A brief history: how OTC hearing aids became legal

For decades, all hearing aids in the United States required a prescription and a visit to a licensed audiologist or hearing instrument specialist. This created significant barriers: the average pair of prescription hearing aids cost $4,000–$7,000, and the process required multiple appointments. As a result, only about 20% of Americans who could benefit from hearing aids actually used them.

In 2017, Congress passed the Over-the-Counter Hearing Aid Act, directing the FDA to create a new regulatory category for OTC hearing aids. After years of rulemaking, the FDA finalized its OTC hearing aid regulations in August 2022, and devices began appearing on store shelves in October 2022. The ruling was widely praised as one of the most significant consumer health policy changes in decades.

Who are OTC hearing aids for?

OTC hearing aids are specifically designed and FDA-cleared for adults (18 and older) with perceived mild to moderate hearing loss. The key word is "perceived" — the FDA intentionally allows self-assessment rather than requiring a professional diagnosis.

You may be a good candidate for OTC hearing aids if you:

• Are 18 or older
• Have difficulty hearing in noisy environments or following conversations
• Find yourself asking people to repeat themselves frequently
• Turn up the TV louder than others prefer
• Have been told by an audiologist that you have mild to moderate hearing loss

OTC hearing aids are not appropriate for children under 18, or for adults with severe to profound hearing loss. They are also not appropriate if your hearing loss is accompanied by pain, discharge, sudden onset, dizziness, or is in only one ear — those symptoms require medical evaluation first.

How OTC hearing aids work

OTC hearing aids work the same way prescription hearing aids do: they use microphones to pick up sound, a digital processor to amplify and shape the sound, and a speaker (receiver) to deliver the amplified sound to your ear. The key difference is in how they are fitted and programmed.

Preset programs

Some OTC aids come with preset amplification profiles — you select the one that sounds best to you. These are simpler and less expensive but offer less customization.

Self-fitting with an app

The most advanced OTC aids use a smartphone app to guide you through a self-fitting process. You take a brief hearing test through the app, and the device is automatically programmed to your results. You can then fine-tune volume, bass/treble balance, and listening programs. This approach can produce results approaching professional fitting for mild to moderate loss.

OTC hearing aid styles

• Receiver-in-canal (RIC/RITE): The most popular OTC style. A small unit sits behind the ear with a thin wire connecting to a speaker in the ear canal. Discreet and comfortable.
• Behind-the-ear (BTE): The processor sits behind the ear and connects to an earmold or dome in the ear canal via tubing. More powerful, good for moderate loss.
• In-the-ear (ITE) / In-the-canal (ITC): The entire device fits inside the ear. Less common in OTC due to fitting complexity.
• Earbuds: Some OTC aids resemble wireless earbuds (like the Sony CRE series or Jabra Enhance). These are discreet and familiar to tech-savvy users.

What OTC hearing aids can and cannot do

They can:

• Amplify sound and improve speech clarity for mild to moderate loss
• Reduce background noise with digital signal processing
• Stream audio from phones, TVs, and other Bluetooth devices
• Be self-adjusted via smartphone apps
• Provide meaningful hearing improvement for many users

They cannot:

• Treat severe or profound hearing loss as effectively as prescription aids
• Be professionally programmed to a clinical audiogram
• Replace medical treatment for underlying ear conditions
• Diagnose the cause of your hearing loss

Cost

OTC hearing aids range from about $200 to $1,600 per pair — a dramatic reduction from the $4,000–$7,000 average for prescription aids. The most popular self-fitting OTC aids (Sony CRE-E10, Jabra Enhance Plus, Lexie B2) typically fall in the $700–$1,000 range. Budget options start around $200 but offer fewer features.

Where to buy OTC hearing aids

OTC hearing aids are available at major retailers including Best Buy, Walmart, CVS, Walgreens, Costco (as a separate OTC category), and Amazon. They can also be purchased directly from manufacturers' websites. No prescription or appointment is required.