Better late than never! Originally signed by President Donald Trump in 2017, on October 19th, 2021, the FDA finally publicly issued its proposal regarding OTC Hearing Aids. This proposal will stay for 90 days to allow public discourse before then continuing the process to be finalized.

These announced guidelines for OTC hearing aids are set to revolutionize the hearing industry in the United States and bring millions of people long-awaited access to hearing.

What are OTC Hearing Aids? Who Are They For?

OTC hearing aids will be a completely new category of hearing aids, separate from the current hearing aids available today. They will serve the same function and purpose as current hearing aids; acting as devices that amplify sounds and for those with hearing loss to better hear and participate in conversations, activities, and daily activities.

As the name suggests these will be available “over the counter” or online for direct purchase; no prescription or type of doctor/health professional visit is required. OTC hearing aids will mainly target individuals with mild to moderate hearing loss. Those with profound or severe hearing loss will still need a prescription and specialized hearing aids from an audiologist/hearing specialist.

Currently, the market is rife with PSAP; Personal Sound Amplification Products. While PSAPs do amplify sounds, they are strictly different from hearing aids in several ways; most importantly they are not medical devices, not FDA regulated, and are not intended for use by those with hearing loss.

These new OTC regulations look to clearly define the differences between PSAP and hearing aids, allowing consumers to best choose the devices that best fit their specific situation. 

Since these new OTC Hearing Aids are purchasable without the assistance/aid of an audiologist, they will be self-fittable and are likely to be self-controllable/adjustable as well!  

As these new OTC Hearing Aids are designed for those with mild to moderate hearing loss, if you experience one or many of the following signs then you may be a prime target for these new devices. 

• Difficulty hearing soft sounds, such as whispers or a gentle stream.
• Television volume levels turned up to levels uncomfortable for others. 
• Speech comprehension can become difficult when background noise is added or in noisy environments like a crowded cafe.
• Requesting others to speak more slowly and loudly during conversations.

What Are The New Regulations?

These new OTC regulations aim to not revise the current hearing aid category but to create a completely different one. With the creation of these regulations, there will be 3 distinct categories of hearing devices, each providing its specific niche and purpose.

These three categories will be prescription hearing aids, OTC hearing aids, and PSAPs. 

The newest category, the OTC, will be widely available. You will be able to pick them up directly from stores or online. Some of the key aspects are as follows:

• They will be classified as medical devices by the FDA
• They will be subject to FDA safety regulations
• They will have defined maximum volume output settings, design requirements, latency limits, warnings on the boxes, and other requirements to ensure safe usage and design. 
• These devices will be available for individuals 18 years and older only; hearing aids for users younger than age 18 would be prescription devices only.
• They are designed for mild to moderate hearing loss; those with severe or profound will still likely need a prescription and hearing aid from an audiologist/health specialist. 

The FDA promises to closely monitor the market and this new category to ensure that the products sold are safe and effective.

Furthermore, the FDA plans to revise the current hearing aid regulatory framework to allow harmonization together with this new OTA category. To read the full documents yourself, click the link below:

FDA OTC Hearing Aids Proposed Rule

PSAPs will be for those without any hearing loss but need a boost to assist with certain activities; some common uses include bird watching and listening to lectures in a large room. 

Hearing aids will see no direct changes, but you can expect there to be some indirect ones as a result of these new OTC regulations. For example, current hearing aids for those with mild-moderate hearing loss are still designed with an audiologist in mind; that means visiting them for the hearing test, purchasing through them, fitting & setting up the hearing aid, and returning for routine maintenance and check-ups.

Will these devices continue to sell and operate in this manner? Or will the slew of new cheaper, easier to access, and still FDA-regulated options make them a thing of the past? 

 Embed from Getty Images

Why Is This Such a Big Deal?

According to the FDA themselves, an estimated 30 million people in the United States suffer from hearing loss. Despite this, only about one in 5 people who could benefit from a hearing aid use one. That’s 24 million people suffering from addressable hearing loss! 

Despite these numbers, hearing aids face many barriers and hurdles that keep them from being widely accepted; their lack of accessibility (requiring a prescription/recommendation from an audiologist/hearing specialist), high cost (on average $2,000 per pair!), and the social stigma surrounding hearing loss & hearing aids among others.

OTC hearing aids look to address two of these barriers directly – accessibility and price. As hearing aids become more widespread and enter public perception, the acceptance of hearing loss and hearing aids as something just as normal as glasses will be sure to come. 

As Health and Human Services Secretary Xavier Becerra states, “today’s move by FDA takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss.”

Olive Union Is Here To Change Everything

At Olive Union, we aim to remove existing barriers and help create affordable, attractive, and accessible hearing options. Hearing is something we believe everyone should be able to enjoy; your favorite songs, a loved one’s laugh, and conversations with friends are all priceless experiences. 

With the Olive Pro, we took our first step by creating the first 2-in-1 Hearing Bluetooth Earbud. These new OTC Guidelines are set to change the market, and we can’t wait. Olive Union plans to be right at the forefront during this exciting period; we’re hard at work even as we speak! 

Stay up to date on Olive Union news & products by joining our Waitlist and subscribing to the Olive Branch Newsletter at the bottom of the page!
 
 
The information in this guide has been written using the following reliable sources:

https://www.fda.gov, https://public-inspection.federalregister.gov/2021-22473.pdf, https://www.nidcd.nih.gov
 
 
 

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One of the unfortunate consequences of hearing loss that doesn’t generate enough discussion is that it can make it difficult to work in certain professions; jobs such as construction or administrative work with heavy phone usage can be difficult for those with hearing loss.

The hope, of course, is that this won’t be the case for very much longer. Improvements in hearing aid technology, alternative hearing devices becoming available, and meaningful advancements in medical treatments are painting a brighter future for those suffering with hearing loss.

A Johns Hopkins professor discussing drug treatments for hearing impairment was quoted in an article in 2019 suggesting that the potential to treat underlying causes — not just symptoms — is “phenomenal.”

That’s promising to hear, but until then, hearing loss can still limit professional opportunities to some extent. What’s more helpful than focusing on those limitations, however, is considering which jobs work well for people who struggle significantly with their hearing.

And the good news is that there are several quality, rewarding jobs for people with hearing loss that come to mind.

Teacher

Teaching is a broad category, but what we’re referring to primarily here is the opportunity that hearing-impaired individuals have to teach children with similar special needs.

Kids in this situation can struggle to relate to other students or teachers, who often don’t have the necessary teaching or training experience. If you know what it’s like to be unable to hear or confidently express verbal communication, however, you may be in a unique position to help children.

Through both general teaching and instruction specific to hearing impairment (such as working on sign language), you can make a big difference and establish a fine career in the process.

Web Designer

Web design has been an appealing profession for many for a long time now, and it’s not difficult to see why. For one thing, there is always demand. As a Lifewire write-up on web design put it, every organization “from large corporations to small non-profits” needs a website (and possibly an app as well).

Additionally, the same write-up noted that the high-end salary for a web designer, as of 2018, was about $125k. Constant demand, good pay, and the chance to work creatively will certainly appeal to a lot of people.

It’s a particularly accessible job for the hearing impaired as well, because most of the communication involved tends to be digital.

Accountant

One perk that web design and accounting actually share is that people aspiring to have careers in these areas can do much of the work online. Internet courses are widely available in both disciplines, and are of course quite accessible to those who struggle with hearing.

Also similar is the demand in both fields. Numbers quoted in a Maryville University rundown of the online bachelors in accounting suggest a median salary of about $72k (similar to the median for web design), with significant growth projected in the coming years. Thus, we have another accessible, in-demand, well-paying job that hearing-impaired individuals can perform with relatively little difficulty.

Doctor

Various careers in medicine can be perfectly fitting as well. Of course, there are some difficulties that come into play. Assistance from materials like specialized stethoscopes can be necessary in day-to-day practice, and it’s certainly the case that some communications with patients can be challenging.

But there are still opportunities for people with hearing impairment to become doctors, and there are few professions as stable or as rewarding.

Data Analyst

Data analysis has been one of the trendier up-and-coming professions of the last decade, and demand isn’t slowing down yet.

Jobs in this field can differ from one another according to specific company needs, but typically they require only that you have sharp math skills and familiarity with programs that help to gather and organize data.

There is no reason for someone with hearing loss to have particular difficulty in this field, and it’s a field in which you can find high-paid and rewarding work helping a given organization to capitalize on its data and optimize performance.

In Conclusion…

While these are just a handful of many jobs accessible to people with hearing loss, they do represent some particularly strong opportunities! Whether you’re looking for a career change or figuring out what your first career will be, these are a few of the jobs that you should definitely keep in mind.

Additionally, we’d add that you should always keep your eyes open for new opportunities. As we alluded to above, options for managing and even treating hearing loss have been improving rapidly over the last decade.

This is improving many people’s ability to live with hearing loss on a day-to-day basis, and it is going to open more doors to more employment opportunities as well.

The future is bright, and the options are only going to diversify and improve from here!

This guest article was specially written for OliveUnion.com

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At Olive Union, we aim to change social perception around hearing aids & hearing loss, and remove existing barriers for people to improve their every day life – one ear at a time. Whether you pick up one of our Hearing Devices or another brands, it’s important for your hearing health and safety you know as much as you can before making that purchase.

Whether you have questions about the price of hearing aids, the different styles of hearing aids, where to purchase hearing aids, whatever it is; we want to make sure you’re well informed and ready.

Check out some of our many articles about hearing aids today, and leave a hearing aid expert.

• Purchasing Hearing Aids
• Hearing Aid User Groups
• Hearing Aid Preowned 
• How To Use Hearing Aids
• How Do Hearing Aids Work?
• Hearing Aid Types
• Hearing Aid Features
• Hearing Aid Alternatives
• Hearing Aids Finance

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Whether listening to our favorite music or laughing along with friends, hearing plays an important part in every aspect of our lives. Through hearing, we can both care for our own health as well as build and maintain relationships with others. Your hearing is important, and it should be treated and regarded so. At Olive Union, we want all ears to be happy and healthy. Take a look at our many articles on hearing health today!

• Hearing Loss
• Tinnitus
• Ear Infection
• Ménière’s Disease
• Misc.

The post Hearing Health appeared first on Olive Union.

Hearing loss can be experienced in one ear or both. Bilateral hearing loss, the term for hearing loss in both ears, is rarely experienced equally in both ears. Often both ears will have hearing loss, but at disproportionate levels. This uneven hearing loss is called asymmetrical hearing loss. To accommodate the unique aspects and special requirements of asymmetrical hearing loss, consider picking up a BiCROS hearing aid.   

What Are BiCROS Hearing Aids Used For?

BiCROS hearing aids are more suitable if you have asymmetrical hearing loss, which we explained above. They come in a pair, with a microphone that picks up sounds from the worse ear and a receiver in the ear with better hearing. This receiver ear processes sound sent there by the microphone.

They essentially amplify sound from both sides, but feed it into the ear with better hearing.  You can get Behind-the-Ear (BTE) and In-the-Ear (ITE) versions.   

What Are The Advantages? 

The advantage of BiCROS hearing aids is that people with single-sided deafness (SSD) can now access sound from their bad side. They harness the fact that you have two ears, but with the introduction of a wireless audio connection, no physical wire is needed for the two components to work together.

They also enable you to be more aware of other noises around you in the same way that other hearing aids amplify sounds.

These hearing aids might feel strange at first and take some time to get used to. It’s important to wear your hearing aids all the time or as much as possible to give your adjustment the best chance.

Are BiCROS Hearing Aids More Expensive Than Normal Hearing Aids?

Just like with other hearing aid types, the price of a BiCROS hearing aid will depend on the brand, model, and technology of the product. Generally, expect them to cost you around $2,500 – $6,000, which is in the same region as ‘standard’ hearing aids.

Sometimes you can give hearing aids a trial run and if you don’t like them you can send them back to receive a refund. If you’re still unsure about BiCROS, ask your hearing health provider whether this might be possible.

BiCROS & CROS Hearing Aids

Although similar, CROS hearing aids are a different type of device, and you should know the difference when shopping for one or the other. For more information, check out our CROS hearing aid article.

The information in this guide has been written using the following reliable sources:  https://www.hear.com, https://actiononhearingloss.org.uk, https://www.healthyhearing.com, https://www.nhs.uk

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