The U.S. Food and Drug Administration announced Tuesday that it will allow over-the-counter hearing aids for consumers 18 and older as early as October. The decision was applauded by audiologists.
The new rules for people with mild to moderate hearing loss will allow consumers to buy hearing aids without seeing a doctor or receiving a prescription.Companies including Best Buy are already making changes in light of the decision Announce Today, it will sell FDA-regulated hearing devices. It’s unclear whether the decision will affect the price of hearing aids, which sometimes cost thousands of dollars. Stephanie Czuhajewski, executive director of the School of Doctor of Audiology, said that while there has been speculation that over-the-counter hearing aids will be cheaper than prescription hearing aids, it still won’t be cheap.
The FDA’s move will revolutionize the way consumers typically need to use hearing aids. Currently, a person must have a hearing test, and sometimes a doctor’s recommendation, before a licensed provider dispenses hearing aids, said Sarah Sydlowski, president of the American Academy of Audiology and deputy chief improvement officer at the Cleveland Clinic.
Aside from the long process of receiving hearing aids, people don’t always consider seeking hearing care, Sydlowski said. But this is an area with a lot of need: Nearly 30 million adults in the U.S. have hearing loss, FDA quote. According to Sydlowski, this can lead to social isolation, anxiety, depression and cognitive decline.
“People haven’t recognized the importance of hearing and hearing loss in their lives,” Sydlowski said. “In some cases, they’ve been a little bit reluctant to take steps to be able to move forward and get what they need. So having the system we have now, which can feel a little bit cumbersome at times, can add some challenges. So , creating an over-the-counter option for people who are just starting to think about managing their hearing or who need more direct access, I think is a good entry point for managing hearing care.”
Nancy M. Williams, president and founder of Auditory Insight, a hearing care management consulting firm, agrees. Often people with hearing loss are battling other chronic diseases.For example, hearing loss is twice as high in diabetic patients, she American Diabetes AssociationPatients with hearing loss also had higher readmission rates because they had a harder time hearing and absorbing instructions from clinicians, Williams said.
“Hearing care has long been on the fringes of the U.S. health care system,” Williams said. “However, research in this area shows that hearing care is an important part of overall health. “
Williams said the most important item in the final rule is that the sound pressure level (dB SPL) is limited to a maximum output of 111 decibels, and with input control compression, the device allows 117 dB SPL — a measure that makes louder sounds more Gentle technique – activated.
“This means that, given the FDA’s interest in making hearing aids comfortable to wear without being distracted by clipping loud sounds, OTC hearing aids can provide a lot of power and amplification,” Williams said. “Even people with moderately high hearing loss can benefit from OTC hearing aids. “
Even people with moderately high hearing loss can benefit from OTC hearing aids, Williams said. “As such, the final rule’s power specification covers the largest share of the total U.S. population of adults with hearing loss,” according to her firm’s estimates. This is because the vast majority of people with hearing loss are in mild and moderate severity. “As a result, we expect the performance of the OTC hearing aid category in terms of pricing and product design to strongly influence the economics of the hearing aid industry as a whole,” Williams said.
While the new ruling will improve access, many audiology professionals still recommend evaluation by a clinician. This includes Czuhajewski of the Doctoral School of Audiology.
“From an ADA perspective, we think it’s important for people to know where their baseline is before making any treatment decisions, and to have an audiological evaluation where possible,” Czuhajewski said. “It’s important to know the type and extent of hearing loss, and it’s important that you know if an over-the-counter hearing aid is right for you. We don’t advocate it as a requirement in the rules, but we do recommend it.”
Williams added that not all people with hearing loss are the same. People who could benefit from over-the-counter hearing aids include those who can hear most sounds (except whispers) and those who have difficulty hearing soft sounds from three feet away, she said. People also use hearing aids for different purposes.
“Retirees may seek hearing aids to better hear their grandchildren’s soft, high-pitched voices, while those still working may rely primarily on hearing aids to perform their jobs satisfactorily,” Williams said. “Executives must Form and function are tailored to specific market segments to truly meet the needs of consumers. “
Still, the change is important, Sydlowski said, especially as hearing loss becomes more common as the use of earplugs and headphones increases.
“We’re exposed to a lot of sounds in a lot of different ways, and we’re not always…that adds to the importance I think of understanding hearing loss and why it’s so important to your health.”
Photo: PIKSEL, Getty Images
