Hearing aids can be bought over the counter in the U.S. The regulations for hearing aids were finalized by the FDA on Tuesday. Millions of Americans with poor hearing will be able to save money with these OTC aids.
It has been a long time since OTC hearing aids were introduced. The FDA was tasked with developing regulations that would create a new category of hearing aids that could be sold in traditional retail or online outlets. The FDA was pushed to speed up its regulatory process by an executive order signed by President Biden. The final language for the FDA's proposed rules for these products was published on Tuesday.
According to the National Institute on deafness and other communication disorders, about 15% of Americans over the age of 18 are thought to be affected by hearing loss, while about 28 million could benefit from hearing aids. Less than a third of those over the age of 70 have ever used a hearing aid, and only a small percentage of adults between the ages of 20 and 69 have ever used one.
Money and accessibility are some of the main reasons for the disparity. Hearing aids can either be purchased through specialty stores or a visit to a doctor or hearing loss specialist. The entire process can cost as much as $2,000, which isn't usually covered by insurance. It is certain that OTC aids are cheaper in general and easier to get.
The rule is expected to help us achieve quality, affordable health care access for millions of Americans in need. The FDA action today makes hearing aids more cost-effective and accessible.
Certain types of hearing aids can only be sold over the counter. Hearing aids for children under the age of 18 will be prescription only. People with mild to moderate hearing loss will be the only ones who will benefit from OTC products. In order to reduce the risk of injury, the FDA will require that products have a lower maximum sound output and user-adjustable volume setting.
The final guidelines on personal sound amplification products were issued by the FDA. These consumer products are not intended for people with hearing loss and can be used to improve a person's normal hearing.
Hearing loss doctors are likely to offer OTC aids through their clinics as well, since they can be self-fitted. Many people may still want a hearing test and a doctor's consultation to make sure that OTC aids will provide them with enough improvement to be worthwhile, according to some surveys.
The FDA rule will take 60 days to take effect, and manufacturers have 120 days to make any necessary adjustments. If everything goes according to plan, OTC hearing aids will be available in stores in October.
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