Are Ceretone hearing aids regulated by the FDA?

Ceretone sells OTC hearing aids in an FDA-regulated category for adults age 18 and older with perceived mild to moderate hearing loss.

Because regulatory wording matters, the clearest customer-facing phrasing is that Ceretone OTC hearing aids are FDA-regulated or FDA-registered rather than making a broad “FDA-approved” claim.

If you need model-specific regulatory details, contact Ceretone Support before you buy.

Need more help? Contact Ceretone Support at (866) 283-4262, support@ceretone.com, or visit the support center.

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