Innovative Solution
Neoasis™ is a non-contact device that can reduce noise levels in a space. Its A.N.A. Technology™ does this by broadcasting a cancelling sound wave in response to the analyzed sound environment. Using calculations performed in a few microseconds, the system determines the optimum sound wave at that moment needed to minimize the sound pressure level over the greatest area. Additionally, the system provides a means for a parent’s or caregiver’s voice to be transmitted into the incubator for critical directed communication with the infant without the interference of the incubator walls.
Publication Of Effectiveness In Simulated NICU Environment
Abstract
Objective
Noise in the neonatal intensive care unit can be detrimental to the health of the hospitalized infant. Means of reducing that noise include staff training, warning lights, and ear coverings, all of which have had limited success. Single family rooms, while an improvement, also expose the hospitalized infant to the same device alarms and mechanical noises found in open bay units.
Methods
We evaluated a non-contact incubator-based active noise control device (Neoasis™, Invictus Medical, San Antonio, Texas) in a simulated neonatal intensive care unit (NICU) setting to determine whether it could effectively reduce the noise exposure of infants within an incubator. In the NICU simulation center, we generated a series of clinically appropriate sound sequences with bedside medical devices such as a patient monitor and fluid infusion devices, hospital air handling systems, and device mechanical sounds. A microphone-equipped infant mannequin was oriented within an incubator. Measurements were made with the microphones with the Neoasis™ deactivated and activated.
Results
The active noise control device decreased sound pressure levels for certain alarm sounds by as much as 14.4 dB (a 5.2-fold reduction in sound pressure) at the alarm tone’s primary frequency. Frequencies below the 2 kHz octave band were more effectively attenuated than frequencies at or above the 2 kHz octave band. Background noise levels below 40 dBA were essentially not impacted by the active noise control device.
Conclusions
The active noise control device further reduces noise inside infant incubators. Device safety and potential health benefits of the quieter environment should be verified in a clinical setting.
Comparison To Earmuff Attenuation
Since studies demonstrated improvements in sleep hygiene and weight gain when using earmuffs, we sought to understand if the Neoasis™ would provide similar attenuation without the downsides of the earmuffs (adhesive applied to skin, blocking of directed parent communication, peeling off, etc.).
Using the set of alarm sounds described in the table, we compared the performance of the earmuffs to the Neoasis™. The tests included conditions where the earmuffs were affixed directly to a mannequin and also to a mannequin with human hair extensions positioned above the ear. Since in normal use earmuffs are applied to the head of an infant, covering the auricles, they may be placed over the infant’s hair.
Measurements were made under four test conditions including (1) no attenuation (control), (2) Neoasis™, (3) earmuffs, and (4) earmuffs positioned on hair. The tests were conducted in a hospital NICU simulator and the sound sequences were generated with actual bedside devices.
For seven of the 10 alarm-based sound scenarios, the Neoasis™ had better attenuation than the earmuffs (see table below). For the remaining three alarm-based sound scenarios, neither earmuffs or theNeoasis™ provided attenuation greater than a just noticeable difference. The earmuffs provided 4.7dB attenuation for voice signals, greater than that provided by the Neoasis™.
Neoasis™ Attenuation Zone Size
| To evaluate the ability of the Neoasis™ to accommodate this variation in position, we moved the mannequin in a range of positions to determine the sensitivity of the Neoasis to patient position. Measurements were taken at both ears as shown below. Note the faint graphic of the infant head, shown to scale, between the right and left ear icons of position 5. The Neoasis™ residual noise sensor is represented by the yellow triangle at the bottom of the graph. |
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| We found that lower frequencies (<500Hz) generally resulted in a broader attenuation zone than mid-range frequencies (~1,000Hz) and that frequencies above 1,400Hz were generally not affected by Neoasis. However, the preponderance of NICU noise occurs in the 500Hz and 1,000Hz octave bands.
An illustrative example of the amount of attenuation at each of the six positions is shown below. The alarm sound tested was the high priority alarm of a Maquet ventilator. The amount of attenuation (y-axis) for each position is shown for each primary frequency of the alarm (x-axis). The location of the single highest and lowest attenuation value is called our for each frequency and the mean attenuation is indicated by the triangle. |
Amount of attenuation at different points in an incubator |
Components Of System
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| Control unit front face and home screen |
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| Assembly of the pieces inside the incubator |
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| Outside noise sensor positioned on the outside of the incubator |
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| Diagram of the assembled system |
Intellectual Property
Invictus is the assignee or has been exclusively licensed 11 issued patents, 10 of which have expiration dates between 2030 and 2040. These patents have claims generally directed towards safeguard techniques, hardware implementations, and other aspects active noise control.
One of Invictus’ patent applications has a notice of allowance. Invictus has two pending application families.
FDA Status
Neoasis™ has not yet been cleared by the FDA.
Neoasis™ is not yet available for sale.