Hearing-aid makers have differing takes on OTC sales option

Americans with mild hearing loss could benefit from a proposed change in federal law that would let them buy their own low-cost hearing aids over the counter, similar to how shoppers can buy nonprescription reading glasses at drugstores, two Minnesota hearing-aid companies say.

The hearing-aid industry has in the past opposed efforts to make the devices available without an exam from an audiologist, on the grounds that the risks were greater than the benefits of unsupervised patients diagnosing themselves and adjusting the $2,400 devices at home.

But critics, including a 2015 presidential science commission, say the existing system works to keep prices so high that few people who would benefit from a hearing aid get one.

Now at least two of Minnesota's major hearing-aid manufacturers say consumers would benefit from proposed legislation introduced in Congress this week that would create a new category of over-the-counter (OTC) hearing aids regulated by the Food and Drug Administration. The devices would be available to people with "perceived mild to moderate hearing impairment."

The bipartisan legislation would require the U.S. Food and Drug Administration to write rules on the safety and labeling requirements for this new category of OTC hearing aids to make sure the manufacturers are held to the same standards as other medical device companies.

The debate over the OTC hearing-aid proposal is likely to resonate in Minnesota, which is home to the world headquarters of Starkey Hearing Technologies and IntriCon Corp., and North American headquarters of Amplifon and ReSound, all of which sell hearing aids under various brand names.

Not that the state industry is uniformly endorsing the OTC hearing-aid proposal.

The association said no study has shown laypeople can accurately self-diagnose the cause or extent of their hearing loss. Conversely, research has found low satisfaction among hearing-aid users in Japan, where the devices are widely available over the counter.

In Minnesota, most hearing aids are sold through specialty retailers where trained staff do hearing tests.

"Abandoning professional services leads to poorer outcomes and hence lower adoption rates," the association said in its Dec. 3 statement.

This week, Arden Hills-based IntriCon departed from that position, issuing its own news release saying the changes would invigorate competition, spur innovation and create a niche for lower-cost devices.

"While some people do need a higher level of care, there is a vast majority of hearing-impaired individuals that could be satisfied going through other channels," IntriCon Chief Financial Officer Scott Longval said in an interview.

Longval said that in the near future, many people will gauge their level of hearing loss using simple hearing tests on smartphones or tablet computers. "And based on that listening test, we'll be able to program the hearing aid to that individual's specific loss," he said.

Eden Prairie's Starkey Hearing Technologies staked out a more nuanced position on the OTC hearing-aid bills pending in Congress.

Asked about the company's view, Starkey issued a comment attributed to Senior Vice President Brandon Sawalich: "Starkey Hearing Technologies believes patients benefit when technology and personalized professional care work together to provide the best experience in our hearing health care system. If an over-the-counter (OTC) hearing aid category is established, these devices could be helpful for mild hearing loss, for whom the benefits of amplification outweigh the risks created by a potential inaccurate self-diagnosis."

That said, the company does not support the bills as currently written, a spokeswoman said.

Unlike IntriCon, Starkey is counted among the world's "Big Six" hearing-aid makers whose business model could come under pressure if OTC hearing aids become widely available. On Thursday, an official with ReSound in Bloomington didn't return a call seeking comment, and a spokesman for Amplifon in Plymouth declined to issue a statement.

Neither Minnesota senator has announced support or opposition to the legislation.

"Sen. Franken uses hearing aids himself, and so he understands that many Minnesotans care about having access to high-quality products that improve hearing," spokesman Michael Dale-Stein wrote in an e-mail. "In the coming days, Sen. Franken plans to look closely at the proposal, and he would like to continue talking with Minnesotans about how the legislation would affect them."