These FDA-approved hearing aids are available without a prescription. But not everyone should use them.
FDA-regulated over-the-counter (OTC) hearing aids are now becoming available online and in stores after years of anticipation. A dozen or so of the devices have already hit the market, and more are anticipated. Here is what we currently know about over-the-counter hearing aids and what to keep in mind if you're thinking about purchasing a set.
They are simple to use.
OTC hearing aids do not require a visit to a physician or audiologist, unlike the process for obtaining prescription hearing aids. You can buy the devices without a prescription, fits, or a professional hearing evaluation. Simply purchase a pair whenever it's convenient for you, then put them to use as soon as you open the box.
OTC hearing aids come in two varieties.
Some over-the-counter hearing aids are "self-fitting," which means that user-specific hearing requirements can be taken into account when setting up the devices. Meaghan Reed, director of Clinical Audiology at Massachusetts Eye and Ear, a Harvard affiliate, says, "You'll know it's self-fitting if the product description talks about putting the device in your ear and completing a hearing test, either online at the manufacturer's website or on an app, so you can adjust the controls and fine-tune the devices.
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Non-self-fitting OTC hearing aids are available. They have several pre-set settings and a volume control.
The FDA controls them.
Manufacturers of the new OTC hearing aid category are required to register the devices with the FDA and abide by certain rules.
Manufacturers of self-fitting devices must show the FDA that their products have been evaluated and shown to be both effective for adults with mild to moderate hearing loss and safe (e.g., with volume control and output limitations). Packaging must specify who might use the products and when seeking medical attention for hearing loss makes sense. "FDA Approved" may appear on the packaging and advertisements for these hearing aids.
Non-self-fitting over-the-counter hearing aids must be registered with the FDA, but manufacturers are exempt from providing proof that the products are secure. The registration essentially states that the device complies with FDA requirements.
They remain expensive.
"Price ranges for OTC hearing aids range from $500 to $1,000 each pair. Self-fitting tools cost more money. Both are less expensive than the prescription hearing aid package, which starts at $4,000 per pair and includes an audiologist's services for a few years "Reed argues. "But even $500 is expensive. We anticipate future technological advancements will result in price reductions."
They are not suitable for everybody.
Those with a perceived mild to moderate hearing loss should use over-the-counter hearing aids. It's a person who normally does well in a one-on-one conversation in a quiet setting but struggles to hear in a lecture hall, at a distance, or with background noise, according to Reed. "They require amplification and the capacity to block out distracting sounds. You should visit your doctor if your hearing loss is more complicated."
Their features and fashions differ.
Depending on the specific model you purchase, OTC hearing aids come in a variety of designs and configurations. For instance, some over-the-counter hearing aids resemble wireless earbuds. Some have a component that rests behind the ear and a tiny wire and speaker that rest in the ear canal, similar to prescription hearing aids.
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Specific microphones and noise-cancelling capabilities are available on several OTC products. Some can broadcast to your smartphone and are Bluetooth compatible.
It takes research to purchase them.
OTC hearing aides are more accessible than prescription hearing aids, but they still require a significant financial commitment. You should research them before making a purchase. Consumer device model comparisons are done by some groups, such as the National Council on Aging (/ncoa-hear).
Obtain a model with the features, fit, and cost that you desire. If you're unsure, you might be able to discuss it with the vendor. Ask the pharmacist for advice if it's a pharmacy, for instance. You might be able to contact customer support if the retailer is online. To gain guidance, you can even schedule a consultation with a nearby audiologist.
Your ability to use the hearing aids is one key factor. Can you use technology well? Would you like to make every modification? Do you prefer operating something with pre-programmed functions?
Make sure the model has two specific traits, regardless of which one you choose. "One of them has a customer service section where you can speak with someone if you're having difficulties installing the devices or if they stop operating for some reason. The alternative is a test run. You must have the option to test them out and return them if they don't work "Instructive words from Reed. "Please keep in mind that OTC hearing aids are still in their infancy. Which products will function best and which businesses will endure the longest are as of yet unknown. But, the devices do have advantages if you have the funds and would like to check them out right away."