M&D Clinical Corner: OTC Hearing Aids
The Clinical Corner is a monthly feature that highlights a variety of important pharmacist topics that is written by Morris & Dickson’s staff pharmacist, Paula Belle (RPh).
This month’s Clinical Corner will provide an overview of OTC hearing aids that covers:
- Facts and figures.
- The role of the pharmacist.
- What factors influence patient use of hearing aids?
- Increasing hearing aid accessibility and uptake by patients.
- FDA Regulations: OTC versus prescription hearing aids.
- Mild to moderate hearing loss symptoms.
- Exclusions for self-care.
- Styles of hearing aids.
- Optional hearing aid features.
- Resources for community pharmacists, including a link to free live CE on 1-26-2023.
Facts and figures
- Approximately 15% of American adults (37.5 million) aged 18 and over report some hearing trouble.
- In the United States, hearing loss is the third-most common chronic physical condition among adults after hypertension and arthritis.
- About 28.8 million U.S. adults could benefit from using hearing aids.
- Among adults aged 70 and older with hearing loss who could benefit from hearing aids, fewer than one in three (30%) has ever used them.
- Even fewer adults aged 20 to 69 (approximately 16%) who could benefit from wearing hearing aids have ever used them.
- Untreated hearing loss causes a measurable impact to the social, occupational, and emotional well-being of adults.
- Those experiencing hearing problems are more prone to having anxiety and depressive symptoms and are likely to experience feelings of social inferiority and irritability.
- In general, poorer quality of life is linked with hearing impairment.
The role of the pharmacist
- Geographically, more than 90 percent of people in the United States live within 2 to 5 miles of a community pharmacy.
- OTC hearing aids may be offered, like reading glasses, in pharmacies and other consumer shops.
- As a result, pharmacists not only may be the most accessible frontline providers, but also be best positioned to promote hearing health and provide on-site consultation.
- In collaboration with audiologists and otologists, pharmacists can bridge the gap for patients in need of hearing assistance.
Working with patients
- OTC hearing aids will be available to patients over the counter at community pharmacies without medical evaluation by physicians and without professional services including hearing tests and device fittings by audiologists.
- As a result, pharmacists are not expected to perform the unique work of audiologists, for example, hearing tests to confirm severity of the patient’s hearing loss before purchase and fitting hearing aids after purchase.
- However, it is likely that patients will approach pharmacists, student pharmacists, and pharmacy technicians with questions about OTC hearing aids when considering devices available at the community pharmacy.
- To meet the needs and expectations of patients seeking OTC hearing aids, pharmacists must understand for whom these devices are appropriate, safe, and effective and for whom these devices may provide harm or limited benefit.
- Pharmacy professionals will be expected to have foundational knowledge of hearing loss and OTC hearing aid devices.
- Throughout the pharmacist’s assessment of the patient’s candidacy for self-care, it is important for pharmacists to relay to their patients a message of collaboration with audiologists by communicating the pharmacist’s narrow scope of practice and referring patients with greater needs to local audiologists for comprehensive hearing health care.
Working with audiologists
- Audiologists may not initially understand or appreciate how pharmacists assist patients who present to the community pharmacy with self-care needs.
- To build trust with audiologists, pharmacists may consider speaking with nearby hearing professionals to explain the pharmacist’s education, training, and expertise in order to build rapport and foster professional awareness with audiologists.
- In addition, pharmacists may consider sharing with audiologists any profession-specific processes which help pharmacists quickly evaluate and assess persons seeking OTC hearing aids at the community pharmacy.
- Pharmacists should also learn how to recognize signs of hearing loss and to refer patients seeking OTC hearing aids who are not candidates (e.g., <18 years old, severe hearing loss, exclusions for self-care) to audiologists.
What factors influence patient use of hearing aids?
- Several barriers likely impede the use of hearing aids in hearing-impaired individuals, such as:
- Their high cost.
- The patient’s perceived stigma of being perceived as old or debilitated.
- The patient’s perceived lack of value (perceived hearing benefit relative to price).
- Motivators for Use of Hearing Aids include:
- The self-perception that the patient will benefit from better hearing.
- Support of the patient’s family and social group.
- The desire to appease others.
- The acceptance of their communication problems.
- The socioeconomic status of the patient.
- The convenience of appointment scheduling.
- The length of time of hearing loss.
- The degree of difficulty understanding speech.
- The degree to which the patient experiences limitation of activities.
- The patient’s personality.
- Willingness to wear hearing aids.
- Self-recognition of the problem.
- Barriers to Use of Hearing Aids include:
- Minimization and/or denial of the problem.
- Financial limitations.
- Lack of motivation/support from family/friends.
- The stigma of hearing devices.
- Competing chronic health problems.
- Negative attitude and unrealistic expectations.
- Family and friends shared experiences.
- Factors Affecting Compliance can include:
- Education level.
- Engagement in the rehabilitation process.
- Degree of speech reception threshold gain.
- Positive support from significant other.
- Education level.
Increasing hearing aid accessibility and uptake by patients
- Prescription hearing aids cost on average more than $5,000 per pair, while the American Academy of Audiology predicts that over-the-counter (OTC) hearing aids will cost $300 to $600 per device.
- The charges and services associated with prescription hearing aids, which take an average of two to three audiology visits to acquire, are not typically covered by Medicare, Medicaid or private insurers.
- At prices similar to monthly car loan payments, hearing health care services are often exclusive to people who have the means to pay high out-of-pocket expenses.
- In a final rule issued by the Food and Drug Administration (FDA), effective October 17, 2022 a regulatory category for over-the-counter (OTC) hearing aids and related amendments to update the regulatory framework for hearing aids was established.
- The FDA established this regulatory category for OTC hearing aids to improve access to hearing aid technology for Americans.
- Before publishing the final rule, the FDA reviewed over 1,000 public opinions during the open comment period.
- The final ruling takes into account a variety of comments related to maximum sound output, product labeling and user controls.
FDA Regulations: OTC versus RX Hearing Aids
- OTC hearing aids are an alternative to prescription hearing aids, which are currently only available from hearing health professionals, such as audiologists, otolaryngologists (ear, nose, and throat doctors), and hearing aid specialists.
- The hearing health professional fits the patient for the prescription hearing aid, adjusts the device based on their hearing loss, and provides other services.
|OTC HEARING AIDS||PRESCRIPTION HEARING AIDS|
|Regulated by FDA||Yes+||Yes+|
|Levels of Hearing Loss Covered||Mild to moderate+||Mild, moderate, severe, profound+|
|Average Price Range Per Pair||$600 to 1200*||$ > 5000*|
|Hearing Exam Required||No+||Yes+|
|Fitting Appointment Required||No+||Yes+|
|Purchasing Options||Retail stores including pharmacies, online, in some hearing care clinics+||Hearing care clinics+|
+Everett, C. Over-the-Counter (OTC) Hearing Aids—What to Know | NCOA.org. 2022 [cited 2022 December]; Available from: https://www.ncoa.org/adviser/hearing-aids/over-the-counter-hearing-aids/.
*Mormer, E. and L. Berenbrock. Over-the-Counter Hearing Aids Address Significant Barriers. 2022; Available from: https://www.medicaldesigndevelopment.com/topics/devices/news/22405654/overthecounter-hearing-aids-address-significant-barriers.
|OTC HEARING AID PROS||OTC HEARING AID CONS|
|Lower average cost compared to prescription hearing aids||Not designed to treat hearing loss that is more significant or associated with an injury or underlying medical condition|
|Some brands offer remote evaluations and adjustments by an audiologist||Self-fitting, which means they cannot be custom fit for the patient’s ear|
|Many come with a smartphone app that allows the patient to adjust the volume and other settings||Typically offer fewer features than prescription hearing aids|
|No in-person hearing care provided after the purchase|
|Most OTC hearing aids come with shorter warranties than prescription hearing aids|
OTC hearing aids pros and cons
- In the regulations established by FDA OTC hearing aids are defined as:
- An air-conduction hearing aid that does not require implantation or other surgical intervention.
- Being intended for use by a person age 18 or older.
- Being intended to compensate for perceived mild to moderate hearing impairment.
- Through tools, tests, or software, allows the user to control the hearing aid and customize it to the user’s hearing needs.
- May use wireless technology or may include tests for self-assessment of hearing loss.
- Being available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online, provided that the device satisfies the requirements in this section.
- OTC hearing aids are an excellent solution for many patients with hearing loss but there are drawbacks compared to prescription hearing aids:
Mild to moderate hearing loss symptoms
- OTC hearing aids are for adults (18 and older) who believe they have mild to moderate hearing loss, even if they have not had a hearing exam. Patients might have mild to moderate hearing loss if, for example:
- Speech or other sounds seem muffled.
- They have trouble hearing when they are in a group, in a noisy area, on the phone, or when they can’t see who is talking.
- They have to ask others to speak more slowly or clearly, to talk louder, or to repeat what they said.
- They turn up the volume higher than other people prefer when watching TV or listening to the radio or music.
Exclusions for self-care
- Individuals with certain medical conditions may not benefit from OTC hearing aids and should consult their physician before purchasing them. These conditions include:
- Vertigo or dizziness.
- Pain in the ear.
- Hearing loss that quickly worsens, comes on suddenly, or comes and goes.
- Tinnitus (ringing in the ears).
- Hearing loss in only one ear or hearing loss that is significantly different in one ear from the other.
- Ear deformities.
- Pus, blood, or fluid draining from ear.
- In addition, anyone with dexterity or cognitive issues should always see an audiologist before purchasing OTC hearing aids.
Styles of hearing aids
- All hearing aids use the same basic parts to carry sounds from the environment into the ear and make them louder.
- Most hearing aids are digital, and all are powered with a traditional hearing aid battery or a rechargeable battery.
- The styles differ by size, their placement on or inside the ear, and the degree to which they amplify sound.
Behind-the-ear (BTE) aids:
- These aids have most parts contained in a small plastic case that rests behind the ear.
- The case is connected to an earmold or an earpiece by a piece of clear tubing.
- This style is often chosen for young children because it can accommodate various earmold types, which need to be replaced as a child grows.
- These are easy to clean and handle, and are relatively sturdy.
“Mini” BTE, or receiver in canal (RIC) aids:
- This aid is a type of BTE aid that fits behind the ear, but is typically smaller in size.
- A narrow tube is used to connect the aid to the ear canal.
- Mini BTEs may have a smaller earpiece for insertion, but may also use a traditional earmold.
- These earpieces may reduce the occlusion effect in the ear canal—a plugged up sensation that causes a hearing aid user’s voice to sound louder inside the head—and increase comfort, reduce feedback, and address cosmetic concerns for many users.
In-the-ear (ITE) aids:
- These aids have all parts of the hearing aid contained in a shell that fills in the outer part of the ear.
- These aids are larger than the in-the-canal and completely-in-the-canal aids.
- They may be easier to handle than smaller aids.
In-the-canal (ITC) aids and completely-in-the-canal (CIC) aids:
- These are tiny cases that fit partly or completely into the ear canal.
- They are the smallest hearing aids available and offer cosmetic and some listening advantages.
- Their small size may make them difficult to handle and adjust.
Optional hearing aid features
- There are several optional hearing aid features that can improve patients’ ability to hear in specific situations and make maintenance easier. These may include:
- Noise reduction. All hearing aids have some amount of noise reduction available. The amount of noise reduction varies. Some also offer wind noise reduction.
- Directional microphones. These are aligned on the hearing aid to provide for improved pickup of sounds coming from in front of the user with some reduction of sounds coming from behind or beside the user. Some hearing aids are capable of focusing in one direction. Directional microphones can improve the ability to hear when in an environment with a lot of background noise.
- Rechargeable batteries. Some hearing aids have rechargeable batteries. This can make maintenance easier by eliminating the need to regularly change the battery.
- Telecoils. Telecoils make it easier to hear when talking on a telecoil-compatible telephone. The telecoil reduces the sounds from the environment and picks up the sounds from the hearing-aid-compatible telephone. Telecoils also pick up signals from public induction loop systems that can be found in some churches and theaters, allowing users to hear a speaker, play or movie better.
- Wireless connectivity. Increasingly, hearing aids can wirelessly interface with certain Bluetooth-compatible devices, such as cellphones, music players, computers and televisions. Users may need to use an intermediary device to pick up the phone or other signal and send it to the hearing aid.
- Remote controls. Some hearing aids come with a remote control, so features can be adjusted without touching the hearing aid. Some hearing aids connect wirelessly to a cellphone and have a cellphone application that allows use of the cellphone as a remote control.
- Direct audio input. This feature allows users to plug in to audio from a television, a computer or a music device with a cord.
- Variable programming. Some hearing aids can store several preprogrammed settings for various listening needs and environments.
- Synchronization. For an individual with two hearing aids, the aids can be programmed to function together so that adjustments made to a hearing aid on one ear (volume control or program changes) will also be made on the other aid, allowing for simpler control.
Resources for community pharmacists
- The American Academy of Audiology is hosting a virtual web seminar entitled OTC Hearing Aids: An Opportunity for Collaboration Between Audiologists and Pharmacists on Thursday, January 26, at 4:00 pm ET.
- To further promote the collaboration of audiologists and pharmacists, this accredited session is being offered for FREE to pharmacists, just use the discount code Pharm2023 when registering.
- To learn more about the web seminar, including learning objectives, and how to register, please visit the website link here: https://eaudiology.audiology.org/products/otc-hearing-aids-an-opportunity-for-collaboration-between-audiologists-and-pharmacists.
- A checklist to help pharmacists understand whether OTC hearing aids will work for a patient: PATIENT HEARING CHECKLIST
- A link to locate nearby audiologists: ASHA ProFind
- A guide to walk pharmacists through that process of referring patients to a local audiologist or ENT when OTC hearing aids are not right for them: GUIDE TO REFERRALS
- Referral form for patients who are not a good fit for OTC hearing aids: REFERRAL FORM
- A graphic to help patients with OTC hearing aids understand when they should stop using an OTC hearing aid and seek help from an audiologist: WHEN TO STOP USING OTC HEARING AIDS INFOGRAPHIC
- A continuing education course, created by a pharmacist and audiologist, that covers the basic information pharmacists need to know about OTC hearing aids, how to assist patients, and when it is appropriate to refer to an audiologist for further testing or care: PHARMACIST LEARNING COURSE: OTC HEARING AIDS
- Pharmacists can research OTC hearing aid manufacturers as many of these may provide training to pharmacists and staff members.
- Key questions for patients to ask when exploring OTC hearing aids: QUESTIONS PATIENTS SHOULD ASK
Paula Belle (BS Pharmacy, RPh) has been the Clinical Programs Coordinator for Morris & Dickson since 2016. Prior to joining M&D, Paula held the positions of Clinical Pharmacist with Pharmacea Services and PharmMD/Adhere Health, as well as Market Pharmacist, Store Pharmacy Manager and District Pharmacy Supervisor with Walgreens. She holds a BS in Pharmacy from the University of Louisiana at Monroe, as well as Immunization and MTM Certifications from the American Pharmacists Association (APhA).
- National Institute on Deafness and Other Communication Disorders. Quick Statistics About Hearing. 2022 [cited 2022 December]; Available from: https://www.ncbi.nlm.nih.gov/pubmed/.
- Centers for Disease Control and Prevention. Occupational Hearing Loss (OHL) Surveillance | NIOSH | CDC. 2021 2021-12-02T09:50:20Z [cited 2022 December]; Available from: https://www.cdc.gov/niosh/topics/ohl/.
- Barnett, M., et al., Factors involved in access and utilization of adult hearing healthcare: A systematic review. The Laryngoscope, 2017. 127(5): p. 1187-1194.
- Hearing Health Foundation. July 28, 2022 How Pharmacists Can Help Bridge the Gap in Hearing Care for Seniors. 2022 [cited 2023 January]; Available from: https://hearinghealthfoundation.org/blogs/how-pharmacists-can-help-bridge-the-gap-in-hearing-care-for-seniors.
- Berenbrok, L.A., M. Deruiter, and E. Mormer, OTC hearing aids: An opportunity for collaborative working relationships between pharmacists and audiologists. Journal of the American Pharmacists Association, 2022. 62(6): p. 1765-1768.
- Food and Drug Administration Department of Health and Human Resources. Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. 2022 2022-08-17 [cited 2022 December]; Available from: https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids.
- Mormer, E. and L. Berenbrock. Over-the-Counter Hearing Aids Address Significant Barriers. 2022; Available from: https://www.medicaldesigndevelopment.com/topics/devices/news/22405654/overthecounter-hearing-aids-address-significant-barriers.
- National Institute on Deafness and Other Communication Disorders. Over-the-Counter Hearing Aids. 2022; Available from: https://www.nidcd.nih.gov/health/over-counter-hearing-aids.
- Code of Federal Regulations. eCFR :: 21 CFR 800.30 — Over-the-counter hearing aid controls. 2022 [cited 2022 December]; Available from: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-800/subpart-B/section-800.30.
- Everett, C. Over-the-Counter (OTC) Hearing Aids—What to Know | NCOA.org. 2022 [cited 2022 December]; Available from: https://www.ncoa.org/adviser/hearing-aids/over-the-counter-hearing-aids/.
- American Speech-Language-Hearing Association. OTC Hearing Aid Resources for Pharmacists. 2022 [cited 2022 December]; Available from: https://www.asha.org/aud/otc-hearing-aid-toolkit/resources-for-pharmacists/.
- Mayo Clinic. Hearing aids: How to choose the right one. 2022 [cited 2022 December]; Available from: https://www.mayoclinic.org/diseases-conditions/hearing-loss/in-depth/hearing-aids/art-20044116.
- National Institute on Deafness and Other Communication Disorders. Hearing Aids. 2022 [cited 2022 December]; Available from: https://www.ncbi.nlm.nih.gov/pubmed/.
- U.S. Food and Drug Administration. Types of Hearing Aids | FDA. 2022 [cited 2022 December]; Available from: https://www.fda.gov/medical-devices/hearing-aids/types-hearing-aids.
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