💨 In a hurry? Our top OTC hearing aid picks for 2023 are:
Lexie B2 Powered by Bose (best sound quality)
Eargo 7(best invisible OTC hearing aid)
MDHearing (best budget-friendly)
Jabra Enhance Select (Telehealth care and affordable pricing)
In October 2022, the FDA outlined new guidelines for the sale of over-the-counter (OTC) hearing aids in the U.S. The move has significant implications for hearing aid wearers like me and the hearing health space in general. It's the biggest and most exciting thing to happen in hearing health in 50 years.
In this guide, we'll look at the state of OTC hearing aids, the leading brands on the market, and where things could go from here.
If you are still trying to decide between OTC and prescription options check out our decision guide here.
Stick around until the end of this article for answers to some frequently asked questions and a little more OTC hearing aid history.
Prefer to watch?
Here's our take on the state of the OTC hearing aid market right now. 👇
Before we get into products, let's start with a bit of background.
Why did the FDA make this move?
Research consistently shows that hearing aids are one of the best investments someone can make in their overall health. Hearing aids increase the quality of life and relationships while decreasing risks of dementia, falls, and more. New research from Johns Hopkins showed that hearing aids decrease the long-term effects dementia by as much as 48%.
Like glasses or other basic assistive technology, better access to hearing aids is good for everyone.
The problem? Hearing aids are notoriously expensive, and most people don't get help from insurance (more about that here).
One reason that hearing aids cost several thousand dollars is that, until October 2022, they required a highly trained professional to program them during an in-person doctor's visit. That same professional typically bundles in 4-5 additional visits for ongoing adjustments and support. Overhead costs add up.
The FDA and lawmakers like Chuck Grassley and Elizabeth Warren created the new OTC hearing aid category to give a budget-friendly option to those with mild-moderate hearing loss.
What You Need to Know About OTC Hearing Aids
- OTC hearing aids do not require a doctor's visit
- OTC hearing aid makers must comply with the FDA to legally use the "OTC" title
- Many OTC hearing aids offer a smartphone app which programs your hearing aids
- Several leading OTC brands offer excellent customer service, but most of the process is self-service
OTC customization approaches:
One big distinction between various OTC hearing aids is the way they are programmed to match your hearing loss. Every person's hearing loss is unique with different frequencies that need more or less of a boost. We see three programming strategies in the current market:
- Preset programs: Not customized to you specifically (least expensive).
- Freeform controls: Gives you dials to freely adjust across frequencies (mid-tier or premium price).
- Onboard test: Tests your hearing aids and programs your device automatically (premium price).
Pros and cons of OTC hearing aids:
- OTC hearing aids are less expensive than their prescription counterparts. The market leader, Lexie B2 Powered By Bose, is $999 for a pair of rechargeable devices.
- OTC hearing aids are more accessible and don't require access to a local doctor. You can buy a pair of OTC hearing aids online or in retail and have them in hand within a day or two.
- OTC hearing aids give you more control over your program. Some people like the feeling of control that OTC hearing aids provide. Prescription devices often require ongoing consultation with your hearing professional for troubleshooting and adjustments.
- OTC hearing aids are not (yet) as advanced as their prescription counterparts. Most OTC hearing aids lack certain features like Bluetooth streaming or rechargeable batteries. This lag will likely change with time.
- OTC hearing aids put you in control but also lack hands-on support. Working with a doctor gives you a point of contact when things aren't going well. OTC hearing brands offer customer service, and some (like Eargo) have on-staff audiologists, but the bulk of the process is designed for self-service.
- OTC hearing aids do not come with custom earmolds, and many people enjoy or need a custom-molded device or a custom-molded earpiece. OTC hearing aids all use rubber domes in a variety of preset sizes. These domes work well for most people.
Frequently asked questions
December 2016 - FDA Takes The First Step
Thirty-nine years after the FDA’s first ruling on hearing aids, the agency came back with a blockbuster announcement in December 2016 that it would no longer enforce the requirement that individuals 18 and up receive a medical evaluation or sign a waiver before purchasing most hearing aids.
In that same announcement, the FDA shared their “commitment to consider creating a category of over-the-counter (OTC) hearing aids that could deliver new, innovative and lower-cost products to millions of consumers.”
March 2017 - Elizabeth Warren and Chuck Grassley Introduce a Bill
In May 2017, Democratic Senator Elizabeth Warren and Republican Senator Chuck Grassley signaled a bipartisan commitment when they introduced the Over-The-Counter Hearing Aid Act of 2017. In May, the two lawmakers co-authored a piece that was published on the Jama Network. They urged the FDA to “ go further than simply doing away with the medical evaluation requirement and create a new category of over-the-counter hearing aids for adults with mild to moderate hearing loss.”
July and August 2017 - Congress Says Yes
On July 12th, 2017, the bill earned bipartisan support in the U.S. House. Three weeks later, on August 3rd, the Senate passed the bill to the president’s desk.
August 18th - Trump Signs The Bill
On August 18th, 2017, President Trump signed the bill into law. The law mandated that the FDA create and regulate a new category of OTC hearing aids. The bill directed the FDA to focus on high standards for safety, consumer labeling, and manufacturing.
2017 through 2021 - The Waiting Game
After a lot of initial debate and speculation, everything went quiet. The FDA went to work on its regulations, and hearing aid wearers had no choice but to wait.
The three-year deadline loomed at the beginning of 2020, and it looked like we would finally get answers. Then came the pandemic. The FDA had bigger things to worry about, and OTC hearing aids got stuck on the back burner.
July 2021 - Biden Signs An Executive order
After nearly four years of crickets, President Biden lit a fire under the issue On July 9th with an executive order that directed the U.S. Department of Health and Human Services “to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter.”
October 2021 - At Long Last, A Proposal
On October 19th, the FDA released the long-awaited proposal for a new class of over-the-counter hearing aids. The 114-page document was long and technical (as it should be). As a part of the brand new guidelines, the FDA established a 90-day comment period where consumers, companies, and doctors could submit their feedback on the bill.
January 2022 - Comment Period Closes
In late January, the comment period closed, with more than 1,000 comments submitted from audiologists, manufacturers, and even hearing aid wearers. As you might expect, the disruptive regulation has been contentious, with many advocates and detractors on both sides.
August 16, 2022 - Final Guidelines Are Published
After reviewing more than 1,000 comments from manufacturers and consumers, new guidelines finally published. The final FDA ruling is over 130 pages long and includes in-depth responses to comments on topics like labeling, applicable technology, the OTC application process, and more. The final ruling made several changes in response to industry comments but largely remained intact.
October 17, 2022 - OTC Officially Go OTC
Starting on October 17th consumers began to see officially labeled OTC hearing aids on shelves at retailers like Walgreens, Best Buy and online. OTC hearing aids can now be purchased without a doctors appointment and will allow fitting at home.
Someone buy Elizabeth Warren and Chuck Grassley a drink. 🍺
For the first time in almost 40 years consumers can now purchase hearing aids at a local Walgreens, CVS or Walmart.
Most brands like Sony, Bose, Eargo and Jabra also sell their products directly online.
Leading OTC hearing aids are high-quality and deliver significant benefit to their wearers. Brands like Bose and Eargo go toe-to-toe with prescription products while products like Jabra Enhance Plus fill a niche in the market.
The biggest difference between OTC and prescription devices is in the level of service they include. If you need a lot of hands on support, OTC might not be the best fit for you.
Over-the-counter hearing aids are for people with mild to moderate hearing loss. If you aren’t sure what level of hearing loss you have, you can take a free online hearing test to establish your level of hearing loss.
Over-the-counter hearing aids are not for people with severe hearing loss. The FDA outlined some specific dB output limits meant to keep more severe hearing loss cases under the oversight of a hearing professional.
If you regularly miss loud noises or you struggle to hear conversations at full volume without background noise, it is recommended that you see an audiologist.
Yes. Eargo and Sony are the leading invisible OTC hearing aid makers.
This is where things get tricky. If you search “hearing aids” on Amazon you’ll find a wide array of products that have not registered with the FDA. Most of these devices are personal sound amplifiers (PSAPS).
In general, PSAPs offer less customization to match your hearing loss and have not gone through the FDA clearance process. Many PSAP products are cheaply made in China and may not even safe for use.
Our suggestion is to use lists like this one to discover legitimate brands. You can then use that information to search in a more targeted way and avoid PSAPs.
Lucid Engage is one of the only behind-the-ear style OTC devices with Bluetooth. Jabra Enhance Plus and Sony CRE-E10 offer streaming capability in an earbud-style design.