In August 2017, the U.S. Food & Drug Administration (FDA) signed the FDA Reauthorization Act of 2017 (FDARA). This act allows the sale of Over-the-Counter (OTC) Hearing Aids. The FDA was tasked with developing the laws surrounding these products by August 2020. With the availability of OTC devices approaching, we thought we’d share our insight on the topic.
Before the authorization of OTC hearing devices, there were two types of on-ear amplifiers available: hearing aids and personal sound amplifiers. Though often confused, the two devices differ in their intended use.
What is a Hearing Aid?
The FDA defines a hearing aid as “any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.” Hearing aids are regulated Class I and Class II Medical Devices whose sale is governed by Federal and State governments. The FDA defines a Personal Sound Amplifier (PSAP) as “a wearable electronic product that is not intended to compensate for impaired hearing, but rather is intended for non-hearing impaired consumers to amplify sounds in the environment for a number of reasons, such as for recreational activities.” At the time of this writing, all devices marketed as “hearing aids” available in retail outlets like Wal-Mart and Walgreens are PSAPs. The definition of OTC hearing devices is pending. Still, it is suggested that OTC hearing aids follow a process of self-diagnosis, self-treatment, and self-monitoring, without the requirement for consultation with a credentialed dispenser. They are intended to fill the gap between PSAPs and traditional hearing aids, allowing an individual with mild-to-moderate hearing loss to self-treat their hearing problems.
How Hearing Aids Work
Hearing aids work by amplifying sounds in the environment to improve audibility for someone with hearing loss. Think of it as a public address (PA) system for ears. All hearing aids have microphones, amplifiers, and speakers. The microphone picks up sound in the environment, the amplifier magnifies the signal from the microphone and tells the loudspeaker how loud to output the sound to your ears.
Today’s hearing instruments are not your grandma’s hearing aids! Many devices have advanced signal processing that helps manage sound in the environment, reduces feedback, and improves comfort.
Where to Buy Hearing Aids
As of May 2020, there are no FDA-approved OTC hearing aids on the market. We believe that once the FDA approves OTC hearing instruments, they will be available anywhere electronics are sold.
Right now, hearing devices are obtained through licensed audiologists, hearing instruments specialists, and medical doctors.
You may be wondering: why see an audiologist once OTC hearing aids are approved? Although OTC hearing aids could provide some assistance for hearing difficulty, if you have a medical condition causing your hearing difficulty, you won’t find that out. An audiologist will test your ears, diagnose the issue, and make appropriate care recommendations specific to you. We take a medical and rehabilitative approach to hearing problems, beyond correcting for deficits on your audiogram.
Cost of Over-the-Counter vs. Professionally Dispensed Hearing Aids
As you can imagine, OTC hearing aids cost less than a hearing aid purchased from a licensed dispenser. Licensed professionals are required to fit the product to your ears. When you buy over the counter, you bypass this step and get a hearing aid right away – whether it fits you or not. OTC hearing aids are an “out of the box” solution, meaning users are responsible for making the appropriate adjustments to correct for their hearing loss. A DIY approach will work for some people, and that is great! However, it will not be a solution that meets everyone’s needs.
Professionally dispensed hearing aids typically have more sophisticated digital signal processing than OTC products. The computer chips in professionally dispensed hearing aids are capable of 1,200 million operations per second. They have advanced feedback and background noise suppression and other functions designed to improve comfort. This kind of technology requires significant Research & Development (R&D), and many hearing aids are Class II Medical Devices.
Hearing aid dispensers sometimes bundled other related items together with the sale of a hearing aid, and the patient doesn’t pay for services related to the hearing instruments for a duration of time. Bundling these items together increases the total sale price of the hearing aids. It’s essential to understand what you’re purchasing. At our office, you buy the hearing aids, warranties, initial supplies like batteries and wax filters, a fitting visit, and two follow-up visits. After that time, you pay as you go. This controls cost upfront and allows you to pay for what you use, not what you might use.
How Effective are Over-the-Counter Hearing Aids?
OTC hearing aids are an out-of-the-box, DIY product. Without the help of a professional, they will only be as useful as the user can make them. For some, this will be adequate or even preferred. However, there will be other people that want professional help.
Hearing aids obtained through a licensed hearing professional should be customized to meet the individual’s hearing loss. At our office, we fit hearing aids to prescriptive targets derived from your hearing test. Using probe-microphone measurements, we adjust the hearing aid’s gain to match these targets.
Potential Complications with Over-the-Counter to Consider
Without the help of a professional, the user has to adjust their hearing aids on their own. OTC manufacturers will likely include a procedure for setting the volume and validating the instrument. Experienced hearing care professionals may design the process, which may be an excellent tool for some users but a tool that could lead to frustration for many others. But how accurate will these methods be? We don’t yet know.
In the words of one of our patients: “You don’t know what you’re missing if you miss it.” This statement is simple yet profound. Will self-fitting yield the best result? How can you know if you have achieved optimum audibility without a tool to measure the output? Only the best hearing care professionals utilize the tools required to measure hearing aid output in the wearer’s ears.
Troubleshooting Over-the-Counter Devices
OTC hearing aids may be sufficient to meet the needs of some people with hearing loss. If you feel successful with these devices and wear them regularly, it is likely that at some point, the hearing aids will require service. For instance, you may need help cleaning the devices. We can help with cleaning your OTC devices.
A Side by Side Comparison of Over-the-Counter vs Professionally Dispensed Hearing Aids
OTC hearing aids have the potential to improve someone’s audibility; however, audibility is only a part of hearing. Hearing is complex. It involves your ability to pick up sounds in your environment (audibility), and your brain’s ability to process those sounds. Thus hearing care is not just about the device.
The goal of a successful hearing aid fitting is restoring audibility or loss of hearing due to physical limitations and malfunctions. When we treat someone’s hearing loss, we are attempting to restore the sounds a person is missing. Often hearing aids alone aren’t enough to treat hearing problems effectively.
An audiologist is an expert in treating hearing problems. They validate and verify that hearing devices are helping to restore audibility before proceeding with additional therapies and strategies to maximize success. Only after a hearing professional truly understands the unique challenges the patient faces, can hearing loss be effectively managed.