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Over-the-counter hearing aid

Over-the-counter (OTC) hearing aids are a new category of hearing aids that consumers will soon be able to purchase directly without having to visit a hearing care professional. These devices are designed to help adults who think they have mild to moderate hearing loss. Like traditional hearing aids, OTC hearing aids make sounds louder so that some people with hearing difficulties can listen, communicate and fully participate in daily activities. In addition, OTC hearing aids will be regulated as medical devices by the United States Food and Drug Administration (FDA).

OTC hearing aids will be an alternative to the current FDA regulated hearing aids, which are currently only available from hearing care professionals, such as audiologists, ENT (ear, nose and throat doctors) and hearing aid specialists. The hearing care professional fits you for the hearing aid, adapts the device to your hearing loss and offers other services.

If OTC hearing aids are available, you can purchase them directly in stores and online, where current hearing aids are not available. You adjust them yourself, and you may be able to control and adjust the devices in ways that users of current hearing aids cannot. Some OTC hearing aids may not look like today's hearing aids at all.

OTC hearing aids are intended for adults with possible mild to moderate hearing loss. They are not intended for children or adults with severe hearing loss or significant hearing problems. If you have severe hearing loss, OTC hearing aids may not be able to amplify sounds at a level high enough to help you.

The FDA sets rules for OTC hearing aid manufacturers to follow. In general, these federal regulations will:

  • Make sure the OTC devices are safe and effective for people with mild to moderate hearing loss.
  • Set parcel label standards to help buyers understand OTC hearing aids and who can benefit from them. The labels also contain warnings and other information you should know before buying or using the hearing aid, such as signs to tell your doctor or other healthcare provider.

Currently, hearing aids available for immediate purchase (without first consulting a doctor) are not intended for people with hearing loss. Importantly, these devices, known as Personal Sound Enhancement Products (PSAPs), are intended for people without hearing loss to increase their ability to hear certain sounds in certain situations, such as when hunting. PSAPs are not regulated by the FDA as medical devices. In contrast, the FDA will regulate future OTC hearing aids as medical devices for adults with hearing loss.

Who are OTC hearing aids for?

OTC hearing aids are for adults who believe they have mild to moderate hearing loss, even if they have not had a hearing examination. You may have mild to moderate hearing loss if you, for example:

  • Speech or other sounds appear muffled.
  • It is difficult to hear when you are in a group, in a noisy environment, on the phone, or when you cannot see who is speaking.
  • You should ask others to speak more slowly or clearly, speak louder, or repeat what they said.
  • You turn up the volume higher than other people prefer when you watch TV or listen to the radio or music.

Consult a hearing care professional if you have trouble hearing conversations in a quiet environment, or if you can hear loud noises, such as cars or trucks, noisy devices, or loud music. These are signs that you may have a more serious hearing loss and that OTC hearing aids will not work well for you. A hearing care professional can help you find a hearing aid or other device that can help you hear better.

Some ear problems need medical treatment. See a licensed physician immediately if you have any of the following symptoms:

  • Fluid, pus, or blood that has come out of your ear in the past six months.
  • Pain or discomfort in your ear.
  • A history of excessive wax or a suspicion that something is in your ear canal.
  • Episodes of vertigo (severe dizzyness) with hearing loss.
  • Sudden hearing loss or rapidly worsening hearing loss .
  • Hearing loss that has become less and less severe over the past six months.
  • Hearing loss or tinnitus ( tinnitus ) in one ear only, or a noticeable difference in how well you can hear in each ear.

Why are OTC hearing aids available now?

Hearing loss significantly impacts the quality of life of tens of millions of adults in the United States and contributes to high health care costs. Untreated hearing loss can lead to isolation and has been linked to serious conditions such as depression, anxiety, low self-esteem, dementia, reduced mobility and falls. Yet only one in four adults who could benefit from hearing aids has ever used them. Making hearing healthcare more accessible and affordable is a public health priority, especially as the number of older adults in the US continues to grow.

Leading experts in science, technology and hearing care are working with researchers, health professionals and consumers to find safe and effective ways to improve access to hearing care for adults. They proposed changing a number of prescriptions that research found hindered adults from getting the hearing aid they need. They have also recommended that the FDA establish guidelines and quality standards for OTC hearing aids.

A law of August 18, 2017, as part of the FDA Reauthorization Act of 2017 , mandated the FDA to create an OTC hearing aid category for adults with potentially mild to moderate hearing loss. As part of this process, the FDA must issue a proposed rule by August 18, 2020 and a final rule within six months of the expiration of the comment period on the proposed rule.

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