Hearing Aids Will Finally Be Made Available As FDA Clears Their Sales

Cleveland Clinic

Experts say that hearing loss can be linked to several health problems. A few examples are high blood pressure and heart disease. Those who can’t hear often buy hearing aids from suppliers that sometimes are out of their area. Now, millions of Americans who suffer from hearing loss will be able to purchase their very own hearing aids from stores and online retailers. They don’t even need to set an appointment with a doctor or getting a prescription before being able to get one.

Finally, the Food and Drug Administration (FDA) has given their stamp of approval so that people can sell over-the-counter hearing aids to those who need it. This doesn’t make the device more accessible, it also makes it cheaper, something that millions can benefit from.

Patients who suffer from mild to moderate hearing loss will be able to buy these hearing aids that will be available at retail stores and online shops. They no longer need a medical exam, prescription, or fitting adjustment that’s made by an audiologist. This was said in a statement made by the FDA last August 2022. With this move, the aids may be in stores as early as mid-October, they said.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said the FDA’s commissioner, Robert M. Califf, MD. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online,” Dr. Califf also added.

study was published last October 2020. This reported that there was an average out-of-pocket cost for prescription hearing aids at around $2,500. This was a little too high for around three-quarters of Americans that have been diagnosed with functional hearing loss, and many of them just couldn’t afford to get one.

The new set of new regulations made by the FDA will be beneficial for those 18 and older in age. The younger ones who suffer from hearing loss and the older ones who have severe hearing impairment will still be required to get prescriptions.

The regulations have also covered several safety measures that have been designed to prevent hearing loss or damage to the ear canal. Included in the list are the following:

  • Lower maximum sound output so that the risk of hearing damage will be avoided
  • Reduced insertion depth when placing it in the canal to avoid injury
  • Adjustable volume controls for the user
  • Instruction manuals that are said in layman’s terms

Hearing loss has been linked to a variety of health issues such as stress, anxiety, depression, high blood pressure, and heart disease. This was according to the experts from the Centers for Disease Control and Prevention (CDC).

“Decreased hearing ability affects multiple activities of daily living and can have a pervasive impact on quality of life,” Angela Shoup, PhD, said. She is the executive director of the Callier Center for Communication Disorders and a professor of speech, language, and hearing at the University of Texas at Dallas.

“Even people with minimal hearing loss may exhibit increased stress due to difficulty communicating,” added Dr. Shoup. She is also the immediate past president of the American Academy of Audiology.

Almost 30 million adults in the U.S. could benefit from these, according to the National Institute on Deafness and Other Communication Disorders (NIDCD). People who suffer from permanent hearing impairment can use these so that speech sounds better and they can also have access to louder volumes. This will definitely enhance their capability to communicate well with the people around. More importantly, it’s the steep prices that often hinder some Americans from purchasing hearing aids, the FDA announced.

The beneficiaries of these hearing aids often have undiagnosed or untreated hearing loss, as stated by the NIDCD. Among adults who suffer from hearing loss, less than one-third of people 70 and older and less than one in six adults ages 20 to 69 years old are able to get the device.

“The biggest problem with current hearing care is affordability, as hearing aids can be expensive and there may be a lack of awareness of the potential adverse effects of hearing loss and the benefits of hearing care,” said David Loughrey, PhD. He is a brain health researcher at the University of California in San Francisco and Trinity College Dublin.

“Additionally, adults often delay seeking hearing loss treatment, sometimes for several years, and may find it harder to adjust to hearing aids when they do,” Dr. Loughrey added. “Over-the-counter hearing aids may help address these problems, as most hearing loss in the population is in the mild to moderate range rather than more severe hearing loss where professional care is more necessary.”

There are some indicative signs of mild to moderate hearing loss. Take note of what you need to watch for so that you’ll know when it’s time to get a hearing aid. According to the National Institute on Aging (NIA), some of the telltale symptoms are:

  • Difficulty hearing the person on the other line of the phone
  • Difficulty keeping track of conversations when two or more are in it
  • Often requesting for a repeat to understand what people are saying
  • Assuming that people are sometimes mumbling
  • Inability to comprehend children when they speak
  • Turning the volume of the TV so high up that you get complaints
  • Problems hearing when there’s background noise

There are several advantages to over-the-counter hearing aids such as cost and accessibility. However, a hearing test by an audiologist is often part of the insurance. When a test is done, the doctor can diagnose the magnitude and type of hearing loss you suffer from, Shoup explained. You will also get a better result rather than heading straight to the store to get the over-the-counter device, Shoup also said.

“Depending on the type and degree of hearing loss, as well as lifestyle needs, an over-the-counter device may be appropriate,” Shoup said. “However, [a professional] evaluation may reveal that medical intervention, another type of technology, or a more comprehensive hearing treatment plan would be more efficacious.”