Two years of university research studies, a rigorous FDA application process, and multiple Q&A sessions with the FDA have culminated into a historic achievement for MDHearing. We have officially received 510(k) approval from the FDA for our smart hearing aids. 

510(k) FDA approval means two important things for MDHearing: 

1. FDA-Cleared status: MDHearing can market its hearing aids as “FDA-cleared self-fitting hearing aids.” Previously, MDHearing could only claim to be “FDA-registered hearing aids.”
2. A certification of quality: 510(k) approval is a certification of quality, showing that MDHearing offers the same or better quality of treatment as other FDA-cleared hearing aids. 

In this article, we explore the 510(k) approval process and why it’s so important for MDHearing. We also look at the key developments that made 501(k) approval possible, as well as a clinical research study from Central Michigan University that compared the performance of self-fit MDHearing hearing aids to professionally-fit devices. 

Please use the following links to navigate:

• What Is FDA 510(k) Approval and Why Is It Important for MDHearing?
• How MDHearing Achieved 510(k) Approval 
• The Central Michigan University Research Study on the Performance of MDHearing Hearing Aids
• How MDHearing Achieves the Same or Better Quality Hearing Care as a Hearing Clinic

What Is FDA 510(k) Approval and Why Is It Important for MDHearing?

The 510(k) approval process is an FDA requirement for medium-risk medical devices such as self-fitting hearing aids. The 510(k) approval process requires medical device manufacturers to submit technical, safety, and performance information—including relevant clinical research—to the FDA. In the case of MDHearing, the FDA required us to submit proof that our smart hearing aids are “substantially equivalent” to similar devices that the FDA has already approved.

As mentioned, 510(k) FDA approval is important for MDHearing because it elevates our hearing aids from the status of “FDA-registered hearing aids” to “FDA-cleared self-fitting hearing aids.” It also provides a higher certification of quality from the FDA, which helps potential customers trust the quality of our products and brand compared to more expensive professionally-fit devices.

How Did MDHearing Achieve 510(k) Approval?

The story of how MDHearing achieved 510(k) approval begins in October 2018—when Bose obtained FDA approval to sell its self-fitting hearing aid (Bose Hearing Aid DEN180026).

In approving the Bose Hearing Aid, the FDA reviewed data from clinical studies of 125 patients. The data showed that self-fitted Bose Hearing Aids offered a similar quality of performance to professionally-fit devices. The FDA approved the Bose Hearing Aid under the De Novo premarket review pathway (intended for novel low-risk medical devices). 

The Bose 510(k) approval opened the door for MDHearing to seek 510(k) FDA approval for its self-fitting aids. As a part of our 510(k) preparations, we asked Central Michigan University (CMU) to conduct a clinical study to evaluate the performance of MDHearing “smart” hearing aids to see how they compared to professionally-fit devices. The overwhelmingly positive results of the study played a critical role in the success of our 510(k) approval process (see the next section for more details on the CMU study).

MDHearing’s FDA 510(k) approval relied on the following information:

• The Central Michigan University clinical study
• Information about the safety, technical details, and performance capabilities of the MDHearing CORE
• Data provided to the FDA during rigorous Q&A sessions

After reviewing the information, the FDA awarded MDHearing smart hearing aids with 510(k) approval on Aug. 4, 2022.

The Central Michigan University Clinical Research Study on MDHearing Hearing Aids

As mentioned in the previous section, the success of MDHearing’s 510(k) approval process hinged on the positive results of the 2021 Central Michigan University clinical research study (Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids). The study reviewed the effectiveness of the MDHearing Smart hearing aids as a self-fit hearing aid versus a clinically-fit hearing aid.

The CMU study took its cues from the Bose hearing aid clinical research study. Bose gained FDA 510(k) approval by showing that its self-fitting DEN180026 device provided the same or better quality of hearing care as professionally fit devices. The Bose study concluded: “It is possible for users to select amplification parameters by themselves using a simple interface that maps to key hearing aid signal processing parameters.” The Bose study showed that participants generally liked the performance of their self-fit hearing aid settings more than the professionally-selected settings.

Similarly, the CMU study on MDHearing hearing aids compared the experience of using self-fit MDHearing hearing aids to that of using the same devices fit in a clinical setting. The study found that the self-fit MDHearing experience was similar to hearing aids fit by a healthcare professional.

Here is a brief summary of the CMU study findings on MDHearing:

• Safe and effective: The study verified the safety and effectiveness of MDHearing smart hearing aids. Specifically, it demonstrated that MDHearing smart hearing aid should perform as intended for treating mild to moderate hearing loss.
• Easy to use: The study analyzed, verified, and validated the usability of the MDHearing smart hearing aid for mild to moderate hearing loss. The study also showed that the user training and device labeling are adequate. The clinical data also showed similar results for patients who self-fit with MDHearing smart hearing aids compared to those who were professionally fit. 
• Same level of performance as the Bose Hearing Aid (DEN180026): The clinical data validated that MDHearing smart hearing aids perform comparably to the Bose Hearing Aid (DEN180026).
• Hearing clinic level care without the clinic: The MDHearing study showed that self-fitted MDHearing smart hearing aids are “substantially equivalent” in performance and customer experience to professionally-fit hearing aids.

The 2 Ways MDHearing Achieves the Same or Better Quality Care as Clinically-Fit Hearing Aids

MDHearing’s self-fitting smart hearing aids offer the same precision-level hearing care that consumers enjoy when they go to an in-person clinic. At the same time, there is:

• No hearing test required: MDHearing customers do not need to take a professional hearing test (or “audiogram”) to use their hearing aids. 
• No in-person visit to a hearing clinic required: MDHearing customers do not need to leave their homes to visit an in-person hearing clinic. 
• No prescription or professional settings required: MDHearing customers do not need to receive a prescription or specialized sound setting adjustments. 
• No unreasonable financial commitments required: MDHearing customers do not need to spend thousands of dollars to treat their hearing loss. MDHearing sells its high-quality, self-fitting hearing aids at $699.98 a pair.

Our recipe for achieving high-quality care, affordability, and convenience—without the clinic—relies on a combination of two strategies: (1) MDHearing’s remote hearing care smart technology; and (2) MDHearing’s personalized telehealth services and world-class customer service.

1. MDHearing’s Remote Hearing Care Smart Technology

The smart hearing aids from MDHearing include a smartphone app that connects the hearing aids to your phone through a wireless Bluetooth connection. 

The MDHearing App provides the following telecare features for remote hearing care:

• App-based “hearing check” and customized sound profile: The MDHearing App offers a personalization process for your unique hearing. Its “hearing check” measures your response to a series of tones, and then creates a “Personalization Profile” for your specific needs. Finally, it automatically programs your hearing aids according to your unique Personalization Profile.
• Remote adjustments: The MDHearing App includes advanced features that allow the hearing specialists at MDHearing to remotely fine-tune your hearing aids. First, users submit a request for assistance through the MDHearing App. Next, one of our hearing specialists will contact you and remotely adjust your hearing settings via the internet.
• Custom adjustments based on a professional audiogram (hearing test): MDHearing customers can also send the results of a professional audiogram to MDHearing. If appropriate, an MDHearing specialist will remotely adjust your hearing aids according to the same tuning standards that hearing clinics use. These are pro-level hearing aid adjustments—just like you would get at a hearing clinic—but they are done at a distance.
• Video support with customer care: MDHearing offers video calls with our licensed hearing specialists so our customers can enjoy a more personalized telecare experience.

As an added bonus, MDHearing customers do not need their smartphones to operate basic volume controls and sound environment settings on their hearing aids. They can operate these basic controls located directly on the hearing aids. This feature is helpful when your phone battery dies. It is also convenient for customers who don’t like to fiddle with a smartphone.

2. MDHearing’s Personalized Telehealth Services and World-Class Customer Service

Most hearing loss patients choose MDHearing initially because they want to save $3,000 to $6,000 on a pair of high-quality hearing aids. But it’s our personalized telehealth services from licensed hearing professionals that motivate our customers to stay with us and recommend us to their loved ones.

According to MDHearing CEO Doug Breaker:

510(k) approval from the FDA is excellent for our smart hearing aids because it proves we offer equivalent technology compared to other FDA-approved devices. But I want to emphasize that self-fitting hearing aids are only half of what we do. We also provide continual telehealth support and remote hearing care from a team of licensed hearing care professionals. Once our customers experience the extra level of professional support we provide, they're happier and more likely to buy again and refer us to friends and family.”

Telecare and customer support from MDHearing include:

• Phone and video conference support from licensed hearing care professionals: MDHearing offers phone and video conference support from our team of hearing professionals. Our telehealth team includes a staff of more than 10 licensed audiologists and hearing care specialists—all based in the United States. 
• Complimentary consultations with a licensed professional: Even if you haven’t purchased a hearing aid from us, you can receive a complimentary phone or video consultation with an MDHearing licensed professional by taking our free online hearing test. During your free consultation, your MDHearing licensed professional may recommend one of our hearing aids, or advise you to undergo further testing at an in-person hearing clinic.

According to MDHearing CEO Doug Breaker:

We’ve had about 3,000 people who have adjusted their hearing aids in the past month through our system. Often, these are people who want to hear better during social activities like pickle ball, church, or family gatherings. We always like to onboard new customers with a licensed hearing care professional through our telecare process and establish that as the ‘normal procedure’ because it delivers the best product performance and customer satisfaction. About half of our customers use the video interface on our app, while the other half prefer to do it by phone.”

Try a 510(k) Approved Hearing Aid from MDHearing Risk-Free!

At MDHearing, our telecare and world-class customer service from licensed hearing care professionals allow us to provide high-quality remote hearing care services to everyone regardless of their financial situation. Now, with 510(k) approval of our smart hearing aids, we are able to reach more patients with quality and affordable hearing care services than ever before. 

With prices ranging from $299.98 to $699.98 a pair, all of our hearing aids come with a risk-free, 45-day trial period. If you are unsatisfied with your MDHearing product within the first 45 days of your purchase, send them back to us for a full refund.

Want to experience MDHearing for yourself? Browse the full line of products now!
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