On August 16, 2022,The Food and Drug Administration released its long-awaited regulations for over-the-counter hearing aids. The regulations were written to create a category for non-prescription devices (that was proposed in 2017), as well as to clean up and amend the existing hearing aid regulations. This rule will take effect in mid-October 2022.
Hearing Resources Audiology Center supports access to OTC hearing aids; we also believe that audiologists are a critical component of hearing health care. Our mission includes consumer education in technology options including prescription fitting solutions and verification of and training to use OTC options.
When it comes to hearing aids, there is no single best device for everyone. There are a lot of factors that go into which hearing aid is the best for each individual person. Hearing loss, lifestyle, auditory processing (higher level brain functioning), dexterity, finances, cosmetics, and personal preference are all important things to consider when choosing the “best” hearing aid.
It’s easy to be confused on the differences between devices that are currently for sale online and in stores, the upcoming OTC hearing aids, and prescription hearing aids. We want to give you some helpful tips when doing your research about options for your or your loved ones’ hearing loss.
PSAPs (Personal Sound Amplification Products)
Personal sound amplification products (PSAPs) are low-cost amplification devices that have been around for a long time. These traditionally can be purchased right off the shelf and via the internet. They are general sound amplifiers that are intended to amplify sounds in specific environments for people with normal hearing. (eg, hunting, listening to distant nature sounds, or listening to distant speakers). They are not programmed to an individual’s specific hearing loss or hearing needs but amplify all sounds equally. The Food and Drug Administration doesn’t allow PSAPs to be marketed as devices to improve impaired hearing.
Over-The-Counter Hearing Devices (OTC)
OTC hearing aids are newly defined by the FDA as medical devices designed to treat perceived mild to moderate hearing loss in adults 18 years and older. The idea is to improve access to hearing aids which may in turn lower costs for millions of Americans.
OTC hearing aids will be sold directly to the consumer and won’t require a hearing evaluation for purchase. We expect some limited customization available via a phone app, but there won’t be any professional care included with purchase. We will not know until mid-October 2022 what will be available or cost ranges or in what stores but do expect an online component.
Some compare OTCs to non-prescription reading glasses. These devices may work for individuals with mild or moderate hearing loss who require only a sound boost in certain settings.
Rx Hearing aids (prescription level devices) – traditional hearing aids
Prescription hearing aids can help with all degrees and types of hearing loss. These are prescribed by an audiologist after comprehensive functional communication assessment to ensure accuracy. Prescription devices offer the most sophisticated technology and are better able to treat the nuances of different types of hearing loss. They are fit via objective and subjective verification procedures including individual real ear measurements (to ensure customized to each individual ear canal resonances). Rx devices also include education and training from your audiologist based on your personal needs.
As always Rx hearing aids, OTCs or PSAPs can’t restore normal hearing, but hearing aids can improve your hearing comprehension by amplifying sounds that you’ve had trouble hearing.
Over-the-counter hearing aids will be here soon and we will all be learning what is involved with their costs, care, and maintenance. When you schedule a hearing test and/or a hearing aid consultation appointment with us, we will discuss all of these factors and more to help you decide what hearing aid would be the best option for you.
We are here for you, no matter what devices you chose. Don’t forget to check out our September blog post for tips on what to look for when considering OTC devices. Contact us anytime with your questions or schedule now for your hearing evaluation and consultation.