Over-the-counter hearing aids are a new category of hearing aids that will be available to the public without visiting a hearing healthcare provider. OTC hearing aids, like professionally fit hearing aids (which moving forward will be categorized as prescriptive hearing aids), will be regulated as medical devices by the U.S. Food and Drug Administration (FDA), but will be made available directly in stores and online. These devices are intended for those who have perceived mild to moderate hearing loss (no hearing test is required). Introduction of OTC hearing aids is an attempt to make treating hearing loss more accessible and affordable. One challenge will be for consumers to know what their hearing loss is and what is needed without the help of a hearing healthcare provider. Research has shown that consumers tend to either over- or under-emphasize their hearing problem.
Who Can Benefit From Over The Counter Hearing Aids?
OTC hearing aids are appropriate for adults only, who have mild hearing loss. While the FDA states that those with moderate hearing loss will benefit from OTC hearing aids, there is sufficient evidence that those with moderate hearing loss will receive less than optimal audibility (volume of speech sounds) without real-ear verification (an objective measurement that shows if the hearing aids are programmed accurately) and proper programming. Many of these hearing losses require a custom fit to the ear to provide optimal benefit, which can only be offered by a hearing healthcare provider.
OTC hearing aids are not appropriate for audiograms (hearing tests) that are low-frequency rising audiograms, notched audiograms (a sharp dip at any pitch followed by a sharp recovery, or a cookie-bite hearing loss), or a steeply sleeping audiogram (occurs for approximately 25% of those with age-related hearing loss). It is also essential to consult a hearing healthcare provider if you have any of the following symptoms:
- Ear pain or drainage
- History of excessive wax build up
- Vertigo or severe dizziness
- Sudden hearing loss
- Hearing loss that has gotten worse in the last 6 months
- Hearing loss or tinnitus in one ear
It is therefore not advised to determine if you are a candidate for OTC by simply counting on your perception of your hearing loss. An examination by a licensed hearing healthcare provider is always recommended regardless of the type of hearing aid chosen.
Over The Counter Hearing Aids: Not For Severe Hearing Loss
OTC devices are not for those with moderately-severe or greater hearing loss or for those with perceived significant hearing difficulty. Similar to any other over-the-counter health product, they are only for mild health problems (e.g., medication, nonprescription glasses). Hearing aids are also just one part of overall hearing health rehabilitation. More severe hearing problems require more than just hearing aids, and a cochlear implant may be a better option overall.
Over the Counter Hearing Aids Regulations
While OTC hearing aids will be regulated by the FDA, at this point only proposed rules from the FDA have been published. The official document is expected sometime during the summer of 2022. Sixty days after the official rules are published they will go into effect.
Over The Counter Hearing Aids And PSAPs
Once the OTC regulations are implemented, there will be 2 categories of hearing aids; over-the-counter and prescriptive.
Prescriptive hearing aids are prescribed and fit by a licensed hearing healthcare professional who customizes the gain-frequency response to provide optimal audibility of speech sounds, while maintaining appropriate loudness and sound quality. Best practices require the use of objective measurements in the ears with hearing aids called real ear measurements or probe microphone measurements. There are also parameters that can be adjusted to optimize the amplification given other individual factors such as cognitive processing, noise tolerance, and previous experience with amplification.
OTC hearing aids will be the responsibility of the consumer. This will include selection and appropriate gain-frequency response, selection of appropriate coupling to the ear, wire or tubing size, and mastery of hearing aid skills such as handling, adjustments, and cleaning. While OTC devices are regulated by the FDA, the companies who sell them are not held to the same standards as licensed professionals who provide prescriptive hearing aids.
PSAPS (Personal Sound Amplifiers) are a wearable consumer electronic device intended to amplify sounds for consumers without hearing loss. PSAPS are unregulated by the FDA, vary significantly in quality and performance, and although they may have all the characteristics of a hearing aid, they are labeled as an amplifier and are unregulated. PSAPs are not intended to treat hearing loss. Commonly used PSAPs include TV Ears and Pocket Talkers.
Why Are OTC Hearing Aids Becoming Available Now?
Hearing health is finally getting well deserved attention from the general healthcare field and government. Hearing impairment is linked to numerous health issues including depression, loneliness, cognitive decline, diabetes, cardiovascular disorders and falls. Yet less than 20% of Americans who would benefit from hearing aids have them. OTC hearing aids are the result of legislation that was passed by Congress in the Over-the-Counter Hearing Aid Act of 2017. This legislation was motivated by the idea that people with hearing loss who do not wear hearing aids often have issues with accessibility and affordability. Also, technological advances and high-tech smartphones have now made OTC devices possible.
Over The Counter Hearing Aids: From An Audiologist’s POV
As an audiologist I understand the importance of treating hearing loss very early. Hearing is essential for engaging and communicating with others. Hearing health is vital for good emotional and cognitive health as well as overall wellness. I am a proponent of anything that will promote good hearing health, whether it is hearing loss prevention or making hearing aids more accessible and affordable. However, hearing health goes beyond making hearing aids affordable and accessible, it is also about quality hearing healthcare. Studies consistently show that audiology best practices result in higher satisfaction, higher benefit, and higher rate of keeping hearing aids compared to hearing aids that are purchased direct-to-consumers or fit without best practices. Studies also have consistently shown that without probe microphone measurements hearing aids are often over or under fit. These measurements are best practice and the only way to verify a patient is receiving the needed audiblity from the hearing aids. Given the recent research showing the detrimental impact that even a slight hearing loss has on neural and cognitive functioning it would be hard for me to ever recommend wearing a hearing aid that has not had the settings verified in the ear with probe-microphone measurements.
Over The Counter Hearing Aids Pros And Cons
Let’s examine the pros and cons of OTC hearing aids:
- Increased communication ability and motivation to engage when compared to those with no hearing aids
- Increased self-sufficiency
- Reduced stigma of hearing aids (the more mainstream it becomes to wear hearing aids the less stigma there will be with them)
- Consumers will be able to self-diagnose, self-treat and self-manage hearing loss, which will save time and reduce cost of treating hearing loss
- No appointments needed
- No cost for diagnostics since none are required (although they are recommended)
- Less expensive since there are no professional service costs for the fitting, verification of the devices, education on hearing aid handling and skills, communication strategies, follow up visits, and ongoing maintenance]
- Consumers must determine whether they need hearing aids themselves
- There are a huge number of options available from simple to complex and consumers will need to determine what is best for them without the clinical expertise of an audiologist
- Purchase decisions will most likely be based on information provided by the manufacturer without the option to the try the devices first
- Not all hearing aids are created equal
- Consumers will need to figure out how to fit the devices, troubleshoot, and manage problems themselves
- Many OTC devices are not as attractive or discreet as prescriptive devices
- Some OTC devices are ill-fit and uncomfortable
- Hearing loss is a chronic disease and as such needs to be managed over a lifetime. The professional expertise of the audiologist helping manage living with hearing loss is an essential part of successful rehabilitation for many with hearing loss
- Research to date shows that most over-the-counter devices underfit in the high pitches, which are essential for speech clarity
- There will be no way for the consumer to verify that they are providing their brain with optimal audibility, which is important for reducing listening effort and cognitive load
- If a consumer is not successful with an OTC hearing aid, they may conclude that hearing aids don’t work for them and not treat their hearing loss currently or in the future
- OTC will likely benefit younger consumers more than older consumers since there is a reliance on user-integrated digital interfaces (mobile devices), at least for the self-fit OTC devices
- Consumers may experience feedback (whistling) or occlusion (sounds like ears are plugged when speaking)
- Research shows that OTC hearing aids that can be self-fit are only appropriate if hearing thresholds (softest sounds heard) are in the range of 25-55 dB with no threshold poorer than 75dB.
- Unfortunately, no hearing test is required for OTC. It is based on consumer perception, which has been consistently shown to be inaccurate
- In once study only 38% were able to correctly classify their hearing status as mild, moderate or severe
- Most consumers are unable to determine if they are at risk for ear disease and may not be diagnosed for medical conditions that can be treated (88% of participants in one study were identified for being at risk for ear disease, but they misclassified their risk)
- In a recent study, those with normal hearing but perceived hearing difficulty wore OTC hearing aids that were reducing speech instead of amplifying speech, essentially plugging the ears
- The same study concluded that most participants were unable to successfully navigate all of the steps in the OTC hearing aid model
- 98% needed reinstruction on use and handling beyond what was provided by the manufacturer
- 53% needed reinstruction on inserting the hearing aids in the ears. This is greatly concerning as the ability to insert the hearing aids correctly significantly impacts hearing aid success (Bennett et al, 2015)
- Consumers are more likely to follow through with treating hearing loss and more likely to report satisfaction with their hearing aids when an audiologist following best practices is involved in the process (Humes et al., 2017)
- Best practices in audiology include: customized hearing aid programming, real ear verification (probe-microphone measurements), education and related counseling from the audiologist
- Overall satisfaction with hearing aids decreases 29% without audiological care (Kochkin, 2014)
- You may not be able to return the OTC devices. Right now there is no requirement from the FDA that an OTC manufacturer needs to accept returns, unlike prescription hearing aids where there is a required 45-day return privilege
- There most likely will not be the same consumer protections mandated by states who require professionals to follow licensing
- The FDA does not restrict loudness levels (gain) for OTC devices, so there is potential for an OTC device to amplify at harmful levels
- Consumers who purchase without going to a hearing healthcare provider are more likely to purchase one hearing aid versus two, not understanding the important advantages of two (e.g., better hearing-in-noise and at a distance)
- While OTC devices may provide benefit in quiet, well fit prescriptive hearing aids will most likely outperform self-selected OTC devices in noise
- The consumer will be on their own for maintaining OTC devices. The ear canal is a hostile environment for microelectronics. Hearing aids need a good amount of upkeep and the ear canals need to remain relatively free of wax
- There will most likely be a much shorter warranty on OTC devices. Prescription devices have a 3 year warranty that covers both repairs and loss and damage
- There will be less consumer confidence without guidance from an audiologist
- Consumers will most likely underfit themselves instead of going through the rehabilitative process of letting their brain adjust and rewire for what they need
- While consumers like the idea of not needing a specialist to obtain hearing loss treatment, studies show that OTC outcomes are better when a hearing healthcare professional supports them through the process
- Skipping the hearing healthcare provider will also eliminate all other forms of hearing rehabilitation including: hearing and hearing aid education, expectation management, cleaning and troubleshooting, phone use, communication strategies and counseling for family members, ongoing verification that the hearing aids are working properly, ongoing maintenance of the devices such as deep cleaning and part replacements, wax removal from ears, hearing check ups, and sending the hearing aids in for in-warranty services for 3 years
As an audiologist I am excited for over-the-counter options as they can help to empower individuals to manage their own health and wellness proactively. However, this option is appropriate only for the more tech-savvy consumers with mild hearing loss. The Lancet Commission, a highly regarded medical journal, states that treating hearing loss in midlife (age 45-65) is the number one modifiable risk factor for dementia. Most of my patients do not come to me until well after mid-life, when there has been significant neural changes due to untreated hearing loss. The seriousness of hearing loss and the value of treating hearing loss must be emphasized, and we need to make it easier for those in the beginning stages of mild hearing difficulty to seek treatment so they continue to stimulate the neural pathway and the brain. In this case, some amplification is better than no amplification.
With that said, OTC is NOT a replacement for those who need the clinical expertise of an audiologist. Those with anything more than a mild hearing problem, who are not tech-savvy, have limited dexterity, poor vision, or have underlying medical issues should seek assistance from a hearing health specialist.
Audiologists can also continue to provide significant value to consumers even if they choose to purchase OTC hearing aids by providing comprehensive testing and recommendations, guiding consumers on selection, and offering education, adjustments and support after the purchase. Unfortunately, these needed services are still not covered by Medicare or other insurance programs.