Americans can buy hearing aids over-the-counter; FDA clears the way

Making basic healthcare facilities available to all, the US Food and Drug Administration on Tuesday announced it had signed the historic legislation that allows millions of Americans to buy hearing aids without any prescription, from over-the-counter.

Up until now, the devices were not accessible if an individual did not have a medical subscription. Moreover, only a handful of retail stores sold the device, making accessibility a major issue.

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Reportedly, FDA changing the rules is expected to benefit nearly 30 million American adults. According to FDA, the finalised rules will reduce the red tapism in the industry. Moreover, it will allow a new class of hearing aids in the market which would not require any standard medical exam or a prescription from a doctor.

“Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible,” Xavier Becerra, Health and Human Services Secretary was quoted as saying by AP.

According to FDA estimates, of the 30 million Americans that need hearing devices, only 600,000 or one-fifth use the device, with the rest not willing to take the tedious doctor's prescription route. Not to forget, the devices are not cheap.

A single pair of hearing aid and their fitting cost as much as $5,000 which puts a heavy dent in the patient's wallet and in most cases, is not covered under health insurance.

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FDA believes that the decentralisation of the process ought to bring the cost down as traditional manufacturers are expected to scale their operations. Experts predict that the hearing market, after the implementation of the new legislation, in a few years will resemble the eye care market where consumers are spoiled for choices and don't have to necessarily rely on prescriptions and medical exams.

However, few caveats have been applied to make sure that patients do not come in harm's way. The new over-the-counter status won't apply to devices that are expected to be used by patients with severe hearing loss. Only a prescription will work in such cases.

(With inputs from agencies)

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