The FDA Finalizes Ruling to Increase Access to Hearing Aids
This week, the U.S. Food and Drug Administration (FDA) made an announcement that’s music to many consumers’ ears. They finalized a new ruling anticipated to increase access and affordability for hearing aids.
These essential tools for many have long received spotty coverage under Medicare and other forms of insurance, leaving consumers to either save up or make do without. Now, many more Americans should be able to access hearing aids without breaking the bank.
All facts and figures can be found in the FDA’s press release on the finalized ruling, unless specifically linked elsewhere.
What the Ruling Changes for Hearing Aid Access
That all sounds well and good, but how exactly does the FDA ruling make hearing aids less expensive or easier to get? The new ruling will allow hearing aids to be bought over the counter, both directly in stores and from online retailers. To further increase their availability, hearing aids will also no longer require a prescription, medical examination, or fitting adjustments. This is anticipated to benefit the nearly 30 million Americans who could use hearing aids, but currently don’t.
Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need. Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible. — Health and Human Services Secretary Xavier Becerra
When Will Over-the-Counter Hearing Aids Be Available?
Not all hearing aids will suddenly become available over the counter, however. This ruling creates a new category of hearing aid identified as over-the-counter (OTC) that will still follow standards to maintain safety and effectiveness. The FDA hopes that this new category will spur competition and innovation to further drive down costs. The effective date for this ruling is October 16, 2022, or 60 days after its publication in the Federal Register.
Hearing aids may be sold before the effective date, but manufacturers of these hearing aids will have 240 days after the publication to comply with any new or revised requirements from the ruling. Currently, the FDA believes that OTC hearing aids will be available as early as October 2022.
Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions. Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective, and affordable hearing aids from their neighborhood store or online. — FDA Commissioner Robert M. Califf, M.D.
The Background of The FDA Hearing Aid Ruling
This FDA ruling has been a long time coming. Congress actually passed a bipartisan order for the FDA to create an OTC category for hearing aids in 2017. This ruling was enforced when President Biden signed an executive order calling on the FDA to allow hearing airs to be sold over the counter within 120 days of the order.
Prior to the rule’s finalization, the FDA opened it up to public comment. It quickly received over 1,000 public comments from consumers, advocacy groups, manufacturers, agencies, and even members of Congress with proposals. Most had to do with ensuring safety and effectiveness. Some of these were used to reshape the ruling, including:
Lowering the maximum sound output to protect hearing from overamplification
Revising the insertion depth into the ear canal
Requiring all OTC hearing aids to have user-adjustable volume control
Simplifying the required device labeling to be easier to understand
● ● ●
This ruling is great news for anyone in need of a hearing aid or are experiencing mild to moderate hearing loss. It will certainly be interesting to watch a new category of medical device grow and see how it influences the rest of the field. Either way, it should make it easier to get your hands on hearing aids, hopefully making them more affordable in the process.
- Medicareful Travel: Senior Trip to Lucerne
- Is Expensive Cookware Worth It?
- The Drug Prices Medicare Can Directly Negotiate
- Does Medicare Ever Cover Cosmetic Surgery?
- Medicareful Travel: Senior Trip to Barcelona
- How Does COBRA Work with Medicare?
- Different Ways Medicare Can Cover Drug Costs
- All About Enrolling in Social Security
- Medicareful Travel: Senior Trip to the Madrid
- Does Medicare Cover Open-Heart Surgery?
- Exercise Tips for Summer
- Medicareful Travel: Senior Trip to Lisbon
- Hosting a Safe Summer Barbecue
- Senior Summer Barbecue Tips
- Does Medicare Cover Biopsies?
- 5 Foods to Avoid if You Have High Blood Pressure
- Medicareful Travel: Senior Trip to the Finger Lakes
- Does Medicare Cover Endoscopies?
- Ways Seniors Can Recover from a Workout
- Is Chocolate Healthy for You?
- Understanding Adult ADHD
- How Does Medicare Cover Hypertension?
- The Symptoms and Treatment of Parkinson's Disease
- How to Determine What Temperature to Use When Cooking
- Eating Healthy on a Budget
- Keeping Fit on Vacation
- Is Your Tonsillectomy Covered by Medicare?
- Tips for the Perfect Hard-Boiled Eggs
- Kitchen First Aid Tips
- What Does FDA-Approved Mean?
- Medicareful Travel: Senior Guide to New York City
- How to Caramelize Onions
- Why Do We Celebrate That? April Fools’ Day
- Medicare and Powers of Attorney
- The Essential Role of Eggs in Cooking
- What are Different Types of Complementary
and Alternative Medicine?
- Tips for Remembering to Take Your Medicine
- What is Medicare Part E?
- Building Your Basic At-Home Senior Gym
- How to Make Stovetop Popcorn
- Medicareful Travel: Senior Trip to New Orleans
- How to Navigate & Read Academic Articles
- Phytonutrients: What Plant Color Says About Nutrition
- How to Prevent or Reduce Inflammation
- Osteoporosis: Risk Factors, Signs, and Treatment
- How to Make Homemade Pretzels
- Researching Your Ancestry and Family Tree
- How Medicare and Social Security Work Together
- What is Nordic Walking?
- Food Questions You've Been Embarrassed to Ask
- How Medicare Changed for 2023 and Beyond
- Tips for Using a Microwave
- How to Clean Your Ears Safely
- Skiing as a Healthy Hobby for Seniors
- 3 More Great Places to Celebrate New Year's Eve
- Why Do We Celebrate That? More New Year's Eve Traditions
- Panettone, the Italian Christmas Dessert
- A Simple Homemade Gingerbread Recipe
- How to Make Christmas Decorating Jollier
- The Science of Winter Weight Gain
- Seasonal Picks: 3 Foods You Should Try This Winter
- 5 Tips to Make Getting Your Christmas Tree Stress-Free
- Show-Stopping Potato Side Dishes for Thanksgiving
- Dishes to Impress Your Friends: Boeuf Bourguignon
- Holiday Travel Tips to Reduce Stress
- Does Medicare Cover Pain Management?
- Is Hunting a Healthy Senior Hobby?
- Ways You Can Get More Politically Involved
- What are Medicare's Lifetime Reserve Days?
- Spooky Spots for Seniors Halloween 2022
- How to Make Soul Cakes for Halloween
- Jack O' Lantern Carving Tips for Halloween
- Easy Ways to Peel a Potato
- 2023 Social Security COLA Largest in Decades
- Exercise Tips for Autumn
- How to Make Candy Apples at Home
- Why are Medicare Insurance Sales Calls Recorded?
- Here's What Medicare Costs in 2023
- CMS Updates Medicare Enrollment Rules for 2023
- Medicareful Travel: Senior Trip to London
- Does Medicare Cover Insomnia Treatment?
- Healthy and Easy Homemade Dog Treats
- The FDA Finalizes Ruling to Increase Access to Hearing Aids
- What the Inflation Reduction Act of 2022 Means for Medicare
- Tips to Make Flying and Airports Less Stressful
- CMS Projects Lower 2023 Part D Average Costs
- The 15 Golden Rules of Airplane Etiquette
- How Often Should You Shower?
- What are Medicare Pilot Programs?
- How to Care for Your Cast Iron Cookware
- Confronting a Loved One About Hurtful Behavior
- What Does Creditable Coverage Mean for Medicare?
- Using Za'atar in Your Cooking
- Dealing with Canceled Flights
- Protecting Your Vacation from Flight Disruptions
- Do Pre-Existing Conditions Affect Medicare Coverage?
- Which is Better: A Bath or Shower?
- Are Weight Loss Medications Healthy?
- Healthy Strategies for Anger Management
- The Health Benefits of Omega-3 Fatty Acids
- The Difference Between Common Cooking Papers and Foils
- What are Medicare I-SNPs?
- Identifying Toxic Relationships in Your Life
- Healthy Ways to Spice Up Your Water
- All About Medicare Dual Eligible Special Needs Plans
- Medicareful Travels: A Senior Guide to All-Inclusive Resorts
- Does Medicare Cover Occupational Therapy?
- Lower 2023 Medicare Part B Premium Could Be on the Way
- Which is Better: Natural or Artificial Sweeteners?
- Tips for Vacationing with Pets
- Is It Better to Work Out Harder or Longer?
- Tips for Traveling with Your Pet
- Are Medicare Part B Giveback Plans Worth It?
- Introducing the Medicareful Living Family Cookbook!
- Medicare Coverage for Treatment of PTSD
- The Causes and Treatments of Nasal Congestion
- Dishes to Impress Your Friends: Spring Rolls
- Medicare Freezes Late Enrollment Penalties for Qualifying Enrollees
- What is a 5-Star Medicare Plan?
- What is PTSD?
- What is Inflammation?
- What You Should Know When Buying Cast Iron Cookware
- Does Medicare Cover STIs?
- The Different Types of Potatoes & When to Use Them
- Does Medicare Cover HIV Screenings and Treatment?
- Gun Safety Rules for Seniors
- 3 Surprising Ways to Feel Better When You're Sad
- Can Your Knee Really Predict the Weather?
- What are Federally Qualified Health Centers?
- Does Medicare Cover Incontinence Treatment?
- The Health Benefits of Cumin
- How to Make Dried Herbs at Home
- The Dangers of Toxic Positivity
- Which is Better: Fresh or Frozen Meat?
- COVID Tests to be Covered by Medicare
- Important Terms and Tips When Reading a Health Article or Study
- Do These 3 Most Common Natural Supplements Actually Work?
- What are State Pharmaceutical Assistance Programs?
- The Mental Health Benefits of Exercise
- The Difference of Cooking with Fresh and Dry Herbs
- Dangers of a Cold Home for Seniors
- Measuring Your Health Apart from Weight Loss
- Using Cumin in Your Cooking
- This Year, Focus on Health, Not Weight
- Does Medicare Cover Respite Care?
- Health Benefits of Gift-Giving
- How to Make Homemade Candy Canes
- Why Do We Celebrate That? Classic Christmas Tree Decorations
- 3 Classic Christmas Cookie Recipes
- Cooking for Beginners: Frying Tips
- Why Do We Celebrate That? Hanukkah Traditions
- The Value of Family Recipes
- What Does It Mean to be a Caregiver?
- Here’s What Medicare Costs in 2022
- Can I Prevent Aneurysms or Ruptures?
- How Can I Trust My Insurance Agent Has My Best Interests at Heart?
- Using Chinese Five Spice in Your Cooking
- What You Should Know About the COVID Booster
- Spooky Spots for Seniors Halloween 2021
- What Does MACRA Mean for You?
- Dishes to Impress Your Friends: Homemade Lobster Ravioli
- Reading and Understanding Your Blood Pressure
- How to Be a Snowbird in Retirement (18 Questions to Ask!)
- Learn the Basics of Medicare | Medicare Basics
- Understanding Medicare Part D’s True Out-of-Pocket Limit