What Otolaryngologists Need to Know About Working with Patients as Over-the-Counter Hearing Aids Become Available

The proposed rules have generated discussion and concern among otolaryngologists and audiologists. “Human beings are very poor judges of their own level of hearing loss,” Dr. Grisel said. “Thus, patients with severe or profound loss may initially seek treatment with an OTC aid.”

Additionally, an individual whose hearing falls within the normal range may perceive mild or moderate hearing loss, purchase and use an OTC hearing aid, and potentially damage their hearing, especially given the lack of a gain limit, Dr. Grisel said, noting that exposure to 120 dB of sound can cause noise-induced hearing loss in just 28 seconds. 

The FDA has defended the 120 dB limit on the grounds that 28 seconds gives the user enough time to act before sustaining injury. The Hearing Industries Association (HIA) and American Academy of Otolaryngology–Head and Neck Surgery have both urged the FDA to limit output to 110 dB and gain to 25 dB, however. 

“The only thing standing between a patient and noise-induced hearing loss is their own perception that there’s a problem and the ability to take it out of their ears,” Dr. Grisel said. “This is problematic given that the hearing aid population tends to have higher levels of cognitive decline and dexterity problems. If these devices are intended for mild to moderate levels of hearing loss, why would you ever need more gain than 25 dB?” 

The otolaryngology community wants people to have easy access to hearing treatment, Dr. Grisel said. “But our concerns are, is this going to be done safely? Are patients with more severe hearing health problems going to miss out on medical treatment? Is the technology safe? Are these products going to achieve their intended goals?”

There is a risk that inappropriately used OTC hearing aids may lead some people to doubt the efficacy of hearing aids and other hearing devices. “If a patient uses an over-the-counter hearing device that doesn’t fit their hearing profile, it might actually make it more difficult for them to hear,” said Doug Backous, MD, a neurotologist with Puget Sound ENT Proliance Surgeons in Washington state. “You’re using a fixed solution for a dynamic problem, which may not help everyone.” 

People who have severe hearing loss and try an OTC device may be disappointed in their results, which, paradoxically, may drive them further from care. “There’s already a perception that hearing loss isn’t treatable, and failed attempts with an OTC hearing aid may discourage people from a professional audiological and otological evaluation and management,” Dr. Moody said.