Hearing devices have come a long way since the days of the ear trumpet. Modern hearing aids have helped raise the quality of life for millions worldwide suffering from disabling hearing loss.
Although hearing aids are not a cure in and of themselves, these important hearing devices help improve and enhance a person’s hearing and overall speech comprehension.
Unfortunately, hearing aids have not always been accessible or affordable for everyone.
Until recently, quality hearing aids were only accessible through retailers in audiology offices — if you had a prescription or proof of hearing test.
However, the rules are changing.
A new rule will allow purchases of over-the-counter hearing aids, making these medical devices more accessible and affordable.
Let’s take a closer look at this proposed rule and how it could benefit millions of Americans suffering from hearing loss.
What Are Hearing Aids?
Whether a person is using over-the-counter hearing aids or prescription hearing aids, the basic parts are the same.
Hearing aids are composed of a:
- Microphone – This is where sound is received and turned into electrical signals.
- Amplifier – Here, the electrical signals are received and boosted.
- Receiver/Speaker – This is where amplified sounds are delivered.
What Are Over-the-Counter Hearing Aids?
So, what makes over-the-counter (OTC) hearing aids unique? Technically, OTC hearing aids represent a new category of hearing aids.
Normally, patients can only buy hearing aids by visiting hearing health professionals like audiologists or otolaryngologists (ENTs) and getting a prescription.
Most audiologist offices have hearing aid company representatives to help individuals purchase hearing aids on-site. They also assist in the self-fitting process.
OTC hearing aids change the game.
Now, with the potential of OTC hearing aids, consumers can buy hearing aids directly without having to visit a hearing health care professional.
While the basic principles behind OTC hearing aids remain unchanged, the availability of some advanced technologies (like Bluetooth) may vary.
Like prescription hearing aids, OTC hearing aids are appropriate for almost any degree of hearing loss, from mild to moderate hearing loss.
Who Are OTC Hearing Aids For?
Like traditional hearing aids, they amplify sound to help wearers listen and communicate better.
One stipulation for OTC hearing aids is that they will only be available for adults (18 and older). Children will still require prescriptions from hearing health care professionals to obtain hearing devices.
While prescription hearing aids are available for all forms of hearing loss, OTC hearing aids serve those with mild to moderate hearing loss.
Those with severe hearing loss will likely have to seek medical advice from hearing care professionals before purchasing hearing aids.
Some signs of mild to moderate hearing loss include:
- Issues understanding speech in noisy environments.
- Speech sounds muffled.
- Constantly needing to turn up the volume on the TV or audio devices.
- Issues hearing someone speak over the telephone.
- Needing to ask people to repeat themselves multiple times during conversations.
It is important to note that if you are experiencing sudden hearing loss, you should seek medical attention immediately.
Furthermore, if you are experiencing trouble hearing due to earwax impaction or have associated symptoms like pain in the ear, tinnitus (ringing in the ears), unilateral (one-sided) hearing loss, dizziness, or vertigo, then it's best to visit a hearing care professional.
Also, more severe forms of hearing loss may require more intensive interventions like cochlear implants.
What Makes OTC and Prescription Hearing Aids Different?
- Differences in design – While prescription hearing aids offer a full range of hearing aid styles, from discreet in-the-canal options to larger behind-the-ear aids, OTC hearing aids options will be limited. They will likely take the one-size-fits-most approach in the early stages.
- Differences in the degree of hearing loss – Prescription hearing aids exist for all degrees of hearing, mild to severe. OTC hearing aids will only be suitable for those with mild to moderate forms.
- Differences in wearers – OTC hearing aids are only for adults. Furthermore, they are made for those with complex ear conditions. Prescription aids suit any age and cover various hearing impairments and conditions.
- Differences in diagnosing – Prescription hearing aids require a hearing test by a hearing care provider who has access to advanced diagnostic tools. With OTC hearing aids, the individual is essentially self-diagnosing (but this depends on the product stipulations).
- Differences in fitment – With prescription hearing aids, a licensed audiologist or hearing care specialist will likely help custom fit the hearing aids to a customer’s specific needs. OTC devices are self-fit, regardless of whether they are purchased at pharmacies or online.
- Differences in affordability – The cost of hearing aids will also be a major difference. While the cost of OTC hearing aids will vary, they will be available at a much lower cost than most prescription hearing aids. Medicare is an option in some cases.
The Proposed OTC Hearing Aid Rule
When Congress passed the Over-the-Counter Hearing Aid Act of 2017, it authorized OTC hearing aids for adults in the United States.
Along with the FDA Reauthorization Act of 2017, the bill helped amend the Federal Food, Drug, and Cosmetic Act.
This act requires the U.S. Food and Drug Administration (FDA) to categorize certain hearing aids as OTC and implement regulations.
According to the bill, OTC hearing aid regulations must:
- Provide reasonable assurances for efficacy and safety regarding OTC hearing aids.
- Establish labeling requirements and output limits.
- Describe requirements for selling hearing aids by mail, online, or in-person without a prescription.
On August 16, 2022, the FDA rules regarding OTC hearing aid guidance were finally revealed.
This historic rule was a big win for public health, allowing access to OTC hearing aids for millions of Americans across the country.
This came on the heels of President Biden’s executive order (EO) on Promoting Competition in the American Economy. This EO gave the FDA a 120-day deadline for allowing hearing aids to be sold over the counter.
According to the National Institute on Deafness and Other Communication Disorders (NIDCD), roughly 15 percent of American adults live with hearing loss. This new rule can help millions of American adults access affordable hearing devices.
Personal Sound Amplification Products
In addition to the new rule, the FDA issued final guidance regarding Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).
This clarified the difference between medical devices like hearing aids from non-medical devices like PSAPs. According to the Hearing Loss Association of America, PSAPs are products made to help those with normal hearing amplify sound.
When Do These New Rules Take Effect?
The final change should occur in fall 2022, around mid-October.
This marks the time when OTC hearing aids will hit consumer shelves.
Over-the-counter hearing aids offer easier accessibility for those looking for affordable new hearing aids.
Although it will still be a few months before they officially hit the shelves, the legislation has already been passed, and the rules are in place.
While OTC hearing aids will no doubt benefit millions of adults in the United States, the best hearing aids will be the ones that work best for you. Taking the time to explore the options is always recommended.
Looking for more info on all things hearing loss? Explore USA Rx’s Hearing Loss Info Hub here.
References, Studies and Sources:
Over-the-Counter (OTC) Hearing Aids | NIDCD
S.670 – 115th Congress (2017-2018): Over-the-Counter Hearing Aid Act of 2017 | Congress.gov
FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans | FDA
Executive Order on Promoting Competition in the American Economy | The White House
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