Devices

FDA OKs OTC Hearing Aids

FDA has published a final rule establishing a new regulatory category of over-the-counter (OTC) hearing aids so that consumers with perceived mild to moderate hearing impairment may purchase hearing aids directly from stores or online retailers without a medical examination, prescription, or fitting adjustment by an audiologist. An agency notice says the final rule is expected to lower the cost of hearing aids.

The notice says FDA finalized the rule after reviewing more than 1,000 comments on its 10/20/21 proposed rule. The OTC category established in the final rule applies to certain air-conduction hearing aids intended for people age 18 and older who have perceived mild to moderate hearing loss.

The final rules notes that the FDA Reauthorization Act of 2017 directed the agency to establish a category of OTC hearing aids through rulemaking and set forth various requirements for OTC hearing aids.

Concurrent with issuing the final rule, FDA issued a final guidance, Regulatory Requirements for Hearing Aids and Personal Sound Amplification Products, to clarify the differences between hearing aids and the new personal sound amplification products.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome