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.
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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
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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
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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.
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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.
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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
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.
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