Over-The-Counter Hearing Aids Update – Forbes Health – Forbes

When the FDA Reauthorization Act of 2017 (FDARA) was signed into law, it included an order for proposed regulations for a new, future category of hearing aids: over-the-counter (OTC) hearing aids. These devices would be available directly to consumers via retail and outline outlets rather than requiring them to go through an audiologist or another hearing health professional for access. However, these new FDA rules are still to be determined.

“The FDA Reauthorization Act of 2017 is a guideline, and FDA rules are procedures,” says Michele Michaels, a hearing health care program manager at the Arizona Commission for the Deaf and the Hard of Hearing in Phoenix. “So until those rules are written, we won’t know exactly how an OTC hearing aid will differ from hearing aids that are currently available.”

Affordable OTC hearing aids have the potential to make hearing aids more easily available to people with some degree of hearing loss who may not otherwise be able to afford them. Users also won’t be required to present a prescription from an audiologist or other hearing health professional in order to purchase them.

While many are excited about the prospect of OTC hearing aids, the idea remains controversial. Members of some hearing health industry associations are concerned about consumers purchasing and using OTC hearing aids without first completing a hearing evaluation conducted by a hearing health professional. They worry people might damage their ears from overamplification or simply not get a positive result with the products and give up on hearing aids altogether, which has all sorts of social and health implications. Meanwhile, the Hearing Loss Association of America (HLAA) openly supports a regulated market for OTC hearing aids.

The FDA Reauthorization Act of 2017 directed the FDA to develop regulations that would make OTC hearing aids available to the public by 2020. However, the regulatory process stalled due to the COVID-19 pandemic. As of June 2021, the FDA plans to meet on OTC hearing aids during the current rulemaking session, likely publishing new regulations in 2022. Once the FDA regulations are published, OTC hearing aids are expected to become available to the public rather quickly.

Source: https://www.forbes.com/health/healthy-aging/otc-hearing-aids-update/