Systems, devices, and methods for treating vestibular conditions using vibrations applied at predetermined directions against a head of a subject

Abstract

Apparatus and methods are described herein that provide a vibratory device that can apply a vibratory signal to a portion of a head of a user such that the vibratory signal can be conducted via bone to a vestibular system of the user and modulate a velocity storage mechanism or induce stochastic resonance based on a therapeutically effective vibratory signal applied to an area overlaying a mastoid of the user. The vibratory device can be effective at treating a physiological symptom and / or condition associated with the vestibular system.

Description

SYSTEMS, DEVICES, AND METHODS FOR TREATING VESTIBULAR CONDITIONS USING VIBRATIONS APPLIED AT PREDETERMINED DIRECTIONS AGAINST A HEAD OF A SUBJECTCross-Reference to Related Applications

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application Serial No. 63,588,646, entitled “SYSTEMS, DEVICES, AND METHODS FOR MODULATING A VELOCITY STORAGE MECHANISMS TO TREAT VESTIBULAR CONDITIONS,” filed October 6, 2024, the disclosure of which is incorporated by reference herein in its entirety.Field of Invention

[0002] Disclosed embodiments relate to systems, devices, and methods for treating conditions and / or symptoms such as, for example, motion sickness, nausea, dizziness, vertigo, migraines, tinnitus, and loss of consciousness, associated with a vestibular system of a subject. More specifically, the present disclosure relates to devices configured to generate vibratory signals and apply them at predetermined directions to a head of a subject, to thereby modulate a velocity storage mechanism in a subject or create stochastic resonance to treat symptoms associated with the vestibular system.Background

[0003] Orientation, balance, position, and movement of a body can be determined by the brain through a combination of signals received from various parts of anatomy, including eyes, ears, and muscles. For example, the vestibular system, in most mammals, is the sensory system that predominantly contributes sensory information related to balance and spatial orientation. The vestibular system of a subject is found in the inner ear of the subject in a system of interconnected compartments forming the vestibular labyrinth.

[0004] An individual’s inner ear has five receptors associated with balance: three associated with three semicircular canals, and two associated with the otolith organs (i.e., the utricle and the saccule). The otolith organs are involved in measuring linear acceleration of the head, e.g., from self-movement and from constant acceleration of gravity. The utricle thatdetects movements in the horizontal plane, and the saccule that detects movements in the vertical plane. The three semicircular canals that are each oriented in a plane along one of three directions in which the head can rotate, the directions being pitch (i.e., nodding up and down), roll (i.e., tilting left and right), and yaw (i.e., turning left and right).

[0005] The semicircular canals and the otolith organs are filled with endolymph, a fluid that moves with the movement of the head or body. The movement of endolymph in the vestibular system of the inner ear can be sensed by nerve cells with hair bundles to determine movement and orientation of the head. Portions called ampulla in the semicircular canals and macula in the otolith organs include hair cells, which function as the sensory receptors of the vestibular system and include hair bundles or stereocilia that detect and transduce movement of the endolymph into signals of body movement and report the signals to the brain. The otolith organs also include a layer of crystals of calcium carbonate called otoconia or otoliths that shift in response to changes in acceleration (e.g., changes in motion or orientation with respect to gravity) leading to movement in the layers below the otoconia and the movement of hair bundles. Additionally, otoliths sink in the direction of gravity and pull on bundles of hair cells to aid in distinguishing directions, e.g., up from down.

[0006] In addition to signals from the vestibular system, horizontal and vertical visual patterns received by the eyes can affect perception of orientation, balance, and position; and differential strain on opposing neck muscles can affect perception of head position and orientation. In some instances, when signals from these sources do not match, an individual can develop motion sickness, experience vertigo, dizziness, vestibular migraines, fainting, or other symptoms. Unmatched orientation, balance, position and movement signals can be the result of extreme or unfamiliar movement during, for example, travel in cars, trains, airplanes, and other modes of transportation. Unmatched signals may also result from simulated perceived movement during, for example, three dimensional (3D) movies, 3D video games, and virtual reality devices. Therefore, it can be desirable to have a device for treating various vestibular conditions that may result from unmatched signals being received from a subject’s vestibular system, eyes, or other anatomy.Summary

[0007] Apparatus and methods described herein can include a vibratory device configured to apply a vibratory signal to a portion of a head of a user such that the vibratory signal can beconducted via bone to a vestibular system of the user. The vibratory signal can cause a portion of the vestibular system (e.g., ciliated cells or hair cells) to activate and generate signals that can modulate a velocity storage mechanism in a subject or cause stochastic resonance in the vestibular system.Brief Description of the Drawings

[0008] FIG. 1 schematically illustrates the operation of a vibratory device to provide a therapeutic effect via velocity storage mechanism modulation and / or stochastic resonance, according to embodiments.

[0009] FIGS. 2A-2B schematically illustrate the operation of a vibratory device to modulate a velocity storage mechanism of a subject, according to embodiments. FIG. 2A illustrates a flow of signals through the vestibular system to a brain of a subject, and FIG. 2B illustrates the placement of the vibratory device relative to a head of a subject so that it can cause modulation of the velocity storage mechanism.

[0010] FIG. 3 is a schematic illustration of various directions that vibratory signals can be applied by a vibratory device to a head of a subject, according to embodiments.

[0011] FIGS. 4A and 4B schematically depict a system for treating vestibular conditions, including a vibratory device, according to embodiments. FIG. 4A depicts an exterior view of the system, and FIG. 4B depicts an interior view of the system and its components.

[0012] FIG. 5 schematically depicts components of a vibratory device of a system for treating vestibular conditions, according to embodiments.

[0013] FIG. 6 depicts a system for treating vestibular conditions being worn by a subject, according to embodiments.

[0014] FIGS. 7A and 7B depict an example system for treating vestibular conditions, including a support element implemented as a headband configured to couple to and support a vibratory device and its electronics, according to embodiments.

[0015] FIGS. 8A-9 provide detailed views of a vibratory device and its electronics, according to embodiments. FIGS. 8A and 8B depict different views of housings that containthe vibratory device and electronics, and FIG. 9 depicts a cross-sectional view of the vibratory device.

[0016] FIGS. 10A-11 depict various views of an example support element of a system for treating vestibular conditions, implemented as a headband, according to embodiments.

[0017] FIGS. 12A and 12B depict two examples of vibratory devices of a system for treating vestibular conditions, according to embodiments. FIG. 12 A depicts a vibratory device configured to apply vibratory signals in a direction that is perpendicular or normal to a surface of a head of a subject, and FIG. 12B depicts a vibratory device configured to apply vibratory signals in a direct that is parallel to or along a surface of a head of a subject.

[0018] FIGS. 13A-13C depict different directions that a vibratory device can apply vibratory signals to a head of a subject, according to embodiments.

[0019] FIG. 14 is a flow chart of a method for operating and / or adjusting the operation of a system for treating a vestibular condition, according to embodiments.

[0020] FIG. 15 schematically depicts measurements of a head of a user, e.g., used to determine an appropriate fit of a support element of a system for treating vestibular conditions, according to embodiment.

[0021] FIG. 16 depicts study results of two different vibratory devices (perpendicular direction device, and parallel direction device), according to embodiments.Detailed Description

[0022] Apparatus and methods are described herein for treating vestibular conditions by using a vibratory' device capable of generating vibratory signals and applying the vibratory signals via bone conduction to a vestibular system of a subject. In some embodiments, the vibratory signals can be configured to modulate a velocity storage mechanism in the subject. Alternatively, or additionally, the vibratory'- signals can be configured to create or induce stochastic resonance in signals processed by a vestibular system of a subject.

[0023] The vestibular system plays a central role in determining an individual’s susceptibility to motion sickness. As described above, sensory signals from a vestibular system of a subject aid in the perception of orientation, balance, position, and movement of a body ofthe subject. The vestibular system contains ciliated cells (e.g., cells with hair-like structures or hair cells) that can detect small movements. Threshold of activation of ciliated cells can include movements as small as 0.3 nanometers. In the vestibular system, movement of fluid following rotation of an individual’s head causes changes in the release of neurotransmitters from these ciliated cell to nearby vestibular neurons. Movement of an otolithic membrane due to acceleration (or change thereof), e.g., gravity or walking, similarly causes changes in activation from the ciliated cells encased in that membrane. Stimulation of the ciliated cells can increase (e.g., cause excitation of) or decrease (e.g., cause inhibition of) the firing rate of the neurons in a vestibular nerve of an individual. The vestibular nerve neurons are active at rest. For example, they can fire 100 spikes per second at rest. From the point of view of rotations of an individual’s head, each rotation can cause excitation on one side (e.g., right side) and inhibition on the other side (e.g., left side) of the individual’s neurons. The vestibular nerve terminates in vestibular nuclei in the brainstem, including the inferior (or descending) vestibular nucleus (IVN). About half of the projections from the utricle and saccule are monosynaptic to the nodulus of the IVN. The IVN can receive signals from the vestibular nerve as well as from the cerebellum. In some embodiments, the one or more signals generated in response to stimulation of the otolith organs can cause a level or pattern of activation of the IVN of the user. The IVN generates output in the form of neural signals, which can be sent to other brain structures via neural projections. These signals can be interpreted by the brain to determine a position and movement of an individual’s head in space.

[0024] In addition to signals from the vestibular system, other sensory modalities, such as visual signals from the eyes, can affect perceptions of orientation, balance, and position; and differential strain on opposing neck muscles can affect perceptions of head position and orientation. When signals from these various sensory sources such as the vestibular system, the visual system, and the proprioceptive system do not match, an individual can develop conditions and / or symptoms like motion sickness, vertigo, dizziness, vestibular migraines, unconsciousness, or other symptoms. For example, unmatched orientation, balance, position, and movement signals can result from extreme or unfamiliar movement during, for example, travel in cars, trains, airplanes, and other modes of transportation, or result from experiencing virtual or augmented 3D environments such as 3D movies, 3D video games, virtual reality devices, etc.

[0025] The velocity storage mechanism (VSM) in a subject involves a neural circuit that accumulates information over time about self-motion. The VSM can include the nodulus and uvula of the cerebellum. This neural circuit plays a central role to maintain eye position relative to gravity during head movement. This neural circuit functions to improve the accuracy of received motion signals over noisy peripheral signals (e.g., from the vestibular system) by integrating the sensed motion over time. The VSM can maintain an internal model of selfmotion, and provide this input to the IVN, thereby impacting the signal generated by the IVN and the position and / or movement perceived by an individual’s brain. This integrating function via the VSM, however, may extend the inter-sensory conflict that can precipitate and / or exacerbate motion sickness. Accordingly, the VSM time constant associated with the integrating function has been found to be prolonged in individuals who are more susceptible to motion sickness. Moreover, decreased VSM time constants correlate with habituation to provocative motion as well as with the effectiveness of anti-motion sickness drugs.

[0026] The VSM serves to maintain an internal model of self-motion. The VSM receives neural signals from the IVN. As noted above, the IVN generates output in the form of neural signals, which can be sent to other brain structures and / or other anatomical structures (e.g., eyes, joints, muscles, etc.). Some of these projections can be sent to the nodulus and uvula of the cerebellum, forming the VSM. Therefore, there is a positive feedback loop of neural signals that exists between the VSM and the IVN. When an individual initiates a head movement, an efference copy of the motor command refines this internal model, thereby improving the estimate of self-motion. Conversely, unexpected head translations — primarily encoded by the otoliths — can introduce predictive errors. This occurs when the sensory inputs fall short of providing the internal model with the data necessary for precise motion prediction. From the perspective of the VSM, passive translations of the head are “practically indistinguishable” from otolith prediction error. Such prediction errors would be expected to further worsen the inter-sensory conflict thought to precipitate motion sickness. Vehicle passengers can experience a large number of such nauseogenic passive head translations even more so when engaged in a task.

[0027] In greater detail, the nodulus forming the VSM functions to adjust the duration and / or timing of the vestibular ocular reflex (VOR) as well as to process input from the vestibular system (e.g., otolith input). Activation of the VOR mainly results from excitation from one inner ear and inhibition from the other. However, this may not be sustained,particularly at low frequencies which are not easily detectable by the inner ear. The positive feedback loop noted above is heavily mediated by the nodulus. The net effect of this positive feedback loop is to integrate the weak signal from the vestibular system (e.g., the otolith input). This effective integration is known as velocity storage. Augmentation of weak peripheral afferent signals is important to the accurate perception and integration of low-frequency head movement, such as, for example, low frequency accelerations less than about 0.1 Hz. Therefore, the process of velocity storage exists to extend the sensitivity (e.g., gain) of low frequency stimuli where the effectiveness of the VOR is less efficient in transducing slow acceleration stimuli. Lesions of the nodulus and uvula can abolish the otolithic process of velocity storage, resetting perrotatory and postrotatory vestibular nystagmus, and the elimination of steady-state otolith nystagmus during off-vertical-axis rotation. Lesions at the midline of the brain also suppress the central velocity storage integration. Such lesions are thought to lead to the experience of various negative symptoms, including vestibular migraines, slower perception of changes in rotational and / or linear movement, longer sensation of movement (e.g., vertigo), loss of balance, motion sickness, etc. For example, there can be a discrepancy between rotational acceleration and linear acceleration. If an individual is in a car that accelerates and goes up a hill, the change in the local vertical is due to the hill and to the linear acceleration. These changes happen slowly (e.g., over several seconds) at frequencies the inner ear may not be equipped to detect. Certain individuals may not perceive the change back to a horizontal movement with congruent deceleration. In other (or the same) individuals, migraines can down-regulate the velocity storage mechanism from higher brainstem structures, such that migraine sensitivity affects the brainstem’s vestibular nuclei, increasing the integration time of the VSM. This can cause periods during which small movements or even neural noise cause a long duration sensation of movement.

[0028] In a natural adaptive response, a brain can ignore sensory information in signals that are chaotic, repetitive, or not novel, or unintelligible. Vibrations from sound can affect the vestibular organs in the inner ear and decrease response, however, very high intensities are required for sound to affect the vestibular system. The technology for delivering high intensity signals is challenging and such high intensity signals may harm or disrupt human hearing.

[0029] Mechanical vibrations can be used to affect the vestibular system to therapeutically treat various symptoms via a surface or bone conduction transducer. Disclosed systems, devices, and methods are directed to the treatment of symptoms associated with conditions ofthe vestibular system that do not produce a high level of heat or audible noise, and have high efficiency in delivering lower frequency vibratory signals, among other features. As noted above, the semicircular canals of the vestibular system can detect angular deceleration of a subject’s head, and the otolith organs can detect linear acceleration and head tilt relative to gravity. The semicircular canals primarily contribute to initial activity of the VSM, and can prolong the VOR beyond the time constant of the inner ear. The VSM can also provide the input for velocity storage charging (e.g., maintaining of the internal model of self-motion). The otolith organs can then modulate the time constant of the VSM, or act as a reset mechanism for the VSM. In some embodiments, disclosed systems, devices, and methods use mechanical vibrations to affect the otolith organs, such as, for example, the utricle, to thereby modulate and / or cause a result of the VSM. In embodiments, systems and methods described herein can apply force levels in therapeutically effective ranges, including between about 87 and about 101 dB re 1 dyne, or about 87 and about 101 dB re lOpN, or 0.22 to 1.12 Newtons (N), including all subranges and values therebetween.

[0030] Alternatively, or additionally, disclosed systems, devices, and methods can be configured to induce stochastic resonance. Noise in the vestibular system (e.g., from asymmetry between left and right sides due to vertigo or hypofunction, or lesser known causes such as vestibular migraines) can add uncertainty and decrease stability of positions and / or movements detected by the vestibular system, e.g., by decreasing the vestibular system’ s ability to detect and code signals related to body motion. Under certain circumstances, a small amount of noise can improve the signal-to-noise ratio of signals, e.g., by improving transmission of incoming information. This can be referred to as stochastic resonance. In some embodiments, systems, devices, and methods described herein can be configured to affect one or more of the semicircular canals (e.g., the horizonal canal) to cause stochastic resonance. The systems and devices can be configured to generate low-frequency bone-conducted vibrations in a predetermined range (e.g., less than about 200 Hz, or greater than about 30 Hz, or between about 30 and about 200 Hz, including all subranges and values therebetween) that is effective at stimulating the semicircular canals (e.g., the horizonal canal). The vibrations can cause sub- perceptual, threshold stimulation of the canals, such that they do not cause discomfort or introduce other sensations, while providing stimulation necessary to induce stochastic resonance.

[0031] Alternatively, or additionally, disclosed systems, devices, and methods can be configured to equalize background activity and / or noise between two (e.g., left and right) vestibular systems, provide masking, and / or induce or cause other physiological reactions. For example, as described in U.S. Patent Application Publication No. 2020 / 0001085 and U.S. Patent Application Publication No. US 2021 / 0321205, the application of vibratory signals can be configured to mask signals sent by the vestibular system that induce certain symptoms, conditions, or sicknesses. Alternatively, or additionally, disclosed systems, devices, and methods can be configured to provide an anchor for the patient to enhance response to sensory signals.

[0032] FIG. 1 schematically illustrates a system 100 configured to impart therapeutic effects to a subject, e.g., by modulating the VSM of the subject or causing stochastic resonance of the vestibular system, according to an embodiment. The system 100 includes a vibratory device 110 that can be configured to apply vibratory signals to a subject’s head, as described in further detail in later figures. The vibratory device 110 can provide vibratory signals conducted via bone to modulate the subject’s VSM, at 120, or to cause stochastic resonance of the vestibular system, at 122, each of which can impart therapeutic effects 130 that may alleviate one or more symptoms or conditions associated with the subject’s vestibular system. Some example conditions can include various types of motion sickness (e.g., sea sickness, air sickness, car and train sickness, sickness from exposure to virtual reality or simulators, sickness from experiences such as rides on a roller coaster, and effects of sopite syndrome), vertigo such as benign paroxysmal positional vertigo, nausea from a variety of causes (e.g., vestibular system testing including caloric electronystagmography (ENG) / videonystagmography (VNG) testing, head impulse testing, vestibular evoked myogenic potential (VEMP) testing such as cervical VEMP and ocular VEMP testing, functional gait assessment, etc., or arising from conditions such as chemotherapy, radiotherapy of a base of the skull, nausea related to pregnancy, nausea from alcohol or poison consumption, etc.), infection, vestibular neuritis, vestibular schwannoma, Meniere’s disease, tinnitus, migraines, Mai de Debarquement syndrome, spatial discordance, sopite syndrome, vestibular weakness, general imbalance, etc.

[0033] In greater detail, the vibratory device 110 can generate vibratory signals, which can be conducted via bone to the bony labyrinth of the inner ear and to the vestibular system. For example, a portion of the vibratory signals can travel through the bone to the subject’s semicircular canals and vestibule housing the subject’s otolith organs, the utricle and thesaccule. The vibratory signals can be configured to modulate the VSM via the vestibular system organs (e.g., semicircular canals and / or otolith organs), the vestibular nerve, and the vestibular nucleus. For example, as depicted in FIG. 2 A, stimulation of the vestibular system organs 202 via vibratory signals (e.g., from system 100) can cause signals to be sent to the vestibular nucleus or IVN 204, which in turn can send signals to the cerebellum 206. The IVN 204 can also receive signals from the cerebellum, and generate an output (e.g., neural signals) that is sent to other brain or anatomical structures, e.g., for processing changes in position and / or movement of the subject. As described above, the cerebellum 206 includes the nodulus and the uvula, which form or implement the VSM. Therefore, stimulation of the vestibular system organs 202 can lead to signals being sent to modulate the VSM. In embodiments, vibratory signals generated by systems and devices described herein (e.g., though the pathway shown in FIG. 2 A) can modulate the VSM by inducing a reduction in a time constant associated with the VSM. In other words, disclosed systems, devices, and methods can be used to deliver vibratory signals, at least a portion of which can modulate a VSM by reducing a time constant associated with signal integration implemented by the VSM. Such modulation of the VSM can in turn alleviate symptoms associated with a vestibular condition.

[0034] Alternatively, or additionally, the vibratory signals generated by the vibratory device 110 can be configured to cause stochastic resonance of the vestibular system. As described above, noise in the vestibular system (e.g., caused by a vestibular malady, such as vertigo) can negatively affect the ability of an individual to respond to weak sensory signals. Under certain circumstances, a small amount of noise can improve the signal-to-noise ratio of signals being generated by the vestibular system, via stochastic resonance. Such stochastic resonance can enhance the vestibular system’s response to weak sensory signals, thereby improving the ability of an individual to react to changes in position or movements. Such can provide therapeutic effects 130, e.g., in reducing vertigo, dizziness, motion sickness, vestibular migraines, unconsciousness, or other conditions and / or symptoms. Alternatively, or additionally, the vibratory signals generated by the vibratory device 110 may provide an anchor for the patient to enhance the patient’s response to sensory signals.

[0035] In some embodiments, the vibratory device 110 can generate and deliver vibratory signals to a head of a subject in one or more directions relative to the surface of the head. For example, the vibratory device 110 can deliver vibratory signals toward and away from a surface of the head (e.g., normal or perpendicular signals, or inclined signals having a normal orperpendicular component), whereby the signals are delivered at a therapeutically effective level to treat one or more vestibular conditions. In such embodiments, the vibratory device 110 can be configured to stimulate the vestibular system organs to modulate or reset the VSM, which can treat one or more vestibular conditions. Alternatively, or additionally, the vibratory device 110 can deliver vibratory signals along or parallel to a surface of the head (e.g., parallel signals, or inclined signals having a parallel component), whereby the signals are delivered at a therapeutically effective level to treat one or more vestibular conditions. In such embodiments, the vibratory device 110 can be configured to stimulate one or more semicircular canals (e.g., a horizontal canal) of the vestibular system. In some embodiments, the vibratory device can be configured to generate acceleration of a head of a subject in one or more planes (e.g., a yaw plane), so that a root mean square (RMS) of the angular acceleration, as sensed by the vestibular system (e.g., the horizontal semicircular canal), reaches at least about 1 degrees per second squared to about 6 degrees per second squared, inclusive of subranges and values therebetween, including, for example, about 3.5 degrees per second squared, about 5 degrees per second squared, etc. In an example implementation, assuming a vibratory signal of about 50 Hz, a RMS force of about 0.8 N, 100% efficacy at transmitting force to the head, and a head of about 14 cm in diameter, the RMS angular acceleration that is generated for the head is about 5 degrees per second squared. In some embodiments, the vibratory device 110 can be configured to vibrate along an axis that is substantially parallel to the surface of the head of the user to generate the one or more vibratory signals along the axis that have a force level of between about .22 Newtons and about 1.12 Newtons, inclusive of all subranges and values therebetween.

[0036] In some embodiments, the vibratory device 110 can be positionable behind the external ear of a subject or overlaying a mastoid (e.g., or a portion of the temporal bone) of a skull of the subject. Alternatively, in some embodiments, the vibratory device 110 can be configured to be placed over other regions of the head of a subject (e.g., frontal bone, parietal bone, occipital bone, etc.). FIG. 2B depicts an example of a vibratory device 300 placed adjacent to a head HD of a user. The vibratory device 300 can be structurally and / or functionally similar to other vibratory devices described herein, including, for example, vibratory device 110. The vibratory device 300 can be configured to apply vibratory signals to the head HD, where the signals are then conducted via bone structure BS to the vestibular system, e.g., to treat one or more symptoms or conditions associated with the subject’s vestibular system. In particular, a portion of the vibratory signals generated by the vibratorydevice 300 can be conducted via bone (e.g., the skull) to the bony labyrinth of the inner ear and to the vestibular system, including the semicircular canals and the vestibule housing the otolith organs, the utricle and the saccule. In some embodiments, the vibratory device 300 can be positioned (e.g., to apply vibratory signals that are substantially perpendicular to the surface of the head) such that the vibratory signals affect (e.g., stimulate) the vestibule to cause the hair cells in the otolith organs in the vestibule and / or other portions of the vestibular system to move, thereby causing neural signals to be generated and sent to the velocity storage mechanism VSM of the subject, thereby modulating and / or resetting the velocity storage mechanism VSM. As described above with reference to FIG. 2A, the movement of the hair cells at the otolith organs causes neurons of the vestibular nerve to send signals to the IVN, which in turn generates neural signals that are sent to the cerebellum that includes the nodulus and uvula. The nodulus and the uvula form the central velocity storage neural network, and therefore the neural signals, when received by the nodulus and uvula, can cause modulation and / or a reset of the VSM. Alternatively, or additionally, in some embodiments, the vibratory device 300 can be positioned (e.g., to apply vibratory signals that are substantially parallel to the surface of the head) such that the vibratory signals affect (e.g., stimulate) the semicircular canals (e.g., the horizonal semicircular canal) to move, thereby inducing stochastic resonance in signals generated in response to movements at the vestibular system. As described above, the stochastic resonance can treat various vestibular conditions (e.g., improve balance, reduce dizziness, etc.) by enhancing the detection and processing of weak signals. In some embodiments, the vibratory device can be configured to generate acceleration of a head of a subject in one or more planes (e.g., a yaw plane), so that a root mean square (RMS) of the angular acceleration, as sensed by the vestibular system (e.g., the horizontal semicircular canal), reaches at least about 1 degrees per second squared to about 6 degrees per second squared, inclusive of subranges and values therebetween, including, for example, about 3.5 degrees per second squared.

[0037] In some embodiments, the positioning of the vibratory device and / or direction of application of vibratory signals can be adapted to selectively target the stimulation of various portions of the vestibular system, e.g., by generating movement (e.g., vibrations) in predetermined directions to selectively stimulate the horizonal canal, the otolith organs, etc. For example, a physician or other medical practitioner can fit a user with a vibratory system (e.g., system 100 including vibratory device 110, vibratory device 300, or any other vibratory device described herein), such that the vibratory system is configured to apply signals in apredetermined direction relative to the surface of the head of the user. The medical practitioner can adjust the vibratory system to change the direction of application of the vibratory signals such that the vibratory signals are configured to stimulate (e.g., impart movement upon) the vestibular system (or portions thereof) to treat a vestibular condition (e.g., vertigo, dizziness, vestibular migraines, unconsciousness, or other symptoms). In some embodiments, the adjustment of the direction of application can be implemented by supporting (e.g., using a headband) the vibratory device relative to the head of the user at a predetermined position and / or orientation. In some embodiments, the adjustment of the direction of application can be implemented using one or more mechanical and / or electrical mechanisms that can be configured to tilt or angle a transducer of the vibratory device, thereby changing the direction of application of the vibratory signals.

[0038] In some embodiments, the vibratory device 110 can be configured to deliver translational and / or rotational vibrations. In some embodiments, the vibratory device 110 can be configured to deliver the vibrations based on one or more waveforms or with one or more predetermined or preset parameters (e.g., a predetermined or preset frequency, or a predetermined or preset intensity or force level). The waveform and / or parameters can be varied or altered to stimulate the vestibular system, e.g., to thereby modulate the VSM, cause stochastic resonance, provide anchoring, etc. The set of parameters can include, for example, a direction of movement and / or rotation, duration, frequency, periodicity, duty cycle, amplitude (fixed and / or variable), or force levels associated with the movements.

[0039] Each parameter can be defined to assume a value within a predetermined range of values. For example, the direction of the vibrations can be a translation in one of a plurality of directions (e.g., up, down, front, back, right, left) with reference to the subject’s head and / or a clockwise or counterclockwise rotation along one or more axes (e.g., up-down, right-left, front- back) and / or a combination thereof. For example, as noted above, the vibratory device can be configured to deliver mechanical vibrations where a significant or predetermined portion of such vibrations is directed or applied in one or more predetermined directions. In some embodiments, the vibratory device can be configured to deliver translational movements or vibrations parallel to a user’s head. In some embodiments, the vibratory device can be configured to deliver vibrations set at a specific angle or range of angles relative to horizontal, e.g., as may be desired to achieve a therapeutic effect. For example, a direction of movement aligned with an axis associated with an anatomical structure of a subject (e.g., the horizonalsemicircular canal) can be configured to provide a predetermined therapeutic effect. The direction of application of the vibratory signals can result from the direction that the vibratory device (e.g., vibratory device 110) is placed on a subject’s head and / or one or more mechanical or electronic components that can adjust an axis along which vibrations are generated by the vibratory device. Further details of such placement and direction of applying vibratory signals are described with reference to FIGS. 12A-13C.

[0040] Systems, devices, and methods described herein can generate vibratory signals based on waveforms having any suitable properties or parameters for modulating the VSM, inducing stochastic resonance, and / or otherwise providing a therapeutic effort. For example, in some instances, the one or more waveforms can be used to deliver vibratory signals that are transiently on and off, or a contiguous sequence of signals, or a constantly on sequence of signals, or signals repeating over a periodic pattern, and / or the like. The duration parameter can be transient (e.g., application for one or more seconds) or prolonged (e.g., a predetermined number of minutes, hours, etc.). The vibrations can be based on a waveform having one or more predetermined parameters. In some instances, the vibrations can be based on a periodic waveform having a frequency of between about 30 Hz and about 200Hz, including all subranges and values in between, for example including a sub-range between about 30 Hz and about 90 Hz. In some instances, the vibrations can be based on a waveform that is aperiodic or has a variable periodicity. In some instances, the vibrations can have a baseline amplitude that is fixed and a variable amplitude that is periodically varied. For example, the baseline amplitude can be determined by a pressure associated with wearing the vibratory device (e.g., using a support element such as a head band) and the variable amplitude can be a variable pressure or force level imparted by the vibratory device via the mechanical vibrations. For example, a variable amplitude associated with the vibratory signals can be between about 60 dB and about 110 dB re 1 dyne, including all sub-ranges and values in between, for example including a sub-range between about 30 dB and about 90 dB re 1 dyne. The vibratory device can be operated using any variations of each parameter from the set of parameters defining the mechanical vibrations and / or the one or more waveforms.

[0041] Further details of certain features of vibratory systems and devices are described inU.S. Patent Application Publication No. 2020 / 0001085, entitled, “SYSTEMS, DEVICES, AND METHODS FOR TREATING VESTIBULAR CONDITIONS,” filed August 30, 2019, and U.S. Patent Application Publication No. US 2021 / 0321205, entitled, “SYSTEMS,DEVICES, AND METHODS FOR TREATING VESTIBULAR CONDITIONS,” filed July 6, 2020. The disclosure(s) of each of these applications is incorporated herein by reference in its entirety.

[0042] FIG. 3 schematically depicts how a vibratory device 400 (e.g., functionally and / or structurally similar to other vibratory devices described herein) can deliver vibratory signals with movements along a variety of translational and / or rotational directions, according to embodiments. The direction of movement can be defined with reference to the subject’s head orientation. As shown in FIG. 3 in a top down view of a subject’s head with face oriented toward the bottom of the page, the vibratory device 400 can be worn such that the vibratory signals are delivered adjacent to or overlaying a mastoid of the subject. The vibratory device 400 can be configured to deliver vibratory signals with movement along the axis denoted by the arrow A’ running front to back of the subject’s head ( top to bottom of the illustration). The vibratory device 400 can be configured to deliver vibratory signals with movement along the axis denoted by the arrow B’ running left to right of the subject’s head (left to right of the illustration). The vibratory device 400 can be configured to deliver vibratory signals with movement along the axis denoted by the cross lines C’ running up to down of the subject’s head (e.g., into and out of the page). In some instances, the vibratory device 400 can be configured and or placed to deliver mechanical vibrations such that a larger or smaller component of the vibrations fall along a specified angle or direction in one or more of these translational directions, e.g., a larger component of the vibrations configured to lie along the front-to-back direction along a specified angle with reference to a straight line defined by the subject’s viewing angle when the subjects looks straight in front.

[0043] In some instances, the vibratory device 400 can be configured or placed to deliver rotational movement about an axis defined with reference to the subject’s head. As shown in the illustration in FIG. 3, the vibratory device 400 can be used to deliver vibrations with movement along a clockwise or counterclockwise direction about the axis defined by the cross lines C’ . Similarly, vibratory device 400 can be used to deliver vibrations with movement along a clockwise or counterclockwise direction about the axes denoted by the arrows A’ and / or B’ (not shown in FIG. 3).

[0044] As described above, in some embodiments, the systems and methods described herein can be used to deliver vibratory signals to modulate or reset a VSM using a vibratory device configured to deliver mechanical vibrations to a subject’s head and / or vestibular systemvia bone conduction. Alternatively, or additionally, in some embodiments, the systems and methods described herein can be used to deliver vibratory signals to induce stochastic resonance in signals associated with the vestibular system using a vibratory device configured to deliver mechanical vibrations to a subject’s head and / or vestibular system via bone conduction. Still alternatively, or additionally, in some embodiments, the systems and methods described herein can be used to deliver vibratory signals to cause masking of vestibular signals and / or equalizing the level of background activity between two (e.g., left and right) vestibular systems. In some embodiments, the systems and methods described herein can cause anchoring (e.g., provide an anchor for the patient to enhance response to signals).

[0045] In some embodiments, systems and devices described herein can include a support element that can be configured to support or hold a vibratory device on a head of a user, such that the vibratory device can apply vibratory signals to the head, which can be conducted via bony structure to a vestibular system of the user. FIGS. 4A-4B schematically depict interior and exterior views of a system 550 for treating vestibular conditions, which includes a support element 510, according to embodiments. The system 500 can be functionally and / or structurally similar to other systems described herein, including, for example, system 100.

[0046] FIG. 4A depicts an exterior view of the system, showing an exterior view of the support element 510 and its components when the system is worn on a head of the user. The support element 510 can be any suitable device that is configured to hold and / or support a vibratory device on a head of a user, such that the vibratory device can impart or apply vibratory signals to the head of the user. In some embodiments, the support element 510 can be implemented as a headband, e.g., an elastic structure that can be worn on a head of a user and hold the vibratory device against the head of the user. Alternatively, the support element 510 can be implemented as a hat, a helmet, a headset, or other wearable structure, and / or the support element 510 can be implemented as part of or include part of a head support device (e.g., a chair, a pillow, etc.). As shown in FIG. 4A, the support structure can optionally include a position indicator 512. The position indicator 512 can be configured to indicate a location of the vibratory device (or a location of generating vibratory signals), such that a user (or medical professional) can quickly identify this location and use it to determine proper positioning and / or orientation of the vibratory device along or against a head of the user. Optionally, the position indicator 512 can also impart other information of the system 550 or vibratory device, such as a type of vibratory device (e.g., a vibratory device configured to apply substantiallyperpendicular vibratory signals, or a vibratory device configured to apply substantially parallel vibratory signals, or a vibratory device with adjustable direction, etc.). In some embodiments, the position indicator 512 can be positioned on the outside of the support element 510 at the location where the support element would be supporting the vibratory device. In some embodiments, the position indicator 512 can be positioned at another location along the outside of the support element but can include one or more markings that indicate a location of the vibratory device. While not depicted, one or more additional markings, indicia, etc. can be used to indicate other information about the system and / or vibratory device.

[0047] In some embodiments, when the system 550 is worn on the head of a user, the support element 510 can support the vibratory device such that the vibratory device is visually imperceptible by other individuals. For example, the support device 510 can be implemented as a headband that fully covers the vibratory device (and / or other components coupled thereto) so that the headband, when worn, appears similar to a standard headband, without showing any portion of the vibratory device or other internal components. The vibratory device and other components supported by the support element 510 can be housed in slim profile housings (e.g., the first housing 502, and the second housing 504) so that the housings do not noticeably alter an outer configuration or appearance of the support element 510. In other words, the vibratory device and other components supported by the support element 510 can be designed to be inconspicuously worn by a user.

[0048] FIG. 4B depicts internal components of the system 550. As shown the system 550 can include a coupling element 508, which can be configured to releasably couple to the vibratory device and other components and / or one or more housings (e.g., the first housing 502, and the second housing 504) that house or contain such components. In some embodiments, the coupling element 508 can include a mechanical attachment, e.g., Velcro or other hook and loop attachments, an adhesive, a strap or belt, or other fastening device. In some embodiments, the coupling element 508 can include a first part that is directly attached to the support element and a second part that is directly attached to a housing containing the vibratory device (and / or other components coupled thereto), and the two parts can be configured to interface with one another to releasably couple the vibratory device and / or other components to the housing. For example, Velcro portions can be attached to the support element and housing containing the vibratory device to releasably couple the vibratory device and / or other components to the housing.

[0049] As depicted in FIG. 4B, the system 550 also include a first housing 502 and a second housing 504, each configured to house one or more additional components of the system 550. While the first and second housings 502, 504 are shown as housing specific components of the system 550, it can be appreciated that other housing arrangements or assemblies can be used. For example, instead of two housings, a single housing can be used to contain the components depicted in FIG. 4B. Alternatively, three housings or more can be used to contain the components depicted in FIG. 4B. Still alternatively, one or more components shown as being in the first housing 502 can be contained in the second housing 504, and vice versa. Therefore, the housing arrangement depicted in FIG. 4B is not intended to be limiting.

[0050] In some embodiments, the system 550 can include first and second housings 502, 504, which contain different components of the system 550, to further facilitate the application of vibratory signals to the head of a user. For example, by having a first housing 502 contain a control unit 560 and a power source 570 of the system 550 and a second housing contain the vibratory device 500 of the system, the system can desirablly keep the vibratory signals or vibrations generated by the vibratory device 500 separate from the control unit 560 and the power source 570. Such can avoid or reduce movement of components of the latter (e.g., the control unit 560 and / or power source 570) that may disrupt their operation, but still keep the latter in close proximity to the vibratory device such that the device has a compact design. A bridge 506 can be disposed between the first and second housings 502, 504 and therefore couple the first housing 502 to the second housing 504. The bridge 506 can be configured to define a passageway for housing electronic wiring, connections, etc. that extend between the components disposed in the first housing 502 (e.g., the control unit 560 and / or power source 570) and the components disposed in the second housing 504 (e.g., the vibratory device 500). In some embodiments, the bridge 506 can be flexible such that vibrations generated at the vibratory device 500 are reduced at the first housing 502 (and components housed therein). In some embodiments, the bridge 506 can be configured to flex to a degree where a first end of the bridge 506 can be disposed at an angle of up to about 70 degrees relative to the second end of the bridge 506, including all subranges and values therebetween. In other words, the bridge 506 can be configured to flex to a degree such that an axis extending through the first end of the bridge 506 is set at an angle of up to about 70 degrees relative to an axis extending through the second end of the bridge 506, including all subranges and values therebetween.

[0051] While the housing 502 is referred to as a “first housing,” and the housing 504 is referred to as a “second housing,” it can be appreciated that such nomenclature can be interchangeably used and is intended, for illustrative purposes, to distinguish between different housings. Therefore, in some instances, the housing 502 can be referred to as the “second housing” and the housing 504 can be referred to as the “first housing.”

[0052] The control unit 560 can be configured to control the operation of the vibratory device 500. In some embodiments, the control unit 560 can be configured to control the operation of a signal generator and / or an amplifier to produce signals (e.g., waveforms) that can be used to control the vibratory device to generate specific vibratory signals. For example, the control unit 560 can control a signal generator to generate a waveform having predetermined characteristics or parameters (e.g., an amplitude, frequence, etc.), which can be sent to the vibratory device to cause the vibratory device to generate vibratory signals based on such waveform. In some embodiments, the vibratory signals generated and applied by the vibratory device 500 can be adapted for each individual and / or for treating different vestibular conditions. Optionally, in some embodiments, the system 550 can include one or more sensor(s) 590, e.g., configured to measure voltage, current, impedance, movement, acceleration, or other data associated with the vibratory device 500. In such embodiments, the control unit 560 can optionally be configured to receive, process, and / or analyze signal(s) from the sensor(s) 590. The control unit 560 can include a processor, a memory, and / or one or more input / output devices.

[0053] In some embodiments, the control unit 560 is operable to store specialized instructions for controlling the vibratory device 500. Such instructions may be stored in memory of the control unit 560 or in a separate memory. In addition, such instructions can be designed to integrate specialized functions and features into the controller to complete specific functions, methods and processes related to treating vestibular conditions disclosed herein. In some embodiments, the control unit 560 may be programmed with the instructions using a software development kit.

[0054] Electrical signals to control the vibratory device 500 may be generated by the control unit 560 based on the stored instructions. These electrical signals may be communicated between the control unit 560 and vibratory device 500 through wired or wireless (e.g., Bluetooth) methods. The electrical signals may include a stored pattern of operation, e.g., the stored instructions accessed by the controller may be used by the controller to generate a seriesof electrical signals that are sent to the vibratory device 500 to cause the vibratory device 500 to turn “on” or “off’ in a pattern that is advantageous to a specific subject based on usage data that has been collected, accumulated, and stored for that user. One pattern may involve a series of vibratory signals where the number of vibratory signals generated and applied over a time period (e.g., per minute) to a subject may be varied, while a second pattern may include a series of vibratory signals where the force level in a number of vibratory signals may be varied. Other types of control signals, such as those that may be used to control the force level and frequency of vibratory signals generated by the vibrating device 500, may be sent to the vibrating device 500 from the control unit 560 based on data received from sensors (e.g., sensor 590 or other sensors). For example, an acceleration sensor may be included in a portable electronic device (e.g., mobile phone) to sense changes in a user’s physical acceleration. In an embodiment, the control unit 560 may be operable to receive data from the acceleration sensor indicating a type of acceleration that may lead to motion sickness. Accordingly, after receiving such data, the control unit 560 may be operable to generate associated electrical signals and send such signals to the vibrating device 500. The vibrating device 500, in turn, may be operable to receive such electrical signals and generate vibratory signals that can be conducted via bone and applied to the vestibular system to, for example, pre-emptively account for motion sickness. The vibratory signals can cause a portion of the vestibular system to move in a manner equivalent to that of a therapeutically effective vibratory signal. For example, the vibratory signals can cause a portion of the vestibular system (e.g. the hair bundles forming the receptors in the semicircular canals and / or the otolith organs) to move in a manner that causes modulation of or a reset of the VSM or introduce some form of stochastic resonance within the vestibular system. In some instances, such modulation or reset of the VSM and / or stochastic resonance can induce a reduction in the effects caused by other vestibular signals or a mismatch in signals perceived by a subject.

[0055] In some embodiments, there may be wired or wireless communications between the system 550 (e.g., via the control unit 560) and other connected devices, e.g., a mobile device (e.g., a cell phone, a tablet), a computer, or a smart home device. In some embodiments, the control unit 560 can be configured to transmit information to and / or receive information from such external devices. For example, the control unit 560 can be configured to send sensor data to an external device for further processing and / or analysis.

[0056] When the vibratory device 500 applies too low a pressure or force, the vibratory device 500 may not be effective at treating one or more vestibular conditions, and therefore, it can be desirable to have sensors and / or adaptable support elements (or different sizes of support elements) to ensure proper placement of the vibratory device against the head of the user. In some embodiments, the sensor(s) 590 can include a pressure sensor or force sensor that is configured to measure a load or force that is applied by the vibratory device against a surface of the head of the user. The pressure sensor can be disposed adjacent to and / or along an interface between the vibratory device 500 (or housing containing the vibratory device 500) and the head of the user. The pressure sensor can then measure the load and / or forces between against the head of the user. The load and / or forced measured by the pressure sensor can be communicated to the control unit 560. In some embodiments, the control unit 560 (or a processor coupled thereto) can be configured to determine whether a sufficient or desirable amount of pressure or force is being applied by the vibratory device 500 against the head of the user. For example, the control unit 560 can determine whether the amount of pressure or force being applied by the vibratory device 500 is within a predetermined range of values or greater than a predetermined threshold value. In an embodiment, the control unit 560 can determine whether the amount of force being applied by the vibratory device 500 is greater than about 2 Newtons. In some embodiments, the control unit 560 can be configured to turn off the operation of the vibratory device 500 when the pressure applied by the vibratory device 500 is less than the predetermined threshold value. Alternatively or additionally, in some embodiments, the control unit 560 can be configured to present an alarm or alert to inform a user of when the vibratory device is applying a force that is between a predetermined threshold value. The alarm or alert can then inform the user to adjust the support element 510 and / or other components of the system 550 (and / or switch out the support element 510 for a tighter support element 510), such that the vibratory device 500 applies a force about the predetermined threshold value against the head of the user.

[0057] Additionally, or alternatively, in some embodiments, a user can be provided a plurality of different support elements 510. Each support element can be configured to support the vibratory device 500 on the head of the user. In some embodiments, the plurality of support elements 510 can include a plurality of differently sized support element 510. For example, the plurality of support elements 510 can include a plurality of headbands, where each headband is a different size. The different sizes of headbands (or other support elements) can enable a user to switch or select between different support elements such that an appropriately sizedsupport element (e.g., a support element configured to support or position the vibratory device 500 at a sufficient level of pressure, such as pressures or forces above a predetermined threshold value) is used. FIG. 15 of the application depicts a head of a user, which shows how a size of the head of the user can be measured, at 1502, so that the user can determine the appropriately sized support element (e.g., headband) to use. For example, when a circumference of the head of the user is 560 mm or less, a headband having a circumference of 475 mm can be used to ensure that the vibratory device 510 imparts forces above about 2 Newtons against the head of the user. When the circumference of the head of the user is between about 560 mm to about 580 mm, a headband having a circumference of about 505 mm can be used. When the circumference of the head of the user is between about 580 mm to about 600 mm, a headband having a circumference of about 520 mm can be used. When the circumference of the head of the user is greater than about 600 mm, a headband having a circumference of about 535 mm can be used. In some embodiments, the headband may have an elastic coefficient such that the headband ensures the vibratory device imparts a force above about 2 Newtons against the head of the user.

[0058] The power source 570 can be any suitable device that can supply power, e.g., intermittently or continuously, to the control unit 560, vibratory device, sensor(s) 590, and / or other electronic components of the system 550. For example, the power source 570 can be an onboard battery. In some embodiments, the system 550 may not include an onboard power source but be configured to couple to an external power source to power the electronic components of the system 550.

[0059] The vibratory device 500 can be configured to generate one or more vibratory signals or vibrations. The vibratory signals can be mechanical vibrations that can be transmitted via bony structure to the vestibular system of a subject, as described above. Further details of the vibratory device 500 are provided with reference to FIG. 5.

[0060] FIG. 5 is a schematic illustration of an example system 650 for treating one or more vestibular conditions, according to an embodiment. The system 650 (e.g., functionally and / or structurally similar to other systems described herein) can include a vibratory device 600 (e.g., functionally and / or structurally similar to other systems described herein). The vibratory device 600 can be located within a housing (e.g., second housing 504) that can define one or more chambers. The vibratory device 600 can include a vibratory element 623, a suspension element 620, a driving circuit 640, and a delivery interface 630. The vibratory element 623 is configuredto be suspended by the suspension element 620 and driven by the driving circuit 640 to move (e.g. oscillate or vibrate) to produce the vibratory signal. The vibratory element 623 can be suspended within the body (e.g. in a chamber) such that the vibratory element 623 can vibrate about an equilibrium position. The movement of the vibratory element 623 can be with respect to the suspension element 620 to produce vibratory signals that can be directed via the delivery interface 630 to treat one or more vestibular conditions as disclosed herein. The vibratory device 600 can be positioned on a head of a subject with the delivery interface 630 on or against a target area TA such that the vibratory signals produced by the movement of the vibratory element 623 can be applied to the target area TA, which can then be conducted via a bone structure BS to a vestibular system VS of the subject.

[0061] The system 650 can also include a support element 610 to support or position the vibratory device 600 on or against the target area TA of the subject to deliver the vibratory signals, as disclosed herein. The support element 610 can be functionally and / or structurally similar to other support elements described herein, including, for example, support element 510. As described above, the support element 610 can be a device or fastening feature that can maintain contact and positioning of the vibratory device 600 with respect to the subject. For example, the support element 610 can be a headband, headset, eye glasses, or a pillow, and so forth.

[0062] The target area TA of the subject to which vibratory signals are applied may be, for example, a surface of the head. Optionally, in some embodiments, the vibratory device 600 may be implanted in the subject’s head, and the target area TA can be a region that is proximate to and / or part of bone structure BS. The vibratory device can be configured to be engageable with the target area TA to effectively deliver therapeutically vibratory signals. In an example instance, the target area TA can be an area behind an external ear of a subject that overlays a mastoid (or a portion of the temporal bone) of a skull of the subject. In such instances, the mastoid may form part of the bone structure BS used to deliver vibratory signals to the vestibular system VS, via the bony structures of the inner ear housing the vestibular system VS. In some instances the zygomatic bone or the zygomatic process of the temporal bone can be a portion of the bone structure BS used to deliver vibratory signals to the vestibular system VS. In other instances, the target area TA can be a portion of a back of the head or the forehead, with the underlying regions of the skull acting as the bone structure BS that conducts the vibratory signals received from the vibratory device 400. Based on the target area TA selectedand its distance from the vestibular system VS, varying force levels can be used to operate the vibratory device 600. For example, when the device is placed on a target area TA such as the forehead area of a subject or behind the head of a subject, regions that are further away from the vestibular system VS than the mastoid, a higher force level may be used as compared to when the device is placed overlaying the mastoid of the subject. As an example, when placed on the forehead or behind the head of a subject, the vibratory device 600 can be configured to apply vibratory signals with a force level up to 14 dB re 1 dyne greater than the force level of vibratory signals that may be therapeutically effective when delivered elsewhere (e.g., region overlying the mastoid).

[0063] When the vibratory device 600 is positioned overlaying a mastoid, the vibratory device 600 can apply a vibratory signal that is therapeutically effective at treating a condition of the vestibular system, e.g., a therapeutically effective vibratory signal. The therapeutically effective vibratory signal can have a resonant frequency of less than about 200 Hz (e.g., about 10 Hz, about 30 Hz, about 50 Hz, about 70 Hz, about 100 Hz, about 150 Hz, and all values and subranges in between). In some embodiments, the vibratory device 600 can be configured to apply vibratory signals that are substantially perpendicular to a surface of the head. In other words, the vibratory device 600 can be configured to apply vibratory signals in directions toward and away from the head. In such embodiments, the vibratory device 600, when positioned over the mastoid, can be configured to apply vibrations that deliver a dosage (for force level) of between about 87 dB re 1 dyne and about 101 dB re 1 dyne (or between about 0.22 N and about 1.12 N at the mastoid, including all ranges and values therebetween. The vibratory device 600, by applying such dosage, can be configured to treat a vestibular condition. In some embodiments, the vibratory device 600 can be configured to apply vibratory signals that are substantially parallel to a surface of the head. For example, the vibratory device 600 can be configured to apply vibratory signals along a surface of the head of the user, angled relative to horizontal at an angle between about 0 degrees and about 90 degrees, including all subranges and values therebetween. In such embodiments, the vibratory device 600, when positioned over the mastoid, can be configured to apply vibrations that deliver a dosage (for force level) of between about 60 dB re 1 dyne and about 92 dB re 1 dyne (or between about 80 dB re 1 pN and about 112 dB re 1 pN, or between about 0.01 N and about 0.4 N) at the mastoid, including all ranges and values therebetween. For example, the vibratory device 600, when positioned over the mastoid, can be configured to apply vibrations that deliver a dosage (forforce level) that is desirably between 60 dB re 1 dyne and about 86 dB re 1 dyne. The vibratory device 600, by applying such dosage, can be configured to treat a vestibular condition.

[0064] As noted above, the vibratory element 623 of the device 600 can be configured to oscillate or vibrate to generate the vibratory signal. In some embodiments, the vibratory element 623 can be housed within a chamber of a housing (e.g., second housing 504). The vibratory element 623 can be suspended at an equilibrium position by the suspension element 620, and an electrical signal can be used to cause the vibratory element 623 to vibrate or oscillate about the equilibrium position to generate a vibratory signal. The vibratory element 623 can be configured such that it can be driven to generate vibratory movements along or about an axis of the vibratory device 600, where the movements produce vibratory signals with suitable properties (e.g. frequency, amplitude, force level, etc.) for treating vestibular conditions. The vibratory device 600, in some embodiments, can be an electromechanical transducer including, for example, a vibratory element 623 implemented as a magnet that can be driven to move along an axis using a suitable driving force such as a magnetic field.

[0065] Depending on where the vibratory device 600 is placed, the dimensional restrictions of the vibratory device 600, and / or the configuration or shape of the vibratory device 600, specific components of the vibratory device 600 can be selected to provide a therapeutically effective level of vibratory signal to treat a vestibular condition. While one vibratory element 623 is illustrated in FIG. 5, one of ordinary skill in the art would appreciate that vibratory device 600 can include one or more additional vibratory elements, which can work together and / or independently to generate vibratory signals to treat a vestibular condition.

[0066] Similar to other vibratory devices or systems, the vibratory device 600 can be associated with a set of resonant frequencies. In some embodiments, the vibratory element 623 may be configured to move in response to a driving force such that the amount of power of the generated vibratory signals at a lowest resonant frequency associated with the vibratory device 600 is greater than the amount of power of the vibratory signals at the remaining resonant frequencies (e.g., higher resonant frequencies) associated with the vibratory device 600. For example, a vibratory device may be configured to have a lowest resonant frequency between about 10 Hz and about 200 Hz, about 10 Hz and about 150 Hz, about 10 Hz and about 100 Hz, about 10 Hz and about 80 Hz, about 30 Hz and about 80 Hz, or about 50 and about 70 Hz, and inclusive of other values and subranges in between. In some embodiments, the vibratory signals generated at the lowest resonant frequency in these ranges can be of greater amount of powerthan vibratory signals that may be generated at other resonant frequencies. In some embodiments, the vibratory element 623, the suspension element 620, and / or other elements of the vibratory device 600 can be selected such that the vibratory device 600 vibrates at a lowest fundamental frequency of less than 200 Hz.

[0067] In the embodiments described herein, the force level represents a unit of “loudness” for bone conduction, and can increase with increasing amplitude of vibration, frequency of vibration, and / or mass of the system (e.g., vibratory device). The force level in combination with frequency produces impulses (e.g., changes in momentum) that are capable of stimulating the vestibular system in a therapeutically effective manner. Momentum is directly proportional to force and inversely proportional to frequency. Therefore, with high frequencies, e.g., above 200 Hz, the force required to produce impulses that are sufficient to stimulate the vestibular system must increase as well. Conventional bone conduction devices (e.g., bone conduction speakers) are designed to produce vibrations with frequencies about 250 Hz, and accordingly, to be able to produce therapeutically effective vibrations, such devices must produce vibrations with high force levels that can be undesirably loud. Most conventional bone conductions systems are incapable of reaching such high force levels without burning out first. With systems and devices described herein, the frequencies applied by the vibratory devices (e.g., bone conduction devices) are low (e.g., less than about 200 Hz) and therefore can be capable of generating therapeutically effective vibrations. Systems and devices described herein avoid producing perceptible levels of audible sound and / or tapping sensations, both of which can be undesirable and distracting to users.

[0068] The driving circuit 640 of the vibratory device 600 can include one or more suitable components, such as, for example, a coil, that can generate a magnetic field. The magnetic field can cause a force to be generated to induce movement of the vibratory element 623 along an axis to produce therapeutic vibratory signals. The driving circuit 640, in some embodiments, can receive an electrical signal (e.g., an electric current) from a control unit (e.g., the control unit 560 and circuitry coupled thereto). In some other embodiments, the driving circuit 640 can itself include an onboard unit that can generate the electrical signal. The electrical signal can be driven through a coil, which can generate a magnetic field to cause vibration or oscillations of the vibratory element 623 (e.g., magnet).

[0069] The electrical signal generated or received by the driving circuit 640 and used to induce movement of the vibratory element 623 can be of suitable properties to produce avibratory signal having specific frequency and force levels. For example, the electrical signal can be selected such that it causes the vibratory element 623 to produce vibratory signals that have a particular range of frequencies (e.g., less than 200 Hz) to treat one or more specific vestibular conditions. In some embodiments, a control unit (e.g., control unit 560) can be capable of changing a frequency of the electrical signal until the electrical signal causes the vibratory device 600 to vibrate at a resonant frequency.

[0070] The delivery interface 630 of the vibratory device 600 can be configured to transfer the vibratory signals generated by the vibratory element 623 to the target area TA of the subject, such that the vibratory signals can be conducted via the bone structure BS beneath to the vestibular system VS. The delivery interface 630 can be configured for and / or adaptable to the structure and / or shape of the target area TA of the user such that the delivery interface can engage with and / or maintain contact during the period of use for transfer of the therapeutic vibratory signals. In some embodiments, the delivery interface 630 can be configured with considerations of comfort and ease of use for the user, for example, during use of the vibratory device 600 to mitigate a vestibular condition or symptom. The delivery interface 630 may further be configured to reduce secondary effects that may be undesirable such as the generation and accumulation of heat, generation of audible noise, lack of air circulation, application of pressure against the target area TA, etc. For example, the delivery interface 630 can include a layer of memory foam material that may aid in adapting to the contours of the target area (e.g., a region behind the ear overlying the mastoid). The memory foam material may also aid in heat dissipation, dampening of audible noise, encourage air circulation, minimize discomfort from pressure applied by a support element such as a head band, etc.

[0071] Optionally, in some embodiments, the system 650 can include a force concentrator 612. The force concentrator 612 can be configured to provide a stiffening area (e.g., an area with stiffer structure). The force concentrator 612, by providing a stiffer area, can be configured to maintain more consistent pressures or forces between the vibratory device 600 and the surface of the head (e.g., or underlying bony structure such as the mastoid). For example, a support structure such as a headband or other wearable head gear oftentimes has a relatively flexible structure. Such flexible structure may be desirable to provide comfort to a user wearing the support structure. However, the flexible structure may lead to inconsistent application of force by a vibratory device against the head of a subject, e.g., due to the flexing of the support element based on head shape, sizes, etc. As such, adding a force concentrator 612, which canprovide a stiffer backing or structure in one area of the support structure can enable more consistent pressure to be applied by the vibratory device 600 against the head of the subject. When the support structure 610 is worn on the head and supports the vibratory device 600 against the head, the force concentrator can be positioned adjacent to the vibratory device 600 in a manner that provides a stiffer backing or support for the vibratory device 600. The force concentrator 612 can then ensure that a sufficient level of pressure or force is applied to the head. In some embodiments, the force concentrator 612 can be implemented as a stiffer (e.g., thicker and / or non-stretch) fabric than adjacent portions of the support element 610. In some embodiments, the force concentrator 612 can be implemented as a plastic sheet or other rigid structure. The force concentrator 612 can be coupled to (e.g., stitched to, glued to, or otherwise secured to) the support element 610, e.g., at a region adjacent to where the vibratory device 600 would attach to the support element (e.g., such as where coupling element 508 is disposed). Alternatively, or additionally, the force concentrator 612 can be disposed between multiple layers of fabric that form the support element 610, such as, for example, inner and outer layers of the fabric of a headband. The force concentrator 612 can have any suitable shape (e.g., circular, oval, square, rectangular, etc.) that can provide a stiffer area for supporting the vibratory device against the head.

[0072] As described above, in some embodiments, a support element for supporting a vibratory device on a head of a subject can be implemented as a headband. FIG. 6 illustrates a vibratory device 700 supported by a headband 710 worn on the head HD of a subject, according to embodiments. The vibratory device 700 can be structurally and / or functionally similar to other vibratory devices described herein, including, for example vibratory devices 500, 600. The headband 710 can be structurally and / or functionally similar to other headbands or support elements described herein, including, for example, support element 510, 610. The vibratory device 700 can include a control unit, similar to control unit 560, described above. The headband 710 can be made of an elastic, Velcro, metal or plastic, or another material that permits the headband 710 to hold the vibratory device 700 on the head HD of the subject to effectively deliver vibratory signals that can be conducted via bone to the vestibular system. The vibratory device 700 can include an onboard power source (e.g., a battery) to power the control unit and / or other components of the vibratory device 700. The control unit may include the necessary electrical driving circuitry to generate the vibratory signals to treat vestibular or other conditions disclosed herein. As shown the headband 710 can be configured to position the vibratory device adjacent or near the mastoid of the subject.

[0073] FIGS. 7A and 7B depict an example system for treating vestibular conditions, including a support element implemented as a headband 810, according to embodiments. The headband 810 can be structurally and / or functionally similar to other headbands and / or support elements described herein, including, for example, support element 510, 610, 710, etc. The headband 810 can be formed of a fabric, such as a natural or synthetic material (e.g., polyester, silk, cotton, rayon, etc.). The headband 810 can include one or more grip portions 806, e.g., formed of silicone or another non-slip material that can maintain the position of the headband 810 on a head of a user. The grip portions 806 can include strips (e.g., horizontal and / or vertical strips), which can be disposed along multiple sides of the headband 810. The grip portions 806 can also include text, e.g., for providing information to a user. For example, the text can include text for indicating where to position and / or attach the vibratory device (or housing containing such) to the headband 810, such as “PLACE HERE” with an arrow or another suitable text indicator. Additionally, or alternatively, the text can include text for indicating where portions of the headband 810 should be placed on the head, e.g., “FRONT,” “BACK,” “LEFT,” and “RIGHT,” etc. The headband 810 can also include a force concentrator 812 (e.g., structurally and / or functionally similar to other force concentrators described herein, including force concentrator 612). The force concentrator 812 can be implemented as a patch that is sewn onto an inside of the headband. The patch can have a stitching that creates a non-stretchable section of the headband 810.

[0074] The system can also include one or more coupling elements 808A, 808B (e.g., structurally and / or functionally similar to other coupling elements described herein, including, for example, coupling element 508). The coupling elements 808A, 808B can be, for example, hook and loop fastening patches, where a loop structure may be disposed on the headband 810 and the hook structure may be disposed on housings 802, 804 (e.g., functionally and / or structurally similar to other housings described herein, including housings 502, 504, respectively) containing the vibratory device and electronic components, and vice versa. The coupling elements 808 A can be coupled to the inside surface of the headband 810 via adhesive, stitching, or any other form of suitable attachment. The coupling elements 808B can be coupled to the housings 802, 804 via adhesive, staples, fasteners, or any other form of suitable attachment. The coupling elements 808 A and 808B can interface with one another to releasably couple the housings 802, 804 (and therefore the vibratory device contained therein) to the headband 810. In some embodiments, the coupling elements 808 A can include multiple patches, and similarly the coupling elements 808B can include multiple patches. In someembodiments, the patches can have different shapes, wherein a patch on the headband 810 can match a corresponding patch on the housings 802, 804 (e.g., a circular patch on the headband 810 can match a circular patch on housing 804, and a square or rectangular patch on the headband 810 can match a square or rectangular patch on the housing 802). The matching, but different, shapes of the patches can ensure correct coupling and positioning of the vibratory device on the headband.

[0075] FIGS. 8A-9 depict views of a system 950 for treating vestibular conditions, according to embodiments. As described above, one or more housings (e.g., housings 502, 504, housings 802, 804) can be configured to house one or more components of a system for treating vestibular conditions, including a vibratory device, a control unit, a power source, etc. Such housings can be releasably coupled to a support element (e.g., support element 510, support element 810) via a coupling element (e.g., coupling element 508, coupling element 808 A, 808B). As shown in FIGS. 8A and 8B, the system 950 can include a first housing 902 and a second housing 904. The housings 902, 904 can be structurally and / or functionally similar to other housings described herein, including housing 502, 504. For example, the housing 902 can include a control unit 960 and a power source. The housing 902 can also include one or more input / output elements 966A (e.g., buttons, slides, etc.), which can be actuated by a user to provide inputs to the control unit 960. For example, the housing 902 can include buttons can be actuated to provide inputs to the control unit 960 for controlling an operation of the vibratory device. In some embodiments, the inputs can be configured to change one or more parameters of the vibratory signals generated and applied by the vibratory device. For example, the inputs can be configured to change a frequency, force level, and / or direction of the vibratory signals being applied. The housing 902 can also include one or more ports 966B, e.g., for connecting the control unit 960 and / or power source to external devices, such as an external charger, an external compute device (e.g., processor), etc. The ports can enable power to be transferred to the power source and / or data to be transferred to or received from the control unit 960.

[0076] The housing 904 can be configured to house a vibratory device 900 (e.g., structurally and / or functionally similar to other vibratory devices described herein). The housing 904 can also be configured to enable a delivery interface 930 (e.g., structurally and / or functionally similar to other interfaces described herein, including, for example, interface 630) to be exposed such that it can be positioned against a surface of the head of a subject. Theinterface can be configured to transfer vibratory signals generated by the vibratory device 900 to the head of the subject.

[0077] The housings 902, 904 can be coupled to one another via a flexible bridge 906 (e.g., structurally and / or functionally similar to other bridges described herein, including bridge 506). The flexible bridge 906 can be configured to allow the shape of the device to conform to the head of the subject when the device is positioned against the head of the user, e.g., via a support element. The flexible bridge 906 can be configured to provide a passageway that allows for passage of wires, and enables coupling of electronic components (e.g., control unit 960) housed in the housing 902 to be coupled to the vibratory device 900 housed in the housing 904. In some embodiments, the flexible bridge 906 can be formed of an overmolded flexible polymer.

[0078] FIG. 9 provides a more detailed view of the internal components of the vibratory device 900. As shown, the housing 904 can include one or more sections 904A, 904B that couple to one another and form a chamber. The vibratory device 900 can be housed within the chamber. As noted above, the vibratory device 900 can be structurally and / or functionally similar to other vibratory devices described herein. For example, the vibratory device 900 can include a delivery interface 930, a magnet 823, a spring or suspension element 920, and one or more electromagnetic coils 924 that are configured to generate magnetic fields to move the magnet 923. In some embodiments, the coils 924 can include two coils that are wound in opposing directions to generate magnetic fields of opposing polarity, e.g., to cause oscillation of the magnet 923. Alternatively, the vibratory device 900 can include a single coil 924 configured to generate magnetic fields of changing polarity, e.g., to cause oscillation of the magnet 923. The single coil can be driven, for example, by two separate driving circuits generating driving signals of different polarity. The vibratory device 900 can include a spring 920 coupled to the magnet 923 and configured to act as a suspension element. The vibratory device 900 can include a mounting plate 928, and the magnet 923 can have an opening 923A that extends through a portion of its length such that the spring 920 can extend through the opening and attach to the far end of the magnet 923 via the mounting plate 928. The delivery interface 930 can be movable along arrow B relative to the housing 904, and be exposed such that it can contact and apply vibratory signals generated by the vibratory device 900 to the head of the user, e.g., for conducting via bone to a vestibular system of the subject. In embodiments, the delivery interface 930 can be implemented as a pad.

[0079] In some embodiments, the mounting plate 928 can be a metallic plate that is configured to reduce stray magnetic flux. For example, a vibratory device with a magnet acting as the vibratory element may have magnetic field lines that stray far from the magnet and cause the vibratory device to be magnetically attracted to metallic objects. This attraction can produce undesirable side effects and make it cumbersome during use. The mounting plate 928 can reduce such stray magnetic flux such that the vibratory device 900 can be used close to other metallic objects without being attracted as much to those objects. Furthermore, the mounting plate 928 can be used to direct the magnetic field lines out from an end of the magnet in a direction perpendicular to (e.g., toward) the coils 924 generating the magnetic fields such that more of the magnetic field lines are directed to enabling movement of the magnet with respect to the vibratory device 900, while reducing stray dissipation or leakage of magnetic field lines in a direction parallel to the coil (e.g., not toward the coil).

[0080] Optionally, in some embodiments, the vibratory device 900 can include a sensor 990. The sensor can be configured to measure one or more parameters of the vibratory device 900. In an example implementation, the sensor can be a force sensor (e.g., a resistive force sensor) that can be disposed between the magnet or vibrating element and the delivery interface. The force sensor can be configured to measure a force that is being applied by the device against the head of the subject, in the direction B. Therefore, the force sensor can be configured to read how tightly the device is being worn and / or measure an output of the vibratory device 900. In some embodiments, the delivery interface 930 can be sized to move with the force sensor, thereby enabling the force sensor to capture an accurate measure of the forces being applied by the device against the head of the subject.

[0081] FIGS. 10A and 10B depict, respectively, outer and inner views of a support element implemented as a headband 1010 of a system for treating vestibular conditions, according to embodiments. The headband 1010 can be structurally and / or functionally similar to other headbands or support elements described herein. For example, the headband 1010 can include two layers or sheets 1010a, 1010b (shown in FIG. 11), such as, for example, an outer layer 1010a and an inner layer 1010b. As shown in FIG. 10 A, the outside of the outer layer of the headband 1010 can include a marking or indicia 1012 (e.g., structurally and / or functionally similar to position indicator 512), which can indicate a location of the vibratory device, when coupled to the headband 1010. As shown in FIG. 10B, the inside layer of the headband 1010 can include one or more grip elements 1016 (e.g., strips, text), which can be configured tomaintain a position of the headband 1010 on the head of the subject. The inside layer can also include text 1014 that indicates where to place the vibratory device, where to position a particular portion of the headband relative to the head, etc. The inside layer can also include two coupling elements 1008, which can be configured to couple to the vibratory device and / or electronics (or housings including the same). The headband 1010 can also include a force concentrator 1012 (e.g., structurally and / or functionally similar to other force concentrators described herein). In some embodiments, the headband can be shaped to ensure that sufficient pressure and / or forces are being applied at the region that overlays the mastoid.

[0082] As discussed above, systems and devices described herein can be configured to apply vibratory signals to the head of a subject in various directions. FIGS. 12A and 12B are schematic illustrations of two example orientations of a vibratory device, to deliver vibrations in two different directions, as described herein. The vibratory device 1100, 1200 depicted in FIGS. 12A and 12B can be structurally and / or functionally similar to other vibratory devices described herein. As shown in FIG. 12A, the vibratory device 1100 includes a vibratory element 1123 coupled to a suspension element such that the vibratory device 1100 can deliver mechanical vibrations in the direction indicated by the arrow Al. The direction Al can be toward and away from a delivery interface 1120 of the vibratory device. The delivery interface 1120 of the vibratory device is configured to be pressed against the subject’s head (e.g., overlaying the mastoid) and interface with the head. When worn by a user, the vibratory device in FIG. 12A is configured to deliver mechanical vibrations substantially directed along an axis normal or perpendicular to a subject’s head. As described above, a vibratory device such as the vibratory device 1100, by delivering mechanical vibrations substantially perpendicular to the head, can stimulate the otolith organs, thereby causing neural signals to be generated that can cause modulation or a reset of the VSM. The modulation or reset of the VSM can be configured to reduce or treat one or more vestibular conditions (e.g., vertigo, dizziness, motion sickness, etc.) Therefore, the vibratory device 1100 can be configured to modulate or reset the VSM, to thereby treat one or more vestibular conditions.

[0083] As another example orientation, FIG. 12B shows a vibratory device 1200 configured to deliver mechanical vibrations in the left-right direction indicated by the arrow A2 in FIG. 12B. The bottom surface 1220 of the vibratory device 1200 is configured to be pressed against the subject’s head (e.g., overlaying the mastoid) and interface with the head. When worn by a user, the vibratory device in FIG. 12B is configured to deliver mechanicalvibrations substantially directed along an axis parallel or tangential to a subject’s head. As described above, a vibratory device such as the vibratory device 1200, by delivering mechanical vibrations substantially parallel to the head, can stimulate one or more semicircular canals of the subject (e.g., a horizontal canal), which can result in stochastic resonance. The stochastic resonance can improve the signal-to-noise ratio of weaker signals, thereby making the vestibular system more responsive to weaker signals and treating one or more vestibular conditions (e.g., treatment-resistant BPPV). In some cases, the parallel (or substantially parallel) vibrations that stimulate the vestibular system can also cause equalizing of the background activity between left and right vestibular systems or provide masking, to thereby treat one or more vestibular conditions (e.g., treatment-resistant BPPV).

[0084] FIGS. 13A, 13B, and 13C are schematic illustrations of different configurations of wearing a vibratory device 1300, according to an embodiment. The different configurations can result in different directions of vibratory signal application, thereby causing different stimulation of the vestibular system in subjects. As described previously, different configurations of wearing a vibratory device 1300 supported by a headband 1310 can be used advantageously to manipulate how a larger or smaller portion or component of the vibratory signals lie along one or more desired directions (e.g., directions indicated by the arrows in each of FIG. 13 A-13C). The headband 1310 and the vibratory device 1300 can be structurally and / or functionally similar to other headbands and vibratory devices described herein, respectively. In the example in FIG. 13 A, a larger component of the vibratory signals may lie along the top- down direction with reference to the subject’s head and a smaller component along the front- back direction with reference to the head than in the configuration in FIG. 13C. Alternatively or additionally, in the example in FIG. 13C, a larger component of the vibratory signals may lie along the front-back direction with reference to the subject’s head and a smaller component may lie along the top-down direction with reference to the head than in the configuration in FIG. 13 A.

[0085] In some embodiments, a physician or other medical professional can fit a user with a headband. For example, the medical professional can select a headband that has an appropriate size, e.g., to enable sufficient forces and / or pressure to be exerted against the head of the user. Alternatively, or additionally, the medical professional can set a direction of applying the vibratory signals to the head of the user. Different users generally have different anatomical structures, and therefore, vibratory signals in a direction that is therapeuticallyeffective for one user may not be similarly effective in a different user. Therefore, by allowing a medical professional or a user to adjust the direction of application of the vibratory signals, the vibratory signals can be set at a direction that can produce the most significant or a greater amount of relief or treatment of a vestibular condition. Therefore, as shown in FIGS. 13 A-13C, the direction that a vibratory device 1300 can be adjusted, e.g., to optimize or increase its stimulation of one or more semicircular canals (e.g., the horizonal canal) of a user. This can be based on the specific anatomical structures of that user.

[0086] FIG.14 shows a flowchart of a method 1400 to test a variety of parameters to define the vibratory signals that can be applied to the head of a subject, e.g., to modulate or reset a VSM of a subject, to cause stochastic resonance, to cause masking, to cause anchoring, etc., which in turn treats or alleviates symptoms associated with a vestibular condition in the subject.

[0087] Optionally, the method 1400 includes, at 1402, generating conditions to trigger a vestibular system reaction (e.g., simulate symptoms that may be associated with a vestibular condition like motion sickness, vertigo, etc.). Some example methods of generating conditions to trigger a vestibular system reaction can include a rotary chair testing method and / or a caloric testing method. Alternatively, some subjects may naturally experience vertigo or other vestibular maladies, and therefore no conditions need to be generated to trigger a vestibular system reaction.

[0088] At 1404, the method includes activating a vibratory device. The vibratory device can be any suitable device described herein and can be activated following any suitable protocol defined by a set of parameters including direction, frequency, amplitude, force level, periodicity, duration, etc. At 1404, each parameter is configured to assume a predetermined value (e.g. ,a first value) and the vibratory device is activated to deliver vibratory signals to the subject’s head via bone conduction as described herein.

[0089] At 1406, the vibratory signals delivered by the activated vibratory device are used to modulate or reset the VSM and / or cause stochastic resonance, as described above with reference to FIG. 1. The modulation or reset of the VSM can be through any suitable method as described herein, e.g., such as through the use of a perpendicular direction vibratory device (e.g., see FIG. 12A). For example, the vibratory signals can modulate the VSM by altering a time constant associated with integrating movement signals by the VSM. Similarly, theevoking of stochastic resonance can be through any suitable method as described herein, e.g., such as through the use of a parallel direction vibratory device (e.g., see FIG. 12B).

[0090] At 1408, the modulation or reset of the VSM and / or the stochastic resonance is directed to treat and / or alleviate a vestibular system reaction (e.g., a motion sickness, vertigo, etc.) and / or vestibular condition.

[0091] At 1410, the method includes measuring one or more observable characteristics of the subject to assess the treatment of the vestibular system reaction (e.g., a motion sickness, vertigo, etc.) and / or vestibular condition. For example, one can solicit input or feedback from the subject to determine whether the applied vibratory signals are alleviating one or more conditions associated with the vestibular system reaction.

[0092] At 1412, the method includes adjusting operation of the vibratory device based on the measured characteristics. Adjusting operation can include varying a value associated with one or more parameters used to define the vibratory signals delivered to modulate the VSM, cause stochastic resonance, etc. For example, adjusting operation of the vibratory device can include turning on / off; adjusting direction of delivery; adjusting frequency, duration, amplitude, force level, and / or power associated with the vibratory signals; and / or the like.

[0093] Systems, devices, and methods described herein have been shown to be effective at treating one or more vestibular conditions, as evidenced by a number of studies, set forth in further detail below.

[0094] For the experiments, the force level of the vibrations produced by the vibratory device was measured with a calibrated Briiel & Kjser (B&K) artificial mastoid (No. 4930) coupled with a B&K sound level meter (No. 2234). The vibratory device was inserted in a holder in the B&K, artificial mastoid designed for holding a bone conduction hearing aid. A force of between 3.5 to 8 Newtons was applied on top of the vibrating device, which sat against the B&K artificial mastoid. Bone conduction levels were quantified with the B&K sound level meter and are expressed as dB re 1 dyne, Newtons, or any other suitable force units (i.e., a force level).

[0095] STUDY 1 - Rotary Chair Trial for Evaluating VSM

[0096] This study investigated the effects of bone-conducted vibrations (BCV) on vestibular function in a background of motion sickness. It was hypothesized that BCV would decrease the VOR time constant, which is associated both with a function of the vestibular pathway known as the central velocity storage mechanism, and is associated with susceptibility to motion sickness. A reduction in time constant and reported motion sickness severity provides both objective and subjective measures about the BCV system in the trial. The study employed rotational chair measurements for assessing the contribution of the VSM to the VOR.

[0097] The study included 38 healthy participants divided into experimental (n=29) and control (n=9) groups (plus a few participants with no motion sickness early on). Participants underwent rotational testing in a clinical rotary chair while wearing a BCV device on their right mastoid. The BCV device included a vibratory element that was configured to apply vibratory signals in a direction toward and away from the head, similar to the vibratory device 500 depicted in FIG. 12 A. The experimental group experienced the device at low and high power settings, while the control group had the BCV powered off. Eye movements were tracked to measure VOR responses. Participants also rated their motion sickness using the Fast Motion Sickness (FMS) scale before and after each rotation sequence.

[0098] During the study, the vibratory device was set at one of three settings — i.e., a high power level, low power level, or turned off — while undergoing velocity step testing at two speeds: 60° / s and 1807s. The same test methodology and equipment was used for all participants. In total, six rotational tests — each including one clockwise and one counterclockwise rotation — was be conducted (2 speeds X 3 device settings) and the order of the high / low / off power settings was be randomized to the first / second / third set of velocity step tests. The operation of the vibratory device was adjusted to a new power level a few seconds before initiating each velocity step test.

[0099] The experimental protocol involved two rotational velocities — 607sec (low velocity) and 1807sec (high velocity) — achieved through rapid acceleration of the rotational chair at a rate of 2007sec2, from rest until the target rotational velocity was reached. The target rotational velocity was then maintained for 60 seconds before a rapid rate of deceleration (200° / sec2) back to a stationary, non-rotating chair position. The acceleration period lasted 0.3 seconds or 1.2 seconds for the low and high velocity conditions, respectively. These two conditions provided complementary information about the velocity storage mechanism (primarily inferred from the low velocity stimulus) as well as any laterality of the effect(primarily inferred from the high velocity stimulus). The chair was be rotated in the clockwise direction for 60 seconds, decelerated, followed by a 60 second rest and observation period, and repeated again in the counterclockwise direction followed by another 60 second rest and observation period. This regimen was carried out for both the low and high target rotational velocities, and with the device activated (high or low power setting) and with the device deactivated.

[0100] Reflexive eye movements (nystagmus) were recorded using specialized goggles while excluding any light from the room. Eye movements during per-rotary and post-rotary nystagmus were normally characterized by two phases — a fast phase (or saccade, roughly 10 to 40 milliseconds in length) rapidly reset the eye position and a slow phase that reflected the contribution of the VOR. The slow phase velocity (SPV) was extracted from the nystagmus signal using standard filtering and processing techniques. Decay of the SPV, measured over the adaptation period of tens of second, was fitted with an exponential function to determine the time constant of the VOR. The SPV time constant was defined as the time elapsed for the SPV to return to 37% of its peak value — attributed to the velocity storage mechanism. The SPV time was measured as an indication of a state of the VSM and / or of modulation of the VSM.

[0101] Analysis shows that BCV significantly reduced the VOR time constant in the experimental group compared to controls. Both low and high power settings were effective. FMS ratings indicated that most participants in the experimental group experienced reduced motion sickness symptoms with BCV, especially at the high power setting. In contrast, control group participants generally reported worsening symptoms across testing rounds.

[0102] The primary finding was a significant decrease in VOR time constant during BCV application, observable both when compared to the control group and when evaluated independently within the experimental group (to be clear, results are statistically significant, whether looking at BCVs on their own, or comparing them to the Off / Off / Off group). This effect was accompanied by improvements in subjective motion sickness ratings, consistent with previous studies on BCV and motion sickness.

[0103] This study provides evidence that BCV can modulate vestibular function by reducing the VOR time constant, which may explain its effectiveness in mitigating motionsickness symptoms. These findings have potential implications for developing non-invasive treatments for motion sickness and other vestibular disorders.

[0104] STUDY 2 - Take-Home Device Trial for Evaluating Directional Device

[0105] A study was conducted in which a take-home device was tested in a telehealth setting. The take-home device included a vibratory device that was configured to apply vibratory signals to subjects’ heads. A first subset of the participants wore a study device similar to the vibratory device shown in FIG. 12B, where the vibratory signals generated by the device were substantially parallel to the head. A second subset of the participants wore a study device similar to the vibratory device shown in FIG. 12A, where the vibratory signals generated by the device were substantially perpendicular to the head. The first subset included a greater number of individuals who had a BPPV diagnosis.

[0106] Each participant was asked at the end of each arm of the study for which they wore a device, whether they felt the device reduced their symptoms. FIG. 16 depicts the proportion of participants who answered “yes” at least 50% of the time with the directional (parallel direction) device (left) and the perpendicular direction device (right). The study results show that the directional device was effective at mitigating or reducing symptoms of vertigo in BPPV in participants. While the perpendicular direction device also alleviated some symptoms, the perpendicular direction device was less effective at mitigating or reducing symptoms of vertigo in BPPV.

[0107] The effectiveness of the directional device may have resulted from the portion of the vestibular system that was stimulated by the directional device. The directional device, given the direction of vibratory signal application, is configured to stimulate one or more semicircular canals of the vestibular system, such as, for example, the horizonal canal, the posterior canal, and / or the anterior canal. In particular, the directional device may be stimulating the horizonal canal at a sub-perceptual level, and acts upon it via stochastic resonance or masking.

[0108] While various inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and / or structures for performing the function and / or obtaining the results and / or one or more of the advantages described herein, and each of such variations and / or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the artwill readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and / or configurations will depend upon the specific application or applications for which the inventive teachings is / are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto; inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods, if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent, is included within the inventive scope of the present disclosure.

[0109] Also, various inventive concepts may be embodied as one or more methods, of which an example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

[0110] As used herein, the terms “about,” “approximately,” and / or “substantially” when used in connection with stated value(s) and / or geometric structure(s) or relationship(s) is intended to convey that the value or characteristic so defined is nominally the value stated or characteristic described. In some instances, the terms “about,” “approximately,” and / or “substantially” can generally mean and / or can generally contemplate a value or characteristic stated within a desirable tolerance (e.g., plus or minus 10% of the value or characteristic stated). For example, a value of about 0.01 can include 0.009 and 0.011, a value of about 0.5 can include 0.45 and 0.55, a value of about 10 can include 9 to 11, and a value of about 1000 can include 900 to 1100. Similarly, a direction may be described as being substantially parallel to a surface when the direction and the surface are nominally parallel. While a value, structure, and / or relationship stated may be desirable, it should be understood that some variance may occur as a result of, for example, manufacturing tolerances or other practical considerations (such as, for example, the pressure or force applied through a portion of a device, etc.). Accordingly,the terms “about,” “approximately,” and / or “substantially” can be used herein to account for such tolerances and / or considerations.

Claims

Claims1. An apparatus, comprising: a vibratory device configured to apply one or more vibratory signals to a surface of a head of a user in a direction that is substantially parallel to the surface of the head to stimulate one or more semicircular canals of a vestibular system of the user to cause stochastic resonance that increases a signal-to-noise ratio of signals generated in response to stimulation of the vestibular system, to thereby treat a physiological symptom associated with the vestibular system.

2. The apparatus of claim 1, wherein the one or more vibratory signals, when applied to the surface of the head of the user, deliver a dosage of force level between about 60 dB re 1 dyne and about 92 dB re 1 dyne to treat the physiological symptom associated with the vestibular system.

3. The apparatus of claim 1, wherein the one or more vibratory signals, when applied to the surface of the head of the user, deliver a dosage of force level between about 60 dB re 1 dyne and about 86 dB re 1 dyne to treat the physiological symptom associated with the vestibular system.

4. The apparatus of claim 1, further comprising: a vibratory element of the vibratory device is configured to vibrate along an axis that is substantially parallel to the surface of the head of the user to generate the one or more vibratory signals along the axis that has a force level of between about .22 Newtons and about 1.12 Newtons.

5. The apparatus of claim 1, wherein a delivery interface of the vibratory device is configured to contact the surface of the head of the user to transferthe one or more vibratory signals to the surface of the head such that at least a portion of the one or more vibratory signals are conducted via a mastoid to stimulate the one or more semicircular canals.

6. The apparatus of claim 1, wherein the vibratory device is coupleable to a support element configured to be disposed around a head of the user to secure the vibratory device over a mastoid of the user.

7. The apparatus of claim 6, wherein the support element includes a force concentrator configured to maintain a force level applied by the vibratory device to the surface of the head of the user above a predetermined threshold, such that the vibratory device contacts the surface of the head of the user with a force sufficient to cause the vibratory signals to be conducted from the vibratory device to the one or more semicircular canals.

8. The apparatus of claim 7, wherein the predetermined threshold is about 2 Newtons.

9. The apparatus of claim 7, wherein the force concentrator includes a non-stretchable fabric coupled to or integrated into the support element.

10. The apparatus of claim 6, wherein the vibratory device is contained in a first housing and is coupled to a second housing containing electronics configured to control the operation of the vibratory device via a flexible bridge, such that a surface of the first housing lies flush with the surface of the head of the user when the support element is disposed around the head of the user.

11. The apparatus of claim 1, wherein the vibratory device is configured to be disposed at a plurality of orientations relative to the surface of the head of the user.

12. A method, comprising: applying, via a vibratory device, one or more vibratory signals to a surface of a head of a user in a direction that is substantially parallel to the surface of the head to stimulate one or more semicircular canals of a vestibular system of the user to cause stochastic resonance that increases a signal-to-noise ratio of signals generated in response to stimulation of the vestibular system, to thereby treat a physiological symptom associated with the vestibular system.

13. The method of claim 12, wherein the one or more vibratory signals, when applied to the surface of the head of the user, deliver a dosage of force level between about 60 dB re 1 dyne and about 92 dB re 1 dyne to treat the physiological symptom associated with the vestibular system.

14. The method of claim 12, wherein the one or more vibratory signals, when applied to the surface of the head of the user, deliver a dosage of force level between about 60 dB re 1dyne and about 86 dB re 1 dyne to treat the physiological symptom associated with the vestibular system.

15. The method of claim 12, further comprising: causing a vibratory element of the vibratory device to vibrate along an axis that is substantially parallel to the surface of the head of the user to generate the one or more vibratory signals along the axis that has a force level of between about .22 Newtons and about 1.12 Newtons.

16. The method of claim 12, wherein the applying the one or more vibratory signals to the surface of the head of the user includes: transferring, via a delivery interface of the vibratory device in contact with the surface of the head of the user, the one or more vibratory signals to the surface of the head such that at least a portion of the one or more vibratory signals are conducted via a mastoid to stimulate the one or more semicircular canals.

17. The method of claim 12, wherein the vibratory device is coupleable to a support element configured to be disposed around a head of the user to secure the vibratory device over a mastoid of the user.

18. The method of claim 17, wherein the support element includes a force concentrator configured to maintain a force level applied by the vibratory device to the surface of the head of the user above a predetermined threshold, such that the vibratory device contacts the surface of the head of the user with a force sufficient to cause the vibratory signals to be conducted from the vibratory device to the one or more semicircular canals.

19. The method of claim 18, wherein the predetermined threshold is about 2 Newtons.

20. The method of claim 18, wherein the force concentrator includes a non-stretchable fabric coupled to or integrated into the support element.

21. The method of claim 17, wherein the vibratory device is contained in a first housing and is coupled to a second housing containing electronics configured to control the operation of the vibratory device via a flexible bridge, such that a surface of the first housing lies flush with thesurface of the head of the user when the support element is disposed around the head of the user.

22. The method of claim 12, wherein the vibratory device is configured to be disposed at a plurality of orientations relative to the surface of the head of the user.

23. An apparatus, comprising: a vibratory device configured to apply one or more vibratory signals to a surface of a head of a user in a direction that is substantially perpendicular to the surface of the head to stimulate receptors in at least one otolith organ of a vestibular system of the user such that one or more neural signals are generated in response to the stimulation of the receptors in the at least one otolith organ, the one or more neural signals, in response to the vibratory device applying the one or more vibratory signals, configured to cause at least one of modulation or a reset of a velocity storage mechanism of the user, thereby treating a physiological symptom associated with the vestibular system.

24. The apparatus of claim 23, wherein the one or more vibratory signals are configured to stimulate the receptors in the at least one otolith organ generates to cause a level or pattern of activation of an inferior vestibular nucleus of the user, the level or pattern of activation of the inferior vestibular nucleus generating the neural signals that cause the at least one of modulation or reset of the velocity storage mechanism.

25. The apparatus of claim 23, wherein the one or more neural signals causes a reset of the velocity storage mechanism to treat the physiological symptom associated with the vestibular system.

26. The apparatus of claim 23, wherein the one or more vibratory signals, when applied to the surface of the head of the user, deliver a dosage of force level between about 87 dB re 1 dyne and about 101 dB re 1 dyne to treat the physiological symptom associated with the vestibular system.

27. The apparatus of claim 23, further comprising:a vibratory element of the vibratory device is configured to vibrate along an axis that is substantially perpendicular to the surface of the head of the user to generate the one or more vibratory signals.

28. The apparatus of claim 23, wherein a delivery interface of the vibratory device is configured to contact the surface of the head of the user to transfer the one or more vibratory signals to the surface of the head such that at least a portion of the one or more vibratory signals are conducted via a mastoid to move receptors in the at least one otolith organ of the vestibular system.

29. The apparatus of claim 23, wherein the vibratory device is coupleable to a support element configured to be disposed around a head of the user to secure the vibratory device over a mastoid of the head of the user.

30. The apparatus of claim 29, wherein the support element includes a force concentrator configured to maintain a force level applied by the vibratory device to the surface of the head of the user above a predetermined threshold, such that the vibratory device contacts the surface of the head of the user with a force sufficient to cause the vibratory signals to be conducted from the vibratory device to the at least one otolith organ.

31. The apparatus of claim 30, wherein the predetermined threshold is about 2 Newtons.

32. The apparatus of claim 30, wherein the force concentrator includes a non-stretchable fabric coupled to or integrated into the support element.

33. The apparatus of claim 23, wherein the vibratory device is contained in a first housing and is coupled to a second housing containing electronics configured to control the operation of the vibratory device via a flexible bridge, such that a surface of the first housing lies flush with the surface of the head of the user when the support element is disposed around the head of the user34. A method, comprising: applying, via a vibratory device, one or more vibratory signals to a surface of a head of a user in a direction that is substantially perpendicular to the surface of the head to stimulatereceptors in at least one otolith organ of a vestibular system of the user such that one or more neural signals are generated in response to the stimulation of the receptors in the at least one otolith organ, the one or more neural signals, in response to applying the one or more vibratory signals, causing at least one of modulation or a reset of a velocity storage mechanism of the user, thereby treating a physiological symptom associated with the vestibular system.

335. The method of claim 34, wherein applying the one or more vibratory signals to stimulate receptors in the at least one otolith organ generates signals that cause a level or pattern of activation of an inferior vestibular nucleus of the user, the level or pattern of activation of the inferior vestibular nucleus generating the neural signals that cause the at least one of modulation or reset of the velocity storage mechanism.

36. The method of claim 34, wherein the one or more neural signals causes a reset of the velocity storage mechanism to treat the physiological symptom associated with the vestibular system.

37. The method of claim 34, wherein the one or more vibratory signals, when applied to the surface of the head of the user, deliver a dosage of force level between about 87 dB re 1 dyne and about 101 dB re 1 dyne to treat the physiological symptom associated with the vestibular system.

38. The method of claim 34, further comprising: causing a vibratory element of the vibratory device to vibrate along an axis that is substantially perpendicular to the surface of the head of the user to generate the one or more vibratory signals.

39. The method of claim 34, wherein the applying the one or more vibratory signals to the surface of the head of the user includes: transferring, via a delivery interface of the vibratory device in contact with the surface of the head of the user, the one or more vibratory signals to the surface of the head such that at least a portion of the one or more vibratory signals are conducted via a mastoid to move receptors in the at least one otolith organ of the vestibular system.

40. The method of claim 34, wherein the vibratory device is coupleable to a support element configured to be disposed around a head of the user to secure the vibratory device over a mastoid of the head of the user.

41. The method of claim 40, wherein the support element includes a force concentrator configured to maintain a force level applied by the vibratory device to the surface of the head of the user above a predetermined threshold, such that the vibratory device contacts the surface of the head of the user with a force sufficient to cause the vibratory signals to be conducted from the vibratory device to the at least one otolith organ.

42. The method of claim 41, wherein the predetermined threshold is about 2 Newtons.

43. The method of claim 41, wherein the force concentrator includes a non-stretchable fabric coupled to or integrated into the support element.

44. The method of claim 40, wherein the vibratory device is contained in a first housing and is coupled to a second housing containing electronics configured to control the operation of the vibratory device via a flexible bridge, such that a surface of the first housing lies flush with the surface of the head of the user when the support element is disposed around the head of the user.

45. A system, comprising: a vibratory device configured to apply a vibratory signal to a portion of a head of a user such that the vibratory signal can be conducted via a mastoid to a vestibular system of the user; and a support element releasably coupleable to the vibratory device, the support element configured to be disposed around the head of the user to secure the vibratory device over the mastoid of the user, the support element including a force concentrator disposed adjacent to the vibratory device, when the vibratory device is coupled to the support element, the force concentrator configured to provide stiffness for maintaining the vibratory device against the portion of the head with a force sufficient to cause the vibratory signal to be conducted from the vibratory device to the vestibular system of the user.

46. The system of claim 45, wherein the support element is an elastic headband, and the force concentrator is a non-stretchable fabric coupled to or integrated into the elastic headband.

47. The system of claim 45, wherein the vibratory device includes a housing defining a chamber and a vibratory element configured to move within the chamber.

48. The system of claim 47, wherein the vibratory element is configured to oscillate along an axis substantially perpendicular to the portion of the head of the user to generate the vibratory signal.

49. The system of claim 47, wherein the vibratory element is configured to oscillate along an axis substantially parallel to the portion of the head of the user to generate the vibratory signal.

50. The system of claim 47, wherein the housing is a first housing, the system further including a second housing, the first housing and the second housing coupled to one another by a flexible bridge such that a surface of the first housing lies flush with the surface of the head of the user when the support element is disposed around the head of the user.

51. The system of claim 47, wherein the vibratory element includes a magnet, the vibratory device further including a coil configured to generate a magnetic field to cause the magnet to move within the chamber.

52. The system of claim 45, wherein the support element is configured to secure the vibratory device at a plurality of orientations relative to the portion of the head of the user.

53. The system of claim 45, wherein the vibratory signal generated has a force level being greater than 87 dB re 1 dyne and less than 101 dB re 1 dyne to treat a physiological symptom of the vestibular system.

54. The system of claim 53, wherein the vibratory signal generated has a force level being greater than 60 dB re 1 dyne and less than 86 dB re 1 dyne to treat a physiological symptom of the vestibular system.

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