People in the United States can buy hearing aids from October without seeing an audiologist.
New rules provide a path for people in the U.S. to purchase hearing aids directly from stores or online retailers without the need for a medical examination, prescription, or a fitting by a licensed hearing care provider.
While the news is a great relief for millions of Americans, it also highlights systemic gaps in the country’s hearing care. “Ultimately, these changes feel a bit like a band-aid on the gaping bullet wound that is the American health care system.”
Over-the-counter (OTC) hearing aids are a new category of hearing aids in the US that can be purchased in stores and online without the need to see a hearing services professional. The US Food and Drug Administration’s new rules for OTC hearing aids promise sweeping changes for hearing healthcare, creating a new class of more affordable and accessible hearing aids. Hearing aids within this category can be sold online and in stores directly to consumers of 18 years and older who have perceived mild to moderate hearing loss without a medical exam or a fitting by a licensed provider.
Peggy Nelson, a professor of audiology at the University of Minnesota, said “I think we’re ready. I think we’re excited to have this be a part of the whole package of hearing health care for people who have hearing loss,” Nelson said. “We don’t know why it has taken so long, honestly.”
Nelson has some concerns about patients’ ability to properly fit themselves with OTC hearing aids.
“I think there will be challenges. People will have to figure out how to just take this thing out of the box and make it work.”
The new rules distinguish between two types of OTC hearing aids: a simpler “wear and go” type that offers a volume control and possibly some pre-established settings to choose from, and a more sophisticated “self-fitting” type that relies on a computer and/or mobile phone app, as well as possibly a hearing screening test, that helps personalise the device for your unique hearing loss and also includes a volume control.
Shari Eberts is a hearing health advocate and author and speaker on hearing loss issues. She said that while OTC hearing aids would not be suitable for her today, they would have been a great option when she was younger.
“My hearing loss is outside the targeted mild to moderate range but they might have come in very handy at the start of my hearing loss journey. Easy access to safe, affordable, and effective hearing solutions for mild hearing loss could have saved me years of struggle.”
The new rules limit how loud OTC hearing aids can be, how deeply they can be inserted into the ear canal, and define performance and design standards, which should raise the standard of product quality and help unsuspecting consumers avoid low quality products.
Buyers should ensure their new OTC purchase has a good warranty and return policy. New types of devices are expected in the OTC space. Some could work well in certain situations but perform differently for different people.
Marshall Chasin, editor of Canadian Audiologist said, “While the initial outlay would be less, if the sound was harsh or hollow or just “not right”, there is no recourse, and this less expensive hearing aid would end up in a drawer rather than on a person’s ears.”
Danny Aronson at online hearing care provider Tuned reckons that resistance to OTC will be about as effective as suing people for sharing music files (i.e., not very).
“People whose business model is selling expensive hearing aids, who work for the manufacturers’ oligopoly, believe that OTC is bad “for patients”? It’s GREAT for patients. It’s just bad for (their) business.
“The purpose of hearing care is not to provide revenue for hearing aid manufacturers, but to actually help real-life people who might have a $300 problem, not a $3,000 problem.”
Hearing aids are only one piece of the puzzle for better hearing – a hearing professional can also provide guidance and tips on how to manage life with hearing loss.
“Audiologists can and should play a critical role in the customer journey. But for that, they need to go back to being hearing care specialists, not hearing aid salespeople.”
HearingTracker is a popular online news and hearing aid review service. It surveyed 730 audiologists and hearing instrument specialists to identify common objections to OTC hearing aids. Based on the results, audiologists seem fairly open to selling and servicing OTC hearing aids with 26% stating that they plan to sell OTC hearing aids in their clinics or on their websites. And 55% indicated that they plan to support patients with OTC hearing aids purchased elsewhere.
OTC devices are not available for complex/severe hearing loss or for under 18 year olds
While the news is a great relief for millions of Americans who often find these expensive medical devices out of reach, it also highlights systemic gaps in the country’s hearing care.
According to author and commentator Sara Novic, “Those like me who require higher-powered devices will still be forced to pay out-of-pocket. No children will benefit from the new category of aids.
“Ultimately, these changes feel a bit like a band-aid on the gaping bullet wound that is the American health care system. Instead of equitable access to care for all, we see the piecemeal doling out of do-it-yourself measures to some and are expected to celebrate.”
But for those millions of Americans who can benefit from a hearing device sooner than later, the lower cost is a big positive.
Advocate Shari Eberts said, “It is hard to justify hearing help to the tune of $6,000 a pair when you just need it sometimes. OTC hearing aids are a great way to meet consumers where they are now.
“And once they get used to hearing well, consumers will be more likely to trade up to prescription devices when they need them. I hope audiologists will embrace these consumers at all stages of their journey.”
Editor in Chief of HearingTracker reckons any initiative that results in earlier identification and treatment of hearing loss should save lives and healthcare dollars.
“Untreated hearing loss is one of the leading culprits in the epidemic of older persons experiencing social isolation and loneliness, which can lead to negative feelings about self-worth and depression”, he said.
“Hearing loss has been linked to cognitive impairment and dementia like Alzheimer’s disease, and has even been shown to reorganise the processing centres of the brain. Researchers have linked untreated hearing loss to a variety of chronic health conditions.”
People in the United States can buy OTC hearing aids from mid-October in stores and online.
Comments from Deafness Forum’s members and affiliates
Better Hearing Australia Brisbane
The extent to which the availability of OTC devices has the potential to improve access, choice and affordability for consumers is a welcome innovation, but please… see your audiologist first. In Australia, we have a world-leading hearing health care system but it’s not perfect and in an already device-centric industry, the potential for consumers to bypass their audiologist altogether is a concern and may lead to poorer outcomes in the long term. After all, good hearing care is about more than just devices.
Better Hearing Australia Central Coast
The arguments for OTC hearing aid regulations have been going on for some years now in America. The upside is that it makes them affordable rather than buying through an audiologist where some of the charge is for correct fitting. The downside is who will pay for repairs if you take them to an audiologist and is there any ongoing support? They are only suitable for mild hearing loss and that it may not be an instant fix as the brain may take some time to adjust. I’m sure there will be significant disappointment as there already is and drawers will receive their share.
Hearing Business Alliance supports Australians living with hearing loss having easy access to aural rehabilitation, which often involves the use of hearing devices. Whilst rudimentary Over-the-Counter devices may be an inexpensive and convenient amplification solution, there are several additional aspects to contemplate. Amplification is just one component used to assist communication strategies. OTC devices are unable to manage more complex hearing situations, such as background noise or hearing outdoors in wind, and a negative OTC experience may dissuade the user from later seeking more appropriate hearing solutions. Prior to obtaining assistance, consumers should consider the appropriate professional diagnosis by audiologists and audiometrists of the type, degree, and possible causes of hearing loss, excluding potentially serious medical origins. Purchasing OTC devices may skip this important step. OTC devices have been described as similar to purchasing magnifying glasses at a pharmacy or petrol station, where graduated lens spectacles were more appropriate.
Hearing Care Industry Association believes that hearing care, particularly in the adult rehabilitation space goes far beyond the role of just the device. The role of the hearing care expert e.g., audiologist/audiometrist, is to determine the correct diagnosis, prescribe the best hearing solution including rehabilitation counselling as part of the overall process. HCIA fully supports consumer choice. Over the counter devices can potentially be a primer or first step for clients on the journey of aural rehabilitation. However, there is also a risk of a client having a negative first experience with over-the-counter devices especially when worn in complex listening situations such as background noise. This negative experience could steer a hearing-impaired consumer away from the benefits of proper audiologically-prescribed amplification.
Dr Brent Edwards, Director of Australia’s National Acoustic Laboratories (part of Hearing Australia) had been involved early on in the US government’s OTC hearing aid planning. He welcomes this change in the US and says “While evidence shows that hearing healthcare professionals play an important role in helping people be successful with their hearing aids, an over-the-counter option allows for more choice by consumers and could motivate some people to receive hearing help earlier.” In Australia, there are no restrictions on who can sell hearing aids, so Australians have already been able to choose whether they want to see a hearing healthcare professional or do it themselves. Australians could benefit from this change in the US if well-known consumer electronics companies start making hearing aids for the US market and these become available in the US.
Soundfair believes that giving consumers choice and control in the face of high prevalence of hearing loss low uptake of hearing aids, is positive. The OTC class provides both people-centred and affordable options for the public, and a stepped care clinical model. As with all change, there are risks. Many hearing professionals worry about the lack of standards and de-valuation of their professional offering. We acknowledge that audiologists are critical to serving people with substantial, medical or highly impactful hearing loss. We also welcome this pathway and its’ potential to encourage earlier and broader hearing health seeking in conjunction with clinical audiological care.
Audiology Australia, Australian College of Audiology, Hearing Aid Audiology Society of Australia and Independent Audiologists Australia were invited to comment.
Our story’s sources
FDA Clears Way for OTC Hearing Aids for People with Mild to Moderate Hearing Loss
NIDCD/NIH Webpage: Over-the-Counter Hearing Aids
CBC Radio Interview with CAA Canadian Audiologist, Editor In Chief
New OTC Hearing Aid Rules: Reactions from Minneapolis-based Starkey and Intricon
The New FDA Rules for OTC Hearing Aids: What Do They Mean for People with Hearing Loss?
The FDA’s new hearing aid won’t solve the bigger problems in the market
OTC Hearing Aids Could Have Saved Me Years of Struggle
The Unintended Consequences of OTC Hearing Aids
FDA’s new hearing aid rules help some but leave others behind
OTC Hearing Aids: Returns – a key piece of the puzzle