NEUROMOD DEVICES LIMITED

Neuromod Devices Limited specializes in tinnitus therapy devices. Specifically, it produces a translingual electrical stimulation system and an electrode array designed for delivering targeted neural stimulation. These devices are intended to help manage tinnitus by stimulating auditory and neural pathways, aiming to reduce symptoms. The system integrates the electrode array for precise and controlled stimulation delivery.

Neuromod Devices Limited is based in the United States. Since it operates within the US market, its devices are subject to regulatory oversight under the US medical device laws, including compliance with FDA standards. This means the company must adhere to FDA requirements for device classification, registration, and listing, such as inclusion in the FDA’s Unique Device Identifier (UDI) database.

Neuromod Devices Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is a centralised system used by the FDA to track and identify medical devices commercially distributed in the US. Listing in the UDI database ensures traceability and compliance with FDA requirements for Class II devices.

Neuromod Devices Limited’s devices are classified as Class II medical devices. This classification is determined by the FDA based on factors like the device’s intended use, potential risks, and benefits. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.

The translingual electrical stimulation system and electrode array developed by Neuromod Devices Limited are designed for tinnitus therapy. The system delivers auditory and electrical stimulation via the electrode array to target specific neural pathways in the body, with the goal of modulating tinnitus symptoms. The precise stimulation is intended to help patients manage or reduce the perception of ringing or noise in the ears.