Adults with mild to moderate hearing loss will now be able to purchase hearing aids without having their hearing tested by an audiologist or other specialist, under a new FDA rule announced Tuesday.
The move is expected to bring down the prices of the devices, some of which cost several thousand dollars and are often not covered by insurance.
Some audiologists pushed back against the agency’s initial proposal in October, warning that these “over-the-counter” devices could be too loud and consumers wouldn’t have the training to adjust them safely and effectively. The FDA responded by lowering the maximum allowable sound output for these devices, and it changed the final rule in other ways as well.
Until now, consumers could only buy hearing aids from audiologists or other qualified technicians. Bipartisan legislation in 2017 mandated the creation of this new over-the-counter category, long sought after by consumer advocates such as the Hearing Loss Association of America. But the FDA took years to work out the details.
The new devices could help up to 30 million adults with untreated hearing loss, FDA Commissioner Robert M. Califf said in a press release on Tuesday.
“Hearing loss is a critical public health issue that affects the ability of millions of Americans to communicate effectively in their daily social interactions,” he said. “The creation of this new regulatory category will allow people with mild to moderate hearing loss to have convenient access to a range of safe, effective and affordable hearing aids at their neighborhood store or online.”
Here’s what you need to know about the new rule:
— Who can get a hearing aid without a prescription?
The rules allow such devices to be sold to any adult with “perceived mild to moderate hearing loss”.
Some audiologists have questioned how well consumers can perceive their own level of hearing loss.
“It’s such a subjective thing,” said Sherrie Davis, director of audiology at Penn Medicine. “The challenge is that what’s sweet to me might not be sweet to someone else.”
She also warned that some hearing problems should not be treated with a hearing aid and that without an exam, consumers will not 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 usually requires surgery.
Still, increased access to hearing aids will be a plus, Davis said.
“So many people are going to have access to amplification that they never had before,” she said.
— How much will they cost?
Not clear. When a person purchases a hearing aid from an audiologist or other reseller, such as the trained technicians at Costco, the cost covers much more than the device itself. Typically, it also covers setting up the device, training the person to use it, and any adjustments and aftercare.
Over-the-counter hearing aids should be cheaper, as the cost will only cover the device itself (although some manufacturers may include an online hearing test). But it’s hard to say how much the costs will drop until the market crashes, 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 will be who can get the lowest,” he said. “And those wouldn’t be the ones you would want to buy.”
The cost of over-the-counter hearing aid electronics is likely similar to fancy $200 headphones, said Frank R. Lin, professor of otolaryngology at Johns Hopkins University School of Medicine.
Over-the-counter hearing aids with lots of features can cost up to $800, said Davis of Penn Medicine.
— Will health 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.
This is always the case with over-the-counter hearing aids. The new rule does not require insurers to cover devices.
— Are they the same as those worn by hunters?
No. Many hunters carry what is 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.
However, some high-end products may be similar to hearing aids and can 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-store and online. No examination or hearing test is required.
Some manufacturers should offer online hearing tests. But audiologists warn that an online test won’t be as accurate as what they would perform in a soundproof setup in their office.
The new rule doesn’t 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 from a store while seeking testing or advice from an audiologist, she said.
“If I was an audiologist, I would find a way to help people in those early stages of hearing loss” who buy hearing aids directly from a store, she said.
— Are the new hearing aids too loud?
The original FDA proposal would have allowed new hearing aids to have a maximum output of 120 decibels, provided they were equipped with a volume control. Critics said the limit was too high, and in response the agency lowered it to 117 decibels in the final rule.
Lin, Hopkins’ doctor, said the criticism was off the mark. Yes, a sound output of 117 or 120 decibels is very loud, equivalent to some chainsaws, he said.
But in everyday life, many ordinary sounds also hit this peak for a fraction of a second. If the FDA had limited the volume 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 normal human speech can approach 115 or 120 decibels for a brief moment.
“If you cut it to 110 and disable those devices, you make those devices useless for a lot of people,” he said.
— Can these hearing aids be returned for a refund?
Critics have urged the FDA to allow consumers to return over-the-counter hearing aids if they are unhappy with the devices. But the agency chose not to include a return requirement in its final rule.
Instead, the FDA only requires manufacturers to clearly state their return policy on device labels. If they do not allow returns, manufacturers must specify this.
Some states have laws that may still require stores to accept returns, the agency said.
— When can I get a hearing aid?
The final rule takes effect 60 days after it was officially published this week in the Federal Register. After that, hearing aids that were previously approved for sale by audiologists can be sold without a prescription.
For new devices or those not previously sold as hearing aids, manufacturers may need FDA clearance.