A change in FDA regulations has cleared the way for OTC hearing aids, which certainly changes how individuals with hearing challenges might go about getting the help they need.
There are several things you need to know about OTC hearing aids, such as how they compare to prescription devices and the advantages of a personalized hearing care journey.
So, what do you need to know about OTC and prescription hearing aids to make an informed choice?
Know the Difference Between Hearing Aids and Personal Sound Amplification Products
It is essential to know the difference between prescription or OTC hearing aids and personal sound amplification products (PSAPs). PSAPs are not tailored to an individual’s hearing loss and aren’t regulated by the FDA or intended to treat hearing loss.
However, the FDA does regulate hearing aids to make sure they provide reasonable assurance of safety and effectiveness. Let’s take a closer look at the FDA’s requirements for hearing aids sold over the counter, which are intended for people 18 years of age and older who have perceived mild to moderate hearing loss, and compare them to PSAPs to help eliminate any confusion.
Over-the-Counter (OTC) Hearing Aids
The new regulation applies to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild to moderate hearing loss. However, authors of the new law were careful to point out that “it is important for people to recognize that hearing loss could be a sign of an easily treatable problem like built-up earwax or a more serious problem like a benign tumor on the hearing nerve. See a doctor when things don’t feel right, when your hearing loss is progressing, or if you are having associated symptoms like dizziness, ear pain, or drainage from the ear canal.”
Personal Sound Amplification Products
PSAPs are regulated as consumer electronics and not medical devices, so they may be more variable in terms of product quality when compared to hearing aids.
Prescription Hearing Aids
OTC hearing aids are similar to “readers” or “cheater” eyeglasses, which are widely available for people who are not ready to commit to fulltime-use eyeglasses or who might not need to use glasses all the time. Those who have significantly impaired vision need custom-fit eyeglasses with prescription lenses.
Similarly, prescription hearing aids are for those who perceive their hearing loss to be more disruptive to communication. Prescription hearing aids are specifically programmed to meet the unique needs of the individual, including their hearing impairment and lifestyle, and are fine-tuned to provide the best possible benefit for the wearer.
Pros and Cons of OTC Hearing Aids
Harvard Health helps with pointing out the advantages and disadvantages of OTC hearing aids by further defining what drives the need and makes them desirable to certain individuals.
Degree of Hearing Loss
People with normal hearing can identify sounds at an intensity (volume) of less than 25 decibels (dB). Those with mild to moderate hearing loss struggle with identifying sound at intensities between 26 dB and 55 dB.
If you have mild to moderate hearing loss, you’ll hear most speech sounds, but softer sounds may be muffled. OTC hearing aids are only able to address this range of hearing impairment, so if you are experiencing severe or profound hearing loss you will need a more powerful prescription hearing aid.
Cost of OTC vs. Prescription Hearing Aids
The average cost of OTC hearing aids is between $300 and $600 per pair, while the average cost of prescription hearing aids is around $2,000 per ear, or $4,000 per pair. OTC hearing aids do not require a hearing exam or fitting, which is considered another way to save time and money.
However, with increased competition, the cost of prescription hearing aids could decrease to $1600 each. The additional cost of prescription hearing aids covers replacement and repair warranties, regular maintenance, monitoring effectiveness, and ongoing counseling and support that do not come with OTC hearing aids.
Device Quality
Because they are regulated by the FDA, OTC hearing aids must meet a specific set of standards to meet the needs of individuals with mild to moderate hearing loss. However, they are not designed to provide you with enough amplification or sound processing capabilities to address more severe hearing loss.
Hearing Test Accuracy and Self-Diagnosis
Most OTC hearing aid users avoid making an appointment with an audiologist, choosing to take a free online hearing test with which they self-diagnose their level of hearing loss in order to purchase an OTC device.
While online hearing tests can alert you to a possible hearing problem, they are not as accurate as a comprehensive hearing assessment conducted by an audiologist. Consequently, you could have a more severe hearing impairment and need prescription hearing aids without knowing it.
Personalizing Your Hearing Care Journey
In contrast to addressing your hearing challenges with OTC solutions, personalized hearing care is provided by a professional audiologist dedicated to your overall hearing health.
Johns Hopkins Medicine defines audiologists as “health care professionals who identify, assess, and manage disorders of hearing, balance, and other neural systems.” Hearing aids are a common solution to hearing loss, and audiologists are professionals at the selection and fitting process, but hearing aids are not a one-size-fits all solution for better hearing.
There is more to personalizing your hearing care journey than prescribing hearing aids. An audiologist will perform a series of evaluations and a lifestyle evaluation that helps determine if hearing aids are the appropriate solution for your hearing challenges.
Keep in mind that your hearing loss could be related to something as simple as impacted earwax or a bug blocking sound; something more complicated, like inflammation, fluid in your ear, or a growth; or something more complex that is related to a more serious medical condition. Hearing aids are not the proper solution for dealing with these issues.
When hearing aids are the right solution, an audiologist will assist you in choosing the right hearing aid, sizing it to fit your ears, and fine-tuning it to ensure that it addresses your specific hearing needs. Most audiology clinics will also:
- ZTroubleshoot your device
- ZProvide regular maintenance and repair
- ZHelp manage warranty claims
- ZAssist with insurance
More importantly, personalizing your hearing care journey is not all about selling and fitting you with hearing aids. Personalized hearing care also includes:
- ZOngoing counseling as you struggle to get used to your hearing aids, providing realistic expectations about
- what they’ll do
- ZAdvice on how to prevent hearing loss with hearing protection or lifestyle changes if you have normal hearing
- ZContinued testing of your hearing to detect any changes and/or evaluate the effectiveness of your hearing aids
- ZAdvice concerning new technologies, styles, and applications that match your unique lifestyle and hearing needs
Personalized hearing care provides greater personal value for the extra money that you spend.
OTC Hearing Aids or Personalized Hearing Care
Here is the bottom line. OTC hearing aids can meet your needs if you have mild to moderate hearing loss, you are looking for a product of better quality and performance than a PSAP, and you want to keep your costs down.
On the other hand, if your hearing challenge can’t be helped by an OTC device, your hearing loss is more severe, or you want greater personalized care, an audiologist will provide the solutions you’re looking for, backed by professional knowledge of all aspects associated with your ears and hearing challenges.
Contact our hearing care clinic to learn more or to schedule a hearing assessment.
