Let’s Call Hearing Aids What They Are: Medical Devices

For a few weeks in early April, a proposed 11th-hour amendment moved through the Florida Legislature. The last-minute amendment would have removed current Florida consumer protection laws that require individuals with hearing loss to be evaluated by a licensed hearing professional before purchasing the hearing aids best suited for their individual needs.

While this amendment was short-lived and was soon removed by both the Florida Senate and House, it is part of a growing list of examples of companies and special interests around the country haphazardly trying to define what an over-the-counter hearing aid is.

For the past few years, the hearing industry has debated the issue of OTC hearing aids. However, this concept is nothing new. Low-cost amplification devices have been sold everywhere from TV commercials to catalogues to online for decades. At best, these products don’t help patients hear better. At worst, they can cause more damage to an individual’s hearing. In 2017, the federal government waded into this debate: A bill touting “affordable and accessible hearing aids” was passed and sent to the Food and Drug Administration to define. The Hearing Industries Association supports this OTC push because under the statute, the FDA is required to spell out technological and labeling requirements to ensure OTC products are safe and effective and are only sold to patients with mild to moderate hearing loss.

Our industry is working with the FDA to ensure all stakeholders are heard, their questions answered, and their concerns accounted for. That is why, from the beginning, HIA endorsed the Hearing Healthcare Professional Associations Consensus Paper on OTC hearing aids. The problem is that it’s been four years since this legislation passed, and the FDA has yet to define an OTC hearing aid. That’s created a vacuum that companies and special interests are quickly trying to fill.

States that don’t wait for the FDA rules are creating dangerous confusion for patients. The FDA has meticulously followed a process of open dialogue with every stakeholder: manufacturers, hearing professionals, industry groups and, most importantly, patients and their families.

Recently, the FDA sent out a consumer warning about companies incorrectly touting FDA registrations for medical devices like hearing aids. As board chair of HIA and the president and CEO of hearing aid manufacturer Starkey, I know what goes into getting FDA approval for a hearing aid. It’s a medical device and must be designed and manufactured with patient safety, care and satisfaction at the core. Companies trying to sell cheap electronics under the name of a “hearing aid” aren’t held to that same standard, and confusion over who is and who is not following the rules is exactly what these companies want; it bolsters their bottom line.

The hearing industry has an obligation to come together, find solutions and reduce confusion. Over-the-counter hearing aids are meant to increase accessibility to hearing health care. This is a good thing. Hearing health is essential, and therefore we must increase access and affordability — but we must do it the right way.

I’m proud HIA is taking the lead on this issue. HIA created a Committee on Innovations in Hearing Healthcare. The purpose of this committee is to provide industry recommendations and solutions for when state and federal governments want insight and to avoid these kinds of 11th-hour amendments from hurting those with hearing loss and their families.

I believe better hearing is best achieved through the hearing professional providing FDA-regulated technology. However, there is a gap in our industry. Together, we must work to educate consumers and lawmakers and find solutions to ensure those with hearing loss get the help they need.


As president and CEO of Starkey and chairman of the Hearing Industries Association’s board of directors, Brandon Sawalich is pushing the hearing industry to revolutionize hearing health care through technological advancements, bold thinking and building high-performing teams — leading the industry into a new decade of innovation.

Morning Consult welcomes op-ed submissions on policy, politics and business strategy in our coverage areas. Updated submission guidelines can be found here.

Morning Consult