As tech firms enter hearing aid market, FDA must protect consumers

As tech firms enter hearing aid market, FDA must protect consumers
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The Food and Drug Administration (FDA) has started consulting with hearing experts and associations as it begins creating regulations for new over-the-counter hearing aids. Having worked with hearing loss patients for more than 25 years, however, I fear that new regulations may not protect consumers as they should. As big players including Apple, Samsung and Bose enter the market with new products, regulators and health care professionals need to remember that hearing loss is a serious medical issue, and create regulations that protect consumer health.

Research shows that over-the-counter hearing aids can perform very well for mild to moderate hearing loss—but results are better when an audiologist fits them and educates the patient. In a study by Indiana University, for example, only about half of participants who tried OTC hearing aids without professional guidance said they were likely to purchase them, compared with 81 percent for those who had help and coaching from an audiologist.

To me, this isn’t surprising. A well-fitted, properly maintained hearing aid can make a world of difference for patients. But easily preventable problems, from wax build-up to humidity, can discourage people from persisting with them. Without guidance, consumers may well begin to think of hearing aids as disposable electronic items. This mindset would benefit technology companies — not generally well-known for their outstanding customer service — while potentially discouraging people from receiving higher quality hearing care.


This isn’t the first time large tech companies have tried to enter the hearing aid market. In the late 1980s and early 1990s, 3M tried with a technologically advanced product. The company couldn’t keep up with the customer service needs and sold the line after just a few years.

As tech companies enter the market, there’s another threat to consumers. Although the new law will make over-the-counter (OTC) hearing aids available only for slight and moderate hearing loss, tech companies will want to reach their largest possible market — including those with more severe hearing loss.

If the tech companies increase the power or gain in these instruments to cater to a larger audience, there’s a strong possibility that users will be exposed to over amplification levels. One of the many misconceptions about hearing is that “louder is better,” a myth that can easily lead to users turn the volume above safe levels, which, ironically, can itself cause hearing loss.

Specific regulations will help protect consumers. First, the FDA needs to limit the “gain”— or maximum loudness — on the devices — to 25 decibels, and a maximum output of 110 DB SPL (sound pressure level) Anything more will make it possible for moderately severe to profound hearing loss to be fit with OTC instruments, which is out of the scope of the law. It would also put mild to moderate hearing loss users at risk for further hearing loss.

Second, the FDA should have steps in place to encourage people to seek professional advice if there is hearing loss worse in one ear, ringing in the ears (tinnitus), ear fullness, ear pain, dizziness or chronic disease which increases the risk of hearing loss. Putting a device on a hearing loss that may have medical ramifications is reckless.

To be sure, I am an audiologist, and it’s possible the new regulations could cost me business. On the other hand, I’ve helped hearing loss patients for more than 25 years — far longer than new tech companies entering the market. I care about these patients and I’ve seen the importance of education, coaching and human interaction. If the OTC law helps more people hear and improves their quality of life, I am all for it. But if the regulations now being developed bypass those who know most about hearing loss, the law will create an even larger problem.

Judy Huch, Au.D., is the founder of the nonprofit Grace Hearing Center in Tucson along with Oro Valley Audiology and Tanque Verde Audiology. She serves on the Arizona Commission for the Deaf and Hard of Hearing.