Preparing to Counsel Patients on OTC Hearing Aids

On August 16, 2022, the FDA finalized a rule that allowed for OTC hearing aids, an important move to increase access to these devices. In just a couple of weeks, OTC hearing aids will be available in many stores, including pharmacies. Now that an appointment with an audiologist may no longer be required, the pharmacist will now be the health care provider individuals are likely to turn to with questions. This final rule offers a potential new avenue to help patients, but can also lead a number of questions for pharmacists.

Elaine Mormer, PhD, CCC-A, professor and vice chair for Clinical Education, as well as the director of Audiology Clinical Education in the Department of Communication Science and Disorders, at the University of Pittsburgh School of Health and Rehabilitation Sciences spoke with Drug Topics® via email about why the rule was so important, what to know to help counsel, and “red flags” to watch out for that indicate an audiologist could be needed.

Drug Topics®:Why is this final rule so important?

Mormer: Hearing loss is the third most common chronic condition in older adults. Hearing aids, the most common treatment for hearing loss, had been unaffordable and inaccessible to millions of Americans prior to these regulations going into effect on October 17, 2022. The sense of hearing provides a critical pathway to understanding and maintaining one’s health and quality of life. With this new FDA- regulated category of OTC hearing aids we should see a significant impact on the public health of Americans.

Drug Topics®:What are the expected costs for the OTC hearing aids? Could this change as more options come to market?

Mormer: For consumers, price predictions for these devices seem to range from $300 to $1000 per pair. This is about 10% of the price that patients currently pay for hearing aid devices and services provided by a licensed audiologist.

Drug Topics®:What should pharmacists know, to help counsel patients?

Mormer: As frontline health providers, especially in rural and underserved areas, pharmacists are well-positioned to support patients’ safe and effective self-care solutions to hearing loss. Below are some key points to keep in mind:

• OTC hearing aids are intended for adults, age 18 and above, who self-perceive mild to moderate hearing loss. There is no requirement for pharmacists to verify age and no requirement for medical clearance or hearing test, prior to purchase.
• OTC hearing aids provide a self-care treatment option for hearing loss. This includes self-managed customization for both physical and acoustic fit, which may involve the patient’s use of software, smart phone, internet, or other accessory.
• Hearing loss can result from a very wide array of etiologies, many of which are medically treatable.In many cases, patients will not be aware of a possible underlying medical cause for their hearing loss. OTC hearing aids will be labelled with “Red Flag” conditions that should be considered exclusions to self-care.
• It can be confusing to differentiate actual OTC Hearing Aids from unregulated Personal Sound Amplification Products (PSAPS). PSAPs are sound amplifiers which are intended to enhance specific listening situations (eg, birdwatching, hunting) for listeners with normal hearing. FDA labeling will require outside packaging to clearly contain “OTC” and “hearing aid” to avoid potential product confusion.
• FDA regulations do not require a manufacturer return policy, so policies of individual suppliers should be considered.
• Hearing aids are not an instant solution to hearing loss. Unlike eyeglasses, there is a slow period of adjustment as the brain adapts to new input from the ears. Adjustment to amplified hearing can require patience and persistence.
• Continuing Education resources are available for pharmacists to learn more about OTC hearing aids. The University of Pittsburgh created an online continuing pharmacy education course on OTC hearing aids which can be accessed at https://pittprofessional.catalog.instructure.com/courses/champ

Drug Topics®:What are the “red flags” in a patient that pharmacists should look out for to suggest going to an audiologist?

Mormer: OTC hearing aid legislation does not pertain to patients under age 18 or to adults who have more than a moderate degree of hearing loss. These patients should be referred to an audiologist. In addition to these exclusions for hearing self-care, the FDA has recognized a list of “red flag” conditions that require referral to hearing health care providers, including otolaryngologists, in certain circumstances. These conditions are listed below:

1. Deformity or injury to the ear

2. Ear drainage in the past 6 months

3. Ear pain or discomfort

4. Earwax or foreign body in ear

5. Dizziness or vertigo

6. Sudden onset, change, or fluctuation in hearing loss, in past 6 months

7. Difference in hearing between ears

8. Ringing or buzzing in ear

Drug Topics®:Could a collaborative relationship between an audiologist and a pharmacist help prevent any serious issue?

Mormer: Audiologists are licensed hearing health care providers specializing in the non-medical assessment and treatment of hearing loss. Additionally, they are trained to recognize ear-related symptoms or conditions requiring medical assessment or intervention. Given these new FDA regulations, collaborations between local audiologists and pharmacists will enhance patient safety in the pursuit of self-care.For example, referral to an audiologist may uncover a potentially serious underlying medical issue, a medically treatable hearing issue, or a risk of hearing damage due to over-amplification.