Lawmakers push FDA to allow over-the-counter hearing aids

Lawmakers weighed a bill to permit the sale of over-the-counter hearing aids on Tuesday at a hearing on ways to ease regulations on medical technology.

The Over-the-Counter Hearing Aid Act of 2017, a measure with bipartisan support offered by Rep. Joseph Kennedy (D-Mass.) and co-sponsored by Rep. Marsha Blackburn (R-Tenn.), would order the Food and Drug Administration to draft regulations allowing companies to sell the devices in retail settings, including online. Under the proposed law, hearing aids could be sold to adults with “mild to moderate hearing impairment.” 

Members of the House Energy and Commerce Subcommittee on Health discussed a number of bills but focused their attention on pressing an official from the Food and Drug Administration on allowing hearing aids to be sold directly to consumers.

Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, agreed there is no reason to restrict the over-the-counter sale of hearing aids for people with mild or moderate hearing loss.

But lawmakers questioned if the agency was dragging its feet on the issue.

Rep. Anna Eshoo (D-Calif.) criticized the agency’s slim two-page testimony–by far the shortest out of any submitted for the committee’s review.

“This is the first time that I’ve seen testimony that really isn’t testimony,” she said.

Shuren said delays internally and with “technical assistance” from other agencies prevented the submission of more detailed written testimony on the issue.

But he offered no exact time frame for further testimony, saying only that the FDA would present a report “in time for review by the committee.”

Many groups have long cautioned against allowing hearing aids to be sold over-the-counter, arguing that they are medical devices and patients need to consult with doctors.

But others say allowing over the counter sales would lower prices and make them more accessible to those suffering from hearing loss.

Rep. Joe Barton (R-Texas) asked if salespersons could offer simple screening tests, after which customers could purchase hearing aids at stores.

“Could there be a sales clerk who would run some tests and have [a] chart and [determine] based on this [that] you’ve got mild or based on that you’ve got moderate [hearing loss], something like that?”

But Shuren sidestepped questions about how to carry out that proposal.

“I think it’s premature to sort of say what would be the right mechanism to put in place,” the FDA representative said. “That would be part of a further dialogue.”

The FDA announced in December 2016 that medical evaluations or waivers would no longer be required for adults to purchase most hearing aids–a move that supporters of the over-the-counter sale of the devices hailed as a mark of progress.

According to the National Institutes of Health, about 30 million Americans aged 12 and older have hearing loss in one or both ears.

In his opening statement, Kennedy emphasized the personal cost of hearing loss for many Americans. 

“Many of us here today have experienced the pain and frustration of loved ones beginning to lose their hearing,” he said. 

Sens. Elizabeth Warren (D-Mass.) has offered a companion bill in the upper chamber. That bill is co-sponsored by Sens. Chuck Grassley (R-Iowa), Maggie Hassan (D-N.H.), and Johnny Isakson (R-Ga.).