Skyline Happenings

Even Bose and Apple are in the game.

Thanks to Mike C.

By Phil Galewitz, Kaiser Health News

Spurred by decades of complaints about the high cost of hearing aids, Congress passed a law in 2017 to allow over-the-counter sales, hoping they would boost competition and lower prices.

Four years later, federal regulators have yet to issue rules to implement the law. But changes in the industry are offering consumers relief.

In August 2017, President Donald Trump signed the legislation that called for the Food and Drug Administration to issue regulations by 2020 for hearing aids that could be sold in stores without prescriptions or visits to audiologists or hearing specialists. That hasn’t happened yet, and President Joe Biden last month ordered the FDA to produce the rules for over-the-counter, or OTC, purchases by mid-November. That means it will most likely take at least until next summer for consumers to feel the direct effects of the law.

Despite the delay, consumers’ options have expanded with more hearing devices’ entering the market, alternative ways to get them and lower prices, particularly for the largest segment of the population with impaired hearing — those with mild to moderate hearing loss, for whom the law was intended.

We don’t know the quality of these devices.

Leading consumer brands Apple and Bose are offering products, and several smaller companies sell aids directly to consumers, providing hearing tests and customer service online from audiologists and other hearing specialists. Even major retailers offer hearing aids directly to consumers and provide audiology services online: Walgreens stores in Arizona, Colorado, North Carolina, Tennessee and Texas sell what the chain says are “FDA-registered” Lexie hearing aids for $799 per pair — far less than half the price of typical devices.

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

“There are many more options than there were in 2017 when Trump signed the Hearing Aid Act into law,” said Nancy Williams, president of Auditory Insight, a hearing industry consulting firm in New Haven, Connecticut. “In a sense, you can say the OTC revolution is happening without the FDA, but the difficulty is it is happening more slowly than if the FDA issued its rules on time.”

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

The federal law creates a category of hearing aids that would legally bypass state dispensing laws and enable consumers to buy aids in stores without consulting hearing aid professionals. Users would be expected to program the devices through smartphones, and companies could offer service via phone or internet.

With more hearing aids and other PSAPs being sold directly to consumers, advocates are eager for the FDA rules to come out, because they worry about the confusion caused by the array of choices — none have the FDA’s full seal of approval.

“The FDA delaying regulations has done more harm than good, because the direct-to-consumer market is filling the void and people are doing what 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 Sen. Elizabeth Warren, D-Mass., gave the FDA until August 2020 to issue regulations. Last year, after the FDA missing the deadline, officials said the Covid-19 pandemic had delayed the rule-making process.

Many in the hearing aid industry are concerned about the unchecked competition likely to come with allowing consumers to buy aids on their own without evaluations by audiologists or other hearing specialists.

Brandon Sawalich, CEO of Starkey, the largest U.S.-based hearing aid company, said consumers need expert assistance to test their hearing, buy appropriate aids, properly fit them and fine-tune their settings.

“It’s not just picking up something off the shelf at 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 perfectly again,” 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 probably can get hearing assistance. “The OTC and direct-to-consumer options open up avenues for those who have no other path to get hearing aids,” said Hope Lanter, an audiologist in Charlotte, North Carolina, with Hear.com, a Netherlands-based online hearing aid retailer.

She said she expects that after the FDA issues its rules, many hearing aid manufacturers will develop lower-cost over-the-counter devices that could be obtained without audiologists’ evaluations. She said that consumers with modest hearing loss might start out with those types of aids but that later, if their hearing worsens, shift to more expensive devices that require assistance from hearing aid professionals.

“In my view, there is enough pie for everyone,” Lanter said, noting that millions of people with hearing loss aren’t getting any help today. More than 37 million American adults have trouble hearing, including nearly half of people over age 60. Only 1 in 4 adults who could benefit from hearing aids have ever used one, federal health officials estimate.Not covered by many insurers

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

The price is concerning because Medicare and many insurers don’t cover hearing aids, although most private Medicare Advantage plans do. Only about half of state Medicaid programs cover the devices, but benefits vary widely, according to data from KFF.

Industry experts predict that new over-the-counter hearing aids will be priced at less than $1,000 a pair — about 25 percent lower than low-cost retailer Costco sells its Kirkland aids, which are dispensed through hearing aid professionals.

Without federal rules, manufacturers have largely waited to develop devices for the OTC market.

Bose chose a different path. This spring it began selling its hearing aids, which can be bought online without doctor’s visits, hearing tests or prescriptions. Bose got FDA clearance in 2018 after it provided data showing that the effectiveness of its self-fitting aids was comparable to that of those fitted with the same devices by hearing professionals. The Bose aids sell for $849 a pair.

Meanwhile, Apple last year integrated hearing assistance into its popular AirPods Pro earbuds, which can be customized using settings on an iPhone. Apple isn’t marketing the free benefit as a hearing aid but instead as similar to a PSAP that amplifies sound to help hearing.

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

Lanter said the stigma around hearing aids will be reduced as people are able to get them more easily. She predicted that consumers will someday buy hearing aids much as they can buy inexpensive reading eyeglasses at the drugstore today, with the option to get prescriptions for higher-quality glasses or ones with more precise fits.

Michelle Arnold, an audiologist and assistant professor at the University of South Florida, said that there is no evidence that consumers would be harmed buying hearing aids without seeing audiologists and that the benefits of getting some improvement in their hearing outweigh any risks. “Will people get the maximum benefit? Maybe not, but it’s better than nothing,” she said