Over-The-Counter (OTC) Hearing Devices: What you need to know today
November 15, 2021

Over-The-Counter (OTC) Hearing Devices: What you need to know today

Updated: July 13, 2021


For several years, modifications on how hearing devices are classified have been in the works. Keeping abreast of updates can be challenging since misinformation abounds on the topic. Below you will find background information as well as the most recent updates.


Two categories of hearing devices historically
Historically, two types of hearing devices where categorized—hearing aids and personal sound amplification products, or PSAPS. 


Hearing aids


For years, programmable hearing aids have been classified by the U.S. Food and Drug Administration (FDA) as Class I or Class II medical devices. The difference between Class I and Class II hearing aids is that Class II hearing aids are those that integrate wireless technology, including ear-to-ear communication and Bluetooth. In order to be fit with one of these Class I or Class II hearing aids, a patient would see a licensed hearing care professional, namely an audiologist or a hearing aid dispenser. The hearing care professional conducts a diagnostic hearing test to determine the level of hearing loss, takes measurements and/or custom earmolds, and fits the person with hearing aids based on a thorough review of the person’s unique hearing loss, common listening environments, and other needs. During the fitting process, live measurements are made while the hearing aids are in the patient’s ear with the hearing care professional using the hearing manufacturer’s computer software to minimize feedback and adjust for optimal sound quality. Additionally, real-ear measurements are used to verify targets are met to insure the person is receiving proper amplification.


Personal Sound Amplification Products, or PSAPS


Available for many years and often confused with hearing aids are PSAPs, or personal sound amplification products, that are available in retail stores and through purchase online, by mail order or over the phone. PSAPs are not hearing aids. Instead, they amplify all sounds without discernment and, therefore, are not intended for those with hearing loss. Devices for those with hearing loss need to be tailored and programmed to an individual’s specific needs. Because of the low cost of PSAPs (anywhere from $10 to $500), many have sought to treat their hearing loss with these devices, however. Historically, the FDA has differentiated between hearing aids and PSAPs as a way of protecting consumers from the potential damage that PSAPs can do to a person’s hearing since the devices can be purchased without a prescription and without a hearing evaluation or ongoing care from a trained hearing care professional.


Changes in 2017 that initiated the redefinition of hearing devices


In 2017, two pieces of Congressional legislation were passed that significantly impact hearing devices—the FDA Reauthorization Act and the Over-the-Counter Hearing Aid Act


FDA Reauthorization Act of 2017


The FDA Reauthorization Act was signed into law in 2017. This sweeping act included revisions and extensions for things like user-fee programs for drugs, generic drugs, and other similar biological products. It also included revisions for medical devices, thus opening the door for a third category of hearing devices—an over-the-counter category. The Act outlines that the new OTC class of hearing products are for people with “self-perceived mild-to-moderate hearing loss.” OTC devices will be available without a prescription or the involvement of a licensed professional for fitting and programming the hearing aids.


Over-the-Counter (OTC) Hearing Aid Act of 2017


The OTC Hearing Aid Act of 2017 was also signed into law in 2017 and is a rider on the FDA Reauthorization Act of 2017. It created a class of hearing aids regulated by the FDA that is available directly to consumers without involvement from a licensed professional like an audiologist or otolaryngologist.


FDA rules for this new class of hearing aid were expected to be released by the end of 2020, but a delay was announced last year noting the COVID-19 pandemic as the overarching factor for delay. However, further delay notices were forthcoming in March and April of this year (2021), pushing out the date when OTC regulations would be released by the FDA to potentially the end of 2022.


July 9, 2021 Executive Order


On July 9, 2021, President Joe Biden issued an executive order that included many health care related directives. The order included a directive to the Department of Health and Human Services, which oversees the FDA, to consider issuing the OTC hearing aid rules within 120 days of the order, or November 6, 2021.


Things to Consider With OTC Hearing Aids


Audiologist resoundingly resist the advent of OTC hearing aids. Using the term hearing aid to describe what will be distributed in the OTC market is misleading, at best, and dangerous at worst, to the public welfare. Here’s why.


 

Hearing loss is a health issue not a retail experience


Hearing loss and other disorders of the ear are health concerns, and should, thus, be diagnosed and treated by an audiologist, the university-trained health care provider with training and certification in conditions involving the ear and hearing. If a person has a heart condition, he seeks out a cardiologist. If a person has diabetes, she visits an endocrinologist. A person with hearing loss and other hearing disorders, like tinnitus and hyperacusis, should be treated by an audiologist or otolaryngologist, the health care providers most qualified to diagnose and treat hearing loss.


Self-fitting and self-programming a recipe for failure


OTC hearing aids are designed to be self-fitting and self-programming. Programming is based on an at-home hearing test that can produce highly varied and potentially inaccurate hearing loss measures and thus can lead to ill-fit and ill-programmed hearing devices. As the majority will likely fail to experience positive results with OTC hearing aids, they may give up on the idea of amplification completely, robbing them of the vast benefits they realize when they have hearing loss that is properly diagnosed and hearing aids that are properly fit and programmed. They also miss out on the ongoing support and care an audiologist provides.


Missed diagnoses of more serious health issues


Audiologists are often a patient’s first line of defense in detecting disease process, acoustic tumor, cerumen impaction, eardrum issues, balance disorders, etc. Hearing loss can result from a myriad of factors. Bypassing qualified hearing professionals for an OTC option may mean that a serious condition goes undetected and untreated.


Hearing loss on the rise worldwide


Hearing loss is on the rise worldwide, further punctuating the necessity for qualified professionals to treat this growing public health concern. Interestingly, political entities use the increase in hearing loss as an argument for OTC hearing aids, reasoning that OTC will offer people greater accessibility to hearing devices. Again, an inaccurately fit and programmed hearing aid, however “accessible,” does not lead to better outcomes, but rather to frustration and attrition.
 

Measuring the cost of OTC hearing devices


Political entities site cost as an overarching factor for the need for OTC hearing aids; yet, closer examination reveals that price gouging on hearing aids has much more to do with the hodgepodge of legal dispensing entities that have been allowed by the government to enter the hearing aid arena. At Johnson Audiology, we implore people to educate themselves on which entities that can dispense hearing aids, albeit legally, are the actual culprits in price gouging. Audiologists earn a doctoral degree from an accredited university, they devote years to their education while in school and beyond, and are bound by strict ethics in the way they treat patients and dispense hearing aids. Other types of dispensing entities, however, like big box store hearing aid counters and franchise hearing aid dispensers, do not necessarily operate under that same ethical code. One could argue that OTC, a retail-based dispensing entity, will likely fall into the same category—more interested in selling hearing devices than helping people be successful on a lifelong journey to healthier hearing. And while the cost may appear cheaper up front for OTC hearing aids, spending less money on a hearing device that provides limited benefit is actually less cost effective in the long run. Reputable audiologists, on the other hand, are committed to offering information and access to a wide range of support options for patients who cannot afford hearing aids. Many audiology practices commit time and human resources in working with patients’ insurance companies and third-party hearing aid plans, despite low reimbursement rates for many services. They work with Veterans by way of the VA, which offers hearing aid benefits, and they help individuals with special needs acquire hearing devices by way of state Vocational Rehabilitation programs. They put patients in touch with non-profit groups, like Easter Seals’ and Lions Club International’s hearing programs, that provide help for hearing health care, all in an effort to get people hearing again. In 2019, Johnson Audiology launched its own 501c3 non-profit to help those in need get hearing aids, the Johnson Audiology Hearing Foundation. Learn more at www.johnsonaudiology.com/foundation.

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As additional information continues to be available about OTC hearing devices, Johnson Audiology will provide further updates.

Untreated hearing loss is changing your brain

By Jan Hollingsworth • May 16, 2024
Research reveals that hearing loss actually rewires your neural pathways Your Amazing Brain Your brain is an amazing organ! This wrinkly, reddish-pink mass weighs about the same as your two-slice toaster, tipping the scales at about three pounds. Acting as a master control center, your brain enables every thought, breath, eye blink, heartbeat, movement—everything—that happens in your body. Rivaling the world’s most powerful supercomputer, your brain can download, process, and react in milliseconds to the tidal wave of information coming from your eyes, skin, nose, tongue, and ears. Neuroplasticity and Your Sense of Hearing Researchers have discovered that the human nervous system—made up of the brain, spinal cord, and a complex network of nerves—has incredible capacity to modify itself, both in function and physical structure. This is called neural plasticity . Dr. Megan Johnson, audiologist and owner of Johnson Audiology explains, “Neural plasticity is going gangbusters in a child’s brain as the child develops and matures into adulthood. Based on years of brain research, we also know that the adult brain is far from being fixed. It, too, changes and adapts when you learn new information or skills or as a response to stress, hormonal fluctuations, drug interactions, injury, and much more.” Dr. Johnson also relates that “your brain displays neuroplasticity when you experience hearing loss.” By measuring brain waves using an electroencephalograph, or EEG, scientists have studied how the brain of a person with hearing loss functions compared to a person with normal hearing. The results are both fascinating and sobering as studies reveal that, in those with hearing loss, the portion of the brain devoted to hearing becomes reorganized. This can be true even with early-stage, mild hearing loss, and the process happens quickly, often in months rather than years. The Hearing Center of Your Brain and Beyond What is actually happening when this takes place? Your brain has a right and a left hemisphere and six major lobes. Think of your frontal lobe as your brain’s boss, where executive functions like decision making, emotion and impulse control, and planning occur. Your temporal lobe, which contains the auditory cortex, is doing the heavy lifting when it comes to interpreting sounds and assigning those sounds meaning. The temporal lobe processes speech and language, and it is where initial learning of new information takes place, which is the first step for logging that information into memory. Dr. Johnson goes on to relate, “When the delicate infrastructure of your ear has become damaged through noise exposure, infection, etc. leading to hearing loss, your auditory cortex cries out to your frontal lobe, saying ‘Help! Help! I’m not receiving any sound to process, so I feel lost.’ The frontal lobe ‘boss’ jumps to attention, and your occipital lobe, responsible for processing vision and touch, takes over the areas in which hearing is normally processed. In other words, your other senses seek to compensate for the deficit due to the loss of your sense of hearing.” Amazing, right? So, where’s the rub? Picture a car assembly line; each worker has an assigned task. One day, the worker who installs the windshields is absent, and the worker who attaches the rearview mirrors is assigned double duty, and a duty that was not part of job training. It is easy to see how the worker left juggling both jobs is compromised, and a car might slip through minus a rear view mirror. Similarly, the areas of your brain that are being taxed to make up for a lack of hearing are overloaded and less able to do their assigned responsibilities. “This explains why so many of my patients with hearing loss relate feeling exhausted and frustrated after a big family gathering—where multiple talkers and sounds must be interpreted—rather than happy and invigorated by the experience. We call this listening fatigue ,” states Dr. Johnson. Additionally, when left untreated long enough, researchers point to the brain’s reorganization due to hearing loss as a significant correlation with dementia. Hearing Technology and Your Brain “But here's the great news!” Dr. Johnson says. When a person is fit with hearing aids or a cochlear implant and sound is restored, the brain has the ability to adjust back—partially or completely—to proper function. How swiftly that happens often depends on how long the hearing loss went untreated and is why she encourages patients to treat hearing loss sooner rather than later. “Here is what I tell patients who are downplaying the importance of hearing: If you won’t treat your hearing loss for the sake of your ears, do it for your brain!”

Move from the Gunbarrel Road office to a new and larger office will allow Johnson Audiology to help even more people in the Chattanooga region

By Jan Hollingsworth • January 9, 2024
Johnson Audiology is pleased to announce that the practice will be moving one of its Chattanooga area offices from its current location on Gunbarrel Road to a new location at 6830 Lee Highway. The move will take place January 15. “We are extremely excited to be re-locating to a much larger space later this month,” Dr. Megan Johnson, founder and owner of the award-winning practice, says. “About a year ago, we realized that we needed more room to meet the needs of our growing patient base so we could help even more people with hearing loss. We sought a place that would allow us to stay in the East Brainerd/Hamilton Place area so that the office would still be conveniently located for patients. Our Hixson office will remain at 5617 Highway 153, Suite 203 and is also being upgraded with a second sound booth and beautiful new decor. These two strategically located offices mean that we can continue to serve patients who live east and west of the Tennessee River.” Dr. Johnson says that when she identified the building on Lee Highway, she knew it was an ideal site for this next growth leap. “Our company culture is anchored on the premise of always offering an exceptional patient experience,” she says. “Thanks to our wonderful family of Johnson Audiology patients, we have outgrown our current office and have found the perfect location for offering the best care to even more of our Chattanooga neighbors.” The new location offers many positive features that will benefit patients: The office is conveniently located off Lee Highway in the area between Shallowford Road and Hickory Valley Road, directly behind Dr. Keith B. Dressler’s orthodontic practice. It is a stand-alone office that is not shared with any other businesses. The building is more than 4,000 square feet, which is double the space of the current office on Gunbarrel Road. The added square footage will accommodate a spacious patient welcome and reception area, three sound booths for hearing testing, and a private area for patient check-out. The building has exam rooms for four full time audiologists and an audiology assistant, a large front desk area, and a sizeable lab for hearing aid maintenance and repair. The office has ample space for the practice’s growing Cochlear Implant (CI) Program with a dedicated sound booth and exam area just for CI patients. The building design allows for easy circular patient flow throughout the office. The building has a dedicated, 20-space parking lot just for Johnson Audiology patients and additional parking for Johnson Audiology staff. Dr. Johnson mentions that the building was a non-medical office previously, so updates were needed to bring it up to par for a bustling hearing health care clinic. It currently is being remodeled, and the parking lot resurfaced. “We have plans to transition to the new building by January 15 with some final touches to the office’s aesthetics continuing through the spring,” she says.  Dr. Johnson wishes to assure folks that measures are in place to alleviate disruption to the service patients receive during this time and thanks patients in advance for their continued support and understanding during the transition. “The new office is going to be incredible!” she says. Initial correspondence has been delivered to patients about the move. Dr. Johnson says, “Patients who have appointments scheduled in early January or those who need walk-in service for hearing aid maintenance and supplies from now until January 15 should continue visiting the Gunbarrel Road location.” Dr. Johnson says, “In February, we will invite our friends and neighbors in the Chattanooga community to an open house celebration, where we will do an official reveal of the new space!” Johnson Audiology has been faithfully serving the citizens of Chattanooga since the practice opened its doors on October 1, 2009. “As we prepare to celebrate our 15th anniversary this year, the new office location on Lee Highway and the upgrades to the Hixson office are evidence of our commitment to patients.” Dr. Johnson goes on to say, “Chattanoogans have named Johnson Audiology Best of the Best in the category of Favorite Audiologist and Hearing Aid Clinic for 11 years straight. And they consistently name Johnson Audiology in the top three in the category of Best Customer Service among all Chattanooga businesses. We seek to live up to those accolades daily!” Dr. Johnson concludes, “One of our patients, Mr. Van Tenpenny, recently had this to say about us: ‘My visit to Johnson Audiology has been life changing! After decades of hearing loss, I am able to hear normal conversations in any environment.’ It is our highest ideal to be here for Mr. Tenpenny and the thousands of other patients like him who prioritize their hearing for the best quality of life.” Do you want to get on the road to healthy hearing? Johnson Audiology is currently accepting new patients at all locations. Call today to schedule an appointment or book online at www.johnsonaudiology.com/schedule.
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