Recently, the U.S. Food and Drug Administration (FDA) finalized a rule change that would allow a class of over-the-counter hearing aids to be available to adult consumers directly without the care and guidance of a hearing health professional. As of Oct. 17, 2022, consumers can purchase over-the-counter (OTC) hearing aids online and at big box stores, pharmacies and even through audiologists, hearing specialists. This new category of OTC hearing aids was created to make hearing aids more affordable and more accessible for people with perceived mild to moderate hearing loss in the hopes that more people will take action to improve their hearing. This new category of OTC hearing aids does not change the current category of prescriptive hearing aids provided by hearing health care professionals for all degrees of hearing loss.
Although hearing loss is the third most common chronic health condition, approximately 70 percent of people who need hearing aids have not yet taken steps to manage their hearing loss. For adults who are perceived to have mild to moderate hearing difficulty, OTC hearing aids may be a helpful starting point to managing hearing health. However, there is concern that patients with more significant hearing loss may try over-the-counter hearing aids and would be disappointed in their results as they are not designed for severe hearing loss. Untreated or under-treated hearing loss is associated with cognitive decline, social isolation, anxiety, depression and can dramatically impact the quality of life. Furthermore, one in 10 people have a medically related hearing loss which cannot be identified without a full diagnostic evaluation by a hearing specialist or health care provider.
If you are considering OTC hearing aids, here are some tips to help guide your decision:
- See an audiologist first. Hearing loss can happen gradually, and you may have a hard time determining how much hearing loss you have. An assessment completed by an audiologist will help you determine whether OTC hearing aids will work effectively or if a prescriptive hearing aid or implantable device is more appropriate. Hearing evaluations are typically covered by insurance, even if hearing aids are not.
- Don’t use an OTC hearing aid if any “red flags” are present. Red flags include an obvious hearing difference between ears, pain or drainage from the ear, tinnitus (ringing in the ears), fullness or pressure in your ears, vertigo or dizziness, or sudden onset of hearing loss. If you have any of these “red flags,” see a physician or audiologist prior to the pursuit of OTC hearing aids.
- Check the OTC hearing aid return policy before you buy. The FDA does not require that OTC hearing aids be returnable but states packaging must indicate the return policy. There are many factors to successful hearing aid use and not all devices will be created equally, so it’s important that consumers have the option to return. Also, be sure to note that devices can be sold refurbished but must be labeled as such. Prescriptive hearing aids are legally required to have a return period of at least 30 days.
- Understand the device’s settings and programming. Not all OTC hearing aids are the same. Make sure the device fits your lifestyle and has settings that can reflect your hearing needs. Understand fully how to adjust the device and its capabilities. If you’re not sure if the OTC hearing aid is doing all it needs to do, an audiologist can measure the settings against your hearing loss and discuss the benefits and limitations with you.
The American Academy of Audiology has multiple documents, frequently asked questions and information on OTC and prescription hearing aids. Visit www.audiology.org/consumers-and-patients/managing-hearing-loss/consumers-and-otc-hearing-aids/ for more information.