April 3, 2022
By JIM HOOD FORMER MISS. ATTORNEY GENERAL
The Food and Drug Administration (FDA) is currently reviewing public feedback on its proposed rule regarding over-the-counter (OTC) hearing aids, which does not require sufficient labeling to inform the consumer of dangerously loud decibel levels.
On Jan. 18, 2022, 43 attorneys general sent a letter to the FDA expressing concerns about the potential for the federal rule preempting state laws in all 50 states regulating warranties, returns and advertising restrictions on hearing aids.
The FDA should protect consumers from being inundated with scam hearing aid advertising campaigns, particularly regarding something as precious as our hearing.
As Mississippi attorney general from 2004-2020, I fought federal preemption of state consumer laws and scam artists daily. Years of loud music and shooting have caused me to recently begin shopping for hearing aids. The pricing is from $20 to thousands of dollars with very little advertising labeling to differentiate between quality, safe sound and cheap static makers. Unsurprisingly, with emerging trends and innovations, threats to consumer safety can become commonplace without proper oversight.
OTC hearing aids may seem like an obvious solution that offers more affordable and accessible options to consumers.
However, for a medical device as intimate and regularly used as a hearing aid, proper safeguards must be established to make sure it does not further harm Americans’ hearing health. Public comments from health professionals, industry groups, and other relevant stakeholders from both sides of the aisle are not confident that the FDA’s proposal in its current form adequately protects patients.
One of the most worrisome sections of the current FDA proposal is its improper output and gain limits.
According to many organizations like the American Academy of Audiology, the FDA’s proposed output level of 115 to 120 decibels (dB) and maximum gain limit of 25dB are dangerously loud for those with “mild-to-moderate” hearing loss – the recommended consumers of OTC hearing aids.
For comparison, 120db is as loud as a live rock concert, which is a harmful noise level even for someone with healthy hearing. Considering the majority of the expected consumers of these new devices will be senior adults, these patients are in danger of unintentionally misusing their new hearing aids at dangerously loud volumes.
Appropriate product labeling on the device packaging would help in mitigating this risk, but the FDA’s proposal also falls short of this crucial criterion. Hearing diagnostics obtained online or through a manufacturer’s app cannot substitute the trained hands of an audiologist. The FDA’s proposed labeling standards mislead consumers into believing professional help is unnecessary.
OTC hearing aids can be an affordable solution to those who wish to better hear the world around them – but only with proper safety features that protect their hearing. Rather than making Americans wait indefinitely for better access to hearing devices, the FDA must adapt these necessary changes without delay and produce a finalized rule that protects vulnerable consumers.
Jim Hood is Mississippi’s former attorney general.
See the original article on Sun Herald.