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Approximately 1 in 7 American adults struggle with hearing loss1. While the resulting communication challenges can be frustrating, research suggests that hearing loss has an impact that goes beyond annoyance2. Fortunately, technology can help. Appropriate hearing aids are widely accepted as valuable and effective assistance, but why is treating hearing loss so important?
Healthy hearing is vital to a person’s overall well-being. When left untreated, hearing loss can significantly impact quality of life, and is associated with depression, anxiety and social isolation3. A landmark study published in 20204 even noted that early treatment of even mild hearing loss was important for the prevention of cognitive decline and dementia.
Finding a hearing aid that provides the best quality sound, helps in challenging listening situations and is comfortable to wear is essential. The wide range of device styles and technologies may seem overwhelming for some, and a new device category has emerged that will likely create additional confusion.
This month, the U.S. Food and Drug Administration (FDA) issued a Final Rule to establish a medical device category for over-the-counter (OTC) hearing aids. This is the result of a 2017 Federal law that directed the FDA to establish a new category for non-prescription hearing aids that would be covered by FDA regulations5. This category is commonly referred to as “Over-the-Counter” or OTC. This announcement means that hearing aids will become more accessible. However, before selecting an OTC product as a solution for hearing challenges, it is essential to understand the available options, benefits, and potential drawbacks of OTC and prescription hearing devices.
Over-the-counter hearing aids are non-prescription hearing aids that will be available at general retailers and online as soon as mid-October 2022. Intended for use by adults with perceived mild to moderate hearing difficulty, the new rule from the FDA applies to certain types of air-conduction hearing aids that differ from prescription hearing aids in a number of ways. These include a lower maximum output volume and user adjusted volume controls, and are intended to help ensure that individuals do not over amplify the sounds around them, which could actually worsen hearing loss.
These over-the-counter hearing-aid devices are typically worn behind the ears or in the ear, and essentially work the same way that wireless headphones do. They capture outside sound and amplify the sound into the user’s ear canal. Some over-the-counter hearing devices can connect to Bluetooth devices such as mobile phones and tablets, allowing a variety of uses including phone calls and audio streaming.
Over-the counter hearing aids approved under the FDA’s proposed rule are generally lightweight and can be adjusted somewhat for comfort. However, it is essential to remember that these are not one-size-fits-all as no two individuals have identical hearing needs. Device labeling is intended to help with selecting an appropriate model.
Because hearing loss tends to develop over long periods of time, it is difficult to accurately assess the severity of your own hearing loss. For this reason, it is recommended that people experiencing a hearing difficulty seek a medical professional’s advice before choosing an OTC hearing aid. Hearing care specialists (Audiologists and Hearing Aid Dispensers) can test hearing and diagnose different types of hearing impairment. This information can help people make informed decisions regarding selecting appropriate devices and managing their hearing loss.
The FDA’s announcement establishing a category of hearing aids for over-the-counter sale has some implications for public health and the hearing aid market.
Only about 1 in 5 people who could benefit from hearing aids use them, and untreated hearing loss is the #1 modifiable risk factor for dementia later in life4. Approving over-the-counter hearing aids is intended to make hearing aids more accessible for those people with mild to moderate hearing loss by removing the requirement to visit a doctor or other hearing healthcare professional, and, by removing the professional services, the overall cost to the consumer can be significantly reduced. It is not yet clear whether the over-the-counter devices will provide adequate benefits to users. This is not necessarily an indication of poor-quality devices, but rather a reflection of how difficult it might be to select an appropriate device for your specific hearing needs and then adjust it appropriately for your preferences in a wide variety of listening environments.
The new rule from the FDA aims to make hearing aid devices more accessible to those with mild to moderate hearing difficulties, but ease of purchase should not be the only factor that influences a decision by potential users. Selecting an appropriate device for the hearing loss of the user, and a style and features that fit the physical and lifestyle needs of the user, and finally, customizing the adjustment of the device and its many features may require more time, effort, and expertise than a quick trip to the local drugstore. There are, in fact, several benefits that prescription hearing aids can provide users. Prescription devices are dispensed only by hearing healthcare professionals but can provide users with an enhanced experience due to the customized adjustment or ‘fitting’ process, which should include verification testing to demonstrate the benefit of using the device in a variety of situations. Medical assessment and clearance by an Ear, Nose and Throat (ENT) physician helps to ensure that the hearing loss is not due to a medically correctable or treatable condition or potentially life-threatening condition. A professional hearing aid evaluation includes hearing testing, personal needs assessment and goal setting. This information helps an Audiologist or Hearing aid Dispenser to guide the selection and personalized adjustment of ideal devices, as well as the development of a hearing rehabilitation plan that is customized for the user. This approach and the associated professional services result in the best possible user performance and satisfaction.
The new rule from the FDA aims to make hearing aid devices more accessible to those with mild to moderate hearing difficulties, but ease of purchase should not be the only factor that influences a decision by potential users. Selecting an appropriate device for the hearing loss of the user, and a style and features that fit the physical and lifestyle needs of the user, and finally, customizing the adjustment of the device and its many features may require more time, effort, and expertise than a quick trip to the local drugstore. There are, in fact, several benefits that prescription hearing aids can provide users. Prescription devices are dispensed only by hearing healthcare professionals but can provide users with an enhanced experience due to the customized adjustment or ‘fitting’ process, which should include verification testing to demonstrate the benefit of using the device in a variety of situations. Medical assessment and clearance by an Ear, Nose and Throat (ENT) physician helps to ensure that the hearing loss is not due to a medically correctable or treatable condition or potentially life-threatening condition. A professional hearing aid evaluation includes hearing testing, personal needs assessment and goal setting. This information helps an Audiologist or Hearing aid Dispenser to guide the selection and personalized adjustment of ideal devices, as well as the development of a hearing rehabilitation plan that is customized for the user. This approach and the associated professional services result in the best possible user performance and satisfaction.
At Earlens, we are leading the revolution in hearing technology and with a unique and superior technology. We have developed a tiny lens that operates as a superior hearing aid—our product provides users with a rich and natural sound that is not achieved with conventional acoustic devices.
The Lens is placed directly on the eardrum, and high-fidelity audio sounds are transmitted directly to the lens from a behind the ear processor and custom fitted ear tip. The Lens gently vibrates the user’s eardrum across the full frequency range6. Using the Lens to directly activate the ear eliminates the need to rely on speakers to produce the amplified sound – the method used by acoustic hearing aids that may result in challenges with whistling feedback and overall disappointing sound quality. Because the Earlens system does not produce acoustic sound, users should not experience any acoustic feedback, and the broad frequency range results in rich, full, clear sound and better speech understanding and clarity in noisy situations7.
The Earlens devices are custom fit to each user to ensure a comfortable and secure fit. The Lens is placed without surgery by a trained ENT physician and cannot be felt once in position. The Lens is powered by the external processor, which uses a convenient, rechargeable battery, and incorporates Bluetooth connectivity for listening to phone calls and other audio from iPhones, iPads, and other iOS devices. Clinical data published from multiple studies illustrate the advantage of Earlens technology, in terms of speech understanding in quiet and in noise7 6. Users strongly prefer the sound quality of listening with Earlens and report reduced listening effort relative to their conventional hearing aids8. The difference is clear.
While this new ruling may address a few of the barriers that impede the adoption of hearing aids, such as perceived hearing benefit relative to price and access, it will not address the top two complaints of acoustic hearing aid users: understanding speech in background noise and sound quality. The new OTC hearing aids work in the same way as the traditional hearing aids widely available by prescription today. They amplify sound through a tiny speaker in a limited bandwidth, potentially reducing the perceived sound quality and measurable benefit to the user
Unlike traditional hearing aids, Earlens works with the natural hearing system by gently vibrating the eardrum via a tiny, custom-built lens, which delivers 2.5X the audible bandwidth of traditional hearing aids, resulting in significantly better speech understanding in background noise and improved clarity compared to conventional hearing aids.
At Earlens, we help people who are struggling with hearing loss find a solution that rises above the rest. We are committed to superior sound quality and provide hearing aid users with the best possible experience. Our product utilizes cutting-edge technology to provide users with an exceptional experience.
Contact a participating provider in your area today to learn more about Earlens and our approach to hearing loss solutions.
1: Blackwell DL, Lucas JW, Clarke TC. Summary health statistics for U.S. adults: national health interview survey, 2012. Vital Health Stat 10. 2014;(260):1-161.
2: Lin FR, Metter EJ, O’Brien RJ, Resnick SM, Zonderman AB, Ferrucci L. Hearing loss and incident dementia. Arch Neurol. 2011;68(2):214-220. doi:10.1001/archneurol.2010.362.
3: Mener DJ, Betz J, Genther DJ, Chen D, Lin FR. Hearing loss and depression in older adults. J Am Geriatr Soc. 2013;61(9):1627-1629. doi:10.1111/jgs.12429.
4: Livingston G, Huntley J, Sommerlad A, et al. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020;396(10248):413-446. doi:10.1016/S0140-6736(20)30367-6.
5: Warren E. S.670 – 115th Congress (2017-2018): Over-the-Counter Hearing Aid Act of 2017.; 2017:27-29. doi:10.1177/0002716211038002s06.
6: Arbogast TL, Moore BCJ, Puria S, et al. Achieved Gain and Subjective Outcomes for a Wide-Bandwidth Contact Hearing Aid Fitted Using CAM2. Ear Hear. 2019;40(3). doi:10.1097/AUD.0000000000000661.
7: Folkeard P, Eeckhoutte M Van, Levy S, et al. Detection, Speech Recognition, Loudness, and Preference Outcomes With a Direct Drive Hearing Aid: Effects of Bandwidth. Trends Hear. 2021;25. doi:10.1177/2331216521999139.
8: Arbogast TL, Levy SC. A Questionnaire to Assess the Subjective Benefit of Extended Bandwidth Amplification Hearing Aids. Hear Rev. 2020;27(2):24-26.
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