Yesterday Donald Trump signed the Food and Drug Administration Reauthorization Act of 2017, legislation that provides for greater public access to over-the-counter (OTC) hearing aids into law. The legislation means that adults with perceived mild to moderate hearing loss can access OTC hearing aids without being seen by a certified and licensed audiologist or hearing instrument dispenser.
What Happens Now?
Initially, the product segment that is Over The Counter hearing aids doesn't exist and there is no guidance for what those devices will be. The Food and Drug Administration (FDA) will be working on the development of the regulations that will guide the implementation of this new legislation. That process can take up to three years, however, signals from the FDA appear to suggest the process will be much shorter than that.
THe FDA will have to regulate this new category of OTC hearing aids to ensure they meet the same high standards for safety, consumer labeling and manufacturing protection that all other medical devices must meet. This will give consumers the option to purchase a safe, high-quality FDA-regulated device at lower cost.
Who Will They Be Suitable For?
The legislation says mild to moderate hearing loss, so I would imagine that the devices would be theoretically suitable for anyone with a hearing loss up to 60 dB across the board. However, it remains to be seen what will be available and from who.
While there are many electronics companies interested in this segment, Bose and Doppler Labs being two of them. Some of the traditional hearing aid manufacturers have signalled interest in the market segment as well.
Interesting Times
I think there are very interesting times ahead for everyone who is involved with hearing loss and hearing healthcare. As the regulations play out and the devices begin to arrive to market, we will keep you informed.
Posted by Geoff
Geoffrey Cooling
Geoffrey (Geoff, anything else makes him nervous) Cooling has been involved with the hearing aid industry for over ten years. He has worked in private practice dispensing hearing aids and as a manufacturer's rep. He has written two books and they are both available on Amazon. He loves technology, passing on knowledge and is legendary for many other things, primarily the amount he curses, his dry and mischievous sense of humour and his complete intolerance of people who are full of themselves. Please feel free to connect with him
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