useless, but it’s good thatFPeople who would never use these features don’t have to pay for them.
8. Nano hearing aids
The premium Nano hearing aid is called the SigmaMore. It’s a rechargeable product that has four different environment settings, and perhaps the coolest thing is that in the app that comes with it, you can take a hearing test, press a button, and your hearing aids will adjust to your test results.
How Over-the-Counter Hearing Aids Are Regulated – What the Terms Mean
To be described as a hearing aid, a product requires some oversight from the FDA about how it’s made and potentially how it works.
The FDA classifies medical devices, including hearing aids, based on the risk they pose to the user. Over-the-counter hearing aids belong to the Class I low-risk group and are often described by the manufacturer as FDA-registered.
Registration means that the FDA knows where a product is made and that the manufacturer has provided information to the FDA about their facility and how they make their products.
It is important to note that registration does not mean that the FDA has verified that the product is working properly, but it does imply that the manufacturer has a quality control system in place to ensure that the products are well made.
Registration is a good sign. It has to be renewed every year and requires a ton of paperwork and high registration fees. Thus, an FDA-registered manufacturer is open to scrutiny and willing to go the extra mile to maintain that registered status.
Some OTC hearing aids, like the Bose Lexie B2, are FDA approved. Authorization means a higher level of FDA oversight than FDA registration.
For Lexie, this focused on the self-fitting app and required the company to show that using the app provided the same performance as fitting the hearing aid by an audiologist.
Thus, FDA clearance carries more weight than registration, as the manufacturer had to prove that the product worked as intended.
No FDA registration or clearance
If the manufacturer is not part of the FDA oversight system, they should not describe their product as a hearing aid.
A product without FDA registration or clearance is not necessarily bad. Good quality PSAPs use the same technology as hearing aids, but you should probably be more careful before buying and research user reviews carefully.
If a manufacturer is registered with the FDA, you should be able to find it on the FDA Establishment Registration and Device List page. If there have been other tests for product clearance, it should also appear as a 510(k) premarket notification.
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Prices were accurate at the time this article was published, but may change over time.