The FDA has issued a rule that gives millions of Americans access to OTC hearing aids in pharmacies or online without a prescription or medical examination.
The FDA has issued a final rule to introduce a new category of OTC hearing aids, which could save consumers millions of dollars while significantly improving access to these devices.
This ruling, which takes effect in mid-October, will allow patients with mild to moderate hearing loss to purchase hearing aids directly from pharmacies, other retail stores or online, without the need for a medical exam, prescription or audiologist. targeted fit adjustment.
“Reducing the cost of health care in America has been a priority of mine since day one, and this rule is expected to help us provide quality, affordable access to health care for millions of Americans in need,” the US Secretary of State said. Department of Health and Human Services. , Xavier Becerra, in a press release. “Today’s action by the FDA is an important milestone in making hearing aids more cost-effective and accessible.”
Nearly 30 million American adults could benefit from and communicate better with hearing aids, but they can be expensive and inaccessible. The promotion is designed to boost competition in the hearing aid technology market by enabling the sale of OTC hearing aids, according to an FDA press release.
The original rule was proposed on October 20, 2021. More than 1,000 public comments were made in response to the FDA’s proposal from consumers, professionals, hearing aid manufacturers, public health organizations, advocacy groups, congressmen and other stakeholders.
The FDA responded by advocating for the safety and effectiveness of hearing aids while also amending the original proposed rule. These changes include lowering the maximum sound output to avoid over-amplification, revising the device insertion depth, adding user-adjustable volume controls, simplifying phrasing, and specifying performance and device design requirements for hearing aids.
The new ruling will repeal certain terms of the state-regulated hearing aids so that the OTC version can be sold. The FDA will also issue regulatory requirements for hearing aids and personal sound reinforcement products (PSAPs) to clarify the difference between hearing aids and PSAPs, which amplify sound for consumers with normal hearing.
Finally, the rule establishes certain guidelines for OTC air-conducting hearing aids. These products can be used by adults 18 years of age and older with mild to moderate hearing loss. However, prescription devices, especially those for persons with severe disabilities or those under the age of 18, are not sold in this category.
“Hearing loss is a critical public health problem that affects the ability of millions of Americans to communicate effectively in their daily social interactions,” said FDA Commissioner Robert M. Califf, MD, in a press release. “By introducing this new regulatory category, people with perceived mild to moderate hearing loss will be able to easily access a range of safe, effective and affordable hearing aids at their convenience store or online.”
American Food and Drug Association. FDA completes landmark rule giving millions of Americans access to over-the-counter hearing aids. FDA website. August 16, 2022. Accessed August 16, 2022. https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids- millions of Americans