Otoharmonics Otoharmonics Levo Tinnitus Treatment System Cleared by FDA


September 10, 2014

Otoharmonics, a company out of Portland, Oregon, won FDA clearance for its Levo tinnitus symptoms treatment system. The system includes an Apple iPad Air preloaded with the Levo Manager app that allows hearing professionals to evaluate a person’s tinnitus, develop a treatment plan, and evaluate how the patient is responding to that treatment.

otoharmonics tinnitus 2 Otoharmonics Levo Tinnitus Treatment System Cleared by FDAThe second component is an Apple iPod touch paired with earbuds that runs an app that generates sounds for the patient to listen to while sleeping. Usage statistics and progress of treatment can be easily shared from the patient’s iPod touch to the clinician’s Levo Manager app for regular review. The earbuds were designed to be comfortable to wear while sleeping. The technology that generates these tones was originally developed at Cedars-Sinai Medical Center and is now available in the Levo system.

From the product page:

The Levo System includes an Apple® iPad Air™ pre-installed with Otoharmonics’ proprietary Levo Manager software. Easy to learn and easy to navigate, the Levo Manager is an interactive tool that can be used side-by-side with patients. The comprehensive software is designed to identify and map each individual’s tinnitus sounds, create personalized therapy, and track patient improvement over time.

User-friendly Levo software allows patients to listen to their personalized sound match on an Apple iPod touch®. Custom fit ear buds, designed to ensure comfort during sleep, allow for optimal positioning and controlled delivery of sound therapy. Used nightly, patients can share their individual progress with their hearing professional to determine needed improvements over time.