About 5 million pairs of hearing aids are sold annually in the United States. The substantial tally allows a lot of children and adults to hear each other, better perceive their surroundings and generally communicate more effectively. The number also represents only a fraction of the population in need of hearing aids.

According to the Hearing Loss Association of America, a Maryland-based advocacy organization, an estimated 50 million Americans experience tinnitus or ringing in the ears. About 90% of those also have hearing loss.

Specifically, about 37.5 million Americans or 15% of the population at least 18 years old have hearing difficulties. Only about 20% of those affected by hearing loss use hearing aids. Reasons vary—vanity to ageism, public conception to limited budgets.

As a result, people with hearing loss wait an average of seven years before seeking help, according to the HLAA. But delaying seeking attention for hearing can have catastrophic results. Physical, emotional and mental health all can be affected. Social skills, family relationships, self-esteem, work and school performance issues also can arise via hearing deficiencies.

But much has changed in the past three years. In the aftermath of President Joe Biden’s executive order on promoting competition in the American economy in July 2021, a new Food and Drug Administration regulation went into effect Oct. 17, 2022, establishing over-the-counter devices in a category separate from prescription hearing aids.

According to the FDA, manufacturers selling hearing aids directly to consumers before Oct. 17, 2022, had until April 14, 2023, to comply with FDA regulations for OTC hearing aids.

Hoglund Family Hearing and Audiology Centers has two locations in Bonita Springs, one in Cape Coral and one in Fort Myers. Its business is to advocate the benefits of better hearing.

“We’re firm believers in the life-changing power of better hearing, so we have been anticipating the introduction of OTC hearing aids since they were first announced,” says the company website. “Anything that broadens accessibility to hearing loss treatment is a good thing.”

Sensorineural hearing loss is the most common of the three major types of hearing loss. Caused by aging, drugs, exposure to loud noise, genetics, injury or disease, it can’t be treated surgically or medically. But hearing aids can restore some hearing ability.

“The over-the-counter hearing aid market is very much evolving still, and that’s to be expected,” says Frank Lin, an epidemiologist who specializes in hearing loss at Johns Hopkins Bloomberg School of Public Health in Baltimore. “This has never happened before. The U.S. is the first country in the entire world to regulate the market for OTC, so everyone is still figuring things out.”

The FDA regulations for OTC hearing aids include stipulations for safety and efficacy:

• OTC  hearing    aids are air-conduction hearing aids intended for adults aged 18 and older with perceived mild to moderate hearing loss;

•  Manufacturers  must use clear, easy-to-read language that states “OTC hearing aid” on the website and/or package. Packaging must also include language that explains who the device is appropriate for and outlines parameters for when someone may need to see a hearing care professional;

• OTC hearing aids cannot amplify sounds more than 111 decibels of sound pressure level, or 117 decibels of sound pressure level for certain devices;

• When fully inserted into the ear canal, the deepest part of an OTC hearing aid must remain at least 10 millimeters from the eardrum. Users must also be able to change the volume.

“We know that hearing aids are not like glasses,” says the Hoglund Centers. “They’re sophisticated devices that require fine-tuning up front and service and support post-purchase. We’ve seen from experience that the best outcome is when an experienced hearing professional is involved—from testing and consultation all the way to selection, fitting and aftercare.”

Kristy Lowery, Ph.D., works with Audibel, a national hearing aid network with several locations in Southwest Florida, and writes perhaps the most convincing assessment of the effects of hearing loss and the use of hearing aids.

“The seriousness of hearing loss was profoundly detailed earlier this year in a study conducted by researchers from the University of Southern California,” says Lowery. “The study determined a direct link between hearing aid use and lower mortality rates in adults with hearing loss.”

That’s something to take in—loud and clear.