The Biden administration announced on Tuesday that hearing aids will soon be available for purchase without a prescription over-the-counter.
The Food and Drug Administration has developed a new category for over-the-counter hearing aids that won’t require an expensive fitting or an examination. As early as October middle could see smartphones in stores.
The tens of millions of Americans who suffer from some degree of hearing loss may find respite from the rule. The new environment may also make it simpler for headphone manufacturers and other tech firms to begin selling headphones that also serve as hearing aids, a sector that several major corporations have been coveting for years.
The legislation to permit the sale of over-the-counter hearing aids was first passed by Congress in 2017. However, the implementation of the regulations took a long time to happen. The FDA released a plan in the fall after President Joe Biden issued an executive order last year requesting that the guidelines be in place as soon as possible. Groups from the hearing aid business retaliated. The latest step in the procedure, the new final rule, will take effect in 60 days and might lead to the availability of hearing aids in drug shops as early as October.
Health and Human Services Secretary Xavier Becerra stated in a statement that “today’s action by the FDA signals a key milestone in making hearing aids more affordable and accessible.”
Some of that access might be provided by headphone manufacturers. Hearing aids and headphones are becoming increasingly interchangeable. In 2018, Bose obtained the first FDA approval for a “self-fitting” hearing aid that, in some circumstances, could be marketed directly to consumers. Since sales of hearing aids were still only permitted through authorized hearing aid dispensers, it wasn’t really over the counter. In 2021, Bose began selling hearing aids, but this spring the business halted that initiative and closed its healthcare section.
The Enhance Plus wireless earphones from the headphone manufacturer Jabra are advertised as “hearing-enhancing.” According to rumors, Apple has thought about getting into the hearing aid industry. However, the AirPods Pro already offer a “Conversation Boost” feature that improves voice recognition. Support for hearing aids is included in the latest Bluetooth audio standards.
On the other hand, audiologists have expressed concerns regarding over-the-counter hearing devices, stating that a professional evaluation is still necessary for those who suffer hearing loss. And it’s still unclear whether tech and headphone businesses, if any, intend to make use of this new hearing aid option. It might inspire companies that already provide hearing aids to make even more improvements in hearing technology. For instance, Eargo attended CES this year, and other businesses have previously made presentations at the trade expo.
However, with the implementation of this new regulation, hearing aids join the list of bodily functions that tech companies have commercialized, such as heart rate and blood oxygen levels, as yet another area where electronics and medical equipment cross.