In 2015, President’s Council of Advisors on Science and Technology (PCAST) recommended that the Food and Drug Administration create a separate class of over-the-counter (OTC) hearing aids that individuals could purchase without consultation from an audiologist
The American Academy of Audiology released a statement and recommendation to the FDA on how to categorize these devices separately from hearing aids. Requirements of the OTC category include but are not limited to:
i. Labeled as intended for use by adults over the age of 18.
ii. Intended for use by adults with mild hearing loss and mild communicative impairments, only. Individuals with more severe forms of loss or impairments should see a licensed audiologist.
iii. Devices should include easy to use instructions and cautions, associated with long-term use.
iv. Labeling should include red flag warning signs that indicate a referral for an audiologic or otologic evaluation.
v. Labeling should indicate that devices are not intended to treat tinnitus, inner ear dizziness, or ear pain.
vi. Labeling should include negative consequences of under fit or inappropriately treated hearing loss.