Congress passed the Over the Counter Hearing Aid Act in 2017, but implementation was delayed because of the pandemic. Earlier this month, President Biden ordered the FDA to release guidelines and standards within the next 120 days.
Over-the-counter hearing aids are meant for people with mild to moderate hearing loss. Dr. Jennifer Phelan is an audiologist at the University of South Dakota's speech and hearing clinic. She says a hearing evaluation isn’t required but is still recommended.
“The hard part is without a hearing evaluation someone isn’t going to know if that’s them,” Phelan says, “And so, without a hearing evaluation people are going to end up going off the perception of how they feel like their hearing is.”
Phelan says over-the-counter hearing aids provide opportunities for audiologists and other hearing healthcare professionals to make recommendations after their patient has had an evaluation.
“I can talk to my patients and give them more options, and that really is where I see the biggest opportunity for us.”
There are already personal sound amplification products sold. Phelan says the proposed federal rules and guidelines could help professionals and consumers make informed decisions.
“Our goal, with looking at the hearing aids, is hopefully being able to say these are products that are regulated, we trust them, this is going to help you.”
The FDA guidelines are expected to be released by mid-November.
This story comes from a recent interview on SDPB's weekday radio program, "In the Moment." Listen to the full interview below.