OTC hearing aids are meant to be less expensive than professionally fitted hearing aids. Reasons for lower cost include technology differences and buying only the device and not any professional services. Current estimates are that OTC hearing aids will cost between $300 and $600 per device.
Why do Americans apply for OTC hearing aid?
What are OTC Hearing Aids?
Over-the-counter (OTC) hearing aids are devices that make sounds louder.
OTC hearing aids:
Are approved for adults 18 years of age and older
Are indicated for individuals with mild-to-moderate hearing loss
Are available in stores or online and the consumer is responsible for setting up the device, including fitting and tuning the sound
Do not require a hearing exam or prescription from a physician or a hearing-health-care professional
Although not required, any consumer can get a hearing test from an audiologist before buying OTC hearing aids. The key benefit is finding out if an OTC hearing aid device can be useful for the consumer’s hearing loss. Not all hearing loss is the same. Through an office visit (which is usually not covered by insurance), the audiologist also can provide support on how to use the OTC hearing aids.
OTC hearing aids are meant to be less expensive than professionally fitted hearing aids. Reasons for lower cost include technology differences and buying only the device and not any professional services. Current estimates are that OTC hearing aids will cost between $300 and $600 per device.
Why Are Hearing Aids Being Offered Over the Counter?
The Food and Drug Administration (FDA) Reauthorization Act of 2017 directed the FDA to establish and develop regulations for a class of OTC hearing aids in response to demands by consumers and other government agencies for affordable and accessible hearing aids in the United States. The FDA is in the process of finalizing regulations that will apply to this new class of amplification devices. These rules will include the following:
1. How loud these devices can be？
2. What labeling will be required？
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Kayla Zhou ( Area Sales Manager)
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Croesus Lo ( Area Sales Manager)
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