You may have heard that President Biden recently signed an Executive Order regarding “Over the Counter (OTC) hearing aids”. Why was this necessary? Don’t we already have OTC hearing aids? This is the first of two articles that will discuss this confusing issue.
Unregulated amplifiers have been sold for many years. True hearing aids are classified as medical devices, regulated by the Food and Drug Administration (FDA) and provided/adjusted by licensed professionals. Unregulated amplifiers must be labeled “Personal Sound Amplification Products (PSAPs)”, and the quality varies greatly. Some are essentially like turning up the volume on your TV. Others have adjustments for base and treble, and may be helpful for a subset of listeners. However, inadequate sound amplification can be worse than no aid at all, and this confusion has caused many consumers to lose faith in the ability of any hearing device to help them communicate.
In 2017, Congress directed the FDA to develop regulations for OTC aids, to be limited to people who perceive that they have a mild to moderate hearing loss. The goal is to balance affordability with safety and effectiveness, and the Executive Order is a directive to carry out this already approved process.
To be successful, however, the regulations must acknowledge that estimates of “perceived” loss differ among individuals, and that there will inevitably be “unintended users” of these products. A group of hearing health associations crafted a consensus paper that spells out the consequences that can be avoided with careful rollout of these devices. It cites studies that have shown that younger people tend to over‐estimate their hearing losses while older people tend to underestimate their hearing losses. In other words, OTC aids are likely to be either too loud or not loud enough for many users. There must be a plan in place to tell them what to do in that case, or they will likely give up in frustration.
Audiologists are the healthcare providers who are uniquely trained to prevent, diagnose and treat hearing disorders. Untreated hearing loss is possible at any age, and has been associated with social isolation, reduced mobility, dementia, and poorer quality of life. Most people have never had a complete hearing evaluation with an audiologist; many have never even had their hearing screened. Stigma can profoundly influence whether someone is even willing to have their hearing tested, perhaps because they are not ready to consider the likely recommendation. This is especially true if they know someone who has had a negative experience with amplification. Unfortunately, many of those negative experiences could have been avoided if the user had received (or taken advantage of) professional support. Most hearing aids need to be individually programmed, not only to compensate for each individual’s loss, but also for their personal perceptions of listening comfort. The audiologist will verify that the aids are appropriately programmed, and if hearing changes over time the aids can be appropriately re-adjusted. And like any electronic device, they can malfunction and need repair. Especially given that they are routinely subject to earwax, dust, sweat, and hairstyling products, etc.
“Loudness” is only one aspect of listening with hearing aids. Many people hear low-pitched sounds well, but lose sensitivity for high-pitched sounds. They will know that someone is talking, but may not understand them even if the overall volume is turned up. Those listeners need very different hearing aids than someone whose loss is equal across the frequency range and just need the volume turned up. It’s also possible to have loss mostly in the low frequencies, and the usual “treble boost” will sound shrill and unpleasant. An OTC aid designed for the “average” listener may not be very helpful for the majority of listeners. Without a frequency-specific hearing test, there is no way to know how your particular loss is configured.
And without a true diagnostic hearing evaluation, the *type* of loss cannot be determined at all. And that can lead to potentially serious consequences. The worst outcome from an inappropriate OTC fitting *isn’t* that someone will get minimal benefit and incorrectly assume that they can’t benefit from hearing aids. Rather, someone may use OTC aids to improve their hearing, when the cause of the hearing loss is something that should be medically addressed. It’s like turning up the car radio to drown out your squealing brakes — a serious problem might be undiscovered until it causes serious problems. During the course of a full diagnostic evaluation, an audiologist will become aware of signs that someone needs to see a physician. These signs are rarely uncovered during a hearing screening alone. Ruling out potential problems is part of “consumer protection”.
Posted: Aug 21, 2021