Should hearing aids be sold at local pharmacies like a pair of reading glasses?
It is a question that federal lawmakers are now considering with bipartisan legislation to create a new category of hearing aids sold over-the-counter for people with mild to moderate hearing loss.
Patient advocate groups like the Hearing Loss Association of America say the proposed legislation would increase access to hearing aids, which cost an average of nearly $5,000 for a pair. Hearing aids aren’t covered by Medicare and typically not paid for by many private insurance companies either. The price includes the fitting and tuning of the device done by an audiologist or hearing aid dispenser.
Medicare doesn’t cover the cost of hearing aids because a statute from the 1960’s specifically prohibited paying for them. At the time, there was little awareness of the impact of hearing loss on health outcomes and the few available hearing aids were not very good or expensive, said Frank Lin, an associate professor of otolaryngology-head & neck surgery at Johns Hopkins University who researches the link between hearing loss and the increased risk of dementia.
Because private insurance companies typically follow Medicare’s lead, they also haven’t covered the cost of hearing aids though some plans are starting to, he said. (Medicare doesn’t cover the cost of eye exams or eye glasses either. Private insurance varies on vision coverage.)
An estimated 30 million Americans have some degree of hearing loss and the numbers are growing. A study published last month by Johns Hopkins University researchers predicted that the number of U.S. adults with hearing loss will nearly double by 2060. Yet it is estimated that 67% to 86% of people who would benefit from using a hearing aid don’t use them.
Patricia Holland was among them. When she first noticed age-related hearing loss, she waited about three years to buy a hearing aid because of the sticker shock.
“I only bought a hearing aid in one ear because the cost was so high but you really need two for balance,” said Ms. Holland, a 79-year-old retiree living in Waltham, Mass. Five years later she finally bought a second hearing aid.
The momentum for OTC hearing aids began with a National Academies of Sciences, Engineering and Medicine report published last year calling for more efforts to provide adults with affordable hearing aids.
The report recommended that the U.S. Food and Drug Administration remove the regulation that requires either a medical evaluation or that individuals sign a waiver that they aren’t getting one before purchasing a hearing aid, a move the FDA subsequently made.
It also called for the creation of a new category of OTC wearable hearing devices—separate from hearing aids used for more severe hearing loss. That is what the current proposed bill would do, while also directing the FDA to devise safety and effectiveness standards for the new class of hearing aids. Technology companies with personal sound amplification products—called PSAPS—that are already commercially available, often at lower prices than traditional hearing aids, are a big proponent of the legislation as it would enable them to market their products for hearing loss.
Barbara Kelley, executive director of the patient advocacy group the Hearing Loss Association of America, says every day they get up to eight emails or calls from people saying they can’t afford to buy hearing aids.
“Cost is a barrier,” she said. “Stigma is a barrier. Access to care is a barrier. People with mild to moderate hearing loss aren’t even taking the steps to get hearing health care.”
She noted that research has shown that untreated hearing loss is associated with many other health conditions, such as increased risk of falls, anxiety, isolation and cognitive declines.
The traditional hearing aid industry—controlled by about half-a-dozen companies—is against the bill while audiologist groups have concerns.
“Hearing loss is a health issue,” said Brandon Sawalich, senior vice president of Starkey Hearing Technologies, the only U.S.-based manufacturer of hearing aids, and chairman of the board of the Hearing Industries Association, a trade group. “Going about it with self-diagnosis and self- treatment is not a responsible way to approach hearing loss.”
The HIA would support OTC hearing aids for mild hearing loss, said Mr. Sawalich, but not moderate hearing loss.
“The proper way to fit hearing aids requires patient service and patient care and that is done through a proper hearing professional,” he said.
Ian Windmill, president of the American Academy of Audiology, a professional organization of audiologists, said the group hasn’t taken an official position on the proposal yet but has some concerns and wants to make sure consumers are properly informed on the different devices and what they are for.
Manufacturers of PSAPS, made by technology companies like Doppler Labs and Bose, are usually smaller than traditional hearing aids, can be adjusted by smartphone apps and are significantly cheaper, usually less than $500 per ear. But the companies currently aren’t allowed to market their products for hearing loss because they are not medical devices approved by the FDA.
“Consumers with mild hearing challenges don’t often want to get a hearing test and go to an audiologist and get a prescription for a costly hearing aid,” said Julie Kearney, vice president of regulatory affairs for the Consumer Technology Association, a technology trade association with 2,200 members, represents companies that make PSAPs.
More at Source: Should Hearing Aids Be Sold Over-the-Counter? – WSJ