In October 2022, new Food and Drug Administration guidelines brought notable changes to the hearing aid market. The guidelines, which were mandated by the Over-the-Counter Hearing Aid Act of 2017, aim to improve hearing aid adoption rates by increasing the accessibility and affordability of hearing aid devices.
Under the guidelines, direct-to-consumer (DTC) hearing devices that have been available for years will now be regulated by the federal government as over-the-counter (OTC) hearing aids. One of the specific measures implemented by the FDA guidelines was the establishment of “prescription hearing aids” and “over-the-counter hearing aids” as two distinct hearing aid categories.
Given that OTC hearing aids can now be obtained without a hearing aid evaluation, they can be purchased at a lower cost from retail stores and online outlets. However, it is important for consumers considering OTC hearing aids to know that their performance can vary widely from prescription hearing aids due to a number of factors.
The added value of prescription hearing aids
Prescription hearing aids can treat hearing loss of virtually any variety or severity that requires amplification, which accounts for more than 80 percent of all cases. Both their components and their level of amplification are fully customizable, which allows an audiologist to use them to precisely match a patient’s hearing loss prescription. Prescription hearing aids are also compatible with various other accessories that can be used to optimize hearing performance for a variety of different listening situations.
Prescription hearing aids — unlike OTC hearing aids — also come with professional, in-person support, often through a local audiology clinic, that facilitates repairs, adjustments, reprogramming, and ongoing maintenance. To obtain that support, however, patients must be willing to make the additional financial investment involved in seeing an audiologist and obtaining prescription hearing aids.
OTC hearing aids offer an easy entry point for those who wouldn’t otherwise consider hearing treatment. They address concerns about cost, which is one of the major deterrents to obtaining hearing aids, by providing an option that is significantly less expensive than prescription hearing aids.
Thanks to the regulatory oversight offered by the recent FDA guidelines, OTC hearing aids now also provide higher levels of effectiveness than they once did. In fact, some of the better OTC hearing aid brands have partnered with prescription hearing aid manufacturers to improve the technology in their devices. However, OTC hearing aids lack the level of performance that can only be achieved following a hearing test, professional support, and verified programming.
The importance of fine-tuning hearing aids
The custom programming that matches amplification levels to a user’s unique hearing loss prescription is what makes hearing aids effective. To achieve optimal effectiveness, that programming should follow Audiologic Best Practice protocols, such as real ear measurement (REM).
The first step toward achieving optimal results is identifying the type and configuration of hearing loss. This involves calculating a prescription for the amount of amplification based on age, gender, experience level, and hearing loss levels. Next, it is critically important to select a rubber dome or custom earmold that is comfortable and capable of controlling the amount of amplification retained inside the user’s ear canal.
After these first two steps are completed, amplification and frequency ranges are fine-tuned to ensure that the user overcomes their level of hearing loss on those frequencies. Real ear measurement protocols, which involve placing probe microphone tubes inside the patient’s ears to measure the amount of amplification they receive from hearing aids, are used at this point to verify prescriptions and programming.
If each of these steps is completed properly, users can expect their hearing aid will provide good, quality sound that improves their hearing. If not, hearing performance will suffer dramatically. When using prescription hearing aids, this responsibility falls on the shoulders of a trained and experienced hearing care professional, such as an audiologist. When using OTC hearing aids, the responsibility falls on the shoulders of the consumer.
To assist consumers, OTC hearing aids often provide smartphone apps that administer a hearing test and attempt to make adjustments based on its findings. In my experience, many OTC hearing aids are limited in the adjustments they allow, and do not adequately match performance to the user’s hearing loss prescriptions.
The need exists for both prescription and OTC hearing aid categories. While prescription hearing aids are always the most ideal option from an optimal treatment outcome standpoint, they do have more barriers to adoption, such as the higher costs associated with the need to have a hearing test from a licensed professional.
OTC hearing aids are more accessible, more affordable, and may increase hearing aid adoption rates, but they are only intended for adults with mild to moderate hearing loss. Those who choose OTC hearing aids and do not experience the relief they seek should consult with an audiologist to determine the reasons for their lack of performance and explore the potential benefits of prescription hearing aids.
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