This new environment could also offer headphone makers and other technology companies an easier way to sell headphone-like devices that act as hearing aids. This is a market that many large companies have focused on for years. Commercial hearing aids have been in development for many years. Congress passed a law allowing over-the-counter sales in 2017, but the process of actually implementing the regulation has been delayed. President Joe Biden issued an executive order last year asking the FDA to implement the rule already, and the FDA presented plans this fall.
The Biden administration announced Tuesday that hearing aids will soon be commercially available and sold over the counter. A new final rule from the Food and Drug Administration has created a new category for over-the-counter hearing aids. This is something that doesn’t require testing or expensive fittings, the device could go on sale as early as mid-October. This rule could help tens of millions of people in the United States with some degree of hearing loss.
In 2018, Bose received the first FDA approval for “self-adapting” hearing aids, which in some cases can be marketed directly to consumers. (Technically, it wasn’t over-the-counter, as there were still some state-level laws restricting the sale of hearing aids to licensed hearing aid suppliers.) Bose will begin selling hearing aids in 2021. However, the company suspended that program and closed its health care division in the spring. His Jabra, a headphone company, also makes hearing aids, and the company’s Enhance Plus wireless his earbuds are marketed as “hearing enhancement.”
The new final rule is the final step in that process and will go into effect in 60 days, and the hearing aids may be available in drugstores as early as October. “Today’s action by the FDA represents an important milestone in making hearing aids more affordable and accessible,” his Secretary of Health and Human Services Xavier Becerra said in a statement. Some of that access may be through headphone companies. The line between headphones and hearing aids has been blurred for years.
And it’s not yet clear if any headphone and technology companies will adopt this new hearing aid option. This could lead to further advances in hearing technology for companies that already manufacture hearing aids. For example, Eargo exhibited at CES this year, and other companies have exhibited at CES in the past.
Apple is reportedly considering entering the hearing aid business, and the AirPods Pro already have a “speech boost” feature that makes it easier to hear voices. The new Bluetooth audio standard also includes support for hearing aids. Audiologists have expressed concerns about over-the-counter hearing aids, saying professional evaluation remains important for those with hearing loss.