On Oct. 19, 2021, the U.S. Food and Drug Administration (FDA) issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of Americans.
The agency proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing aids within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist.
The action follows President Joe Biden’s July 2021 executive order, which called for the FDA to take steps to allow stores to sell hearing aids over the counter.
OTC hearing aids aren’t available yet. If you see something marketed as a hearing aid at a store, be wary. That item is actually a one-size-fits-all sound amplifier, which cannot be fitted for your individual hearing loss.
It is our hope that OTC hearing products will expand access and increase discussions about hearing healthcare products and ear and hearing health. For the consumer, it is important to know that OTC products are designed for people who have milder hearing losses and need help hearing in some places, some of the time. Before purchasing an OTC product, the consumer should visit an audiologist to confirm that their hearing problems are a result of living and aging, rather than disease. Consumers of OTC products should understand that the products are not customized. They serve as “soundscape analyzers” to increase the volume of sound and deliver that sound safely to our ears. These products are not prescribed, have poor battery life relative to hearing aids and plug your outer ear, which makes your own voice to sound hollow. These limitations of OTC products were the primary reasons listed for nonuse of hearing aids in the late 1970s and early 1980s.
Myth: Buying OTC Hearing Aids & Skipping My Hearing Evaluation Is Okay
Reality: Hearing loss is a medical issue that requires care from a licensed professional. Audiologists hold a master’s or doctorate degree in audiology that qualifies them to diagnose, manage and treat hearing and balance problems. In addition, hearing loss is not just a condition of aging. Hearing loss can be a result of, or an indication for, many health conditions.
Myth: OTC Hearing Aids Are for Everyone
Reality: Without an evaluation by an audiologist, there’s no way to know a patient’s degree of hearing loss. OTC hearing aids are designed only for people with mild-to-moderate hearing loss and are not recommended for children or people with severe cases.
Myth: OTC Hearing Aids Work Great
Reality: OTC hearing aids ship with factory presets. Every case of hearing loss is unique, so the chance of finding a pair that works for your specific needs is slim, and retailers will likely not provide adjustments.
Myth: I Can’t Afford Traditional Hearing Aids
Reality: Medical-grade hearing aids vary in price range based upon your specific needs. Most practices have options for every budget, including flexible financing and/or leasing plans.
In fact, entry level hearing aids are similar in price to the current group of OTC products being prepared for release. The difference is that an entry-level hearing aid is a Grade II medical device that can be reprogrammed as your hearing changes.
The cost of hearing aids isn’t just for the devices—it also includes all follow-up visits, adjustments and counseling. Unfortunately, insurance companies rarely reimburse these services for adults. However, your audiologist can refer you to a clinician or therapist specializing in hearing rehabilitation if you need extended counseling or rehabilitation.
When you choose treatment from a Heuser Hearing Institute audiologist, you can take comfort in knowing that we first seek to determine the source of your hearing loss through a comprehensive evaluation. We then prioritize your needs with a customized rehabilitation and treatment plan.
Heuser Hearing Institute is here to solve your ear and hearing-related problems. If an OTC product is right for you, we will make it part of your solution. If you need more than an entry level listening solution, you’ll be in the hands of the region’s premiere hearing health care, education and research facility. Our comprehensive services give back through direct support to Heuser Hearing & Language Academy. As a patient, you also help support children who are deaf and hard of hearing in our community.