FDA Finalizes Rule Enabling Access to OTC Hearing Aids for Millions of Americans

A general view of new hearing aids at the Starkey Hearing Foundation Mission during GRAMMY Camp at University of Southern California in Los Angeles, Calif., on Jan. 22, 2014. Rachel Murray/Getty Images

The Food and Drug Administration on Tuesday finalized regulations to make available hearing aids to millions of Americans without them requiring to see a doctor.

The FDA’s move comes years after President Donald Trump signed the Over-the-Counter Hearing Aid Act of 2017, which would create a new category of hearing aids and replace state-level regulations that require patients to visit a physician for prescriptions and fittings.

The new regulations will expand access to affordable health care while aiming to lower the costs of hearing aids for people with mild to moderate hearing loss, and allow them to get hearing aids over-the-counter (OTC) or online nationwide. Consumers could see OTC hearing aids available in traditional retail and drug stores by mid-October when the rule will take effect, according to the FDA.

Hearing aids are medical devices worn behind or in the ear. They can improve hearing by making louder sounds. In some cases, hearing impairment is temporary and can be restored with medical care. Hearing aids cannot restore hearing to normal levels but in some cases, it can be permanently improved through their use.

High Prices

According to the National Institutes of Health, approximately 15 percent of American adults (37.5 million) aged 18 and over report some trouble hearing. However, only 16 percent of eligible people aged 20-69, and only 30 percent of seniors over 70 use hearing aids, with many not being able to afford the high prices which typically range between $1,000 to $4,000 per ear.

It is hoped that having hearing aids available OTC will help lower prices through increased retail competition.

FDA said that qualified hearing aids will be limited in how much amplification they can offer, as well as other technical requirements, in a bid to direct patients with severe hearing loss toward audiologists. Restricting the volume also aims to lessen the risk of people accidentally worsening their hearing loss.

“There is going to be the option for people to go into the prescription space to see an audiologist ... None of these options are taken away. This just opens up consumer options for people that have relatively simple hearing loss problems that can be helped by an over-the-counter product,” FDA Commissioner Robert Califf said.

Besides lowering health care costs for the American public, this new regulation aims to promote innovation and competition in the hearing aid technology market while ensuring the safety and effectiveness of OTC hearing aids, the FDA added.