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Your View: What you need to know about OTC hearing aids


Americans may soon be able to buy over-the-counter hearing aids without an exam or fitting by a hearing health care professional. That may seem like good news for the 3.75 million adults who suffer some form of hearing loss. However, there are sound reasons (no pun intended) to think twice before going online or heading to a store for better hearing.

First, some history.

Sen. Elizabeth Warren (D-Massachusetts) and Sen. Chuck Grassley (R-Iowa), introduced the bipartisan OTC Hearing Aid Act they felt would make hearing aids “more accessible and affordable for the consumer.” The act was signed into law in 2017. In 2021, the Food and Drug Administration issued a proposal establishing a new category: OTC hearing aids for people “over 18 with mild to moderate hearing loss.” They may be available in the fall.

My colleagues and I are aware this legislation is well-intended. However, as a doctor of audiology for more than 30 years, I have several concerns. First, hearing loss is a medical condition. Someone with vision loss, for example, sees an eye doctor. Those with hearing loss should see an audiologist, not visit a big box store. Hearing aids, like eyeglasses, need to be prescribed and fitted.

Janine Ramirez, hearing aid specialist with the Hear Again America co., examines Phyllis Lange’s ear on Oct. 20, 2021, in Fort Lauderdale, Florida. The Food and Drug Administration announced that people with mild or moderate hearing loss could soon buy hearing aids without a medical exam or special fitting. The agency says 37.5 million American adults have difficulties hearing. The new law states over-the-counter hearing aids are designated for “adults with mild to moderate hearing loss.” How does someone know the degree of hearing loss without a test, by a qualified provider in a controlled environment (sound booth)? A questionnaire that asks what a person can and can’t hear is completely subjective. And it gives only a glimpse into the severity of the hearing loss, not an accurate assessment.

Like fingerprints, everyone’s ears are different, from the shape of the ear canals to the type and degree of hearing loss. Once a person is fitted with hearing aids, an audiologist performs a painless, noninvasive procedure known as real ear measurement.

REM is considered the gold standard in audiology. It ensures the instruments are delivering proper amplification at all sound levels and in every environment. This is imperative, since improperly programmed hearing aids can do more harm than good. If they are set louder than necessary, the sound can cause permanent damage. Sustained loud noise is the most common cause of hearing damage. Even if a person shows the retailer his/her audiogram, there’s no substitute for a professional working with the patient in-person to program the instruments.

Another consideration is that hearing loss can be the result of many things, including wax build up, a foreign object in the ear or an infection. An extremely serious cause of hearing loss is what’s known as an acoustic neuroma. It’s a slow-growing tumor that presses on the hearing nerves in the inner ear. Without treatment, these tumors can be deadly.

Hearing aids won’t help and these conditions will only progress.

Hearing aids are not “one size fits all.” The type of hearing loss and the ear canal’s anatomy determine whether a person needs a custom earmold or a dome in the ear. Domes are prescribed in cases of high-frequency hearing loss (like a child’s voice), and earmolds are used for people with low-frequency loss or loss across all frequencies. However, audiologists consider other factors. People with vision loss, lack of dexterity or debilitating arthritis, for example, can handle an earmold much easier than a tiny dome that is difficult to see/maneuver.

As for cost, a pair of FDA-approved, digital hearing instruments from an audiologist can cost $1,000 or less. Most practices have no-interest payment plans and you can now lease hearing aids, just like you would a car. Whatever the cost, checkups and a starter kit of supplies are included. Most importantly, the audiologist is available to answer questions, make adjustments and provide support.

As audiologists, we earn a doctoral degree from accredited universities and are bound by a strict code of ethics. We refer patients who can’t afford hearing instruments to nonprofit organizations such as Easter Seals and Lion’s Clubs that have hearing health care programs. We send veterans to Veterans Affairs. Our mission is not simply to sell hearing aids but to help people be successful on their lifelong journeys to healthier hearing. There is no safe alternative to hearing instruments prescribed and fitted by a qualified, caring professional.

Dr. Gregory Delfino is an audiologist at Audiology Services in Bethlehem and Nazareth.

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