What is the OTC Hearing Aid and PSAPs?

Firstly,let’s introduce something about the OTC Hearing aid as following:

Over-the-counter (OTC) hearing aids (or OTC wearable hearing devices as recommended in the NAS report noted below), are not yet approved by the FDA. They would be hearing devices for adults with mild to moderate hearing loss purchased directly by consumers from a retailer or online. OTC hearing aids will be regulated by the Food and Drug Administration (FDA) with clear labeling as to use, safety and efficacy. This would be a new option to allow adults with mild to moderate hearing loss to get affordable and easily accessible hearing aids.

Then, please learn something more about the PSAPs here:

PSAPs (Personal Sound Amplification Products) are amplification devices available now that are intended only for those with normal hearing. The Food and Drug Administration (FDA) prohibits manufacturers of PSAPs from marketing their products as hearing aids to people with hearing loss. One example of how PSAPS are marketed is for hunters who want to hear deer in the woods. PSAPs should not be confused with OTC devices. OTC hearing aids or OTC wearable hearing devices are a classification that the FDA must approve before they will become available to consumers.

Why Is HLAA Supporting OTC Hearing Aids?

The NAS has made a clear, evidence-based case that OTC hearing wearable devices should be available for adults with mild to moderate hearing loss. A bill has been introduced in Congress called the Over-the-Counter Hearing Aid Act of 2017 and HLAA supports the bill.

An estimated 86 percent of people who would benefit from hearing aids do not get them, primarily because of high cost.

HLAA believes and OTC hearing aids will provide accessible and affordable hearing health care to millions of people who might not otherwise seek help. Or, for those who have sought help, OTC hearing aids could provide an affordable option.

People usually wait seven to ten years before they seek help. By that time, hearing loss has totally disrupted their lives, impacting their communication at work, with their families, their ability to participate in their communities and in activities that give their lives meaning and fulfillment.

We believe that available, affordable and accessible OTC hearing aids will encourage more people to take the first step sooner toward taking charge of their hearing health. HLAA does not endorse any product or service or any type of technology including hearing aids or wearable hearing devices sold over the counter or through hearing care professionals. HLAA does support quality, safe and effective technologies and hearing aids that give consumers affordable choices to make their own decisions.