Health
Millions of Americans can now buy hearing aids over-the-counter
FDA Finalizes Historic Rule Enabling Millions of Americans’ Access to Over-the-Counter Hearing Aids
Mid-October could see the arrival of more reasonably priced hearing aids.
Today, the U.S. Food and Drug Administration announced a final rule to expand access to hearing aids, which might result in cheaper prices for millions of Americans.
This action introduces a new category of over-the-counter (OTC) hearing devices, allowing consumers with perceived mild to moderate hearing impairment to purchase hearing aids without a medical exam, prescription, or fitting adjustment by an audiologist.
The rule is anticipated to reduce the price of hearing aids, promoting the Biden-Harris Administration’s goal of increasing access to high-quality health care and reducing the cost of health care for the American population.
It is intended to ensure the safety and efficacy of over-the-counter hearing aids while encouraging innovation and market competition in the hearing aid technology sector.
President Biden’s Executive Order on Promoting Competition in the American Economy required the FDA to take procedures to enable over-the-counter sales of hearing aids and set a 120-day deadline, which the FDA met.
In 2017, Congress approved legislation mandating the FDA develop a category of over-the-counter (OTC) hearing aids, but it has not yet been completely implemented.
When the rule takes effect in mid-October, consumers may be able to purchase OTC hearing aids through traditional retailers and pharmacies.
“Reducing healthcare costs in the United States has been a priority of mine since day one, and this rule is anticipated to help us achieve quality, affordable healthcare access for millions of Americans in need,” said Secretary of Health and Human Services Xavier Becerra.
The FDA’s move today signals a key milestone in the effort to make hearing aids more affordable and accessible.
Nearly 30 million American people could benefit from hearing aids. Individuals with persistent hearing loss can use hearing aids to amplify their voice and other sounds, so enhancing their capacity to communicate with others.
Numerous hearing devices can be costly. The final rule aims to stimulate competition and facilitate the sale of safe and effective over-the-counter (OTC) hearing aids in traditional retail stores and online across the nation, giving consumers with perceived mild to moderate hearing loss better access to devices that meet their needs and are less expensive than existing options.
According to FDA Commissioner Robert M. Califf, M.D., hearing loss is a serious public health concern that impacts the ability of millions of Americans to speak properly in their daily social interactions.
“By establishing this new regulatory category, consumers with perceived mild to moderate hearing loss will have easy access to a variety of safe, effective, and reasonably priced hearing aids through their local retailer or online.”
The category of over-the-counter (OTC) hearing aids created by this final rule applies to specific air-conduction hearing aids designed for individuals 18 and older with perceived mild to moderate hearing impairment.
Hearing aids that do not fit the criteria for the over-the-counter (OTC) category (for example, because they are meant for severe hearing loss or users under 18) are prescription devices.
After receiving and considering more than 1,000 public comments on the proposed rule posted on October 20, 2021, the FDA finalized the regulation.
In the final rule, the FDA responds to the comments provided by consumers, professional associations, hearing aid manufacturers, public health organizations and advocacy groups, members of Congress, state agencies, and other stakeholders.
In response to public comments and to ensure the safety and effectiveness of over-the-counter (OTC) hearing aids, the final rule incorporates several changes from the proposed rule, including lowering the maximum sound output to reduce the risk of hearing from over-amplification of sound, revising the insertion depth limit, requiring that all OTC hearing aids have a user-adjustable volume control, and simplifying the language throughout the required device labeling to ensure the safety and effectiveness of OTC hearing aids.
In addition, the final rule incorporates performance parameters and design requirements particular to over-the-counter hearing aids.
In addition, today’s action modifies existing rules that apply to prescription hearing aids to make them consistent with the new OTC category, repeals the conditions for selling hearing aids, and includes provisions that address some of the effects of the FDA OTC hearing aid regulations on state regulation of hearing aids.
Concurrently with the release of the final rule, the FDA issued the final guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs), to clarify the distinction between hearing aids, which are medical devices, and PSAPs, which are consumer products that help people with normal hearing amplify sounds.
The final rule becomes effective sixty days after its publication in the Federal Register. Manufacturers of hearing aids sold before to the rule’s effective date will have 240 days from the rule’s publication to comply with the new or updated requirements.
Before marketing hearing aids that were not on the market prior to the effective date, they must comply with the new or revised regulations, including getting 510(k) clearance, if applicable.
Similar Information
The FDA, an organization within the U.S. Department of Health and Human Services, safeguards public health by ensuring the safety, efficacy, and security of human and veterinary pharmaceuticals, vaccines and other human biological products, and medical devices.
Additionally, the agency is responsible for the safety and security of the nation’s food supply, cosmetics, dietary supplements, devices that emit electronic radiation, and tobacco products.
Additionally, many ask
Are hearing aids something you can just buy?
Hearing aids available over-the-counter (OTC) are, indeed, something that may be purchased without first consulting an audiologist.
People who are experiencing severe hearing loss that cannot be treated with over-the-counter (OTC) hearing aids will be required to have a hearing exam and obtain a prescription from an audiologist or hearing care specialist in order to purchase prescription hearing aids.
OTC hearing aids will not be an option for these individuals.
Are hearing aids something you can just buy?
Does one of Walmart’s stores now sell hearing aids that are now available for purchase in the United States?
Over-the-counter hearing aids are now available at Walmart, which will help customers both hear and feel their best. Copied!
How much of a market is there for hearing aids in the United States?
In 2022, the Hearing Aid Clinics sector is expected to generate revenue of $2.5 billion, making it a market with a size of $2.5 billion.
What percentage of expansion can we anticipate for the Hearing Aid Clinics industry in the United States by the year 2022?
It is anticipated that the total market size of the industry of Hearing Aid Clinics will expand by 4.1% in 2022. How much do hearing aids typically cost in the United States?
Key Considerations Regarding the Lowest-Priced Hearing Aids Hearing aids can cost as much as $7,000 for a pair; however, the less-priced options on this list range from $99 to $6,000 and still provide quality as well as individualized attention to each customer.
When determining which hearing aid is ideal for you, it is important to think about your lifestyle, your budget, and your hearing needs.
Is a Costco membership required to purchase hearing aids at Costco?
You do not need a Costco membership to receive an eye checkup or hearing test at Costco because it is illegal to restrict access to health screenings to the general public.
However, in order to purchase any of the hearing aids or optical devices that Costco has to offer, you will need to sign up for a membership.
Does Medicare cover hearing aids manufacture in 2022?
Hearing aids, as well as the fittings and hearing exams that are performed for the purpose of prescription hearing aids, are not covered by Medicare Parts A and B, which is a shame because they are expensive.
Hearing aids and exams are only two examples of the kinds of hearing services that may or may not be covered by Medicare Advantage plans, depending on the specifics of the plan.
How much money should you expect to spend on a reliable hearing aid?
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between $1,800 and $5,000 per pair, depending on the size.
How Much Does It Typically Cost to Purchase a Reputable Hearing Aid? Hearing aids can be purchased for anywhere between $399 to more than $6,000 for a pair.
A pair of high-quality hearing aids will set you back anywhere from $1,800 to $5,000 on average. Although this range is somewhat broad, it does take into account the lower pricing that is offered by internet carriers.
What is the typical life expectancy of a hearing aid?
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Hearing aids typically have a lifespan of three to seven years, however, they might survive even longer for certain individuals.
The quality of the instrument’s construction, as well as how well it is maintained, as well as the amount of wear and tear that it endures while being worn in your ear for a significant portion of each day are all factors that influence its lifespan.
Why aren’t more people in the United States getting treatment for their hearing loss?
Hearing loss may often be effectively treated, but many people choose not to obtain help because they are unaware of the condition, as well as because they are concerned about the expense and the social stigma associated with receiving treatment.
Hearing loss affects around 36 million people in the United States, as shown by research conducted by the National Institute on Deafness.
What are the reasons that insurance does not cover hearing aids?
The majority of insurance providers have stated that they do not provide coverage for hearing aids since, in their opinion, hearing aids are not a necessary piece of medical equipment; rather, they are categorized as “elective.”
How frequently does it become necessary to get a new hearing aid?
around five years
The typical lifespan of a pair of hearing aids is approximately five years. This is due to the normal wear and tear that occurs, in addition to the damage that can be caused by ear wax and moisture.
How long does it take for your brain to get used to the sound that a hearing aid produces?
It may take you up to four months to become accustomed to your hearing aids and to fully realize their potential benefits. During this time, however, you will be able to use them more effectively. You will almost immediately begin to observe some subtle shifts, but it is critical that you exercise patience during this process. Make sure to give your hearing professional a call for assistance if you have any queries or concerns about the way things are going.
What are the potential drawbacks associated with wearing a hearing aid?
Negative effects of hearing aids
- Tinnitus.
- Headaches.
- Shyness in the region surrounding the ears
- Irritations to the skin
- ear canals that are itchy
- Inability to hear in a normal manner
- An excessive amount of feedback.
Which hearing aid is most suitable for senior citizens?
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Hearing devices that use analog technology are significantly easier to use than digital hearing aids. They take the sound waves and transform them so that they may be read as an electrical signal.
They merely amp up their volume of them. They are one of the best solutions for seniors because the controls are straightforward and straightforward to use.
When will we finally be able to find a treatment for hearing loss?
There is currently no treatment available for hearing loss in adults because no medicine has been developed that can stimulate the regeneration of stereocilia in the ear.
Nevertheless, there are a variety of approaches that can be taken to cure it.
Hearing aids have been helpful for a significant number of individuals who are dealing with hearing loss.
Conclusion
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Health
Protein-Infused Diet Coke: The Viral ‘Dirty Soda’ Trend Taking TikTok by Storm
Protein-Infused Diet Coke: The Viral ‘Dirty Soda’ Trend Taking TikTok by Storm
The rise of quirky, unconventional food and drink trends is a staple of social media, but one concoction that’s recently captured TikTok’s imagination is “Protein Diet Coke,” fondly referred to as a “dirty soda.”
Combining the classic fizz of Diet Coke with creamy protein shakes, this bizarre yet fascinating combination has gained traction for its unique taste, nutritional benefits, and shareable aesthetic appeal.
But is it more than just a passing fad? Let’s dive into why this drink has taken the internet by storm, the health implications, and how you can make your own.
What Is Protein Diet Coke?
Protein Diet Coke is a mashup of two popular beverages: Diet Coke, known for its zero-calorie allure, and protein shakes, a go-to choice for fitness enthusiasts.
By blending these seemingly unrelated drinks, you get a fizzy, creamy concoction that surprises the palate and offers a protein-packed twist.
This beverage has become a TikTok sensation, with videos showcasing creative ways to personalize the drink by experimenting with flavors, toppings, and presentation.
How Did Protein Diet Coke Become a Trend?
The trend began with users sharing videos of themselves trying the drink and reacting to its surprising taste.
The hashtag #ProteinDietCoke amassed millions of views as influencers and everyday users alike showcased their custom recipes. Social media thrives on novelty, and the odd pairing of soda and protein shake fits the bill perfectly.
Moreover, this trend reflects a broader shift toward incorporating fun into fitness and healthy eating. As people explore unique ways to stay healthy, Protein Diet Coke offers a mix of indulgence and nutrition.
Health Benefits of Protein Diet Coke
1. Boosts Protein Intake:
Protein is essential for muscle repair, weight management, and overall body function. By mixing Diet Coke with a protein shake, you create a delicious way to meet your daily protein goals.
2. Low-Calorie Alternative:
For those watching their calorie intake, using Diet Coke and low-sugar protein shakes keeps the drink guilt-free while satisfying cravings for something sweet and fizzy.
3. A Fun Recovery Drink:
The combination of carbonation and protein makes this drink a potential post-workout recovery option. While traditional recovery drinks are effective, Protein Diet Coke brings a fun twist to replenishing nutrients.
Possible Drawbacks of Protein Diet Coke
While this beverage has many enthusiasts, it’s not without its critics.
1. Artificial Sweeteners:
Diet Coke contains artificial sweeteners like aspartame, which some people prefer to avoid due to potential health concerns.
2. Unusual Flavor:
Not everyone loves the combination of cola and creamy textures. For some, it’s an acquired taste.
3. Limited Nutritional Value from Soda:
Though protein shakes provide nutrients, the soda itself doesn’t offer significant health benefits. Consuming it in moderation is key.
How to Make Protein Diet Coke at Home
Ingredients:
- 1 can of Diet Coke (12 oz)
- 1 scoop or 8 oz of your favorite protein shake (vanilla or caramel flavors work best)
- Ice cubes
- Optional: toppings like whipped cream, syrups, or fruit
Instructions:
- Fill a glass with ice cubes.
- Pour the Diet Coke into the glass, leaving some space for the protein shake.
- Slowly add the protein shake to the Diet Coke. Stir gently to combine.
- Customize with toppings or syrups if desired.
- Enjoy immediately!
Why Do People Love It?
The allure of Protein Diet Coke lies in its unexpected combination and social media appeal.
The drink’s unique flavor profile intrigues people, while its aesthetic presentation makes it Instagram-worthy.
Additionally, it’s a fun way to consume protein without feeling like you’re drinking a traditional shake.
Creative Variations of Protein Diet Coke
1. Mocha Protein Soda:
Add a chocolate-flavored protein shake for a mocha-inspired treat.
2. Tropical Twist:
Use coconut-flavored protein powder and garnish with pineapple slices.
3. Spicy Cola Blend:
Mix in a dash of cinnamon or chili powder for a bold kick.
4. Vanilla Caramel Float:
Top with a dollop of whipped cream and caramel drizzle for an indulgent dessert-like drink.
Is Protein Diet Coke Here to Stay?
Trends often fade as quickly as they emerge, but Protein Diet Coke might have staying power due to its flexibility and nutritional appeal. As long as social media continues to celebrate creativity in the kitchen, this quirky beverage is likely to remain a go-to option for adventurous foodies.
Conclusion
Protein Diet Coke is more than just a viral sensation; it’s a testament to how creativity can turn everyday ingredients into something extraordinary.
While it may not replace traditional sources of protein or be everyone’s cup of tea (or soda), it has undeniably carved out a niche in the world of health-conscious indulgence.
Whether you’re in it for the taste, the health benefits, or the TikTok-worthy moments, this “dirty soda” trend is worth a try.
FAQs
1. Can I use regular Coke instead of Diet Coke?
Yes, but keep in mind that regular Coke has significantly more sugar and calories, which might defeat the purpose of a low-calorie drink.
2. What type of protein shake works best?
Vanilla and caramel protein shakes are popular choices because they complement the flavor of cola. However, feel free to experiment with other flavors.
3. Is Protein Diet Coke suitable for kids?
While it’s not inherently harmful, the caffeine content in Diet Coke might not be suitable for children. Opt for caffeine-free soda if making this for kids.
4. Can I make a vegan version?
Absolutely! Use plant-based protein shakes and ensure the soda is vegan-friendly.
5. How often can I drink Protein Diet Coke?
Like any treat, moderation is key. Consuming it occasionally as part of a balanced diet is perfectly fine.
References
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Health
Dave Coulier Opens Up About His Battle with Stage 3 Non-Hodgkin’s Lymphoma
Dave Coulier Opens Up About His Battle with Stage 3 Non-Hodgkin’s Lymphoma
A Beloved Star Faces a Serious Diagnosis
Dave Coulier, best known for his role as Joey Gladstone on the iconic sitcom Full House, has revealed a deeply personal health challenge.
The comedian and actor recently announced his diagnosis of Stage 3 Non-Hodgkin’s Lymphoma, sparking widespread concern and support from fans worldwide.
Coulier’s bravery in sharing his journey sheds light on this complex form of cancer, its symptoms, treatment options, and the importance of early detection.
What is Non-Hodgkin’s Lymphoma?
Understanding the Disease
Non-Hodgkin’s Lymphoma (NHL) is a type of cancer that originates in the lymphatic system, which is an integral part of the body’s immune defense.
This form of lymphoma is distinct from Hodgkin’s lymphoma due to differences in the cancerous cells’ appearance and behavior.
- Lymphatic System’s Role: It helps fight infections and regulates fluid balance in the body.
- Lymphoma’s Impact: NHL occurs when lymphocytes (a type of white blood cell) grow uncontrollably, leading to tumors.
Dave Coulier’s Journey: From Diagnosis to Awareness
The Diagnosis
Coulier disclosed that he had been feeling fatigued and unwell for several months before seeking medical advice.
A series of diagnostic tests, including a biopsy and imaging scans, confirmed the presence of Stage 3 Non-Hodgkin’s Lymphoma.
How He Shared the News
In a heartfelt video shared with his fans, Coulier discussed his diagnosis candidly. The star emphasized the importance of listening to one’s body and seeking medical help when something feels off.
“I’ve always tried to make people laugh, but now, I want to use my voice to educate and inspire,” he said.
Symptoms of Non-Hodgkin’s Lymphoma
Recognizing the symptoms early can make a significant difference in treatment outcomes.
Some common symptoms include:
- Swollen lymph nodes, often painless
- Persistent fatigue
- Unexplained weight loss
- Fever and night sweats
- Abdominal pain or swelling
- Chest pain, coughing, or trouble breathing
Why Early Detection Matters
Coulier’s journey highlights the importance of not ignoring persistent symptoms. Timely diagnosis can improve treatment effectiveness and overall prognosis.
Stages of Non-Hodgkin’s Lymphoma
NHL is categorized into four stages based on its spread:
- Stage 1: Cancer is localized to one lymph node region.
- Stage 2: Two or more lymph node regions on the same side of the diaphragm are affected.
- Stage 3: Cancer involves lymph nodes on both sides of the diaphragm.
- Stage 4: The disease has spread beyond the lymphatic system to other organs.
Coulier’s diagnosis at Stage 3 underscores the critical need for awareness and early intervention.
Treatment Options for Non-Hodgkin’s Lymphoma
Tailored Treatment Plans
The treatment for NHL varies depending on the stage and specific subtype.
Common approaches include:
- Chemotherapy: Often the first line of defense to target rapidly dividing cancer cells.
- Radiation Therapy: Used to shrink tumors in localized areas.
- Immunotherapy: Boosts the immune system’s ability to fight cancer.
- Targeted Therapy: Focuses on specific molecules involved in cancer growth.
Dave Coulier’s Treatment Regimen
While Coulier hasn’t shared detailed specifics about his treatment, he expressed gratitude for his medical team and the support of loved ones.
Living with Non-Hodgkin’s Lymphoma
Physical and Emotional Challenges
Coping with cancer involves more than just physical treatments. Patients often face emotional struggles, including anxiety, fear, and uncertainty.
Coulier’s Positive Outlook
Despite his diagnosis, Coulier remains optimistic, often sharing moments of humor and gratitude. His resilience inspires others battling similar challenges.
Raising Awareness for Non-Hodgkin’s Lymphoma
The Power of Advocacy
Coulier is using his platform to spread awareness about NHL. His message encourages individuals to prioritize their health and support ongoing cancer research.
Supporting Research and Treatment Advances
Progress in lymphoma treatment, such as CAR T-cell therapy and advancements in immunotherapy, offers hope for patients worldwide.
How Fans Can Show Their Support
Messages of Encouragement
Fans have flooded social media with messages of love and encouragement for Coulier. Sharing personal stories of resilience and hope strengthens the community of those affected by lymphoma.
Donating to Lymphoma Research
Supporting organizations focused on lymphoma research and patient advocacy can make a significant impact.
Conclusion:
Dave Coulier’s openness about his battle with Stage 3 Non-Hodgkin’s Lymphoma reminds us of the importance of health awareness and community support. As he navigates this challenging chapter, his strength and advocacy serve as a beacon of hope for others facing similar battles.
FAQs
1. Can Non-Hodgkin’s Lymphoma be cured?
Yes, many cases of NHL can be treated effectively, especially when diagnosed early. Advanced treatments have improved survival rates significantly.
2. How does Non-Hodgkin’s Lymphoma differ from Hodgkin’s Lymphoma?
The primary difference lies in the specific type of cancerous cells. Hodgkin’s Lymphoma involves Reed-Sternberg cells, which are absent in NHL.
3. Are there lifestyle factors that increase the risk of NHL?
While the exact cause is unknown, factors like a weakened immune system, certain infections, and exposure to specific chemicals can increase risk.
4. What support resources are available for NHL patients?
Numerous organizations, such as the Lymphoma Research Foundation, offer resources, support groups, and financial assistance for patients and their families.
5. How can I reduce my risk of developing lymphoma?
Maintaining a healthy lifestyle, avoiding exposure to harmful chemicals, and addressing infections promptly can help lower your risk.
References:
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