Marylanders with hearing loss will soon be able to find help at the store after federal rule change

Millions of consumers across the country will be able to get a hearing aid more easily and affordably under new federal rules that will make some devices available without a prescription at local retailers and online. In Maryland, many of the 1.2 million residents with some hearing loss could benefit.

Hearing loss is a common and often under-recognized problem, and the U.S. Food and Drug Administration’s new rules are aimed at those who may be newly experiencing auditory losses or on the moderate end of losses who have yet to see a specialist.


“The new rules apply only to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild to moderate hearing loss. This is a significant portion of the deaf and hard of hearing population in Maryland,” said Payal Sharmacharya, a spokesperson for the Governor’s Office of the Deaf & Hard of Hearing.

The FDA issued the rules last week, five years after Congress passed a law requiring the agency to create a category for over-the-counter hearing aids to be sold in stores and online. The rules, however, were just issued.


Consumers will be able to buy the hearing aids in retail outlets or online without a medical exam, prescription or fitting by an audiologist as early as mid-October. The rules also require easily understood labeling.

Federal officials expect the expanded access to lower the cost of the hearing aids by fostering innovation in the technology and competition.

There are more than 48 million Americans age 12 and older who are deaf or hard of hearing in at least one ear and 30 million with losses in both ears, according to a 2016 study by Johns Hopkins researchers and cited by state officials. State officials extrapolated from the study and U.S. Census data that there are about 1.2 million Marylanders age 12 or older with losses in one ear and 759,000 with losses in both ears.

The Hopkins study suggested that the prevalence of those deaf and hard of hearing grows with age, so the number of children wouldn’t add significantly to the numbers. But the researchers included those with losses in one ear because they often need accommodations.

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“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” FDA Commissioner Dr. Robert M. Califf said in a statement last week when the rule was issued. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”

Sharmacharya said those with profound hearing loss and children will still require audiology services to measure losses and get prescriptions for hearing aids. She said resources and financial assistance are available in Maryland. That includes through the Hearing Aid Loan Bank, which provides loaner hearing aids to deaf and hard-of-hearing infants, toddlers and children in the state who are under age 19.

The latest federal move follows adoption of federal rules in Maryland in 2018 that expanded Medicaid access to adults who required hearing aids, cochlear implants and other devices. Previously, only those under age 21 qualified for the benefit under Medicaid, the federal-state health care program for low-income residents.

Advocacy groups had been lobbying for the new over-the-counter hearing aid rules to expand access to the devices and expand adoption.


Many people are never diagnosed or treated due to cost, stigma and other barriers, despite the difficulties and other conditions associated with hearing loss, according to the Hearing Loss Association of America

“We are hopeful that over-the-counter options will inspire some to take a first step to treat their hearing loss sooner,” said Barbara Kelley, executive director of the group, in a statement. “Ultimately this can mean a better quality of life, and avoiding the increased risk of dementia, falls and isolation associated with untreated hearing loss.”

Sharmacharya said the state plans to share information about the hearing aids on its social media channels and through direct communication with people affected.