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With the FDA’s approval of Over-the-Counter (OTC) hearing aids in October 2022, the market has witnessed a surge in new hearing aid offerings. While this development is a positive step towards increasing accessibility to hearing assistance, it has also brought about some challenges. The main players dominating this emerging market are large hearing aid companies, often in collaboration with other big corporations. This concentration of power and resources can make it challenging for smaller players and innovative technologies to compete. In this blog, we explore the impact of this dynamic and the crucial role hearing professionals play in helping consumers find the right OTC hearing aid for their needs.
As the OTC hearing aid market expands, major hearing aid companies such as Sonova’s Phonak, Unitron, and Sivanto’s Signia, Rexton, Miracle Ear, and Widex, and GnResound and Beltone have formed partnerships with other corporate giants like Sennheiser, Sony, and Jabra. This level of collaboration suggests that significant financial interests are at play. The dominance of these established players can overshadow the potential of smaller companies and startups with innovative technologies.
Innovation and technology are critical for the advancement of society. Across all industries they play a pivotal role in shaping the way we live, work, and interact with the world. In the realm of healthcare and medical devices, including hearing aids, innovation technology has transformative potential.
First and foremost, innovative technology in the field of hearing aids has the power to significantly improve the quality of life for millions of people with hearing loss. Cutting-edge advancements in hearing aid technology have led to the development of smaller, more discreet, and more powerful devices. These devices offer enhanced sound processing capabilities, noise reduction features, and sophisticated connectivity options that enable seamless integration with smartphones and other devices. As a result, users can experience clearer, more natural sounds, better speech understanding, and improved overall hearing experiences.
Furthermore, innovative technology is driving accessibility and inclusivity for individuals with hearing impairments. With the advent of over-the-counter hearing aids and advancements in telehealth, more people can now access hearing aids and receive professional assistance without the barriers of cost and geographical constraints. Remote programming and adjustments have become possible, allowing hearing professionals to fine-tune hearing aids even from a distance. Which leads to increased convenience and efficiency in hearing care.
Innovation technology also fosters ongoing improvements in hearing aid design, making them more comfortable and user-friendly. The development of rechargeable hearing aids has reduced the reliance on disposable batteries, leading to cost savings and a more environmentally friendly approach. Additionally, ongoing research and development efforts are focused on exploring novel materials and form factors that are ergonomic and appealing to users.
Beyond hearing aids, innovative technology in audiology is enabling significant strides in hearing preservation, ear health monitoring, and early detection of hearing issues. Researchers are continuously working on refining diagnostic tools, leading to earlier identification and intervention for hearing impairments, which is crucial for optimal outcomes.
When big corporate companies decide to venture into the hearing aid sales market, they often seek partnerships with large hearing aid manufacturers. This enables them to tap into the expertise and established products of these manufacturers. However, this alignment with established players can lead to a somewhat conservative approach. Fosucing on utilizing older technology rather than embracing new innovative advancements.
The reason behind this strategy is straightforward. Large hearing aid manufacturers already have well-established product lines that have undergone rigorous testing and received approvals from regulatory authorities. These tried and tested devices are considered safe bets for mass distribution and retail chains. In contrast, new innovative technology from these manufacturers are often reserved for professional fitting hearing aids (the bigger money), where the expertise of hearing professionals ensures proper customization and fitting for individual users.
By opting for older technology, big corporate companies can streamline their supply chains, reduce costs, and reach a wider consumer base. They may prioritize affordability and simplicity, catering to a broad range of customers seeking accessible and affordable hearing aids. However, this approach does have its drawbacks, as it may not fully leverage the potential of the latest technological advancements.
While big corporate companies may find it more profitable to stick with older technology for their mass-market retail chains, this approach can leave some consumers without access to the latest and most advanced hearing aid options. Furthermore, it may perpetuate the misconception that all hearing aids are of similar quality and effectiveness. Potentially discouraging individuals from seeking the expertise of hearing professionals for personalized solutions.
Furthermore, the presence of Fortune 500 companies like Best Buy, Sennheiser, and Sony in the retail supply chain adds another layer of complexity. While this increases the availability of OTC hearing aids, it may also sideline the role of hearing professionals. Consumers may find themselves seeking advice from retail customer service representatives who lack the specialized knowledge required to guide them effectively.
This rapid expansion of OTC hearing aids and the strong retail presence should not diminish the crucial role that hearing professionals play. Audiologists and hearing specialists have invested years of education and training to understand the intricacies of hearing and ear health. Their expertise allows them to assess individual hearing needs, recommend suitable hearing aids, and provide personalized fittings for optimal performance. Hearing care professionals also provide valuable counseling and realistic expectations of the various devices people purchase for optimal success.
Hears Hearing & Hearables, along with other audiology practices, have recognized the importance of being involved in this changing landscape. They understand that empowering consumers with information and choices leads to better outcomes.
Using a hearing aid when needed can lead to numerous positive outcomes, significantly enhancing an individual’s quality of life. First and foremost, improved hearing enables better communication and fosters meaningful connections with loved ones, friends, and colleagues. It allows individuals to actively participate in social activities, conversations, and gatherings without feeling isolated. Moreover, hearing aids can enhance safety, as they help individuals detect important environmental cues like traffic sounds and alarms. By providing clearer speech understanding and reducing background noise, hearing aids enable individuals to enjoy their favorite activities, music, and entertainment. Ultimately, wearing a hearing aid promotes overall well-being, boosts confidence, and empowers individuals to lead fulfilling lives without the limitations posed by hearing loss.
Hears Hearing & Hearables conducts demos to educate consumers about the variations among different hearing aids. Not all devices are the same, and each comes with unique features and sound profiles. Through these demos, people can experience firsthand the differences between devices, helping them make more informed decisions. Although demos add to the cost of the device, it is well worth it if you find what you need.
Choosing an Over-The-Counter hearing aid solely based on the advice of a general customer service representative without proper evaluation can lead to unsatisfactory results. A wrong device fit can cause discomfort and inefficiency, leading to disillusionment with hearing aids as a whole. The customer will return the device. Waiting to embark on the hearing health trail for years until one day a loved one strongly encourages it.
It’s essential to remember the initial purpose of introducing the over-the-counter hearing aids. President Obama aimed to increase competition, lower price points, and enable consumers to find suitable aids until they required professional fitting. Hearing professionals are instrumental in fulfilling this vision by guiding consumers through the options and helping them make informed choices.
At Hears Hearing & Hearables, transparency and customer satisfaction are prioritized. We encourage customers to try different products and exchange them if needed. Striving to find the right OTC hearing aid or even solution that fits individual needs. With a membership-based store, the hope is that Hears Hearing & Hearables will gain enough members and Audiologists in-network to compete with the Big Companies that don’t belong in our space. Audiologists and hearing care professionals will help those who need some hearing and ear guidance.
The advent of OTC hearing aids has opened up new possibilities for individuals with hearing impairments. While big companies and retail giants dominate the market, the role of hearing professionals remains indispensable. Their expertise, guidance, and commitment to consumer satisfaction can help ensure that the right OTC hearing aid is found, leading to improved quality of life for those in need.
When choosing your over-the-counter hearing aid, it’s wise to seek the assistance of hearing professionals. Those like Hears Hearing & Hearables, who genuinely care about finding the best solution for their customers. So, let’s embrace this era of hearing accessibility while acknowledging the importance of professional expertise in making the right choices. Thank you for reading and supporting the professionals who are here to help you hear better. #ShopHearing
Sincerely,
Kim Fishman, Audiologist.
This article also seen on reputable news sources such as The Digital Journal, The Atlantic Report, and The Community Post.
Reviewed by Karen M.
Welcome to our review of the article “Disruptions to the Hearing Health Sector: Implications and Opportunities for Consumer Understanding.” Authored by a team of experts, including Isabelle Boisvert, Adam G Dunn, Erik Lundmark, Jennifer Smith-Merry, Wendy Lipworth, Amber Willink, Sarah E Hughes, Michele Nealon, and Melanie Calvert, this publication explores the dynamic landscape of the hearing health sector and its impact on consumers.
The authors shed light on the challenges and opportunities arising from these disruptions, with a particular emphasis on data privacy, product safety, accessibility, and the importance of equitable hearing health for individuals worldwide.
The introduction of within-ear wearable devices, known as hearables, coupled with the World Health Organization’s call to action, has opened up avenues for increased access to hearing interventions. By addressing the impact of hearing loss on various aspects of life, such as communication, social connections, education, and employment, these advancements aim to enhance overall well-being.
These statements from credible organizations highlight the significance of addressing data privacy, product safety, accessibility, and equitable hearing health to create a positive and inclusive impact on individuals worldwide.
This regulatory change driven by technological capabilities offers safe and effective options for individuals with mild to moderate hearing loss. However, the emergence of OTC alternatives may lead to shifts in market dynamics, affecting traditional hearing aid manufacturers, organizations, and clinicians. This could result in decreased options for some individuals and potentially more aggressive advertising targeting those with severe hearing loss.
For example, this shift of decreased options for individuals with more severe hearing loss is possible as the focus and resources of manufacturers and providers may be redirected towards catering to the OTC consumer market.
Additionally, with the increased availability of OTC devices, there is as mentioned a possibility of more aggressive advertising targeting individuals with severe hearing loss. This could lead to a complex market landscape where individuals with varying degrees of hearing loss are exposed to different marketing strategies and may have limited access to appropriate interventions that address their specific needs.
It is important to consider these implications and ensure that individuals with severe hearing loss continue to have access to comprehensive hearing healthcare options, including professional evaluation and fitting, while also promoting the accessibility and affordability of hearing aids for individuals with mild to moderate hearing loss.
As hearing devices integrate advanced features like biosensors and connectivity to smart home systems, concerns arise regarding data ownership, access, and potential conflicts of interest. The close relationships between device developers, hearing health providers, and financial interests tied to device sales warrant careful attention to ensure data privacy and ethical practices.
Professional education across health and disability sectors plays a pivotal role in meeting the communication and safety needs of individuals with hearing loss. Expanding the knowledge base of professionals can benefit those who lack access to hearing care or opt for direct-to-consumer devices without professional guidance. Empowering a wide range of professionals to support people with hearing loss can improve engagement and satisfaction with healthcare overall.
In conclusion, this thought-provoking article highlights the disruptions and opportunities in the hearing health sector, underscoring the importance of consumer understanding and the need for ethical practices. By addressing access and affordability, data privacy, and conflicts of interest while promoting equitable hearing care, the article paves the way for inclusive and accessible hearing health solutions for all. Hears to U, Hearing & Hearables is aware of all these issues and is the reason why we have created our new online accessible, affordable, transparent, ethical, compassionate store with the goals of building a ethical network of hearing health care professionals.
By prioritizing consumer-centric approaches, Hears to U, Hearing & Hearables located in Minnesota aims to provide reliable and comprehensive information to individuals with hearing loss, empowering them to make informed decisions about their hearing care. Through their initiatives, Hears Hearing & Hearables strives to bridge gaps in transparency, mitigate conflicts of interest, and ensure that safe, evidence-based, and cost-effective hearing and communication support is accessible to all. By championing transparency and equitable care, Hears Hearing & Hearables sets a positive example for the industry, fostering trust in the consumer and promoting inclusive practices.
It has greatly enhanced the way electronic devices connect, providing many conveniences for different niches. Among the many areas it has helped elevate is the hearing experience, especially for hearing aid device wearers.
Audio-sharing Bluetooth, known as LE Audio or AURACAST Audio is a promising capability for all Bluetooth-enabled devices. The new feature allows two or more hearing devices to connect to a source and share the audio. While Bluetooth has been widely used to connect earbuds or headphones to any electronic device to hear its sound, audio-sharing Bluetooth takes it to a new level by allowing more than one hearing device to be connected to an audio source so users can listen to its audio together, regardless of what they are doing, without disturbing others around them.
This new Bluetooth feature can offer many opportunities for streaming audio to a wider audience. It will benefit people who use personal hearing devices such as headphones, earbuds, and speakers when they listen to music (or a television program in a public place like the airport).
At the same time, it will also benefit hearing aid device wearers who need all the conveniences available to make their day-to-day activities lighter. People with hearing loss have a hard time hearing from a distance, like when they’re watching a TV at a sports bar.
“Imagine that you, who may or may not have hearing loss, walk into a sports bar to watch a football game and want to hear the announcers. It will be easy to just connect to that TV with Auracast, LE Audio Bluetooth, and just like that, the sound is right into your Bluetooth audio device. It’s game-changing. Maybe the movie theaters will offer LE Audio for people so you won’t miss a word of that movie,” said Kim Fishman, audiologist and founder of Hears Hearing & Hearables.
With this promising improvement, Hears Hearing & Hearables is keeping tabs on the progress of this Bluetooth upgrade.
Hears Hearing & Hearables is an online Ear and Hearing store that offers carefully curated products for ear and hearing needs, such as amplifiers, streamers, and other assisted listening devices. It also created a community dedicated to hearing wellness.
Hears Hearing & Hearables also supports its members who may or may not have hearing loss by keeping up-to-date with the latest technology, like the new Bluetooth and devices that help people hear to the best of their abilities. Again, one such exciting upgrade in technology is the audio-sharing Bluetooth feature posing with better connectivity as well.
Since Bluetooth technology is quite affordable, hearing device manufacturers will adopt this new LE Audio Bluetooth feature, so many users across the globe will slowly upgrade their units to enjoy its benefits. Hearing aid device wearers will no longer need to use different headphones whenever they wish to hear the same audio as others. They will simply connect their hearing aids to the audio source to listen.
Get the latest on hearing aid devices like this and more only at https://hearshearingandhearables.com. Hears, Hearing & Hearables keeps readers updated across the country with the newest and most exciting technology and features that will benefit the hearing wellness of its clients through its website.
About Hears Hearing & Hearables
Hears Hearing & Hearables was established to create a community dedicated to hearing wellness and to support its customers. It serves its communities by providing excellent, accessible, affordable, and transparent hearing healthcare and hearing healthcare products.
Aside from poor accessibility to healthcare professionals, the expensive cost of hearing aids prevents people from getting the help they need. Hears Hearing & Hearables aims to change this by making over-the-counter hearing aids readily available for people with mild to moderate hearing loss and connecting them with hearing health professionals across the US.
“We want to help people with hearing loss find affordable and accessible hearing solutions,” says the team behind Hears Hearing & Hearables. “While we are membership based, consumers do not need to be a member to shop with us. We work with you to make your hearing better.”
The company carries a range of self-fit hearing aids from reputable brands such as Sontro, Sony, and Jabra. The products highlight a customizable interface to suit every wearer’s preference and a comfortable and sleek build that is discreet and virtually invisible. Each one is carefully chosen for its performance, durability, and intuitive design, enabling wearers to go through their day with ease and confidence.
Beyond providing consumers with high-quality and affordable hearing aids, Hears Hearing & Hearables emphasizes educating consumers about their hearing health.
The Hears Hearing & Hearables team understands how hearing loss can significantly impact one’s way of life – from relationships to work and educational prospects. So they are passionate about empowering clients with comprehensive solutions and meeting them wherever they are in their health journey. The team is available to answer clients’ questions anytime and guide them in choosing the best option that fits their unique situation.
Moreover, by becoming a member, they can access a range of perks, including exclusive rewards and discounts from healthcare partners and the ability to sell and buy gently used products. Members also get to be a part of a supportive community dedicated to empowering each other in their hearing wellness.
Hears Hearing & Hearables offers everything from OTC hearing aids and Assistive Listening Devices to consignment hearing aids and accessories, ear care kits, and hearing aid care products.
Find more information about their product offerings here: https://hearshearingandhearables.com/.
I have always been creative and have thought outside of the box but lately, I am having a hard time sleeping because of all the ideas. I have so many ideas I am having a hard time keeping up with them. Perhaps this is normal for someone who has been in an industry for almost 30 years and my focus on ideas is in my career at this point.
I love working with people. For a few years, I was also in a doctoral program. You would like to think that creativity would be accepted into a Ph.D. program, however, it was not, for the most part. Yes, there were some professors that loved my creativity and passion. Others were something other than accepting. I heard words and sentences from these professors like “high-maintenance”, “not like #otherstudent who is a perfect A student” and “that is not how we do it”. So I realized it wasn’t going to work and left the program.
It has been a pleasure helping people. The trouble is if you don’t own your own space you have to follow what others want you to do, even if it is unethical, or lacks the most important concept, hence helping people. I soon realized that I continued to face issues with these companies lacking creativity and changing the status quo. I had to do what I was told and not what was best or easiest for the person you are helping. Can you believe a group of doctors told me they didn’t want the tail of the dog (me) to lead the dog (them)? And I was only trying to figure out how to help more people to make hearing care more accessible at that time.
Only now do I realize how creatively I developed the model and how successful the model worked at that time. As time ticked along and technology progressed, I realized yet again it was time to make another change in the model. If you don’t progress with the progression, you are the provider/owner/helper to the person who wants to help, and you won’t be around anymore. The person who wants hearing help will go to a more progressive concept, or at worst a cheap option. But we all know cheap is expensive. Ask me what I have observed in hearing health care that isn’t helpful to people and is only dangerous. I don’t need to tell you that hearing is really important.
The business is an e-commerce store that has so many products from ear-cleaning type products to hearing products and even tinnitus therapy products. We also have service available, and not just customer service which is to say normal but fee-for-service on people’s more complicated needs that customer service can’t manage. We have forums and videos and blogs.. oh my! Concepts and ideas for people. What do they need, and how to figure it out? Like a little puzzle figuring out what puzzle piece fits best for that person. Who doesn’t love a good puzzle when challenged?
Not all products are plug-and-play like the Airpods that so many people go and buy. These new products for ears and hearing have been engineered with creativity and thought. We need to handle these products with creativity too.
Right after I graduated college I wanted to become a writer. I have always been told I have an “awkward” writing style. But how I loved the creativity in stories and in literature. For a good little reader, people tell me I should be better at writing and my spelling should also be better. Is that really true? Perhaps my brain thinks awkwardly and that is why I write the way I do.
In 2023, I got my creative juices flowing. I am working with a small team now and it is going great. I am so thrilled at how many people we are helping. Not just fitting hearing aids and making sales either. Other audiologists should jump on the creative bandwagon. Or jump along with me. I could use the help.
How you have gotten others to come on board with you when you can’t completely afford to hire them yet?
Please support small new start-up businesses because these businesses are progressing and trying to make things better. (Respect that growth, unless they are only trying to make money and something cheap.) I challenge myself every day to drop the “old stale donut” and pick up a newly made “goodie”. Thanks for reading. Kim
Understanding that there is no one-size-fits-all solution for this, Hears Hearing & Hearables offers affordable and accessible choices for different people.
There are a variety of products their expert team has in stock as there is no single product for everyone.
“We started Hears Hearing and Hearables because we feel the field is not transparent and often does not have the consumer’s best interest in mind. We want to highlight that everyone has their own needs and therefore we will help find that special solution for each person.”
Kim Fishman, CEO and Audiologist
To ensure that every consumer has a seamless experience, Hears Hearing & Hearables allow them to personally have a choice of the product deemed best for them. This is unlike when going into a clinic which is often owned by a manufacturer (or has conflicts of interest in business) and imposes a product beneficial for the business. Moreover, compared to other online marketplaces, many models are still owned by one manufacturer which does not really give a wide range of quality options.
Not caring about selling only the big-ticketed items. Its delivery model is also transparent with the pricing and products. “Aside from helping our customers find accessible and affordable products when there is no one else to assist them, we can also support them by finding a provider near them that is also trustworthy,” Kim Fishman added. Kim Fishman also shared that they will provide affordable support via telehealth or as she said “teleaudiology”.
It is also worth noting that Medicare does not cover hearing aids while the advantage plans offer discounted options. People think they are getting a hearing aid benefit, but it is not a benefit, it is a discounted hearing aid. Although, those plans are not transparent which can lead to the customer being pushed to a certain product again. Hears Hearing & Hearables ensures that this wouldn’t happen with their proven and tested model in hearing health care and delivery.
Some of Hears Hearing & Hearables products and services are over-the-counter hearing aids, hearing aid chargers, batteries, and tinnitus treatment among others. Even as a new start-up company, many have already left testimonials which can be found on their website that shed light on their personal experience with Hears Hearing & Hearables.
Feedback for Hears Hearing & Hearables has completely endorsed its quality customer service. One of its customers, Bernard said
“They go the extra mile to help and work with you. I live in Maryland and received great advice for my problems. I wish that this service was available in my area.”
To know more about Hears Hearing & Hearables, visit their website now at https://hearshearingandhearables.com and check the best hearing solutions available. For people who don’t know what is best for them, reach out to the awesome team at Hears Hearing & Hearables and they will provide the best support.
About Hears Hearing & Hearables
Hears Hearing & Hearables online was created to help support its patients and to create a community dedicated to hearing wellness. It serves its communities by providing excellent, accessible, affordable, and transparent hearing healthcare and hearing healthcare products.
Phillip, my dad is an honest ethical man who has lived a life of integrity, works to help people, loves my mom, likes to have fun, watches a Gophers football game, and keeps connected with others and learning from others. A man in his 80s, dad is still working, enjoying life, and meeting new people –especially those who he finds interesting in one way or another.
Several days later, I went for a walk with my parents and my dad shared with me, and mom, his excitement and connection with his new friend, who I will call Prof C. Prof C, he emphasized, was quite a character. He was impressed with what Prof C shared about education, teaching and his sense of humor. He told my mom he would like Prof C to come to stay with them and visit. Prof C., he said, is a professor. He shared part of their conversations and ideals. My dad was beyond motivated. You know how you get when you meet someone that empowers you?
Anyway, my dad told me that his hearing aid stopped working halfway through the conference and he struggled. From that comment, he went on to say that Prof C needed his help. He said he could tell Prof C couldn’t hear well or maybe Prof C shared that he couldn’t hear well. Not sure how that went down but he asked me if I could help his new friend. I said “yes, of course” as I too love helping people. So, my dad gave me his email address.
I spoke with Professor C who was interesting and I felt we both were at ease right away talking about my dad and then his own hearing difficulties. Prof C and I had an agenda: to figure out how to help C hear better.
After going back to his own audiologist a dozen or so times over the course of getting his new hearing aids and then his travels he and I finally came up with an idea on what to do.
I won’t name products in this writing as it isn’t about the product. As clinicians, we must be aware of the impact we can make on human lives. Although it isn’t life or death, it is about the quality of your life!
Sending packages in the mail has become easy for me. Since we have an online store, we ship everywhere. So, packing up a new programmed device for Prof C was easy. Prof C had sent me his audiogram, pictures of his molds, and so on. I was hopeful that he didn’t just have plugged wax in his ears. He said wax wasn’t an issue for him. He shared his struggles and concerns with his hearing.
Yes, we had some issues with the cameras and him hearing well at that first meeting. But he quickly figured out how to get the support he needed on his end of the camera as we started working on a new solution. Prof C was a quick learner with all this technology and with support from a young colleague of his, we were Rockin and rollin. Prof C is funny and well I greatly enjoyed conversing with him.
With him hearing better and his happiness in light of the one different product that I sent him, he was very satisfied without needing to try anything else. Those around him noticed the ease at which he could hear better. Did I do much? No, not really. I did what I was supposed to do as a professional. Prof C said he was very, very happy with being able to hear.
We tried to figure out what to do next because he just spent his insurance benefit on this product that didn’t work and led him to believe he was losing his ability to process speech and even considered getting a cochlear implant!
I tried to be as gentle as I could, concerned about what was happening to him. This audiologist is not the only one that pushes one brand from prestigious universities and hospitals. In my practice, I see this weekly. People told me that they did not have a choice, walk-in not hearing well, and were upset. Feeling they are becoming deaf. And with some adjustments and with a demo of other products, I help these troubled consumers find something that gives them the help they need.
If you only work with my product/solution and your patient still isn’t hearing well and your tweaks are not working, perhaps consider trying a different product or referring to someone who does.
Well, I never heard back from his audiologist, but she sent him a note requesting for him to accept an appointment. He accepted the appointment with another audiologist who worked with him on his hearing. They told him that he couldn’t return the device.
He now feels he is hearing somewhat better with his product. Yes, he will keep the demo I sent him until we are sure he is out of the woods. Anything I can do to help him is my pleasure.
Was I a saint? I don’t think so. Was my dad a saint? I don’t think so either. Helping others is what we all need to strive to do for other humans. We are all in this together.
I want to share this story to help other people with hearing loss and to audiologists and hearing care professionals to realize that one solution isn’t always the solution. There are choices and indignities in our industry for being so caught up in one product. This is why transparency is so important. If you are in business with one brand one solution one product, then let your client know that there are other options.
Please be better for the sake of our clients. For those of you with hearing loss feel free to get a second opinion!
And finally, thanks to my dad and mom for raising me to treat others with respect and care.
Isn’t that great? This is a new change several years in the making.
Consumers could see OTC hearing aids in stores or online retailers in October. The rule is expected to lower costs. It is designed to assure the safety and effectiveness of OTC hearing aids while fostering innovation and competition in the hearing aid technology marketplace.
No prescription, no medical exam, no fitting is required, and no licensed seller is required. It is to be marketed to those adults who believe they have mild to moderate hearing loss. “Consumers with perceived mild to moderate hearing impairment”, according to the FDA’s press release.
For some, I am sure that will be the case. For anyone who has gone through the process of purchasing hearing aids with the assistance of an audiologist, you are probably wondering how it could be done safely. Between 2017 and now, the FDA did listen to a few experts.
There are limits to the depth these OTC aids go into the ear. They lowered the maximum sound output and put in user-adjustable volume controls. They also simplified the phrasing in the instruction manual that will come with the device. There will be apps and there will be videos and other helpful hints.
Well OK, but…I am stuck at the “perceived mild to moderate hearing impairment”. How can a person possibly know that? I would not be surprised if most people out there don’t know someone who denies their hearing loss; blames it on people who mumble, or talk too loud, maybe agrees to some loss but insists it is not too bad. Now people are going to admit to a hearing loss, figure it is mild to moderate and go to a store to buy a hearing aid!
Hopefully, that person will go to a hearing care professional and get a diagnosis before buying a product to ensure it will work for them. I guess worst comes to worst they can return it if it comes at no benefit. And it is only money if it doesn’t work.
Buying hearing aids over the counter is not, however, like buying a pair of “readers” at the local pharmacy. These are little computers you are putting in your ear; the process is far more nuanced. Hearing loss is rarely the same across all frequencies. Hearing aids are not a “one size fits all” device. That is why the audiologist or hearing aid dispenser goes through an adjustment period with you and your new aids. Here there is no exam so no way to diagnose potential structural issues within the ear, or with the auditory nerve.
That is great, especially if they can save a little money while improving their hearing. Great! What about all the people this does not help? It does not help children. It does not help those with a more severe loss. We all know how important it is to hear. That is how we communicate with our environment and those around us. What happens when someone buys one of these and it is not helpful? He or she is not going to be anxious to spend more.
No one denies that many more people could benefit from wearing a hearing aid than are currently wearing one. The FDA thinks that about 30 million Americans could benefit from wearing one, yet only about 20% of those who need one, actually wear one. The reasons vary such as access to care (especially in rural areas), and costs and there is still a stigma. We believe that the stigma may be more of an influence on not getting a hearing aid than the cost.
We hope congress does not dust off their hands and think they are done with this topic. They are not done until Everyone who needs hearing aids can be seen. That is what we at Hears Hearing & Hearables work to bring about the right change.
Happy Hearing for All!
Written by Karen (edited by Kim)
I took information for this summary/opinion page from the FDA, and associated pages:
https://www.fda.gov/medical-devices/consumer-products/hearing-aids
https://www.fda.gov/consumers/consumer-updates/hearing-aids-and-personal-sound-amplification-products-what-know
P.S. NOTE: We will be keeping everyone abreast of the new OTC hearing aids as they become available and our thoughts about them. We hope to help you and we hope you will buy them from us. We want you to be successful too.
In 2014 Apple’s iPhone created its own proprietary Low Energy Bluetooth for hearing aids. The Bluetooth used was not directly Bluetooth but a Low Energy (LE) Bluetooth which was created a few years before that. Hearing aid manufacturers had to pay to get the license to use it.
The top 6 manufacturer brands that use Apple’s proprietary low-energy Bluetooth are GnResound, Signia, Widex, Starkey, and Oticon. The Phonak brand does not use low-energy Bluetooth and hence, did not buy into Apple’s proprietary low-energy use. More on Phonak’s connection is below.
To pair to the iPhone, one must go into the settings, into the accessibility, find the (made for iPhones) MFI, open and close the hearing aid battery door and search. Soon the hearing aids would “show” and were able to be paired. There have been many updates with the iPhone and now the “MFI” is replaced with just “hearing aids” .😊 There is a lot behind the scenes with how the Bluetooth streaming actually works with both aids but it is very technical and if you are interested in the technical components, you too may want to refer to the Bluetooth book by Nick Hunn and the Special Interest Group. I digress.
Since android phones did not have a proprietary formula yet, Gn Resound started working with Google to create their own connections as the Bluetooth Special Interest group wasn’t moving at the speed at which Google and Resound wanted. And finally, with the updated 5.0 Bluetooth release, Google now has audio streaming for hearing aids referred to as ASHA.
The hearing aid brands that now connect to Android’s ASHA are GnResound, Signia, Starkey, and Widex. Oticon still does not have the ability at this moment to connect to an Android. Perhaps the Oticon brand will be able to connect soon. And remember Phonak brand does something different as I will explain next.
Phonak brand back in 2017-18 created their own chip that they call Sonova Wireless One Radio Digital Chip (SWORD), now on 3.0. As we mentioned they were able to avoid paying iPhone license fees and connect to Bluetooth directly, not using the Low Energy Bluetooth. They do claim that their Bluetooth chip runs on a lower battery drain compared to a regular Bluetooth connection. The Phonak brand was also able to use a microphone so people could truly talk on the phone hands-free. Like the other technology, there is the technology behind the scenes of streaming the signal to the other aid as Bluetooth only allows unilateral pairing to only one aid. Please refer to the Phonak brand papers to read more of the details or reach out to us at Hears Hearing & Hearables for a copy.
The hearing aids do not have the 5.2 technology yet. They will and the potential is so exciting. Hearing aids currently only pair to the phones and as we know Bluetooth 5.0 and younger are monogamous, meaning unilateral and can not connect to multiple devices. With new 5.2 technology, devices will be able to pair to multiple devices and multiple devices will be able to pair to multiple receivers so that people can share listening experiences. This technology may even replace the old tried and true T coil.
Stay tuned for my next review on 5.2 Bluetooth and what the Special interest group has considered the users, all of us.
Cheers! Kim
We are glad you asked because sometimes we wonder that ourselves. Just kidding. We know what a hearable is and it can have so many features it would be hard to define in one sentence. Let us try.
Where? Well, hearables are made for different environments and situations. There are hearables that will help you hear when you are working out. Those are the most basic though because they are also essentially streamers for your music. A hearable can help you hear on a conference or Zoom call. Or on a phone call in general.
The hearables that interest us are the devices that help you hear in a room, in noise, listening to TV, a lecture, and even in quiet! If you are not ready for a hearing aid, why not get a hearable?
Stay tuned as there will be more hearables coming to the marketplace soon.
Check out our selection of Hearables!
