The recent U.S. Food and Drug Administration rule allowing consumers to buy hearing aids over-the-counter could prompt patients to become their own doctors and not receive the professional care they need, warns one expert.

Dr. Nicole Laffan, assistant clinical professor at Bouvé College of Health Sciences and the Audiology Clinic director at the Northeastern’s Speech-Language and Hearing Center, says she believes that the best practice is to receive professional care for hearing loss and get a prescribed hearing device. She is concerned that the new FDA rule encourages patients to become their own doctors and to determine the level of their hearing loss based on perception.

“I do not think it is for the benefit of the patient,” Laffan says.

One in eight people in the U.S., or 30 million individuals ages 12 years or older, have hearing loss in both ears, according to the National Institute on Deafness and Other Communication Disorders. About 25% of people ages 65 to 74 and 50% of those who are 75 and older have disabling hearing loss.

However, it is a misconception that mainly old people need hearing aids, Laffan says.

“There are many individuals that are experiencing hearing loss at a younger age,” she says. 

Hearing loss can occur because of a variety of reasons such as exposure to noise, ear infection, perforated ear drum, bony growth, diabetes, ototoxic medication, or a traumatic brain injury. Sometimes hearing loss can be repaired with medication or a medical procedure, while other types of hearing loss are permanent, Laffan says. 

The new FDA rule is expected to make hearing aids more affordable for consumers because they won’t need to pay for advice from audiologists and professional services such as hearing evaluation, fitting, adjustment, or maintenance to purchase OTC devices.

“We have determined that the requirements set forth in this rule-making will protect the public health by providing reasonable assurance of safety and effectiveness for hearing aids, as well as promote the hearing health of Americans by lowering barriers to access and fostering innovation in hearing aid technology,” the FDA said.

Laffan feels strongly, she says, that those who treat hearing loss need to educate the public on what it means to get a hearing aid.

“I can’t get any patient in a hearing aid without having a hearing evaluation, because I can’t determine that this patient definitely needs a device without knowing exactly how they hear at each frequency. And then I pick a device that’s powerful enough for their hearing loss and that’s programmed accurately,” she says.

Without a hearing evaluation, consumers won’t know the type or degree of their hearing loss, or what hearing device they might need.

“We are a hearing world. We communicate using speech. It is part of everybody’s job. Yet insurance companies do not support it. Where’s the legislation?”

– Dr. Nicole Laffan

– Nicole Laffan

“The majority of individuals do not have what we call a flat hearing loss,” Laffan says, meaning that the gain, or the power of sounds, don’t need to be the same at each frequency for an individual to be able to communicate well. 

If a hearing device overamplifies some sounds that can result in noise-induced hearing loss, Laffan says. 

“The hearing aid is constantly analyzing the input signal. It is so sophisticated that it determines what is speech and what is background noise, which sounds should be lowered and which should be raised,” Laffan says.  

A professional is able to understand a patient’s lifestyle and cosmetic concerns or ask the patient about any alarming symptoms such as dizziness, tinnitus or asymmetric hearing. 

“Those are some signs that we would say we want you to have medical followup because we want to make sure we can rule out that the patient does not have a tumor,” Laffan says. 

Patients with poor dexterity might struggle with changing batteries, in which case Laffan orders for them rechargeable hearing aids; if a patient can’t cross the midline of their body with one arm due to muscle or other medical issues, she recommends hearing aids that can be inserted with one hand. 

If a person with hearing loss purchases an OTC device and is wrong about their hearing or the fit is wrong or the seal is not tight and they constantly hear whistling, they may not get their money back as the FDA has not created any warranty or return policy yet, Laffan says.

She is also concerned that people with hearing loss who will have bad experience with OTC hearing aids might give up on trying to find the right device and will start to isolate themselves.

Research has shown a direct correlation between untreated hearing loss and the onset of dementia, Laffan says. Patients who struggle with hearing others start to isolate themselves and  change their lifestyle, which leads to depression and has the potential to lead to dementia.

The OTC scenario also does not take into account long-term care. Prescription hearing aids can be modified if a patient’s hearing loss gets worse. 

What might be even less obvious is that both patients and their families will miss out on counseling that an audiologist provides to help them understand the hearing loss and the changes they will need to make to accommodate it. For example, a family member might need to make sure that the person wearing hearing aids is ready to receive an auditory message by calling their name or establishing eye contact; to move closer before speaking or to have a “one-person-talker” rule at the dinner table. 

Laffan is also concerned about children, whose parents might decide to buy hearing aids for them over-the-counter.

“Who will be policing that?” Laffan says. 

Wrong or ill-fitted hearing aids can impact a child’s academic skills, speech and language skills,  self-esteem, and their career path, she says. 

Similar concern goes for individuals with special needs who are not able to communicate well that the sound is too loud or too soft. 

“I strongly believe that professionally fitted devices should be provided in order to help the patient have the best hearing health,” Laffan says. “We are a hearing world. We communicate using speech. It is part of everybody’s job. Yet insurance companies do not support it. Where’s the legislation?”

The U.S. Food and Drug Administration issued the final rule regarding over-the-counter hearing aids for adults with mild to moderate hearing loss on Aug. 17.

In its announcement, the FDA called the rule “historic” and said that consumers might be able to purchase more affordable hearing aids in stores as soon as mid-October. The rule establishes a regulatory category for OTC hearing aids, spells out labeling requirements and conditions for sale, and sets a general limit for sound pressure level. 

Consumers must be 18 years or older to purchase hearing aids over-the-counter in brick-and-mortar stores and online.

For media inquiries, please contact media@northeastern.edu.