FDA Approves Over the Counter (OTC) Hearing Aids
The US Food and Drug Administration (FDA) ruled on August 16, 2022 legalization of ‘Over the counter’ or OTC hearing aids that will take effect within 60 days (estimated mid October 2022). These products will be available online and in stores to customers without the need of a licensed hearing professional to test or fit the products. What does this mean for you, and how are these products different from currently available hearing aids?
What does over the counter hearing aids mean?
Over the Counter hearing aids are a new class of hearing devices. Different from a traditional or prescription hearing aids, these hearing devices do not require a hearing test or licensed hearing professional to fit. Over the counter hearing aids come with general settings with the ability to make small limited adjustments, typically lumping low and high frequencies. There is also a mandatory volume control. These hearing aids are only designed to assist someone with mild to moderate self-perceived hearing loss.
Over the Counter Hearing Aids
Over the Counter Hearing Aids
How is it different from traditional prescription hearing aids?
Traditional prescription hearing aids are specifically customized to the needs and comfort of you, the patient. A licensed hearing professional takes you through a series of physical exams and audio tests to understand your specific hearing needs. Your provider will adjust different frequencies of the device to match your specific hearing loss needs. The hearing aid can be physically molded to your ear for added comfort and better sound quality. The result is the most natural sounding hearing solution possible.
What services are included with over the counter hearing aids?
Typically, over the counter hearing aids are self-fit with no assistance or licensed hearing professional support. At Starkey, we believe that everyone should experience the joy of hearing. That is why we are offering annual exams and trouble shooting appointments to all hearing aid wearers. Regardless of where you purchased or what manufacturer, we can help ensure you are hearing to the best of your ability.
What levels of loss are treatable with which type of device?
The FDA limits over the counter hearing aids to mild-to-moderate self-identified hearing loss only. This is to protect patients from potential harm of over amplification which can result in permanent damage and significant hearing loss. Prescription hearing aids that are fit by a licensed hearing professional can work for all levels of hearing loss from mild to profound.
How will I know what my hearing loss is?
There are several online hearing tests available (Try ours here) however they are not perfect medical tests. The only way to get an accurate reading of hearing loss is to go to a licensed hearing professional. Both an audiogram and a physical examination are required to get an accurate result.
Clinically, hearing loss falls into different degrees. Mild, Moderate, Severe and Profound are some of the most common degrees with variations in between. Your hearing loss degree depends on your ability to hear different pitches (frequencies) at different volumes (decibels dB). Hearing threshold of Mild loss is 26-40 dB, Moderate is 41-55 dB, Severe is 71-90 dB and Profound is over 91dB.