On Aug. 16, 2022, the Food and Drug Administration issued a final rule to create a new category of over-the-counter (OTC) hearing devices and reclassified conventional hearing aids. Under this rule, OTC devices were made available on Oct. 17. A licensed professional must now fit hearing aids classified as “prescription.”
Here are some answers to more common questions about OTC hearing devices.
Do I need a prescription for OTC devices?
No, you can buy them without a prescription or a hearing exam.
Are OTC devices for everybody?
OTC devices are only for adults ages 18 and older with perceived mild to moderate hearing loss. If you have severe hearing loss (requiring more amplification than available with OTC) or are under age 18, you will need prescription hearing devices.
Are OTC devices the same as prescription devices?
No. The significant difference is that OTC devices will be self-fitting, so you must adjust the device settings yourself. In contrast, prescription hearing devices are fit by a licensed hearing professional to provide the right amplification levels for your unique hearing profile.
According to the new FDA guidelines, OTC devices will also have a maximum sound output of 111 decibels to reduce the risk of sound overamplification (noise exposure), user-adjustable volume control and an insertion depth limit in the ear canal. The devices must also meet performance specifications and design requirements.
Is it OK to skip a hearing evaluation and buy OTC devices?
We do encourage everyone to have a comprehensive audiology evaluation before purchasing an OTC device. One must be careful when self-diagnosing their hearing problem. Skipping a hearing evaluation may miss any serious underlying medical issues causing your hearing loss, which could have long-term consequences for your health.
If you currently wear hearing aids, we recommend that you have an updated hearing test. Hearing loss can change gradually over time, especially since OTC devices are only for certain types of hearing loss. These OTC products may not have the necessary amplification to improve your hearing and speech understanding. Most insurance plans will cover a hearing exam.
How will OTC work with an insurance hearing aid benefit?
You will need to contact your insurance company for their policy on OTC devices. Our providers work with many insurance companies to provide prescription hearing aids. While hearing aids are not a covered item with Medicare, most managed care companies offer a hearing benefit or special pricing to their members. Before purchasing an OTC device, check with your insurance provider to see if you have a hearing aid benefit.
What are the benefits of OTC devices?
The primary goal is to expand the accessibility of treating hearing loss for adults. This is especially beneficial for those who do not have hearing aid coverage with their medical insurance. It is estimated that almost 86% of Americans 50 and older with hearing loss do not wear hearing aids. Several research studies report untreated hearing loss has been linked to isolation, cognitive decline, increased falls and overall poorer health.
What role does an audiologist provide?
Audiologists play an important role in treating hearing loss. A thorough case history, including family history and current or past medical conditions, can reveal the cause of the hearing loss. The evaluation includes an assessment of red-flag conditions that require medical attention. These include sudden ear drainage, ear pain, vertigo or dizziness, sudden change in hearing (one or both ears) and ringing or other noises (one or both ears).
Audiologists can explain your test results and offer solutions to improve your quality of life with better hearing and speech understanding. Every patient’s hearing is unique to their lifestyle and hearing needs. Whether you opt for an OTC or prescription hearing aid, our providers will partner with you during your hearing health care journey.
The Bottom Line?
The Audiology Offices wants every person to treat their hearing problem. We support OTC devices, and our practice will be here as a resource for our community. We work with most insurance plans and recommend both OTC and Prescription hearing aids. Please call 800-555-5923 with any questions or to schedule a consultation.