The US Food and Drug Administration has issued a final rule to establish a new category of over-the-counter hearing aids for consumers 18 years of age or older "with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist." The rule takes effect in mid-October. Guidance also clarifies the difference between hearing aids, which are medical devices, and personal sound amplification products. The rule as clarified does not preempt state laws requiring an audiological evaluation for minors.
Read the American Speech-Language-Hearing Association's response
