Hearing Aids Will be Available OTC: Everything You Need to Know – Healthline
The FDA will allow hearing aids to be sold over the counter. This could make hearing aids more accessible and affordable for many people. The hearing aids will start to be available OTC in October.
The Food and Drug Administration (FDA) has issued a new ruling that will improve access to over-the-counter (OTC) hearing aids.
The move will remove some of the barriers — including high costs and medical exam requirements — that have historically prevented many Americans with hearing lo…….
- The FDA will allow hearing aids to be sold over the counter.
- This could make hearing aids more accessible and affordable for many people.
- The hearing aids will start to be available OTC in October.
The Food and Drug Administration (FDA) has issued a new ruling that will improve access to over-the-counter (OTC) hearing aids.
The move will remove some of the barriers — including high costs and medical exam requirements — that have historically prevented many Americans with hearing loss from being able to access hearing aids.
The hearing aids are expected to be available in local pharmacies, drug stores, and online retail stores in mid-October when the rule takes effect.
The rule applies to air-conduction hearing aids, a common type of hearing aid that amplifies sound, for people 18 and older with mild-to-moderate hearing loss.
“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions. Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.” FDA Commissioner Dr. Robert M. Califf, stated in a press release.
In 2017, Congress passed legislation requiring the FDA to permit the sale of OTC hearing aids without a prescription.
In June 2021, President Joe Biden signed an executive order instructing the Health and Human Services Department to improve the availability of low-cost hearing aids.
In October 2021, the FDA reviewed thousands of public comments from patients, public health organizations, and advocacy groups on the proposed rule.
The final rule, which was published on August 16, 2022, will go into effect mid-October 2022.
There are many requirements regarding the hearing aids, including the maximum sound output, how deep the aid can be inserted in the ear canal, the need for a user-adjustable volume control, and the inclusion of clear, simple instructions for use.
Hearing aid manufacturers will have until April 2023 to comply with the new requirements.
Rebecca Lewis, an audiologist and Audiology Director of the Adult & Pediatric Cochlear Implant Program at Pacific Neuroscience Institute at Providence Saint John’s Health Center in Santa Monica, CA, says the OTC hearing aids are best for adults with mild-to-moderate hearing loss.
“If an individual hears reasonably well in quiet but struggles in background noise, they may be a good candidate for an OTC hearing aid,” Lewis said.
Because the OTC hearing aids do not require a medical …….
