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The Round Window E-Cath™ is indicated for irrigation of the middle ear including the round window area of the middle ear and/or the recording of evoked electrophysiological inner ear potentials.

The RW E-Cath™ is an accessory to a tympanostomy tube. The RW E-Cath™ consists of a single triple-lumen tube opening into a hollow fenestrated reservoir tip on the distal end. Two lumcns are empty and are intended to allow fluid inflow and outflow. The third lumen encases the electrode wire lead and insulates it from the other two lumens. The atraumatic blunt distal tip of the electrode is the only part of the electrode that is exposed. The exposed distal tip of the electrode is located on the outside edge of the distal tip where it is intended to come into contact with the floor of the bony round window niche. The proximal end of the electrode contains a lead connector which the treating physician or audiologist can attach to a standard evoked potential recording instrument.

The Round Window u Cath™ (RWuC) is intended to be used by any board certified otolaryngologist or otologist to irrigate the entire middle ear or the round window area of the middle ear. During the course of the irrigation treatment, it is intended that the vent tube through which the RW (C's dual lumen passes, will aerate the middle ear. The treating physician will choose, based on what hels will be most beneficial for his/her patient, the following: { }) the exact fluids to be delivered through the RWAC; (2) the proper quantities; and (3) the duration and interval of treatment (up to 14 days). It is intended that the physician load the RWuC with the initial fluid to be delivered prior to placement. The RWAC is intended to remain in place for up to 14 days. Neuro-Biometrix, Inc. recommends the physician use only fluids indicated for this use. The physician should refer to the fluid labelling prior to use with the RWC.

The RWAC consists of a double lumen (two parallel and attached Tecoffex 80A (polyurethane) extruded tubes) opening into a common fenestrated reservoir tip on the distal end. The soft, flexible reservoir tip of the RWuC will be available in three sizes: 2mm, 3mm, and 4mm diameters. It is intended that the surgeon will choose an appropriate sized tip to fit the anatomy of the patient. The double lumen is bent at approximately a 60-75 degree angle slightly proximal to the reservoir tip. One lumen is intended to serve as an in-flow and the other an out-flow. The outflow lumen is intended to (1) relieve or avoid a build up of air and/or fluid pressure in the device; and (2) facilitate the removal of fluid from the device. A silicone, paparella-type vent tube will be placed around the RWAC during manufacturing.