Over 5% of the world’s population suffers from hearing loss. To put that in perspective, that’s one in eight people in the United States. While it’s more common than you may think, easy access to hearing aids has been an uphill battle for many — until now.
Recent legislation has given millions of Americans access to over-the-counter hearing aids. This means businesses specializing in medical devices are in a great spot, but they need to act quickly. We’ll explore how to capitalize on this legislation by mastering hearing aid storage and logistics.
An Over-the-Counter Ruling: Hearing Aids for Millions
In August of 2022, the U.S. Food and Drug Administration (FDA) issued a final rule to improve access to over-the-counter (OTC) hearing aids, which could lower the costs for millions of Americans. The ruling establishes a new category of hearing aids, which allows people with mild to moderate hearing impairment to get hearing aids directly from stores or online retailers. All of this without the need for a medical exam, prescription, or meeting with an audiologist.
Why Was It Done?
The push for this was part of a larger agenda to expand access to high-quality healthcare while lowering healthcare costs. Following an Executive Order from President Biden, the legislation is the fulfillment of Congress’ 2017 order for the FDA to create a category of OTC hearing aids.
What It Means for Consumers
Around 30 million U.S. adults could benefit from this ruling. Typically, hearing aids have been expensive for the average person. This ruling was intentionally implemented to stimulate competition and facilitate the sale of high-quality OTC hearing aids. In addition to the consumer’s benefit, online retailers are now in a unique spot to provide value to millions of Americans, provided they can master hearing aid storage and logistics (more on that below).
What It Means for Companies
No economic system is perfect. But this is where capitalism allows companies to capitalize on a top-down move from the government and provide real value. Since traditional government Medicare insurance for the elderly does not cover hearing aids or audiology visits, Frank Lin, Director of John Hopkins’ Cochlear Center for Hearing and Public Health, predicts a “wild west” for OTC hearing aids.
All of this competition means ecommerce companies need to do two things to stand out:
- Offer high-quality products at a competitive price.
- Fine-tune their logistics process to keep up with demand.
Since value creation precedes business success, ecommerce companies in the medical device sector need to focus on offering the best customer service possible. Any company that can do that is in an impressive spot to cash in on the projected billions of dollars on the horizon.
How You Can Capitalize
Product development is a given. No business is planning to enter this wild west without the proper ammunition. And any company that does enter the market with suboptimal hearing aids will eventually be driven out of town.
The defining factor to rise above the competition in this market will be logistics. Expert logistics give you an advantage on a couple of fronts:
- Speedier delivery. It allows you to provide added value through faster delivery and efficient and accurate product kitting and assembly.
- Lower order fulfillment costs. Are you currently involved in UPS or FedEx medical device shipping? Partnering with a 3PL lets you leverage the carrier rates to third-party suppliers you wouldn’t otherwise have.
- Storage. Hearing aid storage and shipping will be hurdles for many businesses. Your business needs to be ready from the jump to keep up with demand, and it needs to do so under the watchful eye of a highly-regulated industry.
Again, the rationale behind this ruling was to make it easier than ever for Americans to get access to inexpensive, high-quality hearing aids. Your logistics strategy needs to prioritize this and respond appropriately. The quicker you can get your customers their medical devices at a competitive rate, the more you’ll build brand equity and rise above the competition.
This brings us to our final section: why you need a third-party logistics provider (3PL) to accomplish this task.
How a 3PL Can Help
Keeping up with demand means having the ability and protocols in place to handle a sensitive and highly-regulated industry. Handling the ins and outs of the supply chain requires an understanding of forecasting, best practices, and new technologies that improve processes. We’ll take a look at some of the non-negotiables your logistics partner must have.
FDA Registered
It’s crucial your fulfillment partner is FDA-registered and able to handle and ship Class I and II medical devices. Without this, your business won’t be able to handle hearing aid storage and shipping without falling outside of regulatory bounds.
CGMP Compliant
Your fulfillment house also needs to adhere to and exercise Current Good Manufacturing Practices (CGMP). A CGMP-compliant company means the logistics provider is able to handle medical device storage and logistics, pharmaceutical products, food and beverages, and cosmetics. These regulations are enforced by the FDA to ensure these products maintain a high-quality standard.
Hazardous Materials Certifications
Hearing aids are electronics, which means they’re on the dangerous goods list. You also need to ensure the 3PL you partner with has its Hazardous Materials Certifications (HAZMAT). At Jay Group, we’re FDA-registered, CGMP compliant, and receive bi-annual certifications and training from the Dangerous Goods Council. We have certifications in:
- 49 CFR – Code of Federal Regulations
- IATA – International Air Transport Association
- IMDG – International Maritime Dangerous Goods
- Classes 2, 3, 9 including Lithium Batteries
Expiration Date Management
Last in, first-out (LIFO), first-in, first-out (FIFO), and first expired, first-out (FEFO) fulfillment services help you maximize the value of your inventory by helping you avoid product waste. A technologically-advanced 3PL is able to provide control over the stop-ship date of your product to ensure maximum shelf life. This means customers will always receive a product that can be safely used.
Reverse Logistics
The boom of over-the-counter hearing aid sales may come with product or batch recalls. Your logistics partner needs to have the ability to identify customers who may have received a faulty product, as well as handle repackaging and relabeling. This is done through advanced lot and serial number tracking — a process known as reverse logistics. Should there be issues with a customer’s orders, reverse logistics can help you seamlessly manage returned products.
Sanitary Packaging, Assembly, and Storage
Proper hearing aid storage requires a high level of proper inspection, sanitary handling, and assembly. At Jay Group, we provide critical inspections and package integrity testing. We also complete specialty training to support the sanitary handling needs of your product. We offer:
- Allergen testing.
- Sanitary Transportation of Human and Animal Food training from the FDA.
- Supplementary utilization of gloves when handling your product.
Listening to Consumer Needs
An experienced order fulfillment house and logistics partner helps you listen and respond to consumer needs. Customer satisfaction is of the highest importance in the medical device industry. You need to ensure your partners are on the same page and able to help you scale your business.
If you’re looking to enhance your medical device shipping output, you need to implement systems and a distribution network strategy that can streamline your operations, and manage the ever-evolving supply chain so you can focus on customer acquisition, brand building, and product launches.
Simplify your processes and get the help you need with medical device storage and shipping today. Contact us and we’d be happy to learn about how we can help you.
