Adults with mild to moderate hearing loss will now be able to buy hearing aids without getting their hearing tested by an audiologist or other specialist, under a new FDA rule announced Tuesday.
The move is expected to lower prices for the devices, some of which cost several thousand dollars and often are not covered by insurance.
Some audiologists pushed back against the agency’s original proposal in October, warning that these “over-the-counter” devices might be too loud, and that consumers would lack the training to adjust them safely and effectively. The FDA responded by lowering the maximum allowable sound output for such devices, and it also tweaked the final rule in other ways.
Until now, consumers could buy hearing aids only from audiologists or other trained technicians. Bipartisan legislation in 2017 required the creation of this new over-the-counter category, which had been long sought by consumer advocates such as the Hearing Loss Association of America. But the FDA took years to hammer out the details.
The new devices could help up to 30 million adults with untreated hearing loss, FDA Commissioner Robert M. Califf said Tuesday in a news release.
“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” he said. “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.”
Here’s what to know about the new rule:
-- Who can get a hearing aid over the counter?
The rules allow such devices to be sold to any adults with a “perceived mild to moderate hearing loss.”
Some audiologists have questioned how well consumers could perceive their own level of hearing loss.
“It’s such a subjective thing,” said Sherrie Davis, Penn Medicine’s director of audiology. “The challenge is that what’s mild to me might not be to somebody else.”
She also cautioned that some hearing problems should not be treated with a hearing aid, and that without an exam, consumers won’t know if they need other treatment. For example, the patient may simply have fluid behind the eardrum, which is easily treatable without a hearing aid. In rare cases, hearing loss can be caused by a tumor on the auditory nerve, which typically requires surgery.
Still, the increased access to hearing aids will be a plus, Davis said.
“So many people are going to have access to amplification that never had that before,” she said.
-- How much will they cost?
Unclear. When someone buys a hearing aid from an audiologist or other dealer, such as the trained technicians at Costco, the cost covers much more than the device itself. Typically, it also covers fitting the device, training the person to use it, and follow-up adjustments and care.
Over-the-counter hearing aids are expected to be less expensive, as the cost will cover only the device itself (though some manufacturers may include an online hearing test). But it’s hard to say how much costs will drop until the market shakes out, said James C. Denneny III, executive vice president of the American Academy of Otolaryngology-Head and Neck Surgery.
“When they first come out, the war is going to be who can go the lowest,” he said. “And those would not be the ones you want to buy.”
The cost of the electronic components in over-the-counter hearing aids is likely similar to those in sophisticated $200 earbuds, said Frank R. Lin, a professor of otolaryngology at Johns Hopkins University School of Medicine.
Over-the-counter hearing aids with lots of features may cost as much as $800, Penn Medicine’s Davis said.
-- Will Medicare or other insurance cover my hearing aid?
Many insurers, including Medicare, do not cover hearing aids. Some Medicare Advantage plans, which are managed by private insurers, may include benefits for hearing aids, but they are not required to do so.
That’s still the case with over-the-counter hearing aids. The new rule does not require insurers to cover the devices.
-- Are they the same as what hunters wear?
No. Many hunters wear something called a personal sound amplification product, to better hear animals in the woods. These products have not been approved by the FDA and cannot be labeled as hearing aids.
Some higher-end products may be similar to hearing aids, however, and may now be sold as hearing aids if the manufacturer seeks FDA approval.
-- How do you get an over-the-counter hearing aid?
The devices will be sold in stores and online. No exam or hearing test is required.
Some manufacturers are expected to offer online hearing tests. But audiologists caution that an online test won’t be as accurate as what they would perform in a soundproof facility in their office.
The new rule does not necessarily exclude audiologists from the equation, said Barbara Kelley, executive director of the nonprofit Hearing Loss Association of America. A patient could buy an over-the-counter hearing aid at a store yet still seek testing or guidance from an audiologist, she said.
“If I were an audiologist, I would find a way to help people in these early stages of hearing loss” who buy hearing aids direct from a store, she said.
-- Are the new hearing aids too loud?
The FDA’s original proposal would have allowed the new hearing aids to have a maximum output of 120 decibels, provided they were fitted with a volume control. Critics said that limit was too loud, and in response, the agency lowered it to 117 decibels in the final rule.
Lin, the Hopkins physician, said the criticism was off-base. Yes, a sound output of 117 or 120 decibels is very loud — equivalent to that of some chain saws, he said.
But in everyday life, lots of ordinary sounds also reach that peak for a split second. If the FDA had restricted the loudness to 110 decibels, as some critics wanted, many everyday sounds would be distorted, Lin said.
“If you go to a symphony, there are peak sounds around 120,” he said. “That’s what gives music its liveliness.”
Even regular human speech can approach 115 or 120 decibels for a brief instant.
“If you clip it at 110 and you handicap these devices, you basically make these devices not useful for a lot of people,” he said.
-- Can these hearing aids be returned for a refund?
Critics urged the FDA to allow consumers to return over-the-counter hearing aids if they are unhappy with the devices. But the agency opted not to include a return requirement in its final rule.
Instead, the FDA requires only that manufacturers clearly state their return policy on device labels. If they don’t allow returns, manufacturers have to spell that out.
Some states have laws that may nevertheless require stores to accept returns, the agency said.
-- When can I get a hearing aid?
The final rule takes effect 60 days after its formal publication this week in the Federal Register. After that, hearing aids that were previously approved for sale by audiologists can be sold over the counter.
For new devices or those that were not previously sold as hearing aids, manufacturers may need clearance from the FDA.
