By Dr. Ryan Hill, Audiologist | Hill Hear Better Clinic
Four years after over-the-counter hearing aids entered the market, a new JAMA article raises important questions about their success. But there’s an even bigger issue that deserves attention: Are we making sure hearing aids actually deliver the amplification patients need?
Four Years Later, Are Over-the-Counter Hearing Aids Delivering on Their Promise?
In October 2022, the FDA introduced a new category of over-the-counter (OTC) hearing aids with a goal of making hearing healthcare more accessible and affordable for millions of Americans.
The idea was simple. By allowing adults with perceived mild-to-moderate hearing loss to purchase hearing aids without visiting a hearing care professional, more people might take action to address their hearing difficulties.
It was a significant change for the hearing aid industry.
But four years later, the results have raised questions.
In an October 15, 2026, article published in JAMA, researchers Kathryn A. Phillips and Christine K. Cassel examined the challenges facing the OTC hearing aid market.
Their article, titled Over-the-Counter Hearing Aids 4 Years Later: Regulatory Reform Alone Is Insufficient to Ensure Consumer Benefits, highlights the struggles of several major OTC hearing aid manufacturers.
In July 2026, LXE Hearing, the parent company of Eargo and Lexie, announced it was closing its U.S. operations. Other recognizable brands, including Sony, Sennheiser, and Jabra, have also exited the market, according to the authors.
The article argues that simply making hearing aids more available doesn’t guarantee better hearing healthcare outcomes.
I agree.
But as an audiologist, I believe there’s another critical piece of this conversation that deserves far more attention.
We’re spending a tremendous amount of time talking about how people get hearing aids and not nearly enough time discussing whether those hearing aids are actually fit correctly.
And that distinction could make all the difference.
Buying Hearing Aids Is Not the Same as Treating Hearing Loss
Imagine going to an eye doctor, discovering you need prescription glasses, and then purchasing a pair of glasses without confirming that the lenses match your prescription.
You might see a little better.
You might even think your new glasses are helping.
But are you seeing as clearly as you possibly could?
Probably not.
The same principle applies to hearing aids.
Hearing aids aren’t simply devices that make everything louder. They are sophisticated medical devices designed to deliver specific amounts of amplification across different frequencies based on an individual’s hearing loss.
Two people can have similar hearing test results but require different adjustments because of differences in their ear canal acoustics, listening needs, comfort preferences, and other factors.
This is where professional hearing aid fitting protocols become so important.
Unfortunately, a hearing aid can be purchased, programmed, and worn every day without anyone ever objectively verifying that it delivers the prescribed amplification.
The result?
A patient may be wearing hearing aids but still not receiving the full benefit those devices are capable of providing.
The Missing Piece: Real Ear Measurement
One of the most important procedures in hearing aid fitting is something called Real Ear Measurement, or REM.
Real Ear Measurement is an objective test that allows an audiologist to measure exactly how much sound a hearing aid delivers inside a patient’s ear canal.
Here’s how it works.
A tiny microphone attached to a thin probe tube is placed inside the ear canal alongside the hearing aid.
The audiologist then presents calibrated speech-like sounds through a speaker and measures the amplification the hearing aid produces at different frequencies and input levels.
Those measurements are compared with individualized prescriptive targets based on the patient’s hearing loss.
If the hearing aid is not providing the appropriate amplification, adjustments can be made and the results measured again.
Think of it as verifying the actual performance of the hearing aid rather than trusting the manufacturer’s software to get everything right.
Without Real Ear Measurement, we can estimate what a hearing aid is doing. With Real Ear Measurement, we can actually measure it.
And that matters because a hearing aid that isn’t providing enough amplification may leave important speech sounds difficult to hear, even while the patient believes the device is working properly.
Research Shows That Real Ear Measurement Makes a Difference
This isn’t simply my opinion.
Research supports the importance of verifying hearing aid fittings.
A 2021 systematic review and meta-analysis examined whether hearing aid fittings verified with probe-microphone Real Ear Measurements produced better outcomes than fittings relying on the manufacturer’s initial settings.
The researchers found statistically significant improvements in several areas, including:
· Speech understanding in quiet environments.
· Speech understanding in background noise.
· Self-reported listening ability.
· Patient preference for the verified fitting.
The researchers acknowledged that the available evidence was based on a relatively small number of studies and that the clinical importance of some improvements remained uncertain.
Nevertheless, the findings support the value of objective hearing aid verification.
Real Ear Measurement is also recommended in professional hearing aid fitting guidance, including standards published by the Audiology Practice Standards Organization (APSO).
The message is important: Properly verifying hearing aid performance should be a routine part of quality hearing healthcare, not an optional luxury.
Why This Matters for Over-the-Counter Hearing Aids
I believe OTC hearing aids can play an important role in expanding access to hearing care.
For some individuals with mild-to-moderate hearing loss, a properly selected self-fitting OTC hearing aid may provide meaningful improvement.
In fact, a randomized clinical trial published in JAMA Otolaryngology–Head & Neck Surgery in 2023 found that a self-fitting OTC hearing aid, with access to remote support, provided outcomes comparable to an audiologist-fitted version of the same device over six weeks in the study population.
That’s encouraging.
But it doesn’t mean that professional verification has become unnecessary, or that every OTC hearing aid will perform equally well for every person.
The study evaluated a specific hearing aid, fitting approach, patient population, and follow-up period.
The broader question is how we can help each individual achieve the best hearing outcome possible.
When people purchase OTC hearing aids without professional assistance, several important questions may go unanswered.
Are the devices appropriate for their degree and type of hearing loss? Are they receiving enough high-frequency amplification to hear critical consonant sounds? Are louder sounds being controlled appropriately? And how do we know the devices are delivering the intended results?
These aren’t minor technical details.
They’re fundamental questions about the effectiveness of hearing treatment.
One person may experience significant improvement with a self-fitting OTC device. Another may struggle because the hearing aid doesn’t adequately address their needs.
Without proper testing and verification, that second person may conclude that hearing aids simply don’t work for them.
When, in reality, they may never have experienced what appropriately fitted hearing aids could provide.
The Bigger Problem Isn’t Just OTC Hearing Aids
Here’s where I believe this conversation needs to go even further.
The importance of Real Ear Measurement isn’t limited to over-the-counter hearing aids.
Prescription hearing aids can also be improperly fitted.
Simply purchasing an expensive hearing aid or visiting a hearing care professional does not automatically guarantee that the device has been verified using best practices.
In many cases, hearing aids are initially programmed using a manufacturer’s proprietary fitting software.
While these systems provide a useful starting point, they don’t replace objective verification of the sound delivered in the individual ear.
A hearing aid can look great, feel comfortable, and include the latest artificial intelligence features, yet still fail to provide the prescribed amount of amplification.
That’s why I believe consumers should be asking a different question.
Instead of simply asking, “What’s the best hearing aid?”
They should be asking:
“How will you make sure my hearing aids are actually providing the amplification I need?”
The answer should include Real Ear Measurement.
Better Hearing Requires a Treatment Plan, Not Just a Product
At Hill Hear Better Clinic, we believe successful hearing treatment involves much more than selecting a hearing aid.
A comprehensive treatment plan should include a thorough assessment of hearing ability, an understanding of the patient’s communication difficulties, and a systematic approach to improving hearing performance.
That process includes:
1. Comprehensive hearing testing: Identifying the type and degree of hearing loss and assessing how it affects communication.
2. Speech-in-noise testing: Understanding how well a person can recognize speech when competing background noise is present.
3. Individualized hearing aid selection: Choosing technology and acoustic configurations appropriate for the patient’s hearing loss, lifestyle, and goals.
4. Real Ear Measurement: Objectively verifying that the hearing aids deliver appropriate amplification based on validated prescriptive targets.
5. Fine-tuning and counseling: Adjusting the hearing aids for comfort and performance while helping patients develop realistic expectations and effective listening strategies.
6. Ongoing outcome measurement: Evaluating whether treatment is improving the patient’s everyday communication and making adjustments when necessary.
These steps work together.
Real Ear Measurement is essential to the verification process, but it is not a substitute for counseling, individualized care, or follow-up.
The goal isn’t simply to help someone hear more sounds.
The goal is to help them communicate more effectively and receive the greatest practical benefit from their hearing treatment.
The Future of Hearing Healthcare Should Focus on Outcomes
The recent JAMA article makes an important argument: Regulatory changes that increase access to hearing aids don’t automatically produce meaningful improvements for consumers.
But I believe the discussion also needs to focus much more directly on the quality of the hearing aid fitting itself.
Making hearing aids more affordable is important.
Making hearing aids easier to purchase is important.
Encouraging more people to seek help for hearing loss is important.
But none of those achievements guarantees that an individual will receive an appropriately fitted hearing aid.
As hearing aid technology continues to advance and consumers gain more purchasing options, objective verification becomes an increasingly important safeguard.
Whether someone chooses an OTC hearing aid or a prescription hearing aid, they deserve to understand whether that device is meeting their hearing needs.
And as hearing care professionals, we should be committed to demonstrating that our treatment recommendations actually deliver the intended results.
My Final Thoughts: Don’t Just Buy Hearing Aids. Make Sure They’re Working for You.
The hearing aid industry has spent years focusing on improving technology, lowering prices, and expanding access.
Those are worthwhile goals.
But perhaps the most important opportunity has been right in front of us all along.
We need to do a better job ensuring that hearing aids are properly fitted, objectively verified, and supported by a comprehensive treatment plan.
For patients who have already purchased hearing aids but aren’t experiencing the improvement they expected, the solution may not necessarily be buying something new.
It may begin with determining whether their current hearing aids are providing the amplification they’re supposed to deliver.
Because the best hearing aid isn’t necessarily the newest, most expensive, or most technologically advanced device. It’s the hearing aid that is appropriately selected, properly fitted, and verified to meet your individual hearing needs.
And that’s something every hearing aid user deserves.
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Are Your Hearing Aids Performing as Well as They Should?
If you’re wearing hearing aids but still struggling to understand conversations, especially in background noise, don’t assume that you’ve reached the limits of what hearing aids can do.
At Hill Hear Better Clinic, we emphasize evidence-based fitting practices, including Real Ear Measurement, to help patients get the most from their hearing technology.
Whether you purchased your hearing aids from us or somewhere else, evaluating their performance can be an important step toward better hearing. Learn more at hillhearbetter.com.
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References
1. Phillips KA, Cassel CK. Over-the-Counter Hearing Aids 4 Years Later: Regulatory Reform Alone Is Insufficient to Ensure Consumer Benefits. JAMA. Published online October 15, 2026. https://doi.org/10.1001/jama.2026.19796
2. Almufarrij I, Munro KJ. Does Probe-Tube Verification of Real-Ear Hearing Aid Amplification Characteristics Improve Outcomes in Adults? A Systematic Review and Meta-Analysis. Trends in Hearing. 2021. https://pmc.ncbi.nlm.nih.gov/articles/PMC8083001/
3. Audiology Practice Standards Organization. Standard S2.1: Hearing Aid Fitting for Adult & Geriatric Patients. 2021. https://www.audiologystandards.org/standards/publications/APSO_S2.1_Adult-HAF_20210502.pdf
4. De Sousa KC, et al. Effectiveness of an Over-the-Counter Self-fitting Hearing Aid Compared With an Audiologist-Fitted Hearing Aid: A Randomized Clinical Trial. JAMA Otolaryngology–Head & Neck Surgery. 2023. https://jamanetwork.com/journals/jamaotolaryngology/fullarticle/2803832
5. American Academy of Audiology. Guidelines for the Audiologic Management of Adult Hearing Impairment. https://www.audiology.org/practice-guideline/guidelines-for-the-audiologic-management-of-adult-hearing-impairment/