Spurred on by decades of complaints about the high cost of hearing aids, Congress passed legislation in 2017 to allow over-the-counter sales, in the hopes it would spur competition and lower prices.

Four years later, federal regulators still have not published rules to implement the law. But changes in the industry offer relief to consumers.

In August 2017, President Donald Trump signed legislation calling on the Food and Drug Administration to enact regulations by 2020 for hearing aids that can be sold in stores without a prescription or without a visit to an audiologist or hearing care professional. That has yet to happen, and in July President Joe Biden ordered the FDA to produce these rules for over-the-counter (OTC) purchases by mid-November. This means that it will likely take at least until next summer for consumers to feel the direct effects of the law.

Despite the delay, consumer options have broadened with the arrival of more hearing aids, alternative means of obtaining them and lower prices, especially for the larger segment of the hearing impaired population. – those with mild to moderate hearing loss, for whom the law was intended.

We do not know the quality of these devices.

Major consumer brands Apple and Bose offer products and several small companies sell aids directly to consumers, offering hearing tests and online customer service from audiologists and other hearing specialists. Even major retailers offer hearing aids direct to consumers and provide audiology services online: Walgreens stores in Arizona, Colorado, North Carolina, Tennessee, and Texas sell what the chain calls Lexie hearing aids. “FDA registered” for $ 799 a pair – well under half the price of typical devices.

Nationally, personal sound amplification products, or PSAPs, that are smaller and customizable are now available in stores and online. These devices, which look like hearing aids and sell for a fraction of the price, amplify sound, but some don’t address other components of hearing loss, such as distortion.

“There are a lot more options than there were in 2017 when Trump passed the hearing aid law,” said Nancy Williams, president of Audit Insight, a consulting firm in the hearing aid industry. the hearing in New Haven, Connecticut. “In a sense, you can say that the OTC revolution is happening without the FDA, but the difficulty is that it happens more slowly than if the FDA published its rules on time. “

The price of a standard pair of hearing aids typically ranges from $ 2,000 to $ 8,000, depending on the technology. This price includes professional fitting fees and follow-up visits as well as the device. The hearing aid industry has remained largely insulated from price competition due to consolidation among manufacturers, widespread state licensing laws that require sales through audiologists or hearing care professionals, and the acquisition of hearing aid professional practices by device manufacturers.

Federal law creates a class of hearing aids that would legally bypass state dispensation laws and allow consumers to purchase aids in stores without consulting a hearing care professional. Users would have to program devices through a smartphone, and businesses could offer service over the phone or the Internet.

With a growing number of hearing aids and PSAPs being sold direct to consumers, advocates are eager to see the FDA rules come out because they worry about the confusion caused by the range of choices – none having FDA’s full seal of approval.

“The FDA’s delaying regulations have done more harm than good, because the direct-to-consumer market fills the void and people do whatever they want, and we don’t know the quality of these devices,” said Barbara Kelley, executive director. of the Hearing Loss Association of America, a consumer advocacy group.

The law, sponsored by Senator Elizabeth Warren (D-Mass.), Gave the FDA until August 2020 to issue regulations. Last year, after missing that deadline, FDA officials said the covid-19 pandemic delayed the rule-making process.

Many in the hearing aid industry are concerned about the uncontrolled competition that can arise by allowing consumers to purchase aids on their own without evaluation by an audiologist or other hearing specialist.

Brandon Sawalich, CEO of Starkey, America’s largest hearing aid company, said consumers need expert help to test their hearing, purchase the right aid, fit it properly and fine-tune its settings.

“It’s not just about taking something off the shelf from your local drugstore or ordering something online and putting it in your ear and your life is going to be reconnected and you are going to hear just fine again,” a- he said on a recent podcast. “It doesn’t work that way, and it’s not that easy.”

However, by avoiding professional help, more Americans can get a hearing aid. “OTC and direct-to-consumer options open up avenues for those who have no other way to get hearing aids,” Hope Lanter, an audiologist from Charlotte, North Carolina, at Hear.com, said. an online hearing aid retailer based in the Netherlands. .

She expects that after the FDA releases its rules, many hearing aid manufacturers will develop lower-cost over-the-counter devices that can be obtained without an assessment by an audiologist. She said consumers with modest hearing loss can start with these types of devices, but later, if their hearing deteriorates, switch to more expensive devices that require the help of hearing care professionals.

“In my opinion, there is enough pie for everyone,” Lanter said, noting that millions of hearing impaired people are not getting any help today. More than 37 million American adults have difficulty hearing, including almost half of people over 60. Only 1 in 4 adults who could benefit from a hearing aid have ever used one, federal health officials estimate.

Not covered by many insurers

Unlike most consumer electronics, hearing aid prices have remained high for decades, generating complaints from consumers.

The price is a concern because Medicare and many insurers do not cover hearing aids, although most private Medicare Advantage plans do. Only about half of state Medicaid programs cover the devices, but benefits in those states vary widely, according to data from KFF.

Industry experts predict the new over-the-counter hearing aids will cost less than $ 1,000 a pair, about 25% less than low-cost retailer Costco sells its Kirkland hearing aids, distributed by a hearing care professional.

Without federal rules in place, manufacturers have long waited to develop devices for the OTC market.

Bose chose another path. This spring, she began selling her hearing aids, which can be purchased online without a doctor’s visit, hearing test, or prescription. Bose obtained FDA clearance in 2018 after providing data showing that the effectiveness of its self-adjusting aids was comparable to those fitted with the same device by a hearing care professional. Bose aids sell for $ 849 a pair.

Meanwhile, Apple last year incorporated hearing assistance into its popular Air Pods Pro headphones, which can be personalized using settings on an iPhone. Apple does not market the free benefit as a hearing aid, but rather as a PSAP that amplifies sound to aid hearing.

Several companies like Eargo, Lively and Lexie allow consumers to purchase aids online and get help from specialists to configure them remotely. As long as companies have generous return policies that allow people to try out a few aids to see which works best, the proliferation of online options selling high-quality aids is good news for consumers, Williams said. , the Connecticut hearing consultant.

Lanter said the stigma surrounding hearing aids will be reduced as people get them more easily. She predicted that consumers will one day buy hearing aids as much as they can buy cheap reading glasses at the drugstore today with the option of getting a prescription for better quality glasses or with a more precise fit. .

Michelle Arnold, audiologist and assistant professor at the University of South Florida, said there was no evidence consumers would be harmed by purchasing a hearing aid without consulting an audiologist, and the benefits of an improvement. of their hearing outweigh the risks. “Will people get the maximum benefit from it?” Maybe not, but it’s better than nothing, ”she said.


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