The U.S. Food and Drug Administration (hereinafter referred to as FDA) is making it a reality for millions of people with moderate to mild hearing loss to wear more economical over-the-counter (hereinafter referred to as OTC) hearing aids. The FDA proposes to create a class of approved devices that people can buy without a prescription, hearing test, or having to go through an audiologist.

The FDA stated that the purpose of establishing regulations is to help increase market competition while ensuring the safety and effectiveness of OTC and prescription hearing aids. According to the agency’s statistics, approximately 15% of American adults (approximately 37.5 million people) have hearing impairments.

The FDA hopes to solve some of the obstacles that people with moderate or mild hearing loss may encounter, including cost, transportation, policies and regulations.

As early as 2017, the U.S. federal government passed the Over-the-Counter Hearing Aid Act, which aims to improve the channels for purchasing more economical hearing aids. Prior to this, hearing aids were prescribed because the FDA classified them as Class I or Class II medical devices. US President Biden signed an executive order in July this year, which included instructing the Secretary of Health and Human Services to publish the proposed specifications for OTC hearing aids within 120 days.

At present, several companies have taken actions to gain a firm foothold in the OTC hearing aid market. Earlier this year, BOSE began selling its SoundControl hearing aids after receiving FDA approval, and Jabra introduced enhanced earplugs a few months ago. Other companies are also mixing hardware and technology into hearing aids, including Bragi and Olive Union.

At the same time, Apple recently updated AirPods Pro, whose function reduces environmental noise while amplifying the volume of other people’s voice in conversation. It is said that Apple is also studying how to use AirPods as a health device.