The US FDA has issued a final rule that establishes a new category of over-the-counter (OTC) hearing aids. The move comes as part of a push by the US government to make healthcare more affordable, allowing millions of people to buy low-cost hearing aids without prescription.
Hearing loss affects around 15% of adults in the US, or some 37.5 million people. Getting a hearing aid requires medical exams and prescriptions by audiologists, which can get rather pricey and exclude many people from accessing these vital tools.
But the new FDA ruling allows people aged 18 years and older with mild to moderate hearing impairment to buy certain types of hearing aids from drug stores or online retailers, without needing to consult a doctor or get a prescription. Traditional pathways will still be required to obtain hearing aids for more severe hearing loss or for people under the age of 18.
There are of course strict rules that apply to devices in this new OTC category, to ensure their safety and effectiveness. Maximum sound output will be subject to limits, as will the depth that devices can be inserted into the ear canal. All OTC hearing aids will need to provide users with adjustable volume control, and device labeling and instructions have to be clearly understandable by the general public.
This ruling comes in response to an Executive Order made by President Joe Biden last year on Promoting Competition in the American Economy. Part of that called for the Secretary of Health and Human Services to promote the wide availability of low-cost hearing aids, a move designed to make healthcare more affordable for more people while also encouraging more innovation and competition in the market.
“Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” said Xavier Becerra, Health and Human Services Secretary. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”
Over-the-counter hearing aids should be available to consumers in the US from mid-October.
Source: FDA
