Thanks to a new regulation passed by the FDA, you will soon be able to purchase FDA-certified hearing aids from any major retailer that sells them. This could happen as early as mid-October. Let's talk about what this means for those who use or need hearing aids and how it could save you money.
Why is this important?
Hearing loss affects an estimated 30 million people in the U.S. and can have a significant impact on communication, social participation, and overall health and quality of life. Despite the high numbers of people with hearing loss, and the public health impact of that hearing loss, only about one-fifth of people who could benefit from a hearing aid currently seek help from a medical professional.
The use of hearing aids in people with hearing loss has been linked to the following benefits:
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Reduction in the incidence and severity of cognitive decline
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Reduction in the incidence and severity of depression
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Improved social participation
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Better quality of life
The FDA established the regulation rules with the following goals in mind:
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To protect the public health by providing reasonable assurance of safety and effectiveness of hearing aids
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To promote the hearing health of Americans by lowering barriers to access
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To foster innovation in hearing aid technology
What are the new regulations?
In 2017, Congress passes legislation requiring the FDA to come up with guidelines regarding the ability to sell hearing aids directly to consumers without the need for a prescription. That guidance was released in 2018 but the guidelines were not formalized until 8/16/22.
The new rules allow people with mild to moderate hearing loss to purchase a hearing aid over the counter (OTC), without the need for a medical exam, a prescription, or a fitting adjustment by an audiologist.
The new rules include:
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OTC hearing aids will be restricted to air conduction hearing aids, which can be either behind the ear or in the ear.
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The hearing aid volume level must be able to be adjusted by the user and the amplification level must be limited to prevent accidental ear damage.
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Labeling should be understandable for average hearing aid users (non-experts).
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OTC hearing aids can be made by manufacturers of any kind, but they will be subject to rigorous quality testing procedures before the FDA will license them to be sold.
How does this make hearing aids more affordable?
A large part of the cost of hearing aids comes from the components and the required research and development to pass quality testing. This is unlikely to change in the short term.
Here is where the cost savings comes from:
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You won't need to see a doctor to get a prescription.
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You won't need an audiologist to do hearing testing or hearing aid fittings.
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The hope is that with OTC hearing aids approved, more manufacturers and sellers will enter the market, encouraging more competition, and thus more competitive pricing over time.
Since many insurance companies set limits on coverage for costs related to hearing loss (some provide no coverage), getting rid of the doctor and audiology visits could add up to significant savings. In addition, travel costs can add up for those living in rural areas, or areas with limited medical providers. Eliminating the need for those medical visits, eliminates the travel costs as well.
When might an OTC hearing aid NOT be recommended?
OTC hearing aids are a good idea for those with long term hearing loss that has been previously diagnosed, or for adults with gradual hearing loss over time, particularly associated with aging.
There are times when a visit to the doctor to get an accurate diagnosis of the cause of your hearing loss is important, to see if the hearing loss may be reversible and to determine whether the hearing loss is caused by an underlying serious medical condition. You should see a doctor in these situations:
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Hearing loss in children
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Sudden or severe hearing loss
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Hearing loss that is not symmetrical in both ears
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Hearing loss that is associated with dizziness or vertigo
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You have significant ear pain, or ear drainage
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Headaches or other neurologic symptoms associated with the onset of hearing loss
How do you know if an OTC hearing aid has been through the FDA clearance process?
Don't rely on phrases such as "FDA-registered" or "FDA-approved". These words don't really mean anything as far as certified scientific testing is concerned.
The only way to know for certain that a device has been through the FDA clearance process is to check whether the device or manufacturer shows up in the official FDA database. To do that, use this link Establishment Registration & Device Listing (fda.gov). In the "Establishment or Trade Name" field, type the brand name. If no listing for the product comes up, you are not dealing with a brand that has been given proper FDA clearance.
If you have any questions about OTC hearing aids, please log into your account and send
us your question. We are here to help.
Dr. Anita Bennett MD - Health Tip Content Editor
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