The Food and Drug Administration (FDA) in the United States has issued a directive saying that customers will now be able to purchase hearing aids at retail counters without any prescription or reference. The directive will go into effect from mid-October. The FDA also said that this decision will now allow consumers to opt for more affordable versions of these instruments.
Department of Health and Human Services Secretary, Xavier Becerra, said in a statement, “Today the FDA opens the door to quality, affordable hearing aids to consumers over the counter”. He added, “For many Americans who suffer from hearing loss, safe and effective and high quality hearing aid have been unaffordable”.
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In its press release, the agency said that the decision has been taken to reflect President Biden’s Executive Order on Promoting Competition in the American Economy. It also pointed out that this step will further the Biden-Harris administration’s desire for “expanding access to high-quality health care and lowering health care costs for the American public”. Congress had also passed the Over-the-Counter Hearing Aid Act five years ago.
The FDA has pointed out that around 30 million adults in the United States will benefit from this directive. Individuals suffering from “perceived mild to moderate hearing loss” can now avail of hearing aids directly over the counter or from online stores without having to spend much on associated medical bills.
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However, officials said that this rule will not be applicable for severe conditions, for which patients should seek immediate medical care. The agency has also issued certain directives regarding the manufacture of the device, like lowering the maximum volume and making changes to such devices so that the user can control the volume according to their preference. A limit has also been set to the depth till which the device should be placed in one’s ear.