Roughly 10% of the adult population in the United States has experienced tinnitus lasting at least five minutes in the past year. This amounts to nearly 24 million Americans.

Tinnitus is not a disease; it is a symptom that something is wrong in the auditory system, which includes the ear, the auditory nerve that connects the inner ear to the brain, and parts of the brain that process sound.

Patients listen to this sound while sleeping, and can also track progress over time and personalize therapy to better fit their needs.Most of the time, tinnitus is not a sign of a serious health problem, although if it’s loud or doesn’t go away, it can cause fatigue, depression, anxiety, and problems with memory and concentration. For some, tinnitus can be a source of real mental and emotional anguish.

Otoharmonics‘ Levo System is looking to tackle this issue with its personalized, neuroscience-based sound therapy. Leveraging the brain’s natural cognitive abilities, Levo identifies and maps an individual’s unique sound print using custom-fit ear buds and proprietary software on iOS devices. Patients listen to this sound while sleeping, and can also track progress over time and personalize therapy to better fit their needs.

Developed by the team at Cedars-Sinai Medical Center, Levo got the FDA 510(k) clearance and will soon find its way to patients.

“Receiving 510(k) clearance from the FDA is a major milestone and an achievement that represents the dedication of an entire team,” says Michael Baker, Otoharmonics CEO. “With the ability to personalize therapy based on the individual needs of each person, we’re now raising the bar in tinnitus management.”