The US Food and Drug Administration’s recent rule allowing consumers to buy over-the-counter hearing aids could lead to patients becoming their own doctors and not getting the professional care they need, an expert warns.
Dr. Nicole Laffan, assistant clinical professor at the Bouvé College of Health Sciences and director of the audiology clinic at the North East Speech and Hearing Center, says she believes best practice is to receive professional care for hearing loss and be prescribed a hearing aid. . She worries that the new FDA rule will encourage patients to become their own doctors and determine the level of their hearing loss based on their perception.
“I don’t think it’s in the best interest of the patient,” Laffan says.
According to the National Institute on Deafness and Other Communication Disorders, one in eight people in the United States, or 30 million people aged 12 or older, have hearing loss in both ears. About 25% of people aged 65 to 74 and 50% of those aged 75 and over have disabling hearing loss.
However, it’s a misconception that it’s mostly older people who need hearing aids, Laffan says.
“There are a lot of people who experience hearing loss at a younger age,” she says.
Hearing loss can occur for a variety of reasons such as noise exposure, ear infection, perforated eardrum, bone growth, diabetes, ototoxic medications, or 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 should 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 these regulations will protect public health by providing reasonable assurance of safety and effectiveness for hearing aids, as well as promote the hearing health of Americans by reducing barriers to access and fostering innovation in hearing. assistive technology,” the FDA said.
Laffan believes, she says, that those treating hearing loss need to educate the public about what it means to have a hearing aid.
“I can’t put a patient in a hearing aid without having a hearing assessment, because I can’t determine if that patient really needs a device without knowing exactly how they hear at each frequency. And then I choose a device that’s powerful enough for their hearing loss and programmed with precision,” she says.
Without a hearing assessment, consumers will not know the type or degree of their hearing loss, or what hearing aid they might need.
“The majority of people don’t have what we call flat hearing loss,” says Laffan, which means the gain, or loudness of sounds, doesn’t have to be the same at every frequency in order for it to be heard. an individual can communicate. good.
If a hearing aid overamplifies certain sounds, it can lead to noise-induced hearing loss, says Laffan.
“The hearing aid constantly analyzes 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,” says Laffan.
A professional is able to understand a patient’s lifestyle and aesthetic concerns or question them about any alarming symptoms such as dizziness, tinnitus, or asymmetrical hearing.
“These are signs that we would say we want you to have medical follow-up because we want to make sure we can rule out that the patient doesn’t have a tumor,” Laffan says.
Patients with poor dexterity may find it difficult to change batteries, in which case Laffan orders rechargeable hearing aids for them; If a patient cannot cross the midline of their body with one arm due to muscle problems or other medical conditions, she recommends hearing aids that can be inserted with one hand.
If a hard of hearing person buys an OTC device and gets their hearing wrong or the fit is wrong or the seal isn’t tight and they constantly hear a hissing noise, they may not get their money back because the FDA doesn’t ‘created no warranty or return. politics again, says Laffan.
She also worries that people with hearing loss who will have a bad experience with over-the-counter hearing aids will give up trying to find the right device and start isolating themselves.
Research has shown a direct correlation between untreated hearing loss and the onset of dementia, Laffan says. Patients who have difficulty hearing others begin to isolate themselves and change their lifestyle, which leads to depression and can lead to dementia.
The OTC scenario also does not take long-term care into account. Prescription hearing aids can be changed if a patient’s hearing loss worsens.
What is perhaps even less obvious is that patients and their families will be deprived of the guidance of an audiologist to help them understand the hearing loss and the changes they will need to make to cope with it. For example, a family member may need to ensure that the person wearing hearing aids is ready to receive an auditory message by calling their name or making eye contact; to get closer before speaking or to have a “nobody talking” rule at the table.
Laffan is also concerned about children, whose parents might decide to buy them over-the-counter hearing aids.
“Who’s going to watch this?” Laffan said.
Inappropriate or ill-fitting hearing aids can impact a child’s academic skills, speech and language, self-esteem and career path, she says.
A similar concern applies to people with special needs who are not able to communicate well that the sound is too loud or too quiet.
“I strongly believe that professionally fitted devices should be provided in order to help the patient achieve the best hearing health,” says Laffan. “We are a hearing world. We communicate through speech. It’s part of everyone’s job. However, the insurance companies do not support it. Where is the legislation?
The U.S. Food and Drug Administration released the final rule on over-the-counter hearing aids for adults with mild to moderate hearing loss on August 17.
In its announcement, the FDA called the rule “historic” and said consumers may be able to buy more affordable hearing aids in stores as early as mid-October. The rule establishes a regulatory category for over-the-counter hearing aids, sets out labeling requirements and conditions of sale, and sets a general limit for sound pressure level.
Consumers must be 18 or older to purchase over-the-counter hearing aids in physical stores and online.
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