Hearing experts welcome FDA approval of over-the-counter hearing aids - MedCity News

The 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 has been welcomed by audiology experts.

The new solution, designed for people with mild to moderate hearing loss, will allow consumers to buy hearing aids without the need to see a doctor or get a prescription. Companies are already making changes in light of the ruling, including Best Buy, which announced today will sell FDA-regulated hearing aids. It is unclear whether the decision will affect the prices of the hearing aids, which sometimes cost several thousand dollars. Although there is speculation that over-the-counter hearing aids will be cheaper than prescription hearing aids, they still won’t be cheap, said Stephanie Chuhajewski, executive director of the Academy of Doctors of Audiology.

The FDA’s move will dramatically change what consumers typically need to access hearing aids. Currently, a person must get a hearing test, sometimes get a referral from a doctor and then get a hearing aid from a licensed provider, said Sarah Sydlowski, president of the American Academy of Audiology and associate chief executive of the Cleveland Clinic.

In addition to the lengthy process it takes to get hearing aids, people don’t always think to seek care for their hearing, Sydlowski said. But it’s an area of ​​great need: Almost 30 million adults in the U.S. have some degree of hearing loss, the FDA said cited. This leads to social isolation, anxiety, depression and cognitive decline, according to Sidlowski.

“People still don’t realize the importance of hearing and hearing loss in their lives,” Sydlowski said. “They’re a little more reluctant to take the steps, in some cases, to be able to move forward and get what they need.” So having the system that we have now, which can sometimes seem a bit clunky, probably adds to that challenge. So creating the over-the-counter option where people who are just starting to think about managing their hearing or who need more direct access, I think that’s a great entry point into managing their hearing care.”

It’s a sentiment echoed by Nancy M. Williams, president and founder of Auditory Insight, a hearing management consulting firm. People with hearing loss often struggle with other chronic illnesses. For example, hearing loss is twice as common in people with diabetes, she said American Diabetes Association. Patients with hearing loss also have higher rates of hospital readmissions because they have a harder time hearing and digesting clinicians’ instructions, Williams said.

For too long, hearing health care has been on the fringes of the US health care system,” Williams said. “Yet, research in this area shows that hearing care is an important component of overall health.”

Williams expressed that one of the most important elements of the final rule is the maximum output limit of 111 decibels sound pressure level (dB SPL), with 117 dB SPL being permissible for devices while input-controlled compression – a technology that makes the loud sounds softer — is activated.

“This means that given the FDA’s interest in making hearing aids comfortable to wear without the distraction of loud sounds being cut out, OTC hearing aids can provide a lot of power and amplification,” Williams said.

Even people with hearing loss at the higher end of the moderate category can benefit from over-the-counter hearing aids, Williams said. “Thus, the power specifications of the final rule cover the lion’s share of the total US adult population with hearing loss,” according to her company’s estimates. This is because the majority of people with hearing loss are in the mild and moderate buckets. “So we expect that the shape that the OTC hearing aid category takes, in terms of pricing and product design, will greatly affect the economics of the entire hearing aid industry,” Williams said.

Although the new decision will improve access, many audiologists still recommend that you be evaluated by a clinician. This includes Chuhaevsky of the Academy of Doctors of Audiology.

“From an ADA perspective, we believe it’s important for people to understand where their baseline is and have an audiological evaluation if possible before making any treatment decisions,” Chuhajewski said. “It’s important to understand the type, degree of hearing loss you need to know if over-the-counter hearing aids would work for you. We’re not recommending that this be a requirement in the rule, but it’s certainly something we recommend.

Williams added that not all people with hearing loss are the same. People who could benefit from over-the-counter hearing aids range from those who can hear most voices except whispers to those who struggle with a soft voice three feet away, she said. People also have different uses for hearing aids.

A retiree may seek hearing aids to better hear the soft, high-pitched voices of their grandchildren, while people who are still working may rely mostly on hearing aids to perform their jobs satisfactorily,” Williams said. “It will be essential for executives to tailor form factors and features to specific market segments to truly meet consumer needs.”

Still, the change is significant, especially since hearing loss is becoming more common today with the increased use of earplugs and headphones, Sydlowsksi said.

“We’re exposed to a lot of sounds in a lot of different ways that we haven’t always been … it increases the importance, I think, of having that knowledge about hearing loss and why it’s so vital to your health.”

Photo: PIKSEL, Getty Images

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