MDHearingAids Gain FDA Premarket Clearance for Smart Hearing Aids and App

The US Food and Drug Administration (FDA) announced on August 4 that Chicago-based MD HearingAid—a manufacturer and distributor of online hearing aids with a professional online support and programming component—gained 510(k) premarket clearance for the company’s line of Smart hearing aids and app.

The 510(k) process requires manufacturers to notify the FDA before it intends to market a device and to establish that the device is “substantially equivalent” to a legally marketed “predicate” device that does not require premarket approval (PMA). The application relied on data from a 2021 study conducted at Central Michigan University which compared audiologist-fit devices to the company’s self-fit devices.

MD HearingAid’s Smart hearing aids use an app to assess the hearing status of the user so it can be programmed for their unique hearing profile. The devices can then be further programmed or adjusted remotely by a staff of more than 10 licensed audiologists and hearing aid specialists—all based in the United States.

The hearing aids also come with pre-programmed options so the devices can work right out of the box, without using the app, for those who either don’t have or don’t wish to use a smart phone with the devices. However, the company is finding more and more users preferring and benefitting from the sound customization features and online support.

“We’ve had about 3000 people who have adjusted their hearing aids in the past month through our system,” says MDHearingAid CEO Douglas Breaker. “Often, these are people who want to hear better during social activities like pickleball, church, or family gatherings. They can request a [customer support] ticket or go online and receive support from our professionals. With at least our Volt Max [the company’s premium device], we always try to get customers onboarded with a licensed hearing care professional through our telecare process and establish that as the ‘normal procedure,’ because we believe 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.”

Breaker explains that the company’s objective is to provide high-quality affordable devices paired with what he says is clinical-level support applied via a telecare model. “Getting the 510(k) is great because we've received initial FDA approval for our self-setting device and we can now take it even further. The FDA approval means this is an equivalent technology based on previous submissions. Our data from the clinical study was solid. But I want to emphasize that, from our perspective, it’s really not just about self-fitting; it's self-fitting plus the support we provide from a licensed professional.”

Even with their focus on the provision of professional service via remote care, price is still the dominant factor in the marketing of MDHearingAid’s offerings, says Breaker. The company’s products all come with the professional support component, but when it tests various marketing messages, the $300 to $800 price point consistently comes out on top. “The difference in price from a $1500-3000 hearing aid is very relevant for consumers. However, we know once we get them in the door and provide that extra level of professional support, then they're happier and they're more likely to buy again or refer us to friends and family. So the professional service aspect is obviously an important selling point, albeit maybe less so for the initial first-time purchaser.”