Over The Counter Hearing Aids
Sep 23, 2001

 

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 were 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 ensure 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. Despite this, many have sought to treat their hearing loss with PSAPs because of the low cost (anywhere from $10 to $500). 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

Audiologists 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-degreed 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 true 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.


Hearing loss is a health issue and should be treated as such. Trust your precious sense of hearing to a doctor of audiology, the professional with the education and training to help you succeed on your journey to healthy hearing.

 

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 • 09 Jan, 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.

What is Tinnitus? Causes and Symptoms

15 Aug, 2023
Tinnitus, often described as a persistent ringing or buzzing sound in the ears, is a common auditory phenomenon that affects millions of people worldwide. While tinnitus is not a disease itself, it can be a symptom of an underlying issue. At Johnson Audiology, we are committed to helping you understand tinnitus and guiding you through the steps to manage this often-distressing condition. Understanding Tinnitus Tinnitus can vary in intensity and pitch, and it may present as a constant sound or come and go intermittently. It can be caused by a range of factors, including exposure to loud noise, age-related hearing loss, earwax blockage, and even certain medications. Tinnitus can impact your quality of life, leading to sleep disturbances, difficulty concentrating, and emotional distress. Steps to Manage Tinnitus Consult an Audiologist: If you're experiencing tinnitus, the first step is to seek professional help. A university-trained audiologist, a hearing health specialist, can conduct a comprehensive evaluation to determine the underlying cause of your tinnitus and its impact on your hearing. Identify Underlying Causes: Tinnitus often has an underlying cause, such as hearing loss, a medical condition, or exposure to loud noise. An audiologist can help identify these causes and recommend appropriate treatment options. Customized Treatment Plans: Based on the evaluation, your audiologist will develop a personalized treatment plan tailored to your specific needs. Treatment approaches may include: Hearing Aids: If hearing loss is contributing to your tinnitus, hearing aids can help by amplifying external sounds and reducing the perception of the tinnitus. More than 90% of those who have tinnitus, also, have hearing loss, even if the loss is mild. Sound Therapy: Sound therapy involves using external sounds, such as white noise or nature sounds, to mask or distract from the tinnitus noise. Counseling: Counseling and education can help you better understand tinnitus and learn coping strategies to manage its impact on your daily life. Tinnitus Retraining Therapy (TRT): TRT combines sound therapy and counseling to help you habituate to the tinnitus and reduce its perception over time. Lifestyle Modifications: Your audiologist may recommend lifestyle changes, such as managing stress, avoiding loud noise exposure, and adopting healthy sleep habits. Monitor and Adjust: Tinnitus management is an ongoing process. Regular follow-up appointments with your audiologist allow for adjustments to treatment plans based on your progress and changing needs. Seek Support: Tinnitus can be emotionally distressing. It is important to seek support from friends, family, and even support groups where you can connect with others who are experiencing similar challenges. While tinnitus can be disruptive, understanding the condition and taking proactive steps to manage it can lead to improved quality of life. At Johnson Audiology, our dedicated team of audiologists is here to guide you through the journey of tinnitus management, providing the expertise and support you need to find relief and regain control over your hearing health. Contact us today to take the first step toward a more peaceful and harmonious auditory experience.
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