On August 17, 2022, the Food and Drug Administration (FDA) issued a final regulation that allows the sale of over-the-counter (OTC) hearing aids for those with mild to moderate hearing loss. The new rule was effective October 17, 2022, and can be found at Final OTC Rule.

Background

Generally, hearing aids have been regulated as medical devices and required a prescription. In 2017, the FDA Reauthorization Act of 2017 directed the FDA to establish a category of OTC hearing aids and set forth various requirements. The FDA proposed regulations in October 2021 and received more than 1,000 comments. The final regulations consider the comments, and the FDA’s reaction can be read in the preamble part of the Federal Register notice at the above link.

Final Rule

The final regulations allow the sale of over-the-counter hearing aids that meet specified requirements. The OTC hearing aids are intended for those with mild to moderate hearing loss.  Accordingly, the final regulation contains requirements with respect to the labeling on the outside and the inside of the package, decibel limits on maximum sound output, and design requirements for the hearing aids.  Labeling requirements include a warning that OTC hearing aids are only for users who are age 18 or older. Labeling requirements also include the following, which indicate some limitations of the hearing aids and when to see a doctor:

If you have any of the problems listed below, please see a doctor, preferably an ear-nose-throat doctor (an ENT).

• Your ear has a birth defect or an unusual shape. Your ear was injured or deformed in an accident.
• You saw blood, pus, or fluid coming out of your ear in the past 6 months.
• Your ear feels painful or uncomfortable.
• You have a lot of ear wax, or you think something could be in your ear.
• You get really dizzy or have a feeling of spinning or swaying (called vertigo).
• Your hearing changed suddenly in the past 6 months.
• Your hearing changes: it gets worse, then gets better again.
• You have worse hearing in one ear.
• You hear ringing or buzzing in only one ear.

For hearing aids that have been legally offered for sale prior to October 17, 2022, the final regulation provides that compliance with the new rules for OTC hearing aids must be achieved by April 14, 2023. For hearing aids that have not been offered for sale before October 17, 2022, compliance with the requirements of the regulation must be achieved before marketing the device on or after October 17, 2022.

Cheiron Observation:  Plans covering hearing aids should consider to what degree they wish to cover OTC hearing aids. These are expected to be much less expensive; however, more participants and beneficiaries are likely to take advantage of the ability to purchase devices without a prescription. In addition, plans may want to consider directing participants to an ENT doctor when appropriate.

Cheiron is an actuarial consulting firm that provides actuarial and consulting advice. However, we are not attorneys, accountants, or clinicians. Accordingly, we do not provide legal services, tax advice, or medical advice.