On August 17, 2022, the Food and Drug Administration (FDA) issued a historic rule enabling access to over-the-counter (OTC) hearing aids for adults who believe they may have mild-to-moderate hearing loss. This ruling followed the executive order from President Joe Biden in July 2021, directing the US Department of Health and Human Services to consider issuing proposed rules to allow hearing aids to be sold over the counter.
The rule approving the sale of OTC hearing aids is designed to assure the safety and effectiveness of OTC hearing aids while fostering innovation and competition in the hearing aid technology marketplace.
The FDA also issued final guidance on Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs). This document clarifies the differences between hearing aids (medical devices) and PSAPs (consumer products to amplify sounds for people with normal hearing).
With this rule, the FDA has created a separate category of hearing aids that can be sold directly to consumers in stores and online without needing a medical exam, prescription, or fitting adjustment by an audiologist.
The OTC category established in this final rule applies to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild to moderate hearing impairment. Hearing aids that do not meet the requirements for the OTC category (for example, because they are intended for severe hearing impairment or users younger than age 18) are prescription devices.
The rule will take effect by mid-October 2022, when consumers can buy OTC hearing aids from traditional retail and drug stores.
According to the National Institute on Deafness and Other Communication Disorders, hearing loss significantly affects the quality of life for tens of millions of adults in the United States and contributes to high healthcare costs.
Untreated hearing loss can lead to isolation and has been associated with serious conditions, such as depression, anxiety, low self-esteem, dementia, reduced mobility, and falls.
However, only one in four adults who could benefit from hearing aids has ever used them. Making hearing health care more accessible and affordable is a public health priority, especially as the number of older adults in the U.S. continues to grow.
Leading experts in science, technology, and hearing health care have been working with researchers, health professionals, and consumers to find safe and effective ways to improve access to hearing health care for adults. The availability of OTC hearing aids is a big step in this direction.
Here are some valuable facts about OTC hearing aids:
- Hearing aids are medical devices that the FDA already regulates; The OTC hearing aids will be newly regulated devices for adults with perceived mild to moderate hearing loss.
- Studies have shown that self-assessment for the degree of hearing loss is often underestimated (by younger adults) or overestimated (by older adults). Therefore, proper testing to check for the usability of OTC hearing aids is a necessary first step.
- Online hearing screenings are not a good substitute for a formal audiological exam. This is because an audiological exam will also include:
- Checks for bone conduction
- Use of audiometric masking
- Test for word recognition
- Evaluation for a comprehensive set of audio frequencies
- OTC hearing aids offer an affordable option to many more people and can make the use of hearing aids more widespread.
- OTC hearing aids are not recommended for moderate to profound hearing loss, and it is recommended that you consult an audiologist. This is because if you have moderate to profound hearing loss, you may have difficulty hearing:
- Conversations: You may hear speech but may have difficulty discerning the words clearly, especially in noisy environments. People with moderate hearing loss often need to have parts of a conversation repeated.
- Ambient sounds: Small or loud sounds in your environment, such as rustling leaves, FM radio, barking dogs, alarm clocks, car horns, public announcements, or crying babies, may not alert you the same way as those with normal hearing. This is because these sounds may be dimmer in your hearing if you have moderate to severe hearing loss.
- Extremely loud sounds: People with profound hearing loss are unable to hear even very loud sounds and may only feel the vibrations from the sounds of an airplane, motorcycle, and music concert.
- While an OTC hearing aid may offer some improvement, professionally fit hearing aids are likely to give better results since they are prescribed to meet your specific needs and level of hearing loss.
- OTC hearing aids are not programmed to the wearer’s specific hearing loss.
- While OTC hearing aids may offer a temporary solution, it is vital to evaluate your hearing loss condition medically. During an audiology consultation, an audiologist will include checks for other hearing-related issues that could indicate a serious underlying medical problem - for example, asymmetrical hearing loss.
- Unfortunately, OTC hearing aids do not give enough flexibility for each patient’s unique needs. In this case, one size OTC hearing aid does not fit all.
At Advanced Audiology Care, Dr. Fan advises his patients to get a comprehensive hearing evaluation before considering any type of hearing device. This is because a hearing evaluation will diagnose the problem more accurately and identify whether you need hearing aids for one or both ears.
The final decision about which hearing aid to purchase is always yours. The hearing evaluation will help you make a more informed decision.
If you think you may need an OTC hearing aid, contact Advanced Audiology Care at (848) 257-5510 to schedule an appointment with Dr. Fan for a comprehensive hearing evaluation. You may also request an appointment online.
