This invention can monitor the dynamic activity of the Eustachian tube by inserting a portable device into the inner ear and simultaneously measuring impedance and pressure within a sealed external auditory canal over a predetermined period of time.
The Eustachian tube connects the middle ear cavity with the nasopharynx and plays a role in balancing the middle ear pressure. The opening and closing functions of the Eustachian tube are physiologically and pathologically important. Conditions that block this tube can cause patients to feel pressure or pain, or to suffer hearing loss. A pressure indicator is necessary to evaluate the function of the Eustachian tube. Existing devices can only make measurements at a single point in time while the patient is connected to a non-portable device. The portable invention presented here allows for a more natural assessment of the Eustachian tube function. The Eustachian tube often takes some time to respond to changes in ambient pressure and its functioning can be missed by existing devices, which are designed to record responses only shortly after any stimuli.
The invention presented here is a portable device which is inserted into the ear, measuring both impedance and pressure in the middle ear. The device uses a deep seated ear canal seal or an inflatable seal for the ear canal probe. This minimizes ear canal pressure changes due to movement of the device relative to the ear or from jaw movements and other artifacts. The pressure in the ear canal is regulated with a pump. This allows for setting the pressure at different levels to stimulate responses from the Eustachian tube. Different pressure paradigms can be created to stimulate a response from the Eustachian tube, for example, allowing the pressure to equalize with time or maintaining a pressure differential despite the Eustachian tube opening. The pressure can be presented in step functions, sinusoidal, or any other style of presentation that may be desired. The device electronically records the pressure responses in real time. It also filters out artifacts and displays the signals consistent with the opening of the Eustachian tube. Therefore, this device reliably detects Eustachian tube functionality in a low stress and a non-invasive manner significantly improving diagnosis and assessment of surgical treatments.
- Provides clinically relevant results immediately
- Works even if the ear drum is highly perforated
- Can be used with a variety of fluids in the ear canal, compressible or incompressible