OTC Hearing Aids Are Now Available – Are They Right For You?

Healthy Living Fall 2022

In 2017, the Food and Drug Administration (FDA) released its proposal to allow certain hearing aids to be sold over-the-counter (OTC) without a prescription and without a hearing evaluation. The purpose of the bill was to increase access and lower the costs of getting hearing help. On August 17, 2022, the FDA released its final language.

How does this affect you? As a group of audiologists around greater Los Angeles, who follow best practices and are highly reputable in the profession of audiology, we felt it was important to educate the public on appropriate hearing care.

For years, hearing aids (Class I & occasionally Class II FDA Medical Device) were and will continue to be prescribed and professionally fit by audiologists and hearing aid dealers based on hearing evaluations, lifestyles, and many other considerations. The new FDA language will now include certain hearing aids to be sold over the counter.

The language that was written and approved by the FDA includes:

1. Over-the-counter hearing aids are only meant for those individuals with a perceived mild to moderate hearing loss

2. No hearing evaluation required

3. The purchaser must be 18 years old or older

4. Over-the-counter hearing aids can be sold outside of a medical office

5. Should not have one ear hearing better than the other (see an audiologist)

6. Not for those who have a sudden change in hearing (see an audiologist)

7. Not recommended for those who have tinnitus - ringing, roaring, noise (see an audiologist)

8. Not recommended if someone has a history of chemotherapy and/or radiation to the head/neck (see an audiologist)

9. Not for those who have active drainage from one or both ears (see an audiologist or otolaryngologist)

10. Not recommended for those who have ear pain or discomfort (see an audiologist or otolaryngologist)

11. Not recommended for those who have dizziness (see an audiologist) Although this may be an option for some of our patients, for many this will not be a viable solution. Without a thorough audiologic evaluation, any medical conditions will be missed or not monitored appropriately.

Ask your audiologists if they have vetted over-the-counter hearing aids. They may have insights into which ones may be a better option or even if you are a candidate for OTC hearing aids. If you feel like these OTC aids aren’t providing benefit or you are still struggling, see an audiologist. We are here to professionally test and evaluate your hearing and communication difficulties. It is our job to work with patients to find appropriate solutions to reduce listening fatigue, decrease communication issues, and enhance your quality of life.

Burbank Audiology Center |

Fidelity Hearing Center |

Harbor Hearing |

Love Hearing Services |

West Valley Hearing Center |