5 Best Over-The-Counter (OTC) Hearing Aids In 2023

July 27, 2023
Blake Cadwell
Written by
Blake Cadwell
Amy Sarow, AuD, CCC-A
Reviewed by
Amy Sarow, AuD, CCC-A

Our research for this guide included:

- 200+ Hours of Hands-On Reviews
- 3 Licensed Audiologists Consulted
- 50+ Total Brands Reviewed
- 1,000+ Customer Reviews Considered

Our work is funded through reader support. When you buy through our links, we may earn a commission.

๐Ÿ’จ In a hurry? Our top OTC hearing aid picks for 2023 are:
โ€
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. ๐Ÿ‘‡

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

Images of various over-the-counter hearing aids

The basics: 

  • 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:

Pros ๐Ÿ‘

  • 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.

Cons ๐Ÿ‘Ž

  • 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.

How the 5 best OTC hearing aids compare.

Brand Price Style Bluetooth Batteries Programming Approach
Eargo 7 $2,950 / pair In-the-ear No Rechargeable Onboard test and fitting algorithm
Lexie B2 Powered by Bose $999 / pair Behind-the-ear iPhone Only Rechargeable Onboard test or freeform controls
Engage From Lucid $799 / pair Behind-the-ear iPhone + Android Rechargeable Freeform controls only
Sony CRE-E10 $1,299 / pair In-the-ear iPhone Only Rechargeable Onboard test and fitting algorithm
MDHearing Volt Max $699 / pair Behind-the-ear No   Rechargeable Onboard test and fitting algorithm

Keep scrolling for a full breakdown of each product ๐Ÿ‘‡

Eargo 7
Only Rechargeable and Invisible Product On The Market

Eargo 7

Eargo 7

$1,650 - $2,950 / pair
In the Ear
OTC
Affordable
Rechargeable

Eargo is the disruptor in hearing health. Their product is rechargeable, invisible, and designed with a patented tip that allows your ears to breathe.

Eargo 7 was released in 2023 with new features that adapt to your environment as you move through your day. Eargo has raised hundreds of millions to design their product from scratch and what they've pulled off is impressive.

Think of this product as the Tesla of hearing health. Eargo is best for those with mild to moderate hearing loss. If you want to try something new, this is a great option.

  • How it works:
    โœ”๏ธ Start by purchasing Eargo online or over the phone (or get a free sample product here).
    โœ”๏ธ Once the product arrives at your home, youโ€™ll receive instructions to download the app and self-program the hearing aids to match your hearing loss.
    โœ”๏ธ If you need further adjustments, Eargo has a team of licensed professionals who can make remote updates or provide advice.
  • โ€Overall notes: Eargo stands out for its design, innovation, size, and telecare team. The price is a bit higher than other OTC options but still lower than the national average. โ€
  • Price: $2,950 for Eargoโ€™s newest product (currently on sale)โ€
  • Features: Invisible, self-programmed, rechargeableโ€
  • What audiologists say: โ€œIf you are looking for invisible devices Eargo is one of the best options on the market.โ€ - Ramsay Poindexter
Soundly Scorecard
+
Hearing Loss Level ๐Ÿ”Š
Mild - Moderate
  • Eargo 7 hearing aids are sold over the counter and are appropriate for those with mild-moderate hearing loss
  • If you have more significant hearing loss it is recommended that you access professional care through Telehealth or local care
Care Type ๐Ÿฅ
Over-The-Counter
  • Available for purchase online or at retail stores like Verizon Victra and Best Buy
  • Does not require a prescription from a doctor
  • Customize your hearing aids with an onboard hearing test and app-controls
Sound Quality ๐Ÿ”Š
Strong in Background Noise
  • Eargo has well-developed background noise management algorithms
  • SoundAdjust+ and Clarity Mode adapt to your environment and focus on voices
Comfort ๐Ÿฆป
Somewhat Comfortable For All-Day Wear
  • Eargo sits inside of the ear and is one of the most comfortable non-custom models on the market
  • Eargo creates less occlusion than many in-the-ear options
  • Our team finds all in-the-ear models slightly less comfortable than RIC hearing aids

โ€

Style  ๐Ÿ’ซ
In The Ear - Non Molded
  • Sit inside the ear
  • Only available in one completely-in-canal size (nearly invisible in many ears)
  • Only available in black
Battery ๐Ÿ”‹
Rechargeable Only
  • Eargo hearing aids are rechargeable
  • 16 hours of battery life on a single charge
  • Each pair of hearing aids comes with a small and portable recharge case that carries 2 additional charges
Connection ๐Ÿ“ก
Bluetooth Not Available
  • Eargo 7 does not come with Bluetooth streaming
Dexterity Level ๐Ÿค
Average
  • Eargo 7 is small but comes with rechargeable batteries which prevents difficult battery changes
  • Eargo's recharge case uses conduction charging and magnets which makes handling easier
  • Eargo's devices include a pull-tab that makes it easier to place and remove the devices in your ears
Waterproof Level ๐Ÿ’ฆ
IPX7
  • Eargo 7 hearing aids have an IPX7 rating. Eargo devices can be submerged in a meter of water for up to 30 minutes without damage
App features ๐Ÿ“ฑ
Has An App
  • Eargo uses a smartphone app which includes an onboard hearing test and manual controls for bass and treble
  • Adjust volume and programs without the app by double tapping your ear
Pros

Eargo is a tiny device that sits entirely inside the ear

Eargo is more affordable then custom mold hearing aids

Eargo is self fit using an app

Cons

Only appropriate for those with mild to moderate hearing loss

Requires some tinkering to fine tune the product

Eargo is not Bluetooth enabled due to the tiny size

Get a free (non-working) Eargo sample ๐Ÿ‘‰
Learn More
Image of Bose rechargeable hearing aids
Lexie B2 Powered By Bose
Affordable and Rechargeable

Lexie B2 Powered By Bose

Lexie B2 Powered By Bose

$999 / pair
Affordable
Behind the Ear
Rechargeable
OTC
Bluetooth (iPhone Only)

In July 2022 Bose formed a strategic partnership with Lexie (a well respected hearing healthcare company) to release Lexie B1 hearing aids. In October they released a second model with rechargeable batteries. Then in May 2023 they added Bluetooth streaming capabilities for iPhone users.

Both versions of the Bose hearing aids are self-fit using an innovative app that allows hearing aid wearers to fit, program, and control their hearing aids with clinically proven, audiologist-quality results. Purchase B1 hearing aids for $849 or rechargeable B2 hearing aids for $999 (compare models here).

  • How it works:
    โœ”๏ธ Start by purchasing Bose online or at a local retailer
    โœ”๏ธ Once the product arrives at your home, you'll download the app and self-program the hearing aids to match your hearing loss.
    โœ”๏ธ If you need further adjustments, Lexie has a team of licensed professionals who can make remote updates or provide technical advice.
  • โ€Overall notes: If you have mild to moderate hearing loss, are comfortable with smartphone tech, and are on a budget, Bose is one of the most compelling products available.โ€
  • Price: $849 for a pair of B1 hearing aids or $999 for a pair of B2 hearing aids
  • Features: Rechargeable batteries, Bluetooth Streaming for iPhone users, Programming app, Behind The Ear Styleโ€
  • What audiologists say: โ€œOne of the simplest to use OTC hearing aids, at a very competitive price. A solid option for those who want to self-manage their mild to moderate hearing loss.โ€ - Garrett Thompson, AuD
Soundly Scorecard
+
No items found.
Pros

Strong underlying technology

Self-fitting using the Lexie app

Affordable and rechargeable

Cons

Bluetooth for iPhone only  

Only comes in one color

Costs $150 more than disposable battery version

More Reviews + The Latest Pricing and Discounts ๐Ÿ‘‰
See Price
Lucid OTC Hearing Aid Customization
Engage From Lucid Hearing
Sam's Club Upgrade Option

Engage From Lucid Hearing

Engage From Lucid Hearing

$799
Affordable
Behind the Ear
Rechargeable
OTC
Bluetooth

Lucid Hearing is an under-the-radar brand in the OTC market but has some of the strongest technology and experience. The brand is best known as the manufacturer behind all of the Sam's Club hearing center hearing aids.

The brand released two impressive OTC devices in late 2022. Engage is Lucid's rechargeable, Bluetooth enabled and self-fit hearing aid that sits behind the ear. The product comes in several colors and has one of the most stable Bluetooth connections due to a patented antenna.โ€

  • โ€How it works:
    โœ”๏ธ Start by purchasing Lucid Engage hearing aids online.
    โœ”๏ธ Once the product arrives at your home, you'll download the app and self-program the hearing aids to match your hearing loss.
    โœ”๏ธ If you need further adjustments you can take your hearing aids to a nearby Samโ€™s Club for free service or call Lucidโ€™s hearing specialists.
  • โ€Price: $799 for a pair  โ€
  • Features: Rechargeable batteries, Bluetooth streaming enabled for Android and iPhone, fully customized to your hearing loss using an app, behind the ear style.

โ€

Soundly Scorecard
+
No items found.
Pros

Bluetooth streaming for iPhone and Android

Rechargeable

Self-fit

Cons

Packaging and recharge case are less sleek than Bose and Sony

โ€

Purchase Lucid Engage online or at select retailers ๐Ÿ‘‰
See Price
MDHearing Aid Image in Hand
MDHearing Volt Max
Most Affordable and Rechargeable

MDHearing Volt Max

MDHearing Volt Max

$297 - $699 / pair
Affordable
Behind the Ear
OTC
Rechargeable

MDHearingAid is a Chicago-based brand that has sold over 500,000 pairs of affordable hearing aids since 2009. The brandโ€™s latest product (Volt Max) is programmed using a hearing test administered by a smartphone app. MDHearing sells exclusively online and does not require a trip to a local audiologist. The brand has recently invested in a remote care team that includes audiologists and hearing aid dispensers. Customers who need further tune-ups or care can set up a telecare appointment with a professional for free.

  • How it works:
    โœ”๏ธ Start by purchasing from MDHearing online.
    โœ”๏ธ Once the product arrives at your home, you'll download the MDHearing app and self-program the hearing aids to match your hearing loss.
    โœ”๏ธ MDHearing has a team of hearing professionals who can coach you through the self-fit process.
  • โ€Price: $599 for a pair  โ€
  • Features: Rechargeable batteries, Bluetooth streaming enabled for Android and iPhone, fully customized to your hearing loss using an app, behind the ear style.
Soundly Scorecard
+
No items found.
Pros

Affordable

Self-tuned

Rechargeable

Cons

No Bluetooth streaming

Slightly larger size

Only one color available

Get MDHearing Aids With VIP Support and 45-Day Returns
Learn More
Sony CRE-E10 Hearing Aids in hand
Sony CRE-E10 Hearing Aids
Headphone Hearing Aid Crossover

Sony CRE-E10 Hearing Aids

Sony CRE-E10 Hearing Aids

$1,299 / pair
Affordable
In the Ear
Rechargeable
Bluetooth

Sony teamed up with WS Audiology (the second-largest hearing company in the world) to co-create its products. Sony's CRE-E10 is slightly larger than CRE-C10 but comes with a slick headphone-like design, rechargeable batteries and Bluetooth streaming (currently only available for iOS).

This hearing aid offers prescription-grade sound quality controlled through your smartphone at home (no doctor involved). Sony's hearing aids were released in mid-October and reviews have been glowing. We expect CRE-E10 to be a leading consideration among people looking for a headphone/hearing aid hybrid.

  • โ€How it works:
    โœ”๏ธ Start by purchasing Sony hearing aids online (likely coming to brick-and-mortar stores soon)
    โœ”๏ธ Once the product arrives at your home, you'll download the Sony Hearing Control app and self-program the hearing aids to match your hearing loss.
    โœ”๏ธ Use the app to make real-time volume and sound quality adjustments.
    โœ”๏ธ If you need customer support, you can contact Sony's customer service team. โ€
  • Price: $1,399 at Crutchfield
  • Features: Self-fit using an app, Bluetooth streaming enabled for iPhone, stylish earbud design.
Soundly Scorecard
+
No items found.
Pros

Rechargeable

Modern design

Self-fit at home

Cons

Not compatible with Android

More visible than smaller options

Likely less comfortable for all-day wear

Get More Prices and Reviews on Crutchfield ๐Ÿ‘‰
Get Started

Here are 5 other OTC hearing aids that made our research shortlist.
โ€

Hand holding Sony invisible hearing aids
Sony CRE-C10 Hearing Aid
Best Budget Invisible Style

Sony CRE-C10 Hearing Aid

Sony CRE-C10 Hearing Aid

$999 / pair
Affordable
In the Ear
OTC

Sony teamed up with WS Audiology (the second-largest hearing company in the world) to co-create its products. Sony's CRE-C10 devices are nearly invisible and offer prescription-grade sound quality controlled through your smartphone. CRE-C10 does not offer Bluetooth streaming or rechargeable batteries.
โ€
CRE-C10 uses a size 10 disposable battery that offers over 70 hours of continuous wear. Size 10 batteries are widely available and commonly used in small devices. Sony's hearing aids were released in mid-October, so there are few reviews of the product, but it's safe to say this will be a leading consideration for those who want an in-the-ear style device.

  • โ€How it works:
    โœ”๏ธ Start by purchasing Sony hearing aids online (likely coming to brick-and-mortar stores soon)
    โœ”๏ธ Once the product arrives at your home, you'll download the Sony Hearing Control app and self-program the hearing aids to match your hearing loss.
    โœ”๏ธ Use the app to make real-time volume and sound quality adjustments.
    โœ”๏ธ If you need customer support, you can contact Sony's customer service team. โ€
  • Price: $999 on Crutchfield
  • Features: Self-fit using an app, nearly invisible in most ear canals
Pros

Nearly invisible

High quality sound for a lower price

Self-fit at home

Cons

Not as small as OTC competitors like Eargo

Not rechargeable

Does not allow Bluetooth streaming

Get More Prices and Reviews on Crutchfield ๐Ÿ‘‰
See Price
Sontro hearing aid
Sontro OTC Hearing Aids
Self Administered Test

Sontro OTC Hearing Aids

Sontro OTC Hearing Aids

$999
Affordable
Behind the Ear
OTC

Sontro OTC hearing aids come from a U.S.-based startup called Soundwave Hearing. The founding team has a long history in hearing health and hopes to bring that industry experience directly to the consumer through their new product.
โ€
Sontro hearing aids use disposable batteries and do not allow Bluetooth streaming at this time. To customize your Sontro hearing aids, you will place them in your ears and use the app to take a short hearing test. The devices then work behind the scenes to change their sound output to match the frequencies where you need amplification.
โ€
One thing that makes Sontro unique is its partnership with the hearing care company Amptify. Each pair of hearing aids comes with a month of free onboarding care from Amptify's hearing experts.

  • โ€How it works:
    โœ”๏ธ Start by purchasing Sontro hearing aids online
    โœ”๏ธ Once the product arrives at your home, you'll download the Ototune app and take a hearing test which will customize your devices to match your hearing loss.
    โœ”๏ธ Use the app to make real-time volume and sound quality adjustments.
    โœ”๏ธ If you need customer support, you can contact SoundWave's customer service team. โ€
  • Price: $849 on SoundWave's website
  • Features: Self-fit using an onboard hearing test. Currently the smallest OTC behind-the-ear style device on the market.

โ€

Pros

Experienced founding team

Hearing test to customize the devices to your loss

One month of expert hearing coaching included

Cons

No Bluetooth streaming

Uses disposable batteries

โ€

Purchase Sontro online or at select retailers ๐Ÿ‘‰
Get Started
Hand holding Lexie hearing aids in a case
Lexie Lumen
Great App and Customer Service

Lexie Lumen

Lexie Lumen

$799
Affordable
Behind the Ear
OTC

Lexie was created by parent company hearX Group which got its start through a popular hearing testing app used by over one million people worldwide. That experience gave Lexieโ€™s founders the confidence to rethink how hearing aids are sold and programmed to drive down prices.

Instead of working with local audiologists, Lexie puts the power in hearing aid wearers' hands with an innovative self-fit app. The results are impressive. Since the brand's launch two years ago, Lexie has had more than 500 reviews online with an average of 4.7 stars.

  • โ€How it works:
    โœ”๏ธ Start by purchasing Lexie hearing aids online
    โœ”๏ธ Once the product arrives at your home, you'll download the Lexie Hearing app and take a hearing test which will customize your devices to match your hearing loss.
    โœ”๏ธ Use the app to make real-time volume and sound quality adjustments.
    โœ”๏ธ If you need customer support, you can contact Lexie's award-winning customer service team. โ€
  • Price: $799 on Lexie's site ($50 off with code SOUNDLEX23)
  • Features: Self-fit using an onboard hearing test, innovative rewards program
Pros

Affordable

Award-winning self-fit app

Available at Walgreens nationwide

Cons

Not as advanced as other OTC devices in background noise

Uses a tube to send sound to the ear instead of a wire

Get $50 off Lexie Lumen and B1 hearing aids with code SOUNDLEX23 ๐Ÿ‘‰
Get Started
Image of Lucid Fio in a mans ear
Fio From Lucid Hearing
Nearly Invisible Design

Fio From Lucid Hearing

Fio From Lucid Hearing

1,699
In the Ear
OTC
Rechargeable

โ€

Fio is Lucid's invisible style product that offers rechargeable batteries and allows customization using the Lucid app.

The Lucid Fio is a lot like the Eargo hearing aid (although slightly larger) at around 40% less price. Like Eargo (and most invisible hearing aids), Fio does not allow Bluetooth streaming.

One notable feature in Fio is that in order to adjust programs or the volume, you will need to place the devices back in their recharge case.

  • โ€How it works:
    โœ”๏ธ Start by purchasing Lucid Fio hearing aids online.
    โœ”๏ธ Once the product arrives at your home, you'll download the app and self-program the hearing aids to match your hearing loss.
    โœ”๏ธ If you need further adjustments you can take your hearing aids to a nearby Samโ€™s Club for free service or call Lucidโ€™s hearing specialists.
  • โ€Price: $999 for a pair  โ€
  • Features: Rechargeable batteries, fully customized to your hearing loss using an app, nearly invisible design.
Pros

Rechargeable

Nearly Invisible

Self-fit

Cons

Volume and sound adjustments must be made while the product is in the charging case

Does not allow Bluetooth streaming

โ€

Purchase Lucid Fio online or at select retailers ๐Ÿ‘‰
Learn More
Jabra Enhance Plus
Best Hearing Aid Headphone Hybrid

Jabra Enhance Plus

Jabra Enhance Plus

$799 / pair
In the Ear
Rechargeable
OTC
Affordable

Jabra Enhance Plus is a new product from GN Hearing (the parent company to ReSound). The earbud-style product is self-customized to your hearing loss and can alternate between amplifying the sounds around you, playing music and podcasts or both.

You can read my full review of Jabra Enhance Plus here. It hasnโ€™t replaced my hearing aids, but it offers a great starting point for someone who isnโ€™t ready to take the leap and needs support in specific situations.

  • How it works:
    โœ”๏ธ Start by purchasing Jabra Enhance Plus hearing aids online.
    โœ”๏ธ Once the product arrives at your home, you'll download the app and self-program the hearing aids to match your hearing loss.
    โœ”๏ธ If you need further support you can call Jabra's customer service team.
  • โ€Overall notes: Jabra Enhance Plus won't replace your all-day hearing aids but they can provide a boost to those with mild to moderate hearing loss that aren't ready to take the leap. โ€
  • Price: $799 for a pairโ€
  • Features: Self-fit, simple to get started, modern design, Bluetooth streaming and rechargeability
Pros

Modern headphone appearance

Fantastic music and podcast quality

Easy to use app

Cons

Not as comfortable as traditional hearing aids for all-day use

Picks up some wind noise

โ€

Purchase Jabra Enhance Plus online or at select retailers ๐Ÿ‘‰
Learn More

New Entrants - Sennheiser and HP

Image of Sennheiser and Nuheara hearing aids

More OTC hearing aids will hit the market over the next months (and years). Headphone maker Sennheiser and hearing health giant Sonova released Conversation Clear Plus in early January. Nuheara and Hewlett-Packard have teamed up to release a self-fitting device called HP Hearing Pro and eyewear giant EssilorLuxottica snapped up a hearing tech company with hopes to create a hearing aid and eyewear mashup.

One thing is sure, hearing aid wearers wonโ€™t have a shortage of options.

What OTC Means For The Future

Itโ€™s hard to predict the future, but, inevitably, the coming OTC regulation will significantly impact the future of hearing health. The 2017 bill intended to increase competition to drive down prices, make the buying process more transparent, and give people access who canโ€™t easily get to an audiology office.

These are some of the most common assumptions among hearing health experts:

  • Technology will not replace the need for audiologists; instead, it will likely change their role. OTC changes will probably focus audiology work on those with severe hearing loss and complex needs. Audiologists are trained in a much broader set of areas including cochlear implants, vestibular, aural rehab and more.
  • Prices will come down as technology makes self-care easier. This is excellent news for people who have historically been priced out of hearing health treatment.
  • Things will be confusing for a while as new brands emerge and traditional brands shuffle to sell directly to consumers. Online scams will do what they can to take advantage, and clear, well-researched information will be more critical than ever.
  • All of this will take time. OTC guidelines first became a discussion in 2016, and progress has been made, but itโ€™s slow. Expect the impact of OTC hearing aids to play out over decades, not just a few years.

โ€

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Frequently asked questions

What's the history of OTC hearing aids?
+

December 2016 - FDA Takes The First Step

Thirty-nine years after the FDAโ€™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 โ€œcommitment 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.โ€

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 โ€œ 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.โ€

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 presidentโ€™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 โ€œto consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter.โ€

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. ๐Ÿบ

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Where can I purchase OTC hearing aids?
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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.

Are OTC hearing aids good?
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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.

Who is a candidate for OTC hearing aids?
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Over-the-counter hearing aids are for people with mild to moderate hearing loss. If you arenโ€™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.

Are there any invisible OTC hearing aids?
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Yes. Eargo and Sony are the leading invisible OTC hearing aid makers.

What's the difference between OTC hearing aids and PSAPs?
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This is where things get tricky. If you search โ€œhearing aidsโ€ on Amazon youโ€™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.

Whatโ€™s the best OTC hearing aid with Bluetooth streaming?
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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.