Hearing Aids
Clarissa Chan, PharmD
Through new legislation, OTC hearing aids may soon be available online and at local pharmacies for people with mild to moderate hearing loss without the need for audiologist intervention, allowing millions of Americans access to basic hearing needs. Since pharmacists will be at the forefront of helping people with hearing loss address hearing self-care needs, it is important for pharmacists to understand the basics of hearing care and collaborate with local audiologists to refer cases that are beyond self-care options.
Two experts, Lucas Berenbrok, PharmD, BCACP, associate professor at the University of Pittsburgh School of Pharmacy, and Elaine Mormer, PhD, CCC-A, audiologist and professor at the School of Health and Rehabilitation Sciences of University of Pittsburgh, collaborated to help pharmacists understand the future of hearing care. They answered some common questions about OTC hearing aids for mild to moderate hearing loss.
What is the significance of the OTC hearing aid legislation?
FDA’s OTC hearing aid legislation was proposed in October 2021 to permit hearing aids for people with mild to moderate hearing loss to be sold at local stores and online without specialist examinations and fittings. The goal is to increase affordability of safe, effective, and high-quality hearing aids for all Americans, HHS said. The agency also hopes to encourage competition, since hearing aids often cost more than $2,500 and are not covered by many insurance plans. Increased access would have a profound impact on communication and social connection to promote general well-being.
However, many hearing care professionals, including audiologists and hearing aid dispensers, are dependent on hearing aid sales to make a living.
“Some audiologists feel threatened that pharmacists will impose on their turf, [jeopardizing] their practice and profession,” said Mormer. “Others see OTC hearing aids as an opportunity to strengthen and grow their practice by working collaboratively with pharmacists. Some see it both ways.”
A frequent response from hearing care professionals during FDA’s open comment period was regarding the proposed output level or maximum sound, said Mormer. Some respondents noted that the maximal output level allowed for OTC hearing aids will be too high, placing patients at risk for further hearing loss. Others noted that OTC hearing aid volume can be adjusted to safe levels by patients themselves. However, debate remains about whether persons using OTC hearing aids will be able to recognize when amplification may cause hearing damage, said Mormer.
“Every pharmacist should establish and foster a collaborative working relationship with local audiologists in their community,” said Berenbrok. “Audiologists can be found using the Find an Audiologist tool from the American Academy of Audiology.”
What will pharmacists be asked once OTC hearing aids are available?
“It is important for pharmacists to remember that OTC hearing aids are self-care products that may not be safe or effective for everyone,” said Berenbrok. “Some people may have questions about their own eligibility for using OTC hearing aids.”
People may also have technical questions about the features and functions of the devices, like Bluetooth connectivity, customizations and controls, manufacturer’s warranty, etc., said Berenbrok.
What should pharmacists know when helping patients select hearing aids?
“Pharmacists should first establish the eligibility of persons seeking OTC hearing aids. Only persons with mild-to-moderate hearing loss should use OTC hearing aids,” said Berenbrok. “Secondly, OTC hearing aids should only be sold to adults 18 years and older.”
Pharmacists should also be familiar with contraindications which would exclude certain people with hearing loss from safely using OTC hearing aids.
How can pharmacists help troubleshoot hearing aid problems?
Patients with defective devices should be referred to the manufacturer. Patients with complex listening needs or who require refined customizations should be referred to an audiologist, said Berenbrok.
Examples of complex listening needs include listening in environments with high or distracting background noises or in settings where the content of listening is sensitive or high stakes, like restaurants and health care facilities, respectively, Berenbrok said. Examples of refined customizations include needs for custom ear molds or output levels personalized to the listener that cannot be achieved with an OTC hearing aid. ■
Exclusions for hearing loss self-care can be remembered using the mnemonic device EARSCANS:
- Experiencing dizziness or balance issues
- Asymmetrical hearing loss
- Ringing or other noises in the ear
- Sudden onset of hearing loss
- Cerumen or other occlusions in the ear
- Apparent physical deformity of the ear
- Noticeable drainage or fluid from the ear and
- Sensation of pain in the ear