Santa Monica-based auditory assistance startup seeks FDA approval

Source: Santa Monica Daily Press

A Santa Monica-based startup has developed — and now seeks approval from the US Food & Drug Administration (FDA) for — a mobile app that could combat the onset of dementia and cognitive impairment. 

AudioCardio delivers inaudible sound therapies designed to maintain and strengthen your hearing while providing relief from tinnitus by stimulating the cells inside your ear. As the website suggests, “It’s like physical therapy for your hearing.”

The app launched about five years ago and received substantial critical acclaim from within the scientific community. By obtaining approval by the FDA, the medical claims of the app can be more expansive, detailed and in-depth pertaining to how it helps users maintain and even restore hearing.

The app utilizes something called Threshold Sound Conditioning (TSC), a non-invasive acoustic technology that is designed to maintain and restore your natural hearing ability and reduce the symptoms of tinnitus. A Stanford study undertaken in 2015 showed 78.6 percent of its participants had a positive change in hearing within three weeks. Another study, this one on the effect of TSC on the potential improvement of hearing, was published in 2020 in the international journal Laryngoscope Investigative Otolaryngology

Chris Ellis founded AudioCardio in Santa Monica after watching his grandfather struggle with cognitive decline, dementia and Alzheimer’s while also suffering from a loss in hearing.

“I started just doing some information gathering and research online. And I found a study associating untreated hearing loss with a higher risk of cognitive decline and dementia,” Ellis said.

“My intent was to deliver something that was easily accessible, that was affordable and didn’t have a negative stigma associated with it. We say this a lot because that’s truly what it comes down to, less than 15 percent of the people who could benefit from a hearing aid actually own one.”

TSC works by stimulating the cells at just below the audible level to build up enough stimulation to activate them. As they activate and connect to nearby cells, these connections become stronger and more efficient in sending sounds to the brain so that you can recognize them as meaningful sounds.

And now, a new study by the Journal of the American Medical Association suggests a strong link between dementia and cognitive impairment to hearing loss, where maintaining and restoring hearing combats the advancement long term.

“We’re aiming to assist people, anyone, who suffer from hearing loss. What happens to someone who has untreated hearing loss is that they get frustrated. They’re frustrated because they’re having a hard time understanding conversation, social settings … at home or in a restaurant,” Ellis said.

“When that happens, they start to isolate themselves … and they can become depressed. And we all know that staying social and being active is very good for your mental, cognitive health. And of course for your health overall.”

As for the timeline on the FDA approval request, Ellis said that it could — and probably will — take well over a year.