Over-the-Counter Hearing Aids Are On the Way

Audiologists weigh in on the new devices

By Deborah Jeanne Sergeant

Availability of over-the-counter hearing aids may become reality sometime this year.

The Food and Drug Administration recently proposed guidelines on allowing a new class of hearing aids to be sold without a prescription for people 18 and older with mild to moderate hearing loss.

Congress approved OTC hearing aids in 2017. However, the industry has been waiting on the FDA’s guidance. The bill states: “The regulations for over-the-counter hearing aids must: (1) provide reasonable assurances of safety and efficacy; (2) establish output limits and labeling requirements; and (3) describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription.”

Hearing instruments currently available include personal sound amplification products, which are currently available over the counter and hearing aids, which are prescription-only devices presently.

PSAPs are devices for people with normal hearing. These simply ramp up all sound and are used for certain hobbies such as bird watching.

OTC instruments, once available, should offer more sophisticated help than PSAPs, but the FDA is still deciding how to describe and regulate these products.

Hearing aids are much more sophisticated instruments than PSAPs lower cost OTC aids. They help users with hearing loss amplify and make sense of wanted sounds such as conversation. Top-of-the-line models use Bluetooth technology to communicate with each other to boost the user’s ability to locate sound origin. Some models can transmit phone calls and smart TV output directly to the user’s ears. OTC products will likely be much simpler as the cost associated with this kind of technology would disincentivize many consumers to purchase them.

Katherine Joyce, an audiologist at UR Medicine, sees a few benefits to offering OTC hearing aids.

“Obviously, the goal of over-the-counter hearing aid is to improve access to hearing aids,” she said. “They have lower pricing, which is a barrier for a lot of folks.”

Prescription hearing aids start at about $5,000; over-the-counter models could cost as little as $200. Consumers who feel any stigma about obtaining hearing aids may feel more comfortable purchasing devices at a familiar location—their local drugstore—instead of seeking help at a hearing device office.

Joyce said that currently, non-FDA approved devices are being sold as “hearing assistance devices” for fairly high prices, a practice she said is “price gouging. The output can be whatever you want because it’s not regulated. It can hurt you. They can be a few hundred dollars. If you pay that much, you’ve been had.”

The bill specifies that OTC devices must have reasonable assurance of safety. This may help reduce risk of injury, since the instruments do not require a professional to adjust them.

One of the aspects of OTC devices that troubles Joyce is the wording “mild to moderate hearing loss” referring to patients who would be good candidates.

“It’s vague,” she said. “Who determines that? If you come in here, you have an audiologic examination. There are degrees of hearing loss we’ll measure.”

She said that people presenting with a profound hearing loss often do not realize the extent of their hearing loss. On average, most people wait 7 to 10 years before addressing their hearing loss and do not realize how bad their hearing has become.

She hopes that patients will at least initially visit an audiologist for an exam to see if OTC devices might be appropriate and to seek follow-ups for adjustment to their devices.

Joe Kozelsky, retired audiologist and honorary board member of the Hearing Loss Association of America Rochester Chapter in Fairport, fears that many consumers will not know the difference between a well-made hearing aid and a simpler over-the-counter device.

“On one hearing aid, a circuit process at 56,000 times a second,” he said. “You don’t get that with OTC devices that amplify. It’s not easy to do.

“In addition, hearing aids also monitor the environment to detect the optimal signal you want to hear. This is happening 500 times a second. You’ve got these two factors in operation with a hearing aid circuit you don’t have with general headphones or earpieces. Hearing aids are very, very complicated.

“In addition, they ‘talk’ to each other. If someone’s on the left side you want to hear, they turn up the left side and turn down the right side. They record how many hours a day the individual uses the hearing aid. They also know what noise environments you’ve been in during that period of time.”

This type of sophisticated data logging helps hearing aid dispensers know how they need to adjust aids for the user’s optimal success.

Kozelsky said that a study from the University of Indiana indicates that the level of satisfaction among hearing instrument consumers was much higher with the guidance of a professional than when selecting an OTC device themselves.

“At one time, I queried my colleagues about who could pick out a hearing aid and walk out the door happy, and the consensus was 2% to 5%,” he added. “They’re a lot more complicated than people realize.”

Hearing instruments also need maintenance, cleaning and in some cases, battery replacement (although rechargeable devices are becoming more available).

Kelly L. Thurber is a New York State registered hearing care professional with Empire Hearing & Audiology. The organization’s New York locations include Webster, Penfield, Greece Amherst, Niagara Falls, Auburn, Cicero, New Hartford, Rome, East Syracuse and Liverpool.

Thurber compares OTC devices to drugstore reading glasses.

“If your vision is impaired, you should see an optometrist for an assessment and prescription glasses. But, if you just need a little help reading small print, a pair of OTC ‘cheaters’ can provide some help,” Thurber said.

In a similar sense, people with hearing issues should seek an evaluation from a pediatric otolaryngology specialist or audiologist to rule out any medical issues before seeking a hearing instrument. Wax build-up, ear infections or tumors could all cause hearing impairment and may be medically addressed. Simply picking up a hearing aid at the drugstore would not address the problem.

For those with an actual hearing loss, a professional exam is still important.

“Without undergoing a comprehensive hearing evaluation from a licensed hearing care professional, the actual degree of loss is unknown,” Thurber said. “The risk is that the brain will not receive the appropriate levels of amplification necessary for proper sound and speech processing with an OTC hearing aid, this could be too little or too much amplification.”

Hearing care professionals have completed training to help them offer custom hearing aid adjustments to the device that can offer the ideal hearing experience for the patient, which is especially important for patients with severe to profound hearing loss.

Mike Halloran, president of Beltone based in Glenview, Illinois, sees easier adoption as a plus of OTC hearing instruments.

“With the caveat that we still don’t know the final guidelines on OTC products, we welcome this new regulation and believe it will help many more people with mild-to-moderate hearing loss,” Halloran said.

Beltone operates locations in Batavia, Blasdell, Tonawanda, Fayetteville, Liverpool and Watertown.

Halloran said that only 20% of people treat their hearing loss. New products and care models can help people seek treatment earlier. OTC devices “will be great for consumer choice, providing people with lots of ways to treat their hearing loss sooner. That’s a very good thing.”

He expressed some concern over potential for confusion over the various types of hearing devices. He hopes that the FDA guidance will help consumers know what they are purchasing and that they will continue to seek the care of a hearing professional.