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Many of you may already be aware of the recent FDA rule which promote the sale of Over the Counter (OTC) hearing aids for individuals with hearing impairments. Before you run out to the pharmacy to find out if you can pick up an OTC hearing aid for yourself and/or loved one, its necessary to understand the specifics of the U.S. Drug and Food Federal Administration ruling.

What kinds of OTC are included in the FDA ruling?

According to the FDA press release on August 16, 2022, the category of OTC hearing aids that is covered under this ruling includes “certain air-conduction hearing aids” designed for people 18years and older who experiences mild to moderate hearing impairment. Hearing aids for severe impairment and/or children younger than 18years old must be prescribed by an Audiologist.

It is estimated that close to 30million adults could benefit from this ruling.

When will the OTC hearing aids be available for purchase?

The rule is supposed to take effect 60days from publication in the Federal Register, approximately mod October to November 2022.

The Need to Consult an Audiologist

It’s of the view of the Agency that individuals should still consider contacting a specialist who can properly assess and recommend the proper type of hearing device necessary to address the category of hearing loss you/your family member may be experiencing. This will help avoid a minor problem becoming a major one in the long haul. It is also significant for individuals/families to understand the difference between hearing devices which are meant for voice amplification and medical devices designed to address hearing loss/impairment. A trained specialist will be able to help you to identify the proper device you may need or not need.