Over-the-counter hearing aids are devices that consumers can buy directly from traditional retailers and pharmacies without the need for a visit to a hearing health professional.
In 2017, Congress passed bipartisan legislation requiring the U.S. Food and Drug Administration (FDA) to create a category of OTC hearing aids, but it was not fully implemented until now, with OTC hearing aids available in traditional retail and drug stores as soon as October 17, 2022, when the rule took effect.
OTC hearing aids are for adults 18 years of age or older who think they have mild-to-moderate hearing loss. You may have mild-to-moderate hearing loss if, for example:
Currently, the FDA regulations state that OTC hearing aids are for adults (18 years of age or older). Children should see a hearing health professional for evaluation and obtaining a hearing aid.
The primary benefit of OTC hearing aids is the lower cost and ease of purchase of these devices compared to hearing aids obtained from a hearing health professional. Concerns related to OTC hearing aids start with the most basic question: Does the customer have hearing loss and is it the type for which OTC hearing aids are designed? Additional consideration should be given if the individual’s hearing loss comes from a medical problem that can be corrected (eliminating the need for a hearing aid) or addressed to prevent worsening the hearing loss or more serious problems. These conditions would be missed without an evaluation by a hearing health professional. Obtaining the best result and avoiding pain and infection depend on a properly fitting hearing aid. If your OTC hearing aid becomes painful to put in your ear, you should see an ENT (ear, nose, and throat) specialist, or otolaryngologist.
The cost of OTC hearing aids will depend on the complexity and features of the device as well as other provisions included in the sale, such as service, returns, and the degree of support the manufacturer provides. Companies that provide telephone-based help and remote programming of the devices charge approximately $1,500 to $3,000 for a pair of OTC hearing aids. Off-the-shelf devices that do not offer those services may cost approximately $200 to $800 for a pair of devices.
Medicare currently does not cover any hearing aids. Medicaid coverage for those over 18 years old will vary by state, and you have to check with your Medicaid program. Some private health insurance plans do not cover the cost of hearing aids, so you should check with your particular insurance regarding coverage for OTC hearing aids.
The marketplace for OTC hearing aids has just opened (as of October 17, 2022) and identifying the right device for you may be challenging. As more devices become available, it may become easier to select the right device for you. You should also consider these issues:
Manufacturers of OTC hearing aids are required by the FDA to report their return policy; however, OTC sales do not require a return policy, so you should review that policy before buying an OTC hearing aid. Most reputable prescription hearing aid dispensers offer a one-month trial period, and you should look for something similar for your OTC hearing aids before purchasing them.
Different OTC hearing aids will offer different features, may be programmable, and will likely be offered at different price points, but most OTC hearing aids will probably be compatible with other devices. If compatibility is important to you, be sure to check if your OTC hearing aids will work with your smart phone before purchasing them.
For people with the type of hearing loss that would benefit from OTC hearing aids, there are additional options you may consider:
The list below describes conditions that need medical attention to prevent additional problems and complications. You should see a doctor—preferably an ENT specialist—if you have any of these red flag conditions indicating that there is a medical condition causing your hearing loss, including:
If you need help deciding if you have hearing loss, if OTC hearing aids are right for you, or if you need prescription strength hearing aids, a hearing specialist—ENT specialist or an audiologist—can help you. Tell them if you are experiencing any red flag conditions listed above. And be sure you know the return policy of the OTC hearing aid you are considering.
The information on ENThealth.org is provided solely for educational purposes and does not represent medical advice, nor is it a substitute for seeking professional medical care.