[UCRDBR] Over the Counter Hearing Aids - FDA Ruling

[Departmental Benefits Representatives]

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September 27, 2022

To:
Department Benefits Representatives (DBRs)
From:
HR Benefits Office on behalf of UC Office of the President
Re:
FDA ruling on Over the Counter (OTC) Hearing Aids


The U.S. Food and Drug Administration (FDA) issued a final ruling on affordable over-the-counter (OTC) hearing aids<https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans> for individuals who are 18 years old and older with perceived mild-to-moderate hearing loss impairment.

OTC hearing aids will become available as soon as the rule takes effect on October 17, 2022. Devices can be purchased without a medical examination, prescription or fitting by an audiologist.  They will be available through retailers, drug stores or online.  Under the FDA ruling, these devices must meet performance and design requirements specifications.  OTC hearing aids are different from existing Personal Sound Amplification Products (PSAPs) that amplify all sound frequencies equally and are not customized to an individual's hearing needs.

OTC hearing aids are not covered by UC medical plans; however, they are eligible expenses under the University of California's Health Flexible Spending Account (Health FSA) and Health Savings Account (HSA).  More information on eligible expenses can be found by visiting https://www.wexinc.com/insights/benefits-toolkit/eligible-expenses/.

For more information on the FDA ruling, members can visit
https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans.

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