The Food and Drug Administration announced Tuesday that it will allow over the counter hearing aids for consumers 18 years and older as soon as October. The decision is being applauded by audiology experts.
The new ruling, intended for people with mild to moderate hearing loss, will allow consumers to purchase hearing aids without needing to see a physician or receiving a prescription. Companies are already making changes given the decision, including Best Buy, which announced today it will be selling FDA-regulated hearing devices.
It’s not clear whether the decision will affect prices of hearing aids, which sometimes cost several thousand dollars. While there’s speculation that over-the-counter hearing aids will be cheaper than prescribed hearing aids, it still won’t be inexpensive, said Stephanie Czuhajewski, executive director of Academy of Doctors of Audiology.
The FDA’s move will drastically change what it normally takes for consumers to access hearing aids. Currently, a person has to take a hearing test, sometimes earn a referral from a physician and then have a hearing aid dispensed by a licensed provider, said Sarah Sydlowski, president of the American Academy of Audiology and associate chief improvement officer of Cleveland Clinic.
On top of the long process it takes to receive hearing aids, people don’t always think to seek care for their hearing, Sydlowski said. But it’s an area with a lot of need: almost 30 million adults in the U.S. have some hearing loss, the FDA cited. This leads to social isolation, anxiety, depression and cognitive decline, according to Sydlowski.
“People don’t recognize yet the significance of hearing and hearing loss in their lives,” Sydlowski said. “They’re already a little bit unwilling to take the steps, in some cases, to be able to move forward and to get what they need. And so to have the system that we have now, which might feel a little bit cumbersome at times, probably adds to some of 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 this is a great entry point into managing their hearing care.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
This is a sentiment echoed by Nancy M. Williams, president and founder of Auditory Insight, a management consulting firm in hearing healthcare. Often people with hearing loss are battling other chronic conditions. For example, hearing loss is twice as common in people with diabetes, she said, citing the American Diabetes Association. Patients with hearing loss also have higher rates of hospital readmission because they have a harder time hearing and absorbing clinicians’ instructions, Williams said.
“For far too long, hearing healthcare has been on the periphery of the U.S. healthcare system,” Williams said. “Yet research in the field has shown that hearing healthcare is an important component of overall health.”
Williams expressed that one of the most significant items of the final rule is the maximum output limit of 111 decibels of sound pressure level (dB SPL), with 117 dB SPL allowable for devices while input-controlled compression — a technology to make loud sounds softer — is activated.
“What that means is that given the FDA’s interest in making hearing aids comfortable to wear, without the distraction of loud sounds being clipped, OTC hearing aids can provide a lot of power and amplification,” Williams said.
Even people with hearing losses on the higher end of the moderate category could benefit from OTC hearing aids, Williams said. “Thus, the final rule’s power specifications encompass the lion’s share of the total adult U.S. population with hearing loss,” according to her company’s estimates. That’s because the vast majority of people with hearing loss are in the mild and moderate severity buckets. “So we expect that the shape that the OTC hearing aid category takes, in terms of pricing and product design, will strongly influence the economics of the overall hearing aid industry,” Williams said.
While the new ruling will improve access, many audiology professionals still recommend getting evaluated by a clinician. This includes Czuhajewski of Academy of Doctors of Audiology.
“From an ADA standpoint, we believe that it’s important for people to understand where their baseline is, and to have an audiologic evaluation, if possible, before making any decision about treatment,” Czuhajewski said. “It’s important to understand the type, the degree of hearing loss you have, to know if over the counter hearing aids would work for you. We did not advocate that that be a requirement in the rule, but certainly it’s 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 hear most voices except for whispers to those who struggle with a soft voice three feet away, she said. People also have different uses for hearing aids.
“A retired person may pursue hearing aids to better hear grandchildren’s soft, high-pitched voices, while people still in the workforce may primarily rely on hearing aids to satisfactorily perform their job,” Williams said. “It will be essential for executives to tailor form factors and features to specific market segments in order to truly meet consumer needs.”
Still, the change is a significant one, especially as hearing loss becomes more prevalent today with increased use of earbuds and headphones, Sydlowsksi said.
“We are exposed to a lot of sound in a lot of different ways that we weren’t always … that increases the importance, I think, of having this knowledge about hearing loss and why it’s so vital to your health.”
Photo: PIKSEL, Getty Images
