FDA Releases Draft Over-the-Counter Hearing Aid Regulation

Washington, D.C., Oct. 19, 2021 (GLOBE NEWSWIRE) — Today the FDA issued draft guidelines for over-the-counter (OTC) hearing aids, a first step toward giving Americans more options to address mild to moderate hearing loss. When the rule is finalized, adults 18 and older will be able to purchase OTC hearing aids online or at retail outlets without a medical exam or fitting by a hearing care professional. While final regulations and the first OTC products are still months away, now is an opportune time to educate ourselves on the various types of hearing devices that will be available.

Today there are primarily three types of devices that provide hearing help:

1. Sound amplifiers: One-size-fits-all devices, called PSAPs (personal sound amplification products), intended for recreational use for individuals with no hearing loss that simply make all environmental sounds louder. These are considered hearing “amplifiers” not hearing “aids.”

2. Hearing aids: Medical devices for people with hearing loss, most frequently prescribed by a hearing health professional and customized to fit and adjusted to discern sounds in all listening situations. OTC devices are intended for adults with mild to moderate hearing loss and will be sold online and in retail stores without the assistance of a hearing care professional. They will be distinct from prescription hearing aids.

3. Implants: Cochlear implant solutions, or bone-anchored hearing systems, that are designed for those with severe-to-profound hearing loss.

Differences Between OTC and Prescription Hearing Aids

Manufacturers will develop new products to bring to the over-the-counter market. Specifications about new features are yet to be revealed; however, there are some distinct differences to help you determine the best option for you.

1. Self-fit vs. Custom-fit. OTC hearing aids will be self-fitting and designed for adults with mild to moderate hearing loss. Without the support of a hearing care professional, the price is likely to be lower. While there may be some adjustable features, it will be up to you to determine your amount of hearing loss and to make any adjustments. For the first time user, the challenge with self-diagnosis could be that you won’t necessarily know what you’re missing. For instance, you may perceive the device is helping you hear “normally,” but normal for you may mean missing the full spectrum of sounds available. In contrast, prescription hearing aids are customized, meaning a hearing health professional will test and identify your level of hearing loss and customize your hearing aids to optimize your hearing.

2. Technology Differences. There is a broad range of features offered on various hearing aids. As new products become available, you’ll want to check the features for the products you’re considering. For instance, do you want rechargeable or replaceable batteries? (Rechargeable batteries may be more expensive in the short term, but easier to use and less expensive over time.) Do you want Bluetooth audio streaming? (Streaming is helpful when talking on the phone, watching TV, etc.)  Do you want feedback control, volume control, a directional microphone? (These features allow you some control over the device.) Do you want a hearing aid that fits behind the ear or is placed in the ear? (Behind the ear may be more comfortable; in the ear may be more appealing and easier to use). Do you want a telecoil? (A telecoil allows you to connect to your telephone or a loop system that provides direct audio input to sound in large-area listening situations.) One thing you do want to know: the trial period and return terms, no matter what type of device your purchase.

3. The Price Differential. Check out the price of your options. When available, OTC products will likely be less expensive because they may offer fewer features and they will be sold without the added services of a hearing professional. In contrast, hearing aids from a hearing professional can cost from $1,500 a pair and higher, depending on the technology, features, and the cost of services from the hearing care professional. Remember to check your insurance plan. Today, traditional Medicare doesn’t cover hearing health, but most Medicare Advantage programs include a hearing benefit as do some federal and private health insurance plans.

Like other technology you use daily there is an upfront investment, so to demonstrate the true value, consider the cost per day over the life of the hearing aid, usually 5 years. For a few dollars a day, you can stay connected and engaged. The investment on your hearing could even benefit your budget in the future since untreated hearing loss is associated with 46% higher total health care costs over a 10-year period.¹

“If you have mild or moderate hearing loss, and are comfortable with self-diagnosis and self-fitting, over-the-counter hearing aids or devices could be a great option for you,” said Barbara Kelley, executive director of the Hearing Loss Association of America. “But if you have more significant hearing loss, you will benefit from the personalized care provided by a hearing health professional. Even if you have a moderate hearing loss, you may still want to see a professional for assistance with your diagnosis, and help selecting the best device for you, whether it’s an OTC device or a customized hearing aid. The good news is that you will soon have more options. But, don’t wait for OTC devices to come to market. If you think you have a hearing loss, get tested now.”

Why bother with getting hearing help? 

Most people who have hearing loss ignore the problem for far too long. According to the National Institute on Deafness and Other Communication Disorders, National Institutes of Health, among adults aged 70 and older with hearing loss who could benefit from hearing aids, fewer than one in three (30 percent) has ever used them. Even fewer adults aged 20 to 69 (approximately 16 percent) who could benefit from wearing hearing aids have ever used them.² Overall, an estimated 38-48 million Americans have a hearing loss.^3,4

To be healthy and vibrant, it’s important to take action when you notice hearing loss. Why? Hearing loss is associated with higher rates of depression, dementia and falls that require hospitalization.⁵ Even mild hearing loss doubles the risk of dementia, moderate loss triples the risk and those with severe loss are 5 times more likely to develop dementia.⁵

Another problem associated with hearing loss is isolation. The COVID-19 pandemic has demonstrated how important staying connected is to our happiness and wellbeing. Now more than ever, hearing well is a priority.

“Good hearing increases social engagement, improves communication, lowers the risk of isolation and depression, and is part of healthy aging,” says Kate Carr, president of the Hearing Industries Association. “Hearing aids available today offer great technology to address hearing loss at various prices. And when OTC hearing aids are approved and available, Americans will have more options to hear well and stay vital. And if you opt for an OTC device and experience difficulties making it work for you, don’t give up. Check in with a hearing care professional for assistance.”

About Hearing Industries Association (HIA)

HIA is a forum for the companies that manufacture and distribute hearing aids, components and supplies for the hearing aid industry. Our mission is to be the trusted voice on hearing health care for product innovation, public policy, patient safety and education. Visit our website www.betterhearing.org, follow us on Facebook @betterhearingHIA, or check out our blog to stay in the know on hearing options as new products become available.

About HLAA

The Hearing Loss Association of America (HLAA) is the nation’s leading consumer education that opens the world of communication to people with hearing loss through information, education, support and advocacy. HLAA has communication access programs, holds the Walk4Hearing, has 120 chapters across the country, and holds educational programs through webinars and annual conventions. Visit our website www.hearingloss.org and follow us on Facebook @HearingLossAssociation.

#HearWellStayVital, #TestYourHearing

¹ Trends in Health Care Costs and Utilization Associated With Untreated Hearing Loss Over 10 Years.” Nicholas S. Reed, Aylin Altan, Jennifer A. Deal, Charlotte Yeh, Alexander D. Kravetz, Margaret Wallhagen, Frank R. Lin JAMA Otolaryngol Head Neck Surg. 2019 Jan; 145(1): 27–34. Published online 2018 Nov 8. doi: 10.1001/jamaoto.2018.2875, PMCID: PMC6439810.

² Based on calculations by NIDCD Epidemiology and Statistics Program staff using data collected by (1) the National Health Interview Survey (NHIS) annually for number of persons who have ever used a hearing aid [numerator], and (2) periodic NHANES hearing exams for representative samples of the U.S. adult and older adult population [denominator]; these statistics are also used for tracking Healthy People 2010 and 2020 objectives. See also Use of Hearing Aids by Adults with Hearing Loss (chart).

³ “How many people have hearing loss in the United States?”, Johns Hopkins. (2018, December 11). https://www.jhucochlearcenter.org/how-many-people-have-hearing-loss-united-states.html

⁴ “Hearing Loss Facts and Statistics”, Hearing Loss Association of America (HLAA). (2018). Bethesda, MD. https://www.hearingloss.org/wp-content/uploads/HLAA_HearingLoss_Facts_Statistics.pdf

⁵ “The Hidden Risks of Hearing Loss.” Johns Hopkins Medicine. https://www.hopkinsmedicine.org/health/healthy_aging/healthy_body/the-hidden-risks-of-hearing-loss