The line between headphones and hearing aids is about to get way blurrier

Photo by Chris Welch / The Verge

The Biden administration said Tuesday that hearing aids will be sold over the counter. There is a new category for over-the-counter hearing aids that don't need an exam or expensive fitting. The devices are expected to be in stores in October.

There are tens of millions of people with hearing loss in the United States. Many big companies have been eyeing the market for hearing aids for a long time, and the new landscape could make it easier to sell them.

Congress passed legislation to allow over-the-counter sales of hearing aids, but the process of putting the regulations into action took longer than expected. The FDA put out a plan in the fall after President Joe Biden ordered them to put the rules in place. Hearing aid groups disagreed. Hearing aids could be available in drug stores as early as October as a result of the new final rule.

The FDA action today is a significant milestone in making hearing aids more cost-effective and accessible.

The access could come through the companies that make headphones. There is a line between hearing aid and headphones. Bose received the first FDA clearance for a self-fitting hearing aid that can be sold directly to consumers. There were still state laws that restricted hearing aid sales to licensed hearing aid dispensers. Bose began selling hearing aids in 2021, but stopped that program in the spring of this year.

The Enhance Plus earbuds are marketed as hearing-Enhancing. According to a report, Apple is considering entering the hearing aid business. Support for hearing aids is included in the new standards.

People with hearing loss who use over-the-counter hearing aids need to be assessed by a professional. It is not clear which companies are going to use this new option for hearing aids. It could lead to more advancement in hearing technology. Other companies have presented at the trade show in the past, including Eargo, which was at this year's Consumer Electronics Show.

Hearing aids become an area where gadgets overlap with medical devices because of the new rule.