Regulatory Info

Cleared for sale in the US


    • FDA 510(k) clearance
    • Includes specialized software, purpose-built high fidelity earbuds and Apple® mobile digital devices
    • Among the first to clear Apple® hardware as a medical device

The Levo System is an FDA-cleared medical device that provides patients a patented personal sound therapy which through neural habituation leverages the cognitive abilities of the brain to reduce the symptoms of their tinnitus and improve the quality of a patient’s daily life.

Quick Links

Levo Therapy

Levo System

The Science


System Manual


1209 Orange Street
Wilmington, DE 19801, USA

General Inquiries:
Product Support:
Phone Number: Toll Free: +1 (866) 306-1387

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