![]() 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. ![]() This information can help people make informed decisions regarding selecting appropriate devices and managing their hearing loss. Hearing care specialists (Audiologists and Hearing Aid Dispensers) can test hearing and diagnose different types of hearing impairment. ![]() For this reason, it is recommended that people experiencing a hearing difficulty seek a medical professional’s advice before choosing an OTC hearing aid. Device labeling is intended to help with selecting an appropriate model.īecause hearing loss tends to develop over long periods of time, it is difficult to accurately assess the severity of your own hearing loss. However, it is essential to remember that these are not one-size-fits-all as no two individuals have identical hearing needs. Over-the counter hearing aids approved under the FDA’s proposed rule are generally lightweight and can be adjusted somewhat for comfort. 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. They capture outside sound and amplify the sound into the user’s ear canal. 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. 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. 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. 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. 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. This announcement means that hearing aids will become more accessible. This category is commonly referred to as “Over-the-Counter” or OTC. 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 regulations 5. ![]() Food and Drug Administration (FDA) issued a Final Rule to establish a medical device category for over-the-counter (OTC) hearing aids. 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. A landmark study published in 2020 4 even noted that early treatment of even mild hearing loss was important for the prevention of cognitive decline and dementia.įinding a hearing aid that provides the best quality sound, helps in challenging listening situations and is comfortable to wear is essential. When left untreated, hearing loss can significantly impact quality of life, and is associated with depression, anxiety and social isolation 3. Healthy hearing is vital to a person’s overall well-being. Appropriate hearing aids are widely accepted as valuable and effective assistance, but why is treating hearing loss so important? While the resulting communication challenges can be frustrating, research suggests that hearing loss has an impact that goes beyond annoyance 2. Approximately 1 in 7 American adults struggle with hearing loss 1.
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