Over-The-Counter Hearing Aids

What are they, and when will they be available?

What are over-the-counter hearing aids?

Over-the-counter (OTC) hearing aids are a new category of hearing aids that will soon be available for purchase in stores and online without a prescription. The new category of products will provide an alternative amplification option for adults with mild or mild-to-moderate hearing loss.

Why do we need MORE hearing aid options?

Almost 1 in 8 Americans aged 18 and older reports trouble with hearing. By the age of 70, about 1 in 3 adults suffers from hearing loss. However, fewer than a third of seniors who would benefit from a hearing aid has ever used one.

While hearing aid and assistive hearing technologies have made incredible advances over the past decade, the share of people using them hasn’t increased much at all.

Why don’t more people use hearing aids?

Cost is one of the biggest barriers to obtaining a hearing aid. Consequently, low-income patients with no access to an insurance that covers hearing aids are particularly underserved. Another barrier is the stigma of wearing a hearing aid, which mainly affects younger adults. Most people don’t realize they have a problem until their hearing loss has progressed beyond the mild-to-moderate category, meaning they often wait until they need more powerful and individualized—and hence more expensive—hearing aids.

OTC hearing aids could lower some of these barriers by making hearing aids more accessible and more affordable initially. To a degree, lower-cost hearing aids and hearables have addressed these challenges, but OTC hearing aids should open up the market and make these kinds of hearing aids more accessible for consumers.

How does hearing loss develop?

Age-related hearing loss is one of life’s unavoidable consequences for a large portion of the population. As children, we can hear frequencies up to 20 kHz. In our 20s and 30s, we slowly lose the ability to hear high-pitched sounds. First, our hearing thresholds for high frequencies increase, meaning we can only hear these sounds by making them louder. Eventually, as our hearing continues to decline, we can’t hear certain frequencies at all.

As we enter our 40s and 50s, age-related hearing loss starts cutting into frequencies detected by a hearing test (8 kHz and under). People with noise-induced and other forms of hearing loss, can of course show a decline in those frequencies much sooner.

What’s important to understand is that age-related hearing loss is happening so gradually that most people don’t notice it until it’s far advanced. By wearing hearing aids early on, however, it’s possible to slow its potential health impact.

What are consequences of hearing loss?

Hearing loss becomes problematic when it starts diminishing speech comprehension. Human speech ranges from around 125 Hz up to 8 kHz, but the frequencies most important for speech intelligibility are those around 1-4 kHz. Once a hearing test reveals mild-to-moderate hearing loss within these frequencies (ie, thresholds of 26 dB HL or more), hearing aids become beneficial.

Losing the ability to follow conversations is strongly correlated with social isolation, mental decline, and dementia. In fact, according to the Lancet Commission, hearing loss may account for 8% of dementia cases, which equals about 800,000 cases of dementia diagnosed globally each year. In an aging population, hearing loss affects an increasing number of people, as do dementia and other conditions associated with hearing loss.

This is devastating on both a personal and societal level. One study estimates that the global economic cost of hearing loss is almost one trillion dollars each year. Nearly half of the costs were related to quality of life. The authors note that “small reductions in prevalence and/or severity of hearing loss could avert substantial economic costs to society.”

Key characteristics of OTCs

The FDA is about to pass clear definitions for what exactly constitutes an OTC hearing aid, and how it will differ from prescription hearing aids. Here’s what we know about the pending OTC definition based on the FDA Reauthorization Act of 2017 (FDARA) and the FDA’s proposed rule published in October 2021:

  • OTC hearing aids will provide adequate amplification for mild-to-moderate hearing loss
  • They will be for adults only (18+ years old)
  • OTC hearing aids will use “same fundamental scientific technology as (current/traditional, ed.) air conduction hearing aids”
  • An OTC hearing aid is an “air-conduction hearing aid that does not require implantation or other surgical intervention.”
  • OTC hearing aids will be “available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.”
  • The user will be able to control their OTC hearing aids and customize them as they see fit
  • OTC hearing aids may include self-assessment tests
  • OTC hearing aids may include wireless technologies
  • There currently is a proposed maximum OSPL90 output level at 120 dB sound pressure level (SPL) at any frequency (ie, this limits the amplification to the upper region of a “moderate hearing loss”)

Furthermore, the FDA is set to put limits on the insertion depth, distortion control, self-generated noise level, and latency of OTC hearing aids.

Note: Direct-To-Consumer (DTC) hearing aids are hearing aids that are sold online or in stores, but that do not adhere to OTC hearing aid regulations (since regulations have yet to be published). Personal Sound Amplification Products (PSAPs) are intended to “enhance” situational listening, but should not be considered a solution for hearing loss.

OTC vs. traditional hearing aids: What’s the difference?

On the surface, OTC hearing aids will work much like self-fitted and traditional hearing aids. Even the technology will be the same or similar to what you can find in hearing aids today. The key difference is you’ll be able to get these hearing aids without the help of a hearing care provider. That should help to reduce the costs, but you’ll also be missing out on important services like amplification validation, which is offered by most good audiologists.

Pros & Cons of OTC hearing aids

Here are some potential good and bad points that the new OTC hearing aid regulations may bring.

Pros

OTC will provide increased access to hearing devices
OTC will eventually lead to the creation of new self-fitting hearing aid technologies by consumer electronics companies
OTC will lead to the demise of bad hearing care providers and an increase in overall quality of hearing care services (ie, a greater adherence to best practices)
OTC could lead to more regulation of the direct-to-consumer marketplace
OTC will put pressure on hearing care providers to be more transparent with their pricing (“unbundling” product costs from services)

Cons

OTC could put you at risk of improperly treating your hearing loss and/or missing a serious health issue
There is no guarantee that your OTC hearing aids will be programmed correctly
OTC may not drive down the costs of medical-model hearing aid technology
Instant-fit or “fit and go” OTC (as opposed to the more regulated self-fitting OTC) devices could open the market to more unscrupulous companies and poor-quality amplification

What are your options today?

Professionally-fitted hearing aids are currently available for purchase through state-licensed audiologists and hearing aid specialists. The average price for a professionally-fitted hearing aid, including a hearing aid fitting and follow up care, is $2372, according to a recent Hearing Tracker survey.

For those who cannot afford professionally-fitted hearing aids, there are quite a few routes. Please consider looking into options for financial support and our affordable hearing aids guide. If you are not ready to pursue professionally-fitted hearing aids, but still need help hearing, take a look at our hearable technology guide.

Who should get OTC hearing aids?

OTC hearing aids are more affordable hearing aids for adults with mild-to-moderate hearing loss. They’re suitable for people who don’t have access to insurance that covers traditional hearing aids. Potential buyers should be comfortable with self-managing electronic devices, customizing them using apps, and regularly optimizing their settings. A recent study also suggests that people who have had experience with conventional hearing aids and who are comfortable with smartphone technology are more likely to benefit from OTC hearing aids.

Prior to investing in OTC hearing aids, buyers should consult with a hearing care professional to confirm the level of their hearing loss and rule out underlying and/or treatable conditions, which might be covered by insurance.

What are self-fitting hearing aids?

Self-fitting hearing aids are air conduction hearing aids that don’t require a prescription or the assistance of a hearing care professional. Instead, users can customize their hearing aids using built-in technology and software.

The FDA first introduced a classification for self-fitting air conduction hearing aids in October 2019, after Bose had filed for a de novo classification (establishing a new FDA class of devices). Bose’s hearing aid was the first self-fitting hearing aid to receive FDA clearance.

Thanks to Bose leading the way, other devices falling under the self-fitting hearing aid definition can now be marketed and sold in the US after clearing the FDA’s premarket notification process, known as PMN or 510(k). Going forward, self-fitting hearing aids will fall into the OTC hearing aid category, but they won’t be exempt from the 510(k) requirement. They will, however, need to meet OTC regulations within 180 days of the FDA passing its final ruling.

Most recently, Jabra—which is the sister-company to GN Audio which makes ReSound and Beltone brand hearing aids—launched a hearing aid that would be classified as a self-fitting hearing aid. The company has opted to wait until the FDA regulations are finalized before offering these devices outside of the professional channel. However, you can get this product, called Jabra Enhance Plus, through hearing care providers, and HearingTracker Audiologist Matthew Allsop has reviewed it in a recent video.

Finally, the current proposed FDA rules includes a subset of what the Agency calls “fit and go” OTC hearing aids, devices that would not rely on an app or computerized self-fitting process. Instead, these aids would have more basic amplification options (eg, a simple volume control, a limited number of program settings you might toggle through via a button, etc) and would be exempt from the more stringent 510K premarket approval requirements that apply to “self-fitting” OTC aids.

Update: Bose was authorized to market the Bose Hearing Aid as a direct-to-consumer self-fitting hearing aid. However, the company stated in early May 2022 that it is discontinuing its SoundControl hearing aid and exiting the hearing aid market.

When will over-the-counter hearing aids be available?

Technically, Over-The-Counter hearing aids don’t exist yet, though the FDA is expected to finalize its rules and pass regulations that will permit the sale of OTC hearing aids before the end of the year.

The legalization of OTC hearing aids has been many years in the making, and numerous government and quasi-government agencies and committees have been involved (see timeline below for details).

The legislative ball really started rolling in August 2017 when President Trump signed the Over the Counter Hearing Aid Act, which authorized direct sales of hearing aids without a medical referral or prescription. However, the Act gave the FDA until August 18, 2020 to publish regulations for the new category.

Primarily due to the Covid-19 pandemic, the FDA failed to meet the 2020 deadline. In July 2021, President Biden signed an Executive Order designed to promote competition in the American economy, including the “wide availability of low-cost hearing aids.”

In October 2021, the FDA proposed a rule to establish OTC hearing aids via the Federal Register. The proposal outlines steps needed to create a regulatory category for OTC hearing aids, such as amending existing regulations, as well as a OTC hearing aid requirements, including labeling, output limits, and condition for sale.

The FDA also made provisions that would essentially remove hearing aids from its restricted device category and instead rely on states and licensing boards to oversee existing hearing aid dispensing laws (as long as these laws don’t conflict with the intent of the new OTC rules). The public was granted a 90-day comment period, which ended in January 2022, and this generated a large volume (almost 1100) of comments.

Although the FDA has until July 17, 2022 to finalize its ruling, US senators are urging the agency to pick up the pace. Conservatively, there is an ~8 month delay from final rulemaking to regulation issuance and publication in the Federal Register. So depending on when the FDA finishes reviewing the comments and publishes its final rule, we’re probably looking at late 2022 or early 2023 for the final rules to take effect.

Dr. Scott Gottlieb, until recently the head of the FDA, stressed that there are many issues surrounding the new market—including concerns by audiologists about how the federal law will affect their individual state licensing guidelines, and about how competition from unregulated suppliers might affect their business— which might result in a lengthy comment process.

OTC Hearing Aid Timeline

 
 
 
 
 
28 June 2022

US Senators Warren and Grassley Increase Pressure on FDA

On April 7, Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) introduced a bill which would force the agency to “issue a final rule within 30 days following enactment.” The two Senators issued a strong follow-up letter and report on June 29 accusing the “Big 5” hearing aid manufacturers of an “astroturf” lobbying campaign to influence FDA and weaken the OTC rule.

 
 
 
 
 
08 February 2022

US Senators Urge FDA to Finalize OTC Hearing Aid Rule

Eleven senators, including Senators Grassley and Warren, posted a letter to FDA’s acting commissioner Janet Woodcock, urging the FDA to “finalize the rule without delay” and to “exclude any unnecessary restrictions that hinder access to OTC devices or limit their effectiveness for Americans with mild or moderate hearing loss.”

 
 
 
 
 
17 January 2022

Public Comment Period for the FDA’s Proposed OTC Regulations Closes

About 1100 comments to the draft regulations were received. The FDA begins to review this public feedback in order to finalize its regulations.

 
 
 
 
 
20 October 2021

FDA Issues Proposed OTC Hearing Aid Rules

The FDA proposed a rule to establish a regulatory category for Over-the-Counter hearing aids and to update the regulatory framework for hearing aids accordingly. The new regulations were open to public commentary for 90 days.

 
 
 
 
 
09 July 2021

Biden Signs Executive Order to Promote Competition in the American Economy

Biden’s Executive Order instructs the Secretary of Health and Human Services to “promote the wide availability of low-cost hearing aids” within 120 days of his order.

 
 
 
 
 
18 August 2020

FDA Statutory Deadline

Final regulations from the FDA were expected to be published on or before this day. However, this deadline was missed.

 
 
 
 
 
18 August 2017

President Trump Signs OTC Hearing Aid Legislation into Law

The Over the Counter Hearing Aid Act was signed into law by President Trump, as a part of The FDA Reauthorization Act of 2017 (FDARA)

 
 
 
 
 
02 August 2017

US Senate Passes OTC Hearing Aid Legislation

The Over-The-Counter Hearing Aid Act of 2017 passes through the Senate as a part of The FDA Reauthorization Act of 2017 (FDARA).

 
 
 
 
 
12 July 2017

OTC Hearing Aid Legislation Passes Through House

The Over-The-Counter Hearing Aid Act of 2017 passes through the House as a part of The FDA Reauthorization Act of 2017 (FDARA). The OTC Hearing Aid Act was previously merged into the Medical Device User Fee and Modernization Act (MDUFA), which itself was passed as part of the FDARA.

 
 
 
 
 
20 March 2017

OTC Hearing Aid Act of 2017 Introduced

The Over-The-Counter Hearing Aid Act of 2017 was introduced into the 115th Congress by US Senators Warren and Grassley. The Act was originally introduced on 06 Nov 2016, but was re-introduced in the new congressional session.

 
 
 
 
 
07 December 2016

FDA Eliminates Physician Waiver Requirement

The FDA eliminates the so-called “physician waiver” system which requires consumers either to see a physician for a medical evaluation or sign a waiver prior to obtaining a hearing aid. This helps open the way for more streamlined online and OTC sales of hearing aids. (Some state licensing laws still require professionals to observe the waiver system.)

 
 
 
 
 
02 June 2016

NASEM Report on 'Hearing Health Care for Adults'

The National Academies of Sciences, Engineering, and Medicine (NASEM) releases its final report Hearing Health Care for Adults: Priorities for Improving Access and Affordability, which recommends, among 12 items, the establishment of an OTC class of hearing aids.

 
 
 
 
 
23 October 2015

PCAST Report on 'Aging America and Hearing Loss'

The Obama Administration’s President’s Council of Advisors on Science and Technology (PCAST) issues its report, Aging America & Hearing Loss: Imperative of Improved Hearing Technologies, recommending the FDA designate as a distinct category “basic” hearing aids and adopt separate rules for such devices.

 
 
 
 
 
15 April 2015

FTC Hosts 'Now Hear This' Workshop

The US Federal Trade Commission (FTC) holds an influential workshop titled “Now Hear This” which looks at issues surrounding technology and competition in hearing aid distribution, as well as how OTC hearing aids might impact customer satisfaction, the use of amplification products, consumer safety, and professional care.

 
 
 
 
 
01 February 2010

NIDCD Publication on Hearing Care Affordability and Accessibility

Audiologists Amy Donahue, Judy Dubno, and Lucille Beck publish a paper in Ear & Hearing summarizing a 3-day workshop sponsored by the National Institute on Deafness and Other Communication Disorders (NIDCD), in Bethesda, Md. The goal is to develop a research agenda that helps increase the accessibility and affordability of hearing care for adults with mild to moderate hearing loss.

 
 
 
 
 
07 August 2005

FDA Citizen's Petitions Filed by Audiologists

Two prominent audiologists file separate FDA Citizen’s Petitions. One seeks to abolish the “physician waiver” requirement that forces consumers to either see a physician or sign a waiver prior to obtaining a hearing aid; the other asks FDA to establish a “one size fits most” category of OTC hearing aid. Both petitions are denied.

Online Hearing Aid Sales

To understand the full landscape of products being sold online, check out my full talk, presented to staff Knowles Electronics in April 2021:

Closed captions are available on this video. If you are using a mobile phone, please enable captions clicking on the gear icon.