1954 South Main St.
Wake Forest, NC 27587

Phone: 919-570-8311
Fax: 919-573-0797

OTC Hearing Devices

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 17th, 2022, the FDA released its final language. Here is what consumers and patients needs to know:

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 hearing aids to be sold over the counter.

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

  1. Over-the-counter hearing aids are only meant for those individuals who perceive they have a mild to moderate hearing loss
  2. No hearing evaluation is 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)
  11. Not recommended for those who have dizziness (see an audiologist)

For some of our patients, this may be an option, however, for many this may not be a viable solution. Without a thorough audiologic evaluation, any medical conditions will be missed or not monitored appropriately. Think of OTC hearing aids like reader glasses in the drug store. They will work in a pinch for some, but eventually the prescriptive device will be needed.

Our plan at Wake Audiology is to embrace OTC hearing devices and help guide our patients to their best hearing solution. We’ll help consumers confirm that their OTC product is appropriate for their hearing with real ear measurements. We’re also prepared to clean and offer limited-service plans to help maintain these devices until ready for prescription 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.