Hearing-aid sound limits must be safe

For the first time in the United States, the U.S. Food and Drug Administration is likely to allow hearing aids to be sold over the counter for adults with mild to moderate hearing loss.

Roughly one of every seven Hispanics in the U.S. has some level of hearing impairment. According to the National Institutes of Health, this problem is more likely to occur among those who are over the age of 65, do not have a high school education, have diabetes or prediabetes and are among the lowest income tiers. The Chicago Hispanic Health Coalition applauds the FDA in seeking to make certain hearing aids more affordable and easier to acquire. At the same time, the FDA's attempt to provide increased access and affordability cannot come at the risk of consumers' safety.

The FDA is proposing to allow OTC hearing aids to have a maximum output level that is higher than the World Health Organization and leading associations of hearing care specialists recommend for patients with mild to moderate hearing loss. The CDC indicates such levels can do damage to a person's hearing in as little as nine seconds. If these proposed regulations take effect, people who buy hearing aids in a retail store for help with their hearing impairment could be risking the possibility of suffering increased permanent hearing damage.

We believe the FDA should lower the maximum output level for over-the-counter hearing aids to a standard that is indisputably safe. We also want to stress the importance of requiring multilingual labeling.

We look forward to the FDA developing a final rule that more adequately ensures OTC hearing aids will not risk consumers experiencing hearing loss by the very medical devices they seek to help address their medical condition.

Esther Sciammarella

Chicago Hispanic Health Coalition