According to the National Institute on Deafness and Other Communication Disorders (NIDCD), a law established as part of the FDA Reauthorization Act of 2017 directed the FDA to create a new category of hearing aids for adults with perceived mild-to-moderate hearing loss called over-the-counter (OTC) hearing aids.
As part of this process, in October 2021, the FDA formally proposed a rule to establish the new OTC hearing aids category. When finalized, the rule will allow hearing aids within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist. Hearing aids for severe hearing loss or for users younger than age 18 would still require a prescription.
Why introduce a new category of hearing aids?
Only one in four adults who could benefit from hearing aids has ever used them. Making hearing aids more affordable is a public health priority, especially as the population ages and the number of people with hearing loss continues to grow. Policymakers believe making hearing aids available over-the-counter can improve access to hearing healthcare for adults.
While details regarding the sale of OTC hearing aids have not been finalized, there are some important points to be aware of if you are considering the purchase of hearing aids in the near future.
What are over-the-counter hearing aids?
The NIDCD states that OTC hearing aids are a new category of hearing aids intended to help people with perceived mild-to-moderate hearing loss.
OTC hearing aids will be an alternative to today’s FDA-regulated prescription hearing aids, which are currently only available from hearing healthcare professionals, such as audiologists, otolaryngologists (ear, nose, and throat doctors), and hearing aid specialists.
When OTC hearing aids become available, you will be able to buy them directly in stores and online. OTC hearing aids will be for adults with perceived mild-to-moderate hearing loss. They are not meant for children or for adults who have severe hearing loss or significant difficulty hearing. If you have severe hearing loss, OTC hearing aids might not be able to amplify sounds at high enough levels to help you.
The FDA is establishing regulations that manufacturers of OTC hearing aids will need to follow. In general, these federal regulations will:
- Ensure that the OTC devices are safe and effective for people with mild-to-moderate hearing loss.
- Set standards for package labels to help buyers understand OTC hearing aids and who might benefit from them. The labels will also include warnings and other information you should know before buying or when using the hearing aid, such as signs that indicate that you should see your primary care provider or other healthcare professional.
Prescription Hearing Aids
Currently, all hearing aids are prescription devices. But when OTC hearing aids become available, individuals who have more severe hearing loss will not be candidates for them. They should continue to wear prescription hearing aids that are dispensed and fit by highly trained hearing healthcare professionals, such as audiologists.
These hearing aids are programmed just for the individual’s hearing loss, and typically include features that more advanced hearing aids use, such as Bluetooth connectivity and directional microphones.
Do I need a hearing evaluation for hearing aids?
Technically, a hearing evaluation will not be needed in order to purchase OTC hearing aids once they become available. However, it will be strongly recommended. In addition, all professional organizations including the Academy of Doctors of Audiology, the American Speech-Language-Hearing Association and the American Academy of Audiologists, recommend a hearing evaluation before purchasing either OTC or prescription hearing aids.
A comprehensive hearing evaluation is the best way to determine the type and degree of hearing loss and will help you determine which type of hearing aid is the best option for you, OTC or prescription. Without a hearing evaluation, it would be difficult for you to know exactly what type of hearing loss you have and what your best options are.
In addition, if you purchase OTC hearing aids in a retail store or online, be aware that you will be responsible for fitting the hearing aids and making sure they work correctly yourself. If you purchase hearing aids from a hearing healthcare professional, they will fit and program your hearing aids, and will provide you with service and necessary support.
More information should be available in the coming months regarding the availability of OTC hearing aids. Until then, schedule an appointment with a doctoral-level audiologist for a comprehensive hearing evaluation to determine whether you have a hearing loss, and what your options are.
