Roughly 40 million adult Americans experience hearing loss, but only a small fraction of them have ever used a hearing aid. Cost and accessibility have been the main deterrents, but according to a recent Gizmodo article, both are about to change for the better. Back in 2017, through the FDA Reauthorization Act, the FDA was assigned to establish regulations for a new category of hearing aids that could be sold via traditional retail or online. Last July, President Biden signed an executive order pushing the FDA to speed along its regulatory process.
The new rule will only allow for certain kinds of hearing aids to be sold over-the-counter. For example, hearing aids intended for children under 18 will continue to only be available via prescription, and OTC hearing aids will only be for people with mild to moderate hearing loss. The FDA will also mandate that OTC products have a lower maximum sound output and adjustable volume settings to reduce risk of injury. OTC hearing aids will mostly be sold in drugstores, and will be available as early as mid-October 2022.