F.D.A. approves over-the-counter hearing aids, A long-awaited rule was just completed on Tuesday, and it means that starting later this fall, millions of people in the United States won’t need a doctor’s prescription to get hearing aids.
According to the Food and Drug Administration, the new regulation eliminates unnecessary bureaucracy by establishing a new category of hearing aids that do not require a medical exam, a prescription, or any other kind of specialty evaluation.
Instead, they will be available for purchase over the counter at pharmacies and other retail establishments, as well as online.
Adults who only have mild to moderate hearing loss are the target demographic for these devices. The Food and Drug Administration (FDA) estimates that the usage of hearing aids could be beneficial to over 30 million adults; however, only around one-fifth of persons who have hearing impairments actually use the devices at this time.
In October of 2017, the FDA made its initial proposal for the rule. Midway through the month of October, the new regulation will become effective.
The potential for monetary savings was noted by officials in the Biden administration.
According to a statement released by the Department of Health and Human Services Secretary Xavier Becerra, “today’s move by the FDA signals a critical milestone in making hearing aids more cost-effective and accessible.”
The decision comes after years of pressure from both medical professionals and consumer advocates to make the devices more readily available and more affordable.
Currently, the cost is a significant barrier. Hearing aids can cost more than $5,000 to purchase in the United States due to the cost of the device and the services required to fit it. Hearing aids are not covered by insurance, and Medicare only pays for diagnostic testing; therefore, insurance coverage is quite limited.
The new status of over-the-counter will not apply to devices for more severe hearing loss; these products will continue to be available only with a doctor’s prescription.
Consumer electronics businesses have been producing lower-cost “personal sound amplification” devices for years; but, due to rules in the United States, these products are not allowed to be advertised as hearing aids, and the FDA does not examine them.
The new rule makes it very clear that the aforementioned instruments are not suitable replacements for hearing aids that have been approved by the FDA. Companies that market them in an inappropriate manner could be subject to sanctions, such as monetary fines or the seizure of their products.
The Food and Drug Administration (FDA) stated that it modified several aspects of its first proposal in response to comments from the public. One of these aspects involved clarifying how the federal rule will affect state restrictions on hearing aids.
When the federal rule goes into force, it is anticipated that traditional manufacturers will start providing cheaper models that are sold directly to consumers. Advocates believe that the market for hearing aids will one day mimic the eye care industry, in which customers have the option of purchasing reading glasses from a drugstore or bifocals through a prescription.
The declaration made on Tuesday is a response to prodding from medical committees and Congress, which in 2017 asked the agency to lay out a plan for hearing aids that may be purchased without a prescription.