Hearing Aids
Loren Bonner and Lauren Howell, PharmD
Whether pharmacists like it or not, OTC hearing aids are out on pharmacy shelves, said Dan Zlott, PharmD, APhA’s senior vice president of education and business development, during a panel session at the 2024 Inaugural OTC Hearing Aid and Hearing Self-Care Symposium hosted by the University of Pittsburgh. Pharmacists are getting questions about OTC hearing aids, too.
Pharmacists, audiologists, community health workers, researchers, and others all came together at the June 2024 event to discuss a public health issue that’s currently being addressed through interprofessional collaboration.
FDA-approved OTC hearing aids became available for purchase on October 17, 2022, at retail stores. With their arrival arose an opportunity for pharmacists and audiologists to collaborate, as well as for community pharmacists to begin leveraging other members of their teams—like pharmacy technicians and community health workers—to make hearing health even more accessible in their communities.
“As a pharmacist, I don’t want to be an audiologist,” said Zlott. “I’m not trained and [frankly] have no desire, but I get questions about OTC hearing aids all the time, and I want to help my patients.”
APhA offers an interprofessional advanced training program on OTC hearing aids (see box).
“We jumped on this because it’s essential,” said Zlott.
Training program modules range from screening for hearing loss and when OTC hearing aids are not appropriate to those on ear wax removal and OTC hearing aid selection and fitting.
“Maybe [a pharmacist] can point you to a product or maybe to a professional,” said Zlott.
Zlott noted that the module on referrals is perhaps the most important—and pharmacists who have gone through the training program agree. He advises pharmacists to form local connections with audiologists and to be a source for help, too.
According to Zlott, some program feedback they have received when they asked participants “what will you do differently after participating in the activity?” include:
Determine the appropriateness of OTC hearing aids for select patients, making referrals to an audiologist or physician when needed.
Be aware of the medical specialist to refer patients to for needs the pharmacist cannot meet.
Reach out to local audiologist(s) to confidently refer patients if they are not candidates for OTC hearing aids.
“There is a theme of referring and wanting to be connected to local audiologists. It came up over and over in the comments,” said Zlott. “The overwhelming majority of pharmacists are interested in working with audiologists and it being a collaborative relationship.”
Public health issue
“Patients need to know and understand the medications they are taking,” said Zlott. From a pharmacist’s perspective, it’s important for adherence that the patient can hear and understand, he said.
Many pharmacists may not realize how widespread hearing loss is.
According to Kelly Kind, AuD, PhD, from NIH who delivered the keynote address at the symposium, hearing loss is a public health issue in the United States. Roughly 13% of Americans aged 12 years and older have measurable hearing loss in both ears. This includes nearly two-thirds of individuals aged 70 years and older, according to NIH.
“America is rapidly aging, and age is the number one risk factor for hearing loss,” said Kind. Hearing loss is associated with a variety of poor health outcomes, she said, including declining physical function, falls, loneliness, and depression. It’s associated with higher health care expenditures, too. The costs include the economic burden from lost productivity and excess medical costs in the billions, according to NIH.
Research even points to an association between hearing loss and dementia, said Kind.
“Despite knowing all this, the reality is that most with hearing issues don’t seek care,” she said.
Some of the main barriers include cost and stigma.
According to the American Academy of Audiology, OTC hearing aids are meant to be less expensive than professionally fitted hearing aids. Reasons for lower cost include technology differences and buying only the device, not any professional services. OTC hearing aids typically cost between $300 and $600 per device.
In September 2024, FDA authorized the first OTC hearing aid software device intended to be used with the Apple AirPods Pro headphone. In other words, it allows compatible versions of the AirPods Pro to serve as an OTC hearing aid.
But with the entrance of OTC hearing aids—and a new software device—there’s a lot that patients need help with.
Leveraging pharmacy staff
Roughly 56% of counties across the United States have no available audiological resources. OTC hearing aids are designed to make hearing more accessible for patients, with the intention to leave out the audiologist in the process.
In rural Alabama, where most older adults don’t have access to a hearing professional, Marcia Hay-McCutcheon, PhD, from the University of Alabama Department of Communicative Disorders, is spearheading a team-based program to bring hearing health to these communities. Through her team’s research, which she presented at the symposium, they have found that adults with hearing loss didn’t know where to find services; traveling to an audiologist was excessive; and finances and insurance were lacking for patients.
“What seemed feasible from all of this was a collaboration between pharmacists and audiologists,” said Hay-McCutcheon.
However, they quickly realized that pharmacists were busy in their day-to-day work.
“Pharmacists in our Alabama cohort were very interested in having a pharmacy technician involved,” Hay-McCutcheon said. This past August, they began training pharmacy technicians “for the provision of OTC hearing aids in rural community pharmacies” and are establishing a multimodal training program for pharmacy technicians that will support those with hearing loss in rural communities.
At Klingensmith’s Drug Stores, an independent pharmacy chain in western Pennsylvania, Adam Cippel said his family, who runs the pharmacies, thought it would be a great opportunity for them to offer OTC hearing aids to patients, especially being located in rural, lower-income areas with majority older adult populations.
They employ two community health workers, and Cippel, who also spoke during the symposium, said they are integral to their OTC hearing aid program. Community health workers ask patients how their hearing is and can tell them about what the pharmacy offers.
“Even pharmacy technicians are extremely busy,” said Cippel. “Community health workers can be an even better solution because this is a very time-intensive service you are providing.” ■
APhA’s Pharmacy-Based OTC Hearing Aids advanced training program
For pharmacists and student pharmacists interested in more information on self-fit hearing aids and how to best meet the needs of their patients with hearing loss, APhA offers an interprofessional advanced training program on OTC hearing aids. The program reviews epidemiology of hearing loss, laws and regulations related to OTC hearing aids, and the pharmacists’ OTC hearing aid patient care process. To access the program, visit www.pharmacist.com/Education/Advanced-Training-Self-Paced/Pharmacy-based-OTC-hearing-aids. ■
Self-fit hearing aids are just as effective as audiologist-fit hearing aids based on long-term outcomes
Since the FDA approval of OTC hearing aids in 2022, self-fit hearing aids have gained popularity and have increased access to hearing aids for many Americans with hearing loss. A JAMA study from July 2024 found that based on long-term outcomes, self-fit hearing aids, or OTC hearing aids, may be just as effective as those fitted by an audiologist.
“The results are very encouraging that certain persons with mild to moderate hearing loss can benefit long-term from OTC hearing aid use,” said Lucas Berenbrok, PharmD, associate professor of pharmacy and therapeutics at the University of Pittsburg School of Pharmacy, who was not involved with the research.
Early studies on OTC hearing aids have predominantly focused on a patient’s ability to adjust the acoustic characteristics, the outcomes of the self-fit method, and user satisfaction with devices. Due to the short period of time that has passed since FDA approved OTC hearing aids, many questions remain regarding the sustainability and long-term efficacy of these devices.
Participants in the study were randomly assigned to two groups: one that received self-fit hearing aids and one that had an audiologist fit their device. The primary outcome was self-reported hearing aid benefit measured using two different standardized questionnaires—the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the International Outcome Inventory for Hearing Aids (IOI-HA). The APHAB is designed to assess the perceived benefits and problems with hearing aid use to determine the effectiveness of hearing aids in different listening environments. The IOI-HA is supposed to evaluate the impact of hearing aids on the quality of life and satisfaction of users.
After 8 months of using either the self-fit or audiologist-fit hearing aids, no clinically meaningful difference was found between the two groups.
“Pharmacists can look to this study to support pharmacy’s participation in hearing self-care at community pharmacies,” said Berenbrok. “Hearing self-care can include recognizing hearing loss, recommending OTC cerumen removal products, and offering OTC hearing aids.”
While the study supports individuals with mild to moderate hearing loss benefiting from using self-fit devices, OTC hearing aids are not for everyone. Pharmacists should be aware of the appropriate candidates for self-fit hearing aids, and those who do not meet the criteria for OTC hearing aid use should be referred to a hearing professional for further examination and evaluation.
“Pharmacists may face many challenges when deciding to offer OTC hearing aids,” said Berenbrok. Pharmacists should be aware that their patients may need assistance with setting up or troubleshooting an OTC hearing device and may consider engaging other members of the pharmacy team, such as technicians and interns, to help patients understand the nuances of their device.
He said before offering OTC hearing aids, pharmacists may consider education—certificate training or continuing education—to learn more about hearing and how OTC hearing aids can help certain individuals.
“Pharmacists play an important role in public health. In the matter of hearing health, pharmacists can help hearing professionals champion hearing self-care by offering affordable OTC hearing devices at accessible health care destinations like community pharmacies,” said Berenbrok. ■