What Are OTC Hearing Aids?

Over-the-counter (OTC) hearing aids are devices designed to amplify sound for adults with mild to moderate hearing loss. They are available in stores or online without a prescription or hearing exam. Users are responsible for fitting and adjusting the devices themselves.

While a hearing test is not required, consulting an audiologist can help determine if OTC hearing aids are a good option and provide guidance on usage. These devices are generally more affordable than professionally fitted hearing aids, costing between $300 and $600 per device.

Why Are Hearing Aids Available Over the Counter?

The FDA was directed to create regulations for OTC hearing aids to make hearing solutions more accessible and affordable. These regulations will set limits on volume, labeling requirements, and sales guidelines.

Many people delay seeking hearing help for years, which can increase risks of depression, falls, and cognitive decline. OTC hearing aids aim to provide earlier, more affordable access to hearing assistance. However, individuals with complex medical needs or significant hearing loss should consult an audiologist for a personalized care plan.

Who Can Use OTC Hearing Aids?

OTC hearing aids are approved for adults (18+) with mild to moderate hearing loss. A hearing test is recommended but not required. To determine if OTC hearing aids may be suitable, consider the following:

• Can you hear well in quiet, one-on-one conversations?
• Do you need hearing help in only a few situations rather than most?
• Does slightly increasing phone or TV volume help, but not excessively?

If you answered yes, you may have mild to moderate hearing loss. OTC hearing aids require users to fit and adjust the devices themselves, often using manual controls or an app.

Can Children Use OTC Hearing Aids?

No. OTC hearing aids are not approved for children, as childhood hearing loss requires specialized medical care and precise sound delivery for brain development.