By Anita Giles MS, CCC-A Audiologist
Physicians Hearing Center
Hearing is about more than just the ears. Hearing is a complex brain process. It’s the sensory system that collects and transmits information for the brain to interpret, which provides safety alerts, interprets speech, monitors our own voice, and keeps the sound areas of the brain healthy.
When the ears are unable to collect sound information, they need help. How do you assist your ears when they are no longer able to do this and keep your brain healthy? Devices called hearing aids are used.
The FDA recently finalized their hearing aid guidance for Over the Counter hearing devices, which are purchased without a medical exam or fitting by an audiologist. What exactly does this mean and how does it apply to us?
The goal is to increase the number of people who get help when they think that they have a mild/moderate hearing loss. Treating hearing loss in its early stages reduces the risks of cognitive decline, dementia, falls, social isolation, and depression.
The FDA is now using two classifications for hearing aids:
These are categorized as medical devices with standards of quality and safety regulated.
Over the Counter Hearing Aids:
Over the Counter devices are only approved for ADULTS older than age 18 with perceived mild/moderate hearing loss and are not customizable for all degrees/types of hearing loss. You make the decision about what you buy and then fit and program it yourself without professional support. Manufacturers are only required to provide email/physical address contact information. Over the Counter devices are less expensive due to technology differences and no professional services associated with the purchase.
Prescription Hearing Aids:
Prescription Hearing Aids are higher level technology devices fit by audiologists based on a comprehensive evaluation of your hearing and customized to your specific hearing loss and communication needs. Audiologists are skilled in selecting the appropriate technology, programming, and maintaining the devices, and providing follow-up care as your hearing health care partner.
Other Available Devices:
These are considered consumer electronics, not medical devices so quality can vary widely. The FDA DOES NOT regulate their safety and effectiveness. Hearing can be damaged over time if used too loudly. These devices DO NOT treat hearing loss.
Personal Sound Amplification Products:
Personal Sound Amplification Products are meant for people with normal hearing who want to amplify sound in certain situations. PSAPs make the sound louder at all frequencies and can’t be adjusted to boost specific sound ranges. They ARE NOT recommended for people with hearing loss.
(BUYER BEWARE: Personal Sound Amplification Products are being advertised as hearing aids.)
Devices worn in or on the ear (headset, earbuds) and wirelessly receive a sound signal from another device (e.g., phone, TV). Hearables provide situation-specific listening solutions but do not meet listening needs for an entire day of communication.
Hearing loss is a health care concern. It is important to identify and address any medical issues and determine the degree/type of hearing loss. The Gold Standard for the treatment of hearing loss is a comprehensive audiologic evaluation with a licensed audiologist before using any type of assistive device; just like with other health products sold to the public, it is buyer beware.
Have your hearing assessed and make an informed decision.
American Academy of Audiology
American Speech Language Hearing Association
OTC hearing aids
If you have significant hearing loss or have any of the symptoms listed below, you should not purchase an Over the Counter hearing aid without first seeing an audiologist or ear, nose, and throat (ENT) physician.
The following symptoms are examples of medical issues that should be evaluated before considering Over the Counter hearing aids:
• Malformed or misshapen ear at birth or due to trauma
• History of drainage from the ear within the previous 90 days
• History of sudden or rapidly progressive hearing loss within the previous 90 days
• Dizziness just experienced or experienced over a long time
• Hearing loss in only one ear or sudden or recent onset of hearing loss within the previous 90 days
• Significant ear wax accumulation or a foreign body in the ear canal
• Pain or discomfort in the ear
Seek medical advice if any of the above symptoms occur after using an Over the Counter hearing aid.
Who can wear Over the Counter hearing aids?
Over the Counter hearing aids will work if you have a mild to moderate hearing loss. They are not effective or right for a moderate to severe degree of hearing loss. You must be 18 years and older to wear Over the Counter hearing aids. Children should never wear them.
You must consult a medical provider before buying an Over the Counter hearing aid if you have any of the following medical conditions:
• ear deformity
• fluid, pus, or blood coming from the ear
• hearing loss or ringing (tinnitus) that occurs in only one ear or that is noticeably different in one ear
• pain or discomfort in the ear
• history of excessive earwax or feeling that something is in the ear
• pain or discomfort in the ear
• sudden, quickly worsening, or fluctuating hearing loss
• vertigo or severe dizziness
Note: Individuals with cognitive or dexterity issues may not be suitable candidates for Over the Counter hearing aids and should seek a consultation with an audiologist for hearing loss management.