AI in hearing aids and accessibility technology mostly means software that separates speech from noise, adjusts sound automatically, captions conversations or describes surroundings. Some of it now runs on everyday consumer devices, and US rules since 2022 allow over-the-counter hearing aids for adults with perceived mild to moderate loss. These tools can help, but a hearing assessment by a professional is still the right starting point.
Most talk about AI in medicine is about hospitals: radiology, sepsis alerts, clinical notes. The adoption numbers there are real but slow, held back by procurement, integration and liability.
Meanwhile, a quieter change has reached millions of people through their phones and earbuds. Live captions on a phone call. A camera app that reads a menu aloud to someone with low vision. Earbuds that can be set up as hearing aids from a phone, without a clinic visit. Hearing aids whose chips run neural networks trained to pull a voice out of restaurant noise.
The argument of this piece is that consumer AI is transforming assistive technology faster than clinical AI is transforming hospitals, and for a simple reason: the buyer is the user. That speed brings real benefits and some real risks, and people who could benefit need a clear guide to both.
How big is the hearing loss problem?
Larger than most health systems treat it. The World Health Organization’s World Report on Hearing, published in 2021, estimated that more than 1.5 billion people live with some degree of hearing loss, a number that could reach nearly 2.5 billion by 2050. Most people who would benefit from a hearing aid do not use one. Cost, stigma, access to audiologists and the hassle of fitting all play a part.
The stakes go beyond hearing. The 2024 update of the Lancet Commission on dementia prevention listed hearing loss among 14 modifiable risk factors and estimated it accounts for about 7% of dementia cases at population level, one of the largest shares of any single factor.
Evidence that treating hearing loss changes cognitive outcomes is still developing. The ACHIEVE trial, published in The Lancet in 2023, randomized 977 adults aged 70 to 84 with untreated hearing loss to a hearing intervention, including hearing aids and audiologist support, or to a health education control. Over three years, there was no significant difference in cognitive decline across the whole group. But in a prespecified analysis of participants from an existing heart study, who were older and at higher risk of cognitive decline, the hearing intervention slowed decline by 48%. It is an encouraging signal, not a settled answer.
What does “AI” mean in a hearing aid?
The term is used loosely, so it helps to separate the main functions.
Speech in noise. The hardest situation for people with hearing loss is a noisy room. Traditional hearing aids amplify everything, including the clatter. Newer devices use machine learning models, often deep neural networks running on dedicated chips, to separate speech from background noise in real time.
Automatic adjustment. Hearing aids can classify the sound environment, such as a quiet room, a car or a crowd, and switch settings automatically instead of making the user fiddle with programmes.
Self-fitting. Some devices let users run a hearing test on their phone and configure the device themselves, without an audiologist.
Related accessibility features. Live captioning of conversations and calls, sound recognition that alerts deaf users to alarms or a baby crying, and image description tools for blind and partially sighted people all rely on the same kinds of models.
Some of these features live in medical devices. Others live in ordinary phones and earbuds and never went near a regulator. That split is what makes the field move so fast.
How did hearing aids become a consumer product?
Regulation opened the door. In August 2022 the US Food and Drug Administration finalised a rule creating a category of over-the-counter hearing aids for adults 18 and over with perceived mild to moderate hearing loss. From October 2022 these could be sold in shops and online without a medical exam, prescription or audiologist fitting.
Then technology companies walked through it. In September 2024 the FDA authorized the first over-the-counter hearing aid software designed to run on a mainstream pair of consumer wireless earbuds, through its De Novo pathway for novel low- to moderate-risk devices. The feature uses self-fitting: the user takes a hearing test on a phone and the software configures the earbuds. The FDA based its decision on a clinical study with 118 participants with perceived mild to moderate hearing loss across several US sites.
That is a remarkable shift in distribution. A device category that used to require a clinic visit and often cost thousands of dollars can now, for some people, be switched on through a software update to something already in their pocket.
A worked example: two routes to better hearing
This example is hypothetical.
Margaret, 68, struggles to follow conversation at family dinners and turns the television up louder than her husband likes. She suspects mild hearing loss but has put off an appointment for years.
On the first route, she sets up hearing features on earbuds she already owns. The phone test suggests mild loss in both ears. She uses them at dinners and finds conversation easier. Cost is low and the stigma she feared is absent, because everyone wears earbuds.
On the second route, prompted by the phone test, she books a hearing assessment. The audiologist confirms mild to moderate loss in one ear but finds that the other ear is worse than expected and the pattern is asymmetric. She is referred to a doctor to rule out a medical cause, which turns out to be benign. She then chooses a device, with professional fine-tuning.
Both routes improved her hearing. Only the second checked for the uncommon causes that a self-test cannot identify. The best outcome is probably a combination: consumer tools that lower the barrier to trying, and a professional assessment for anyone with warning signs or a poor result.
When should you see a professional instead of buying over the counter?
Over-the-counter devices and consumer features are designed for adults with perceived mild to moderate loss. They are not appropriate for everyone. FDA labelling for OTC hearing aids lists “red flag” situations where people should see a doctor, and general clinical guidance points the same way. See a clinician promptly if you have:
- Sudden hearing loss or a sudden worsening, which can be a medical emergency
- Hearing loss in only one ear, or much worse in one ear
- Ear pain, discharge, bleeding or a visible deformity of the ear
- Dizziness or balance problems with hearing loss
- Ringing or noise in one ear only
- Severe hearing loss, or any hearing concern in a child
If none of these apply, OTC devices can be a reasonable place to start. A professional hearing test remains the best way to know what you are dealing with.
The strongest counterargument: is faster really better?
The case against the consumer surge deserves a hearing.
Self-fitting relies on the user’s own test in uncontrolled conditions. People may not notice that their loss is asymmetric or progressing. Audiologists do more than fit a device: they counsel, adjust over weeks, identify when something medical is going on, and support people through the frustrating first months when many give up. The ACHIEVE intervention included that support, and the trial’s positive signal should not be credited to hardware alone.
There is also the question of evidence. Many accessibility features on phones never went through clinical trials because they are not regulated as medical devices. A captioning tool that mishears a medication name, or a scene description that misses a step, can cause real harm to someone relying on it.
These concerns are valid. But the old system was failing most people it was meant to serve, and the answer is not to slow the consumer route down. It is to connect it to professional care, so that a phone test becomes a referral when it should, and so that people who try an OTC device and struggle know where to go next. We have made a similar point about inclusion in general: a ramp is not inclusion, and a cheaper device is not access unless the support around it exists too.
What this means for patients, clinicians and regulators
For people with hearing or vision loss. Consumer AI tools can be genuinely useful and are worth exploring, but they do not replace an assessment. Watch for the red flags above. If a device is not helping after a few weeks, see an audiologist rather than giving up on hearing support altogether.
For clinicians. Patients will arrive having already tried consumer features. Rather than dismissing them, clinicians can help people get the most from what they have, and focus professional time on assessment, complex cases and counselling. For those caring for people with dementia, addressing hearing is a practical step worth raising, a theme related to our piece on families running dementia care.
For regulators. The OTC hearing aid rule is a good example of regulation expanding access while keeping safety guardrails such as labelling and red-flag warnings. The harder question is the growing grey zone of accessibility features that function like medical devices but are regulated as ordinary software. The choice of regulatory pathway shapes the whole market, as we argued in the device regulator you choose is really a business model.
Frequently asked questions
What are AI hearing aids?
They are hearing aids or hearing features that use machine learning to process sound, most often to separate speech from background noise, adjust automatically to different environments or help users fit the device themselves. The term covers both prescription devices and some over-the-counter products. The AI label alone says little; what matters is whether the device suits your hearing loss.
Are over-the-counter hearing aids as good as prescription ones?
For adults with perceived mild to moderate hearing loss, over-the-counter devices can help, and the FDA allowed them from October 2022 for that group. They are not intended for severe loss, children or people with warning signs. Prescription devices come with professional fitting and follow-up, which some people need. A hearing test can help you decide.
Can consumer earbuds really work as hearing aids?
In September 2024 the FDA authorized the first over-the-counter hearing aid software that runs on a mainstream pair of consumer earbuds, based on a study of 118 people with perceived mild to moderate loss. Such features can help some adults, but they are not suitable for everyone. Check the red-flag symptoms and consider a professional hearing assessment.
Does treating hearing loss reduce dementia risk?
The evidence is promising but not settled. The 2024 Lancet Commission estimated hearing loss accounts for about 7% of dementia cases. The ACHIEVE trial found no overall effect on cognitive decline over three years, but a 48% slowing in a higher-risk subgroup. Treating hearing loss is worthwhile for communication and quality of life regardless.
When should I see a doctor about hearing loss?
See a clinician promptly for sudden hearing loss, loss in one ear only, ear pain or discharge, dizziness, ringing in one ear, or any hearing concern in a child. Sudden hearing loss can need urgent treatment. Otherwise, a routine hearing test is a sensible first step before or alongside trying any device.
Hospital AI is still waiting for procurement sign-off. Assistive AI already shipped, as a software update, to people who had waited years for help. The task now is to make sure the fast route leads to care, not around it.
Have you or a relative tried over-the-counter hearing aids or accessibility features? What worked, and what didn’t?
