On Aug. 17, 2022 the FDA issued a ruling that will allow over-the-counter, or “OTC,” hearing aids to be sold in the U.S. We are excited because this may allow people who have been hesitant about pursuing hearing aids to give them a try.
Our office has had several calls in the last week about OTC devices. Since we do not plan to carry these devices, our support to the consumer and programming for these devices will be limited. Therefore, we have put together a list to compare what we know so far.
Please keep in mind that this list will be constantly evolving at the federal and state level as more information becomes available:
OTC Hearing Aids
- Can be sold in “big box stores” and pharmacies
- Must be 18 years old to purchase/use
- No hearing test required
- Only suitable for people with “perceived” mild to moderate hearing loss
- No return policy
- No trial period
- No service or “fitting” assistance from a professional
- Unable to be programmed for a specific hearing loss
- Will come equipped with a volume button on the device to turn overall volume up and down or the device may be compatible with a smart phone app for the user to adjust
- Not recommended for people with tinnitus, dizziness, ear pain or discomfort, hearing in one ear better than the other or active drainage
Prescription hearing aids
- Will continue to be fit by audiologists or hearing aid dispensers in-office, and insurance claims will be submitted for those who are covered
- Your hearing health care professional can fit them on any age patient and take into consideration previous or current health conditions
- A hearing test is required for frequency specific programming of the hearing aids, and a “prescription” for the volume you need for each frequency
- These devices can be fit for mild to profound hearing losses
- The trial period/return policies vary by state
- There is still an onboard volume control or app adjustment
- Follow-up fine tuning and cleaning/maintenance routine from your hearing health care professional
- Verification of fitting prescription by your hearing health care professional
Please keep in mind that as these devices reach the market the federal and state laws regulating them may change. As always, we are committed to providing you with the best hearing solutions.
At this time, we will only continue to sell and fit prescription hearing aids using best practices in our office. OTC hearing aids are expected to arrive on store shelves in October 2022. We will be able to clean and check OTC devices for a fee and perhaps assist you on your hearing health care journey, but we are not sure how insurance coverage will be handled concerning OTC hearing aid devices.
Please don’t hesitate to contact Hearing Systems in Houston for more information about these new devices. 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.
Source: Hearing Matters Podcast webinar held on August 18, 2022 with Starkey Chief Innovation Officer Dave Fabry, Ph.D., Starkey Chief Compliance Officer Michael Scholl, and former FDA executive Nancy Stade