This change is expected to expand access to high-quality hearing care while also driving innovation and lowering costs, potentially saving consumers an average of $2,800 to $3,000 per pair.
Who OTC hearing aids are for (and not for)
OTC hearing aids are air‑conduction devices for adults with perceived mild‑to‑moderate hearing loss. They are not for children or for people with severe/profound loss or “red‑flag” symptoms (e.g., ear pain or drainage, sudden hearing loss, one‑sided loss, persistent dizziness). If you have red‑flag symptoms or more significant loss, see a licensed hearing care professional (ideally an ENT or audiologist).
OTC vs. prescription hearing aids
OTC hearing aids do not replace prescription hearing aids. Prescription devices remain available and are generally recommended for more complex or severe loss. Importantly, the 2022 rule repealed the prior federal medical‑evaluation requirement for adults; states may still regulate provider practices for prescription devices. Any hearing aid that does not meet the OTC requirements is a prescription device.
Signs of Mild‑to‑Moderate Hearing Loss
An OTC hearing aid might be right for you if you have mild‑to‑moderate hearing loss. Here are some of the most common signs:
Often struggle to hear people in noisy places or group conversations.
Frequently turn up the TV or radio volume.
Find that speech sounds muffled or unclear.
Have trouble hearing on the phone.
Often need to ask others to repeat themselves.
If you’re not sure about your level of hearing loss, seeing a hearing professional for a quick check‑up can be very helpful. And if you experience ear pain, drainage, sudden hearing changes, hearing loss in only one ear, or dizziness, see a licensed hearing professional before buying an OTC device.
Key safety and labeling requirements
OTC hearing aids have to meet strict FDA safety rules. They must limit how loud they can get to prevent hearing damage, include a way for you to adjust the volume, and meet quality standards for sound and background noise. Every package must also include clear, easy‑to‑read labels with safety warnings (such as when to see a doctor), the manufacturer’s contact details, and any information about returns or warranties.
Types and common features
OTC products come in familiar styles (e.g., in‑ear, behind‑the‑ear/receiver‑in‑canal). Many models offer app‑based setup, preset or self‑fitting options, Bluetooth audio/phone streaming, directional microphones, noise reduction, and rechargeable batteries. Features vary - check manufacturer specifications and instructions.
Costs and where to buy
Prices vary widely by brand, features, and services. At launch, major U.S. retailers and pharmacies (e.g., Walgreens, CVS, Walmart, Best Buy) offered OTC hearing aids with examples ranging from about $199 to $3,000 per pair. Federal estimates suggested potential savings up to ~$3,000 per pair versus traditional channels, but actual savings depend on what you buy and any services you add. To see how current models compare on features and prices visit our OTC hearing aid comparison guide.
Insurance and Medicare
Original Medicare (Part A/B) does not cover hearing aids or routine fitting exams. Some Medicare Advantage (Part C) and commercial plans may include hearing benefits (coverage, allowances, and networks vary by plan), so check your policy before you buy.
Why earlier access matters
Many people wait about seven years after noticing symptoms to seek help. Untreated hearing loss is linked with social isolation, depression, falls, and cognitive decline. Recent randomized evidence suggests that treating hearing loss slowed cognitive decline over three years in older adults at higher risk, though it did not show a preventive effect across all participants. Treating hearing loss improves communication and quality of life even when cognitive benefits are uncertain.
Questions to ask before you buy
What is the return window, trial period, and warranty (if any)?
Is the device preset or self‑fitting? Are there clear instructions/app tutorials?
Do you need a smartphone or computer for setup or adjustments?
How do you adjust volume and other settings?
Are they water/sweat‑resistant?
Battery: rechargeable vs. disposable; expected runtime.
Do they support Bluetooth?
What customer support channels are available (email/chat/phone)?
If buying in a store, does staff provide basic counseling on OTC hearing aids?
How to get started
Consider a hearing check (in‑person or validated app‑based screening) to set a baseline.
Review FDA “red‑flag” symptoms; see a clinician first if any apply.
Compare models and features against your needs (noise reduction, rechargeability, app control).
Buy from a reputable retailer with a clear return window, and wear the devices consistently during the trial.
If benefit is limited, consult an audiologist/ENT to consider prescription options or additional rehabilitation.
Bottom line
OTC hearing aids are a lower‑barrier option for many adults with mild‑to‑moderate hearing loss. They’re widely available without a prescription and must meet FDA safety and labeling standards. Use the return window to confirm real‑world benefit - and seek professional care promptly for red‑flag symptoms or if your hearing needs are more complex.
