Ear wearable oxygen monitoring system

Abstract

A device for monitoring an oxygen saturation level of a wearer includes a first body portion, a second body portion, and a connection member. The first body portion includes a processor, a memory operably coupled to the processor, at least one light emitting diode, and at least one optical sensor configured to detect a reflected portion of light emitted from the at least one light emitting diode during operation. The second body portion includes a collar, and a connection member is mechanically coupled to each of the first body portion and the second body portion. The memory stores instructions for causing the processor to cause light to be emitted from the at least one light emitting diode when the device is positioned on an ear of a wearer and during operation of the device, and to calculate an oxyhemoglobin saturation level of the wearer based on a reflected portion of the light.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 342,100, filed on May 14, 2022, entitled “EAR WEARABLE OXYGEN MONITORING SYSTEM,” the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to physiological monitoring techniques, and more particularly, to monitoring the oxygen level of a wearer of a device. Background Art

[0004] Conditions such as pulmonary hypertension can be treated by providing supplemental oxygen therapy to the patient. Supplemental oxygen therapy can include delivering oxygen to the patient continuously or during specific events such as exercise or sleep. Summary of the invention

[0005] In some embodiments, a device for monitoring the oxygen saturation level of a wearer of the device includes a first body portion, a second body portion, and a connecting member. The first body portion includes a processor, a memory operably coupled to the processor, at least one light emitting diode operably coupled to the processor, and at least one optical sensor, the at least one optical sensor configured to detect a reflected portion of light emitted from the at least one light emitting diode during operation. The second body portion includes a grommet, and the connecting member is mechanically coupled to each of the first body portion and the second body portion. The memory stores instructions for causing the processor to cause light to be emitted from the at least one light emitting diode when the device is positioned on the wearer's ear and during operation of the device, and to calculate the wearer's blood oxygen saturation level based on the reflected portion of the light.

[0006] In some embodiments, a kit includes a device for monitoring the oxygen saturation level of a wearer of the device, a charger housing, and a plurality of flexible ear pads. The device is configured to be positioned on the wearer's ear and includes a first body portion, a second body portion, and a connecting member that is mechanically coupled to each of the first body portion and the second body portion. The first body portion has a processor, a memory operably coupled to the processor, at least one light emitting diode (LED), and at least one optical sensor. The at least one optical sensor is configured to detect a reflected portion of light emitted from the at least one light emitting diode during operation, and the reflected portion of the light may include light reflected from the surface of the wearer's ear. The memory stores instructions for causing the processor to calculate the wearer's blood oxygen saturation level based on the reflected portion of the light. The charger housing is configured to house the device and to provide power to the device. Each flexible ear pad from the plurality of flexible ear pads is configured to be mechanically coupled to the second body portion, for example via a collar / ring region of the second body portion.

[0007] In some embodiments, a method of manufacturing an oxygen saturation level monitoring device includes: bonding an electronic board to an ear pad using at least one of silicone or epoxy such that the electronic board is secured to the ear pad within a cavity defined in a surface of the ear pad; and attaching the ear pad to a chassis. As described herein, the chassis may include a first body portion, a second body portion, and a connecting member. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1A-Figure 1C is a presentation of a wearable oxygen monitor configured to be worn around a portion of a user's ear, according to some embodiments.

[0009] Figure 1D-1E yes Figure 1A-Figure 1C An exploded view of a wearable oxygen monitor is presented, showing its components.

[0010] Figure 1F-1J yes Figure 1A-Figure 1C Wearable oxygen monitors and Figure 1A-Figure 1C A rendering of the charger case for the wearable oxygen monitor.

[0011] Figure 2A-2N is a diagram of a wearable oxygen monitor configured to be worn around part of a user's ear, according to some embodiments.

[0012] Figure 2O-Figure 2V is a diagram of a charger housing in a closed configuration, the charger housing being configured to accommodate a Figure 2A-2N wearable oxygen monitors and Figure 2A-2N Powering a wearable oxygen monitor.

[0013] Figure 2W-Figure 2AD yes Figure 2O-Figure 2V FIG. 1 is a diagram of a charger housing in an open configuration, the charger housing accommodating Figure 2A-2N Wearable oxygen monitor.

[0014] Figure 2AE-Figure 2AF yes Figure 2O-Figure 2V An image of the charger housing in an open configuration and without housing a wearable oxygen monitor.

[0015] Figure 2AG is a rendering of a charger case with a panel removed to show the underlying shape of a recess / pocket configured to receive a wearable oxygen monitor, according to some embodiments.

[0016] Figure 3 is a schematic diagram illustrating components of a wearable oxygen monitor according to some embodiments.

[0017] Figure 4 is a block diagram illustrating components of a wearable oxygen monitor according to some embodiments.

[0018] Figure 5 is a block diagram illustrating components of a charger housing according to some embodiments.

[0019] Figure 6 is a diagram of a wearable oxygen monitor when worn around the upper portion of a user / wearer's ear, according to an embodiment.

[0020] Figure 7A-7C is a representation of a wearable oxygen monitor configured to be worn around part of a user's ear in various stages of assembly and showing its components, according to some embodiments.

[0021] Figure 8A-8U is a representation of a flexible electronics assembly for a wearable oxygen monitor according to some embodiments.

[0022] Figure 9A-9B is a rendering of an ear pad having an optical sensor circuit positioned within a recess of the ear pad in accordance with some embodiments.

[0023] Fig. 9C is a photographic image showing a bottom view of an assembled ear pad with optical sensor circuitry according to an embodiment.

[0024] Figure 10A-10C are diagrams of a wearable oxygen monitor showing a collar without ear pads, a collar with thin ear pads, and a collar with thick ear pads, respectively, according to some embodiments.

[0025] Fig.11 is a flow chart illustrating a method of manufacturing a wearable oxygen monitor according to some embodiments.

[0026] Figure 12 to Figure 60 is a wireframe of a user interface screen of a mobile application that interacts with a wearable oxygen monitor in accordance with some embodiments.

[0027] Figure 61A-Figure 61N is a representation of a flexible electronics assembly and components therein for a wearable oxygen monitor according to some embodiments. DETAILED DESCRIPTION

[0028] Some health conditions, such as pulmonary hypertension (PH), pulmonary arterial hypertension (PAH), and idiopathic PAH (IPAH), are managed by oxygen administration and, associated with oxygen level monitoring. However, known devices for monitoring oxygen levels, such as pulse oximeters, are typically worn on a patient's finger for discrete time periods for measurement and then removed, for example because they are not designed for continuous wear or are uncomfortable to wear continuously. Furthermore, when a patient is sleeping, he or she typically does not wear a pulse oximeter and cannot view the digital reading of the pulse oximeter. Thus, for example, while he or she is sleeping, a known pulse oximeter may not be able to effectively notify a patient of a severe drop in his or her oxygen level, potentially leading to a worsening of the condition or even death. Furthermore, known pulse oximeters do not include automatic emergency detection and response capabilities. In other words, the user takes active action to measure his or her oxygen level if he or she is able to do so and takes another active action to resolve the problem (e.g., using other devices such as a phone to call a doctor or emergency services) when the level is determined to be too low, potentially wasting valuable time.

[0029] Embodiments of the present disclosure include a wearable oxygen monitor that can be worn continuously and performs continuous oxygen monitoring, as well as alerting the wearer / user when the detected oxygen level detected during oxygen monitoring is below a predetermined or predefined threshold. In some embodiments, the wearable oxygen monitor includes a first body portion, a second body portion, and a connecting member or connecting portion, which is arranged or positioned between the first body portion and the second body portion. The first body portion includes a processor, a memory operably coupled to the processor, at least one light emitting diode (LED), and at least one optical sensor, the at least one optical sensor being configured to detect a reflected portion of light emitted from the at least one light emitting diode during operation. The second body portion includes a collar, and the connecting member is mechanically coupled to each of the first body portion and the second body portion. The memory stores instructions for causing the processor to cause light to be emitted from the at least one light emitting diode when the device is positioned on the wearer's ear and during operation of the device, and to calculate the wearer's blood oxygen saturation level based on the reflected portion of the light. Additional details regarding certain aspects of the wearable oxygen monitor described herein can be found, for example, in U.S. Patent No. 10,987,067, entitled “Wearable Headphone Oxygen Monitor,” issued on April 27, 2021, the entire contents of which are incorporated herein by reference for all purposes.

[0030] In some implementations, the connecting member includes or is made of nylon and is thus only slightly compliant (but primarily rigid), and the adjustability of the wearable oxygen monitor and / or the conformity of the wearable oxygen monitor to the shape of the wearer's / user's ears is achieved via a pair of ear pads, one or both of which can be flexible (e.g., silicone pads), and at least one of the ear pads can be interchanged with different sizes. In other words, at least one flexible ear pad from the pair of flexible ear pads can be removed from the wearable oxygen monitor and replaced with an ear pad having a different size. In some such implementations, only one flexible ear pad from the pair of flexible ear pads is configured to be easily removable and replaceable by a user. The removable ear pad can be coupled to the second body portion, for example, via its annular structure (also referred to herein as a "loop" or "annular opening"), as discussed further below.

[0031] In some implementations, at least one optical sensor is positioned within and secured to a cavity defined within a surface of one of the ear pads (e.g., a flexible ear pad coupled to the first body portion and optionally not configured to be easily removed / replaced by a user, or a non-flexible ear pad optionally not configured to be easily removed / replaced by a user). The at least one optical sensor can be "potted" in a substance such as an epoxy (e.g., an optically clear epoxy such that the optical signal is not disturbed / altered, or is minimally disturbed / altered).

[0032] In some implementations, the wearable oxygen monitor of the present disclosure includes a flexible conductor (e.g., having a substantially S-shaped or curved / snaking "ribbon" shape) such that at least a subassembly of the wearable oxygen monitor can "flex" to accommodate positioning the wearable oxygen monitor on the ear of the user / wearer. Alternatively or additionally, the wearable oxygen monitor of the present disclosure can include a DC power line communication transceiver chipset (e.g., Maxim MAX20340).

[0033] In some embodiments, a wearable oxygen monitoring kit includes an ear wearable device ("wearable oxygen monitor"), a charger housing, and optionally a set of flexible ear pads configured to be interchangeably attached to the ear wearable device via a loop, as shown and described herein. Each flexible ear pad from the set of flexible ear pads can have a different set of associated sizes, so that the "fit" of the ear wearable device can be adjusted / customized for different user (ear) sizes / geometries. Improving the fit of the ear wearable device relative to the user / wearer can result in improved optical signal quality during operation of the ear wearable device, as well as improved user comfort and ergonomics. In some such implementations, the charger housing and the ear wearable device are configured to exchange data and power via one or more (e.g., two) charging contacts (e.g., simultaneously). Although described above as "flexible" for the purpose of conforming to the user's ears, the ear pads may alternatively be formed of a non-flexible or substantially non-flexible material, such as for applications requiring greater durability / ruggedization (e.g., for underwater use, military use, etc.).

[0034] In some embodiments, during manufacture / assembly of the wearable oxygen monitor, an optical plate (i.e., a circuit board including at least one optical sensor and / or at least one optical detector) is bonded to an ear pad using silicone (e.g., optically clear silicone) or another material such as an epoxy, thereby producing at least a subassembly (i.e., the optical plate and the ear pad) that is waterproof and provides optical transparency sufficient for acceptable performance of the at least one optical sensor and / or at least one optical detector.

[0035] In some embodiments, the wearable oxygen monitor of the present disclosure may include an alert mechanism, such as a button or a touch screen, that initiates / activates one or more processes (e.g., stored in a memory of the wearable oxygen monitor and executable via a processor (e.g., a microprocessor) of the wearable oxygen monitor when a user interacts with it. The one or more processes may include an emergency plan. The emergency plan may include, but is not limited to, one or more of: contacting emergency services (e.g., initiating a phone call to 911), sending a short message service (SMS) message (i.e., a text message) alert to a pre-programmed phone number (e.g., to a mobile device of the user or other designated person), emitting a sound from a sounder of the wearable oxygen monitor (e.g., an electronic beep effect emitted via a speaker), generating vibrations by a tactile feedback element (e.g., a piezoelectric transducer) of the wearable oxygen monitor, transmitting a signal to a mobile device (e.g., via a transceiver onboard the wearable oxygen monitor) to cause an alert, such as a sound effect and / or vibration, etc.

[0036] In some embodiments, the wearable oxygen monitor is configured to dial 911 (or other emergency services) in response to a button press (or other interaction with a warning mechanism) by the wearer / user, for example as part of a defined emergency plan. The wearable oxygen monitor may also include a speaker and a microphone so that the oxygen monitor acts as a headset. For example, the wearer / user may hear the voice of an emergency response dispatcher via the speaker of the wearable oxygen monitor, and the wearer / user may speak to the emergency response dispatcher via the microphone of the wearable oxygen monitor. In some implementations, in response to a button press and in addition to dialing 911, the wearable oxygen monitor may also be configured to simultaneously trigger the generation of a warning text message and its transmission (e.g., via a wireless communication channel) to one or more emergency contact numbers (e.g., three separate emergency contact numbers), which are stored in the memory of the wearable oxygen monitor and / or accessible by the wearable oxygen monitor via its mobile software application. The (one or more) warning text messages may include one or more of the following: a warning message, a vital sign / biometric of the wearer / user, and an indication that 911 has been called.

[0037] In some embodiments, the wearable oxygen monitor is in the form of a wearable, hardware-based headset that is sized and shaped to fit and be worn around a portion of a wearer's ear (e.g., a helix, scaphoid, pinna, or any other portion of the outer ear). The headset can be clipped to, mechanically attached to, or otherwise grasp a portion of the ear. For example, the headset includes a gap or recess defined therein that is sized and shaped to accommodate a portion of the ear. When the ear portion is inserted into or received by the gap or recess, the headset can be configured to apply a bias or elastic force that provides a squeezing action about the ear portion so that the headset is securely held on the wearer's ear. The wearable oxygen monitor may include one or more of the following: one or more light emitting diodes (LEDs), one or more photoelectric sensors / photodetectors, one or more lightweight, energy-efficient wireless sensors (e.g., (one or more) temperature sensors, (one or more) pressure sensors, (one or more) accelerometers, (one or more) GPS sensors, etc.), a speaker, a microphone, a processor, and a memory operably coupled to the processor. The memory stores instructions executable by the processor during operation. During operation, one or more LEDs (e.g., red and / or green LEDs) may emit light through a portion of the ear, and the light transmitted through the portion of the ear may be detected at one or more photosensors / photodetectors. One or more biometrics or vital signs (e.g., blood oxygen level, blood oxygen saturation (SpO2), heart rate, body temperature, pulse rate, respiratory rate, blood pressure, hydration, etc.) may then be calculated based on the amount of light detected at the one or more photosensors / photodetectors and / or based on the amount of light absorbed by the ear (and therefore not reaching the one or more photosensors / photodetectors). For example, blood oxygen saturation (SpO2) may be calculated based on the amount of light absorbed by the ear and by using Beer's law (also known as the Beer-Lambert law, which states that absorbance is proportional to the concentration of one or more attenuating substances in a material sample). In some implementations, the accuracy of the determination of blood oxygen saturation increases with the thickness of the portion of the ear where the wearable oxygen monitor is positioned during operation.

[0038] In some embodiments, the one or more LEDs include two LEDs - the first LED is a red (650nm) LED and the second LED is an infrared (950nm) LED. During operation, when light from each of the two LEDs passes through adjacent portions of the ear, light emitted from the first (red) LED is partially absorbed by deoxyhemoglobin in the portion of the ear, and light emitted from the second (infrared) LED is partially absorbed by oxyhemoglobin in the portion of the ear (the amount of which can be determined based on the detected light at the (one or more) photodetectors / (one or more) photosensors). The oxygen concentration can then be calculated / detected, for example, based on the ratio between the amount of light absorbed by the deoxyhemoglobin and the amount of light absorbed by the oxyhemoglobin. In some embodiments, the one or more LEDs include at least one red and / or infrared LED for detecting the wearer's blood oxygen concentration and at least one green LED for detecting the wearer's pulse. In some implementations, the determination of the blood oxygen concentration includes adjusting the detected signal (e.g., at the photodetector / photosensor) to correct for ambient or surrounding light, such as sunlight. The adjustment can be based on, for example, an additional light sensor located on an outer surface of the wearable oxygen monitor. Such adjustments may be made, for example, when the wearable oxygen monitor is worn outdoors, in an environment with low lighting, and / or in an environment with direct or indirect lighting sources.

[0039] The memory may communicate with / via and / or store software applications compatible with one or more mobile devices (e.g., Windows, iOS, Android). The wearable oxygen monitor may be lightweight, energy efficient, and configured to communicate with the wearable oxygen monitor using one or more wireless communication protocols (e.g., The wearable oxygen monitor headset may include a power source that can be charged via a wired or wireless charging pod. Charging of the headset can occur when the headset is at least partially contained within the charging pod and optionally when in electrical contact with the charging pod.

[0040] In some embodiments, the emergency plan is activated in response to the wearer interacting (e.g., pressing, tapping, swiping, etc.) with the alert mechanism a predetermined number of times (e.g., once, twice, three times, four times, etc.) and / or at a predetermined frequency (e.g., three quick taps within 1-5 seconds of each other). For example, a wearer pressing a button on a wearable oxygen monitor three times can trigger implementation / deployment of the emergency plan.

[0041] In some embodiments, the wearable oxygen monitor is configured to communicate with a software application running on a mobile device (e.g., a smart phone, tablet, laptop, etc.) of the wearable oxygen monitor user / wearer or other individual (e.g., smart phone, tablet, laptop, etc.) (e.g., via wireless network communication). The software application may include code that causes the storage of all vital records (e.g., blood oxygen level, heart rate / pulse, body temperature, hydration level, etc.) detected by one or more sensors onboard the wearable oxygen monitor, so that these vital records can be sent or shown to a medical provider, for example. Alternatively or in addition, the software application may facilitate, for example, the wearer / user of the wearable oxygen monitor or other authorized individuals to define / set / customize one or more set points or thresholds. One or more set points or thresholds may include oxygen levels that will trigger a warning or alarm. Alternatively or in addition, the software application may facilitate, for example, the wearer / user of the wearable oxygen monitor or other authorized individuals to define / set / customize one or more emergency contact phone numbers, to which an SMS message will be sent and / or the one or more emergency contact phone numbers will be called when a warning / alarm is triggered.

[0042] In some embodiments, the wearable oxygen monitor includes a processor and a memory operably coupled to the processor. The memory stores instructions executable by the processor during operation. The instructions may include, for example, continuously and / or at predetermined time intervals (e.g., every second, every 2 seconds, every 3 seconds, every 4 seconds, every 5 seconds, every 6 seconds, every 7 seconds, every 8 seconds, every 9 seconds, every 10 seconds, every 11 seconds, every 12 seconds, every 13 seconds, every 14 seconds, every 15 seconds, every 16 seconds, every 17 seconds, every 18 seconds, every 19 seconds, every 20 seconds, every 21 seconds, every 22 seconds, every 23 seconds, every 24 seconds, every 25 seconds, every 26 seconds, every 27 seconds, every 28 seconds, every 29 seconds, every 30 seconds, every 45 seconds, every minute, every 5 minutes, every 10 minutes, every 15 minutes, every 30 minutes, etc.) to calculate oxygen concentration.

[0043] The time interval may be configurable by a wearer / user of the wearable oxygen monitor and / or another authorized user, for example, via a software application running on a mobile device of the individual and via wireless communication with the wearable oxygen monitor. In some implementations, the instructions include instructions to compare a measured oxygen concentration level (measured by the wearable oxygen monitor) to a predetermined threshold value stored in a memory of the wearable oxygen monitor. The predetermined threshold value may be configurable by a wearer / user of the wearable oxygen monitor and / or another authorized user, for example, via a software application.

[0044] In some embodiments, the wearable oxygen monitor is configured to emit an alarm sound and / or vibration in response to detecting that the wearer / user's oxygen level is below a defined threshold (e.g., indicating an "alarm state"). The intensity, amount, and / or frequency of the alarm sound and / or vibration may increase over time until the wearer / user acknowledges the alarm (e.g., via the wearer / user's interaction with a warning mechanism of the wearable oxygen monitor, or via a graphical user interface (GUI) presented by a software application of the wearer / user's mobile device). Alternatively or in addition, the intensity, amount, and / or frequency of the alarm sound and / or vibration may increase as and / or in proportion to an increase in a calculated difference between the detected oxygen level and a defined threshold, such that the increased intensity, amount, and / or frequency of the alarm sound and / or vibration indicates an increased severity of the alarm state. Similarly, the intensity, amount, and / or frequency of the alarm sound and / or vibration may decrease as and / or in proportion to a decrease in the calculated difference between the detected oxygen level and a defined threshold value, such that an increased intensity, amount, and / or frequency of the alarm sound and / or vibration indicates a decreasing severity of the alarm state. The wearable oxygen monitor may terminate the alarm sound and / or vibration when it is detected that the current oxygen level is equal to or greater than the defined threshold value.

[0045] In some embodiments, for example, by using a software application, the oxygen level detected by the wearable oxygen monitor (and, optionally, other sensor data collected by / detected at the wearable oxygen monitor) is stored locally (e.g., within the memory of the wearable oxygen monitor) and / or transmitted (e.g., via a transceiver of the wearable oxygen monitor) to a cloud-based server or other repository. The wearable oxygen monitor, the cloud-based server, and / or the software application associated with the wearable oxygen monitor can be configured to analyze the sensor data collected / detected at the wearable oxygen monitor, for example, to determine one or more conditions or biometric parameters based on the sensor data, to detect time-varying patterns associated with the sensor data, etc. In addition to the detected oxygen level and optional other sensor data, the locally stored and / or transmitted data may include information such as the time and date of the detection event associated with such data, an identifier of the headset, an identifier associated with the wearer, etc. The data stored on the cloud-based server can be downloaded from the cloud-based server by the wearer / user and / or other authorized personnel to be presented to a physician, for example, for the purpose of diagnosis, investigation of an abnormal event, etc. The ability of the wearer / user to download data from the cloud-based server may be limited to, for example, daily or weekly. Alternatively or in addition, the user may send a request to the cloud-based server that includes a query that specifies a date range for which he / she wants to retrieve data. Although described herein with respect to oxygen levels, the systems and methods of the present disclosure may alternatively or additionally be used to detect other biometrics or vital signs, such as heart rate / pulse, body temperature, hydration level, salinity, etc.

[0046] In some embodiments, the mobile software application is configured for use with one or more wearable oxygen monitors of the present disclosure. The mobile software application may be compatible with one or more of Android, iOS, and Windows, and may facilitate continuous communication between one or more mobile devices running the mobile software application and the wearable oxygen monitor (e.g., via one or more wireless sensors of the wearable oxygen monitor). The mobile software application may be configured to record / store detected vital signs / biometric information (e.g., continuously, periodically, intermittently, and / or upon request or interaction with its user), and optionally upload the detected data to cloud-based storage for future reference. The mobile software application may be configured to send and / or receive signals so that one or more of the detected data values ​​(and / or their graphical representations, for example, over time), including, for example, oxygen levels, heart rate, etc., are displayed, for example, in a GUI of the wearer / user's mobile device. The mobile software application may be configured to, in addition to biometric information detected by the wearable oxygen monitor(s), identify and / or cause storage (e.g., in a database or other repository) of geometry (e.g., geographic data such as GPS data) and / or barometric data (e.g., environmental data such as atmospheric pressure), and / or track the occurrence of acute / emergency events over time (e.g., as indicated by the triggering of an emergency plan). The data received and / or stored by the software application may include crowdsourced data (e.g., from multiple different wearable oxygen monitors associated with multiple different wearers, optionally without including identifying information associated with the individual wearers).

[0047] In some embodiments, data detected by one or more wearable oxygen monitors and information derived from these data are stored in a common repository and used to train a machine learning (ML) or artificial intelligence (AI) algorithm. The trained ML / AI algorithm can be used, for example, to predict future acute / emergency events (i.e., perform predictive analysis) based on current (contemporaneous) sensor readings detected at a particular wearer's wearable oxygen monitor. When a future acute / emergency event is predicted, an "early warning" warning can be generated and presented to the wearer / user (e.g., via a GUI of the wearer's mobile device, via a software application running thereon) so that the wearer / user can take remedial or preventive measures (e.g., increase oxygen intake).

[0048] Figure 1A-Figure 1C is a representation of a wearable oxygen monitor 100 configured to be worn around a portion of a user's ear, according to some embodiments. Figure 1A-Figure 1CAs shown in , the wearable oxygen monitor 100 includes a first body portion 100A and a second body portion 100B, which are mechanically coupled by a connecting member 110. At least a portion of the first body portion 100A and the second body portion 100B can be integrally formed or monolithically formed with each other, such as formed of nylon, plastic, or another suitable material.

[0049] Figure 1D-1E yes Figure 1A-Figure 1C An exploded view of the wearable oxygen monitor 100 is presented, showing its components. For example, Figure 1D As shown in FIG. 1 , the wearable oxygen monitor 100 includes a battery 102, an antenna 104, a vibration motor 108, a charging contact 112, a back cover 105, and a decorative surface 106. Each of the battery 102, the antenna 104, the vibration motor 108, the charging contact 112, the back cover 105, and the decorative surface 106 can be accommodated in a first main body portion (i.e., Figure 1A-Figure 1C 100A) within and / or attached to the first body portion. Figure 1E is relative to Figure 1D 1 and 12. The embodiment of the present invention is a view from a different perspective and shows additional components of the first body portion - namely, the processor 114, the accelerometer 116, the flash memory 118, the biosensor 120 and the flexible ear pad 124. Figure 1E The second body portion is also shown to include a collar 121 and a removable ear pad 122 positioned within the collar 121 .

[0050] Figure 1F-1J yes Figure 1A-Figure 1C Wearable oxygen monitors and Figure 1A-Figure 1C 1 is a diagram showing a charger housing 150 for a wearable oxygen monitor. The charger housing 150 has a lower / base portion and a cover portion, the base portion and the cover portion being coupled to each other by a hinge. Figure 1F As shown in , the wearable oxygen monitor 100 is mounted within and partially received in a complementary shaped recess in the charger housing 150. In other words, when positioned inside the charger housing 150, a first portion of the wearable oxygen monitor 100 is located within the recess and a second portion of the wearable oxygen monitor 100 is positioned within a recess defined by the cover of the charger housing 150.

[0051] Figure 2A-2N is a diagram of a wearable oxygen monitor 200 configured to be worn around a portion of a user's ear, according to some embodiments. Figure 2O-Figure 2V is a diagram of a charger housing in a closed configuration, the charger housing being configured to accommodate a Figure 2A-2N wearable oxygen monitors and Figure 2A-2N Powering a wearable oxygen monitor. Figure 2W-Figure 2ADyes Figure 2O-Figure 2V FIG. 1 is a diagram of a charger housing in an open configuration, the charger housing comprising Figure 2A-2N Wearable oxygen monitor. Figure 2AE-Figure 2AF yes Figure 2O-Figure 2V An image of the charger housing in an open configuration and without housing a wearable oxygen monitor. Figure 2AG is a rendering of a charger case with a panel removed to show the underlying shape of a recess / pocket configured to receive a wearable oxygen monitor, according to some embodiments.

[0052] Figure 3 is a schematic diagram showing components of a wearable oxygen monitor 300 according to some embodiments. Figure 3 As shown in , the wearable oxygen monitor 300 includes a memory 328, a processor 326, a transceiver 330, one or more batteries or other power sources 332, one or more LEDs 322 (optionally, in a row or array), one or more optical sensors 324, and optionally one or more speakers 334 and / or microphones 336. The one or more batteries 332 are electrically coupled to and configured to power each of the processor 326, the transceiver 330, the (one or more) LEDs 322, the (one or more) optical sensors 324, the (one or more) optional speakers 334, the optional microphone 336, and the optional memory 328. The processor 326 is operably coupled to each of the memory 328, the (one or more) LEDs 322, the (one or more) optical sensors 324, the transceiver 330, and the optional microphone 336.

[0053] The wearable oxygen monitor 300 optionally includes an alert mechanism (e.g., an actuatable button) electrically connected to the one or more batteries 332 and operably coupled to at least one of the processor 326 and the transceiver 330. The transceiver 330 may be configured to send and / or receive communications (e.g., to / from a remote computing device, such as a mobile device of a wearer / user of the wearable oxygen monitor 300 or other authorized personnel), for example, including data collected / detected by the one or more optical sensors 324 and / or the processor 326 and / or stored in the memory 328. The processor 326 may be configured to control (e.g., based on processor executable instructions stored in the memory 328 and / or received via the transceiver 330) at least one of the one or more LEDs 322, the microphone 336, the speaker 334, or the one or more batteries 332 via an electrical conduit (not shown). During operation, and when worn around a portion of a wearer / user's ear, the one or more LEDs 322 emit light such that the emitted light is reflected by a portion of the ear (e.g., a surface or surface layer) in a direction toward the one or more optical sensors 324. The one or more optical sensors 324 detect a signal in response to the reflected light. In some implementations, the processor 326 determines the wearer's oxygen level based on the detected signal, and optionally stores the determined oxygen level in the memory 328, optionally along with date information, time information, and / or other sensor data detected based on one or more other sensors (not shown) onboard the wearable oxygen monitor 300. Alternatively or additionally, raw data including the detected signal (optionally along with data detected using one or more other sensors) can be sent via the processor 326 and using the transceiver 330 to a remote computing device, such as a cloud-based server, a remote mobile device, etc., for use in determining the oxygen level based on the raw data.

[0054] Figure 4 FIG. 4 is a diagram showing a wearable oxygen monitor 400 (such as Figure 1A-1E and / or Figure 2A-2N A block diagram of the components of a wearable oxygen monitor (shown in FIG. Figure 4As shown in , the wearable oxygen monitor 400 includes a vibration motor 440 operably coupled to a motor drive circuit 442, a battery (e.g., lithium polymer ("LiPo")) 432 operably coupled to a battery monitoring circuit 446, a system voltage regulator (e.g., 1.8V) 448, and a battery charging power management integrated circuit ("PMIC") 450. The battery charging PMIC 450 is operably coupled to a direct current ("DC") power line communication ("PLC") transceiver (e.g., MAX20340) 452. Each of the DC PLC transceiver 452, the battery monitoring circuit 446, and the motor drive circuit 442 is operably coupled to a system on chip ("SoC") (e.g., Nordic nRF52 series) 444, which in turn is operably coupled to an antenna 446 (e.g., The SOC 444 is operably coupled to one or more optical sensors 424, an accelerometer 454, a serial peripheral interface ("SPI") flash memory 456, and a serial wire output ("SWO") programming connection (e.g., a pogo pin) 458.

[0055] Figure 5 FIG. 5 is a diagram showing a charger housing 500 (such as Figure 2O-2AF A block diagram of the components of the charger housing shown in FIG. Figure 5As shown in , the charger housing 500 includes a battery 502 (e.g., a lithium polymer battery) operably coupled to each of a battery monitoring circuit 504, a regulator 516 (e.g., 3.3V), a DC to DC converter 518, and a battery charging PMIC 520. The battery monitoring circuit 504 is operably coupled to a microcontroller 506 (e.g., an STM32G0 series microcontroller), which in turn is operably coupled to each of a DC PLC transceiver 526 (e.g., MAX20340), a SWO programming connection 522 (e.g., TagConnect), an LED driver 508, and a button 512 or other actuator 512 (e.g., to trigger a "wake-up" of the charger housing and / or check the battery charge level). The LED driver 508 is operably coupled to one or more LED indicators 510 (e.g., to indicate the battery charge level, such as based on lighting color and / or lighting state). The battery charging PMIC 520 is operably coupled to a universal serial bus (USB) 524 (e.g., Type C), and the DCPLC 526 is operably coupled to a "charge output" contact from a pair of contacts 530 that also includes a ground contact. The pair of contacts 530 can be configured to communicate with Figure 4 The external charging contacts 438 of the wearable oxygen monitor 400 are mechanically mated and electrically coupled.

[0056] Figure 6 6 is a diagram of a wearable oxygen monitor 600 according to an embodiment when worn around the upper portion of a user / wearer's ear, with a first body portion 600A and a connecting member 610 visible. The connecting member 610 may be made of nylon, plastic, or any other suitable material. Figure 6 600 is shown as being positioned around the upper portion of the ear, but the wearable oxygen monitor 610 may alternatively be positioned on the earlobe or any other portion of the ear. For example, the wearable oxygen monitor 600 may be positioned around the helix, scaphoid, pinna, or earlobe of the ear. During placement or "wearing" of the wearable oxygen monitor 600, the gap between the first body portion 600A and the second body portion of the wearable oxygen monitor 600 may be expanded by, for example, moving the first body portion and the second body portion away from each other, expanding the radius of curvature of the connecting member 610, and / or deforming the connecting member 610. Once positioned on a portion of the user's ear ("second configuration"), and external forces are removed from the wearable oxygen monitor 600, the first body portion 600A and the second body portion may naturally move toward each other a distance equal to a portion of the gap, for example, by means of the shape memory or inherent spring force (or biasing force) of the connecting member 610, so that the wearable oxygen monitor 600 remains securely positioned on a portion of the user's ear during use (e.g., during movement of the user).

[0057] Figure 7A-7C 7 is a representation of a wearable oxygen monitor 700 configured to be worn around a portion of a user's ear in various stages of assembly and illustrating its components, according to some embodiments. Fig. 7A As shown in FIG. 7 , a wearable oxygen monitor 700 includes a first body portion 700A and a second body portion 700B, and the first body portion 700A and the second body portion 700B are mechanically coupled by a connecting member 710 . Figure 7B-7C The wearable oxygen monitor 700 includes a decorative surface 706, a back cover 705, a connecting member 710 connecting the first body portion and the second body portion 700B, and an electronic device 760 (for example, including Figure 3-Figure 4 ), flexible ear pad 724, collar 721, and adjustable ear pad 722.

[0058] Figure 8A-8U is a flexible electronic assembly for a wearable oxygen monitor according to some embodiments (e.g., Figure 7A-7C Presentation of electronic device 760). Figure 9A-9B is a presentation of an ear pad (eg, an ear pad of a first body portion) having an optical sensor circuit positioned within a recess of the ear pad in accordance with some embodiments. Fig. 9C is a photographic image showing a bottom view of an assembled ear pad with optical sensor circuitry according to an embodiment. Figure 10A-10C are diagrams of a wearable oxygen monitor showing a collar without ear pads, a collar with thin ear pads, and a collar with thick ear pads, respectively, according to some embodiments.

[0059] Fig.11 is a flow chart illustrating a method of manufacturing a wearable oxygen monitor according to some embodiments. Fig.11 As shown in , method 1100 includes bonding the electronic board to the ear pad (e.g., Figure 7C The ear pad is attached to the chassis at 1104 by attaching the electronic board to the ear pad within a cavity defined in the surface of the ear pad.

[0060] In some embodiments, a device for monitoring the oxygen saturation level of a wearer of the device includes a first body portion, a second body portion, and a connecting member. The first body portion includes a processor, a memory operably coupled to the processor, at least one light emitting diode, and at least one optical sensor, the at least one optical sensor configured to detect a reflected portion of light emitted from the at least one light emitting diode during operation. The second body portion includes a collar, and the connecting member is mechanically coupled to each of the first body portion and the second body portion. The memory stores instructions for causing the processor to cause light to be emitted from the at least one light emitting diode when the device is positioned on the wearer's ear and during operation of the device, and to calculate the wearer's blood oxygen saturation level based on the reflected portion of the light.

[0061] In some implementations, the second body portion further comprises a flexible ear pad. Alternatively or additionally, the first body portion may include a flexible ear pad. Alternatively or additionally, the device further comprises a vibration motor, and the memory further stores instructions for operating the vibration motor in response to detecting an event. The event may include at least one of: detecting an alarm condition, detecting a low battery condition, or detecting successful positioning of the device on the wearer's ear.

[0062] In some embodiments, the connecting member may include nylon. Alternatively or additionally, the first body portion may include a flexible ear pad, and the at least one optical sensor may be positioned (e.g., potted) within a cavity defined in the flexible ear pad. For example, the at least one optical sensor may be fixed within the cavity by epoxy.

[0063] The processor and memory may be positioned on a circuit board, and the at least one optical sensor may be electrically coupled to the circuit board via a flexible conductor.The flexible conductor may be substantially S-shaped.

[0064] In some embodiments, the apparatus further comprises at least one of a microphone or a speaker operably coupled to the processor, and the memory further stores instructions for causing the processor to activate at least one of the microphone or the speaker in response to detecting the alarm condition.

[0065] In some embodiments, the apparatus further comprises a wireless transceiver operably coupled to the processor and configured to communicate with the mobile software application, the memory further storing instructions for causing the processor to send a signal representing the measurement data to the mobile software application via the wireless transceiver.

[0066] In some embodiments, the memory further stores instructions for causing the processor to send a signal to the mobile software application according to a predetermined schedule, the signal representing the measurement data.

[0067] In some embodiments, the device also includes at least one sensor operably coupled to the processor, the at least one sensor including at least one of a body temperature sensor, an air quality sensor, a humidity sensor, an altimeter, or an air pressure sensor, and the memory also stores instructions for causing the processor to store data collected by the at least one sensor in the memory.

[0068] In some embodiments, the device also includes at least one sensor operably coupled to the processor, the at least one sensor including at least one of a body temperature sensor, an air quality sensor, a humidity sensor, an altimeter, or an air pressure sensor, and the memory further stores instructions for causing the processor to send a signal to the mobile software application according to a predetermined schedule, the signal representing data collected by the at least one sensor.

[0069] In some embodiments, the reflected portion of the light is a first reflected portion of the light, and the instructions for causing the processor to calculate the wearer's blood oxygen saturation level include instructions for causing the processor to calculate the wearer's blood oxygen saturation level based on the first reflected portion of the light and the second reflected portion of the light.

[0070] In some embodiments, the device further comprises a warning mechanism (e.g., a button) operably coupled to the processor, and the memory further stores instructions for causing the processor to generate and send a signal representing a warning in response to detecting a user interaction with the warning mechanism. In some embodiments, the device is waterproof. In some embodiments, the second body portion does not include any electronic components.

[0071] In some embodiments, a kit includes an ear wearable device, a charger housing, and a plurality of flexible ear pads. The ear wearable device is configured to be positioned on the ear of a wearer, and the device includes a first body portion, a second body portion, and a connecting member that is mechanically coupled to each of the first body portion and the second body portion. The first body portion has a processor, a memory operably coupled to the processor, at least one light emitting diode, and at least one optical sensor, the at least one optical sensor being configured to detect a reflected portion of light emitted from the at least one light emitting diode during operation, the reflected portion of light being reflected from a surface of the wearer's ear. The memory stores instructions for causing the processor to calculate the wearer's blood oxygen saturation level based on the reflected portion of light. The charger housing is configured to house the device and to provide power to the device. A plurality of flexible ear pads, each of the plurality of flexible ear pads being configured to be mechanically coupled to the second body portion. The second body portion may include an annular opening, and each of the plurality of flexible ear pads may be configured to be mechanically coupled to the second body portion via the annular opening. Alternatively or additionally, the device and charger housing may be configured to enable data to be exchanged between the device and the charger housing (eg, via a pair of electrical contacts).

[0072] According to some embodiments, the wearable oxygen monitor of the present disclosure may include one or more (e.g., in any combination) of the following capabilities:

[0073] Continuous oxygen monitoring;

[0074] Heart rate monitoring;

[0075] Generate and send alerts;

[0076] Activate predefined emergency plans;

[0077] Interaction with mobile software applications; and / or

[0078] Predictive analytics.

[0079] In some embodiments, a wearable monitoring system includes a wearable oxygen monitor and a mobile software application ("mobile application") running on a computing device of a user or wearer of the wearable oxygen monitor. During operation of the wearable oxygen monitor (i.e., when the wearable oxygen monitor is powered on and worn by the wearer), the wearable oxygen monitor may continuously monitor the wearer's oxygen level, for example, by comparing the measured oxygen level to a predefined oxygen level threshold. Based on the monitoring, and in response to detecting that the measured oxygen level is below the predefined oxygen level threshold, the wearable oxygen monitor may generate a warning including a representation of a hypoxic condition, and send a signal representing the warning to the mobile application to cause the warning (including one or more of text, graphics, video indications, and audio indications) to be displayed and / or played by the mobile application and the computing device (e.g., via a graphical user interface (GUI) of the computing device and / or one or more speakers thereof).

[0080] In some embodiments, during operation, the wearable oxygen monitor detects data associated with one or more physiological conditions of the wearer (collectively referred to herein as "vital signs"), including but not limited to oxygen level, heart rate, etc., such as multiple instances of changes over time. The wearable oxygen monitor can store the vital signs in a memory of the wearable oxygen monitor in response to detecting the vital signs. Alternatively or in combination, the wearable oxygen monitor can send signals representing the vital signs to one or more remote computing devices (e.g., a user or a wearer's mobile computing device optionally running a mobile application) for storage and / or display (e.g., via a GUI). The vital signs can then be accessed and retrieved by the wearer or user. In addition, the wearer can provide access to the vital signs to medical personnel, for example, by providing access credentials (for the wearable oxygen monitor and / or mobile application) to the medical personnel and / or by generating and sending (via the mobile application) an email or other message including a representation of the vital signs to the medical personnel.

[0081] In some embodiments, the wearable monitoring system includes a wearable oxygen monitor and a mobile application running on a computing device of a user or wearer of the wearable oxygen monitor. The wearable monitoring system is configured to generate and send one or more warnings when a vital sign is determined to not meet a predetermined condition (optionally customizable by the wearer / user). For example, the wearable monitoring system (e.g., the wearable oxygen monitor and / or the mobile application) can be configured to generate and send one or more warnings when the oxygen level measured by the wearable oxygen monitor decreases below a predefined (optionally customizable) level (also referred to herein as a "trigger" or "threshold"). Additionally, the wearable monitoring system may be configured to generate and send one or more warnings in response to when the user / wearer presses a warning mechanism (e.g., an actuatable button) on the wearable oxygen monitor or otherwise interacts with the wearable oxygen monitor (examples of which include, but are not limited to, voice commands, rotation of a component of the wearable oxygen monitor, sliding of a component of the wearable oxygen monitor, pressing or squeezing a component of the wearable oxygen monitor (e.g., for a predefined duration, with a predefined amount of force, a predetermined number of times in succession (e.g., 3 times), in a predefined pattern, etc.), removing a component of the wearable oxygen monitor, removing the entire wearable oxygen monitor from the wearer's ear, etc.).

[0082] One or more warnings may include an indication of a "hypoxia" condition and / or associated instructions to execute one or more commands, such as initiating a phone call (e.g., via a mobile device running the mobile application) or otherwise contacting emergency services (e.g., 911), sending an SMS, email, or other message to one or more emergency contacts, emitting a sound from a sounder of the wearable oxygen monitor (e.g., an electronic beep effect emitted via a speaker), causing vibrations to be generated by a tactile feedback element (e.g., a piezoelectric transducer) of the wearable oxygen monitor, transmitting a signal to a mobile device (e.g., via a transceiver onboard the wearable oxygen monitor) to cause a warning such as a sound effect and / or vibration, etc. A user or wearer can define, via the mobile application, custom values ​​for one or more of the following: (one or more) threshold oxygen levels, detection intervals (e.g., for oxygen levels, blood oxygen saturation levels, or other vital signs), vital sign calculation frequency (e.g., calculating oxygen concentration at 1-30 second intervals), thresholds for other vital signs and / or biometrics, emergency contact information (e.g., phone number, email address, name, etc.), emergency plan data, prioritization of vital signs, prioritization of emergency contacts, access rights for healthcare providers, and the like.

[0083] In some embodiments, the wearable monitoring system includes predictive analysis capabilities and / or interacts with a predictive analysis system to provide an advance warning ("early warning") to the wearer or user before an acute health episode occurs, for example by identifying / detecting patterns based on the wearer / user's previous acute health episodes. The predictive analysis capabilities can be implemented using software (such as artificial intelligence (AI), machine learning, or other algorithms) and / or hardware. The recognition / detection of patterns can be performed by analyzing biometric data (including vital signs and / or other data detected and / or collected by the wearable monitoring system) optionally in combination with geometric data and / or barometric data collected by using the wearable monitoring system. For example, the collected geometric data and / or barometric data can be compared with historical data about the occurrence of hypoxia warnings / alerts and / or emergency service calls (e.g., 911 calls) to identify one or more patterns or correlations that can be used to predict the wearer's next warning, predict a set of conditions under which the wearer may experience a warning event, generate one or more early warnings for display via a GUI of the wearer's mobile computing device, etc.

[0084] In some embodiments, the wearable monitoring system includes a wearable, hardware-based headset and a and The headset is configured to communicate with the computing device running the mobile application, for example by using an energy-efficient, lightweight wireless protocol such as (GSM), Cat Cat Cat Narrowband RFID,

[0085] or The headset includes one or more of the following components: one or more light emitting diodes (LEDs), one or more photosensors / photodetectors, one or more lightweight energy-saving wireless sensors, a speaker, a microphone, one or more air quality monitoring sensors, and one or more body temperature sensors. During operation of the headset, the one or more LEDs can cause light generated by the one or more LEDs to be transmitted through a portion of the ear of the wearer of the headset so that the transmitted light is detected by the one or more photosensors / photodetectors, which are arranged on the opposite side of the portion of the ear compared to the one or more LEDs. The amount of light absorbed by the ear can be determined / calculated based on the amount of transmitted light detected by the one or more photosensors / photodetectors. Then, the blood oxygen saturation (SpO2) level can be calculated based on the amount of light absorbed by the ear, for example by using the Beer-Lambert law ("Beer's law"). The calculation of the amount of light absorbed by the ear and / or the calculation of the SpO2 level can be performed by a processor of the headset, a mobile application, and / or a processor of a remote computing device communicating with the headset.

[0086] In some embodiments, the wearable monitoring system includes a wearable, hardware-based headset (wearable oxygen monitor), a charger (e.g., Figure 1F-1J) and a mobile application. The wearable oxygen monitor may be in continuous communication via the mobile application, for example using one or more wireless antennas or sensors. The charger may be a wireless charger configured to wirelessly charge the earphones when the earphones are at least partially physically contained within the charger (and, optionally, when the cover or lid of the charger is closed). The earphones may be configured to generate and / or send an alarm in response to detecting that the wearer's oxygen level is below a predefined threshold. In addition, the earphones may be configured to generate and / or send multiple alarms in response to multiple detections of the wearer's oxygen level being below the predefined threshold over time. In response to detecting that the difference between the wearer's measured / detected / calculated oxygen level and the predefined threshold becomes larger over time (i.e., the wearer's measured / detected / calculated oxygen level decreases over time and is both below the predefined threshold), the frequency of generating and / or sending alarms may increase. Similarly, in response to detecting that the difference between the wearer's measured / detected / calculated oxygen level and the predefined threshold becomes smaller over time (i.e., the wearer's measured / detected / calculated oxygen level increases over time and is below the predefined value), the frequency of generating and / or sending the alarm can be reduced. In addition, in response to detecting that the difference between the wearer's measured / detected / calculated oxygen level and the predefined threshold becomes larger over time, the intensity or severity of the alarm can increase over time, and / or the type of alarm generated / sent can change over time. For example, the sound emitted (from the wearable oxygen monitor and / or from the computing device running the mobile application) can become louder, the frequency of flashes (on the wearable oxygen monitor and / or the computing device running the mobile application) can increase, the text description of the alarm (e.g., presented to the wearer / user via the GUI of the mobile device running the mobile application) can change from "low" to "medium" or from "medium" to "high", etc. Similarly, in response to detecting that the difference between the wearer's measured / detected / calculated oxygen level and the predefined threshold becomes smaller over time, the intensity of the alarm can be reduced over time, and / or the type of alarm generated / sent can be changed over time. For example, the sound emitted (from the wearable oxygen monitor and / or from the computer device running the mobile application) can become quieter / softer, the frequency of flashes (on the wearable oxygen monitor and / or the computer device running the mobile application) can be reduced, the text description of the alarm (e.g., presented to the wearer / user via the GUI of the mobile device running the mobile application) can be changed from "high" to "medium" or from "medium" to "low", etc. The alarm can terminate when the wearer's most recently measured / detected / calculated oxygen level reaches a "normal" level (e.g., equal to or above the predefined threshold).

[0087] The embodiments described herein can be used to monitor symptoms, predict the progression of, and / or be part of a treatment plan for one or more conditions such as pulmonary hypertension (PH), pulmonary arterial hypertension (PAH), idiopathic PAH (IPAH), pulmonary fibrosis, scleroderma, cystic fibrosis, lupus, sickle cell anemia, asthma, chronic obstructive pulmonary disease (COPD), heart disease, and Eisenmenger syndrome.

[0088] In some embodiments, the wearable oxygen monitor is configured to continuously or intermittently monitor vital signs such as oxygen level and heart rate, and transmit data related to the vital signs (e.g., via a mobile application) for storage in a record in a memory or other repository, via the mobile application (e.g., by using a cloud-based server). In some such cases, when storing the vital signs, the mobile application may also cause some or all of the following additional information to be stored: the wearer's GPS location, the wearer's altitude (e.g., by using a Google application programming interface (API) retrieval), an indication of indoor air quality (e.g., detected by an onboard sensor of the wearable oxygen monitor), ambient temperature, and ambient humidity level.

[0089] The wearer or user of the wearable oxygen monitor can then retrieve / download the records (e.g., based on a specified date or date range) to present to a physician, e.g., for the purpose of diagnosis and / or investigating the reasons behind the adverse fluctuations. Alternatively or additionally, the records can be automatically downloaded, e.g., according to a predefined, customizable schedule (e.g., daily, weekly, monthly), and sent to the wearer and / or other users, medical providers, etc., via email.

[0090] In some embodiments, the wearable oxygen monitor is configured to initiate a phone call to emergency services (e.g., 911) in response to the wearer or user pressing a warning mechanism (e.g., an actuable button thereof) or otherwise interacting with the interface of the wearable oxygen monitor. The button press (or other interaction) may also trigger activation of an onboard speaker and microphone to facilitate the phone call, so that the wearer or user can speak into the microphone and hear the other party's phone call via the speaker. This allows the wearer / user to inform the emergency services of the situation and request appropriate assistance. Optionally, the button press (or other interaction) may also trigger (e.g., simultaneously) the generation and wireless transmission of a warning via an SMS text message to one or more user-defined emergency contact phone numbers (e.g., defined in a mobile application).

[0091] Alternatively or additionally, in some embodiments, the wearable oxygen monitor is configured to generate and send an SMS text message to one or more (e.g., 3) emergency contacts predefined by the wearer (e.g., as part of a predefined emergency plan) in response to the wearer or user (e.g., a bystander) pressing a button of the wearable oxygen monitor (or otherwise interacting with its interface). The SMS text message may include one or more of the following: a warning message, the wearer's vital sign data, the wearer's current GPS location, and an indication as to whether emergency services (e.g., 911) have been called.

[0092] In some embodiments, during operation, the wearable oxygen monitor is positioned on a portion of a wearer's ear and is in continuous communication with a mobile application that is simultaneously running on the wearer's mobile computing device (e.g., via one or more wireless antennas, such as or The wearable oxygen monitor continuously or intermittently detects the wearer's oxygen level and heart rate over time and sends a signal to cause the wearer's detected oxygen level and heart rate to be displayed via a GUI of the wearer's mobile computing device. The display of the detected oxygen level and heart rate can be, for example, in the form of a graph, curve, or chart. The display can be dynamically updated in real time or approximately real time in response to new measurements of oxygen level and heart rate. As used herein, "approximately real time" can refer to an event that occurs immediately after a predicate event, adjusted for processing-related delays (e.g., calculation delays, transmission delays, etc.). When triggered, a warning can be displayed in the GUI along with or in lieu of the displayed data.

[0093] In some embodiments, the wearable oxygen monitor is an Internet of Things (IoT) device and includes an onboard Long Term Evolution (LTE) module / chip for 5G connectivity with other computing devices within the IoT.

[0094] In some embodiments, a first housing portion of a wearable oxygen monitor includes one or more air quality sensors, a speaker, a warning mechanism (e.g., an actuatable button), and a microphone. In some such embodiments, two or more of the microphone, speaker, and one or more air quality sensors "share" (i.e., are open to external air vents) a common opening in the shell / wall of the first housing portion, while the remainder of the shell / wall of the first housing portion and the entire outer shell / wall of the second housing portion are sealed and waterproof. The one or more air quality sensors may be configured to detect one or more of: biovolatile compounds (BVOCs), temperature, humidity, carbon monoxide, carbon dioxide, sulfur dioxide, nitrous oxide, particulate matter, ozone, and / or other gases. For example, in some embodiments, the one or more air quality sensors are configured to detect temperature, humidity, and one or more BVOCs, and output a relative "score" of the ambient air quality. Alternatively or additionally, the first housing portion may include, for example, a sensor for identifying the relative positions of multiple users (e.g., patients within a hospital). 5.1 Direction Finding Capability. The batteries described herein may be rechargeable or non-rechargeable. The body temperature sensor(s) described herein may include one or more thermal conductivity probes and / or one or more non-contact temperature sensors, such as thermopile infrared (IR) sensors.

[0095] In some embodiments, the first housing portion of the wearable oxygen monitor includes an analog processing circuit and / or one or more internal measurement sensors. The one or more internal measurement sensors may include, for example, one or more of the following: an altimeter, a gyroscope, an accelerometer, a GPS sensor, a magnetometer, a galvanic skin response (GSR) sensor, or a humidity sensor. The processor of the wearable oxygen monitor may be operably coupled to each of the analog processing circuit and the one or more internal measurement sensors.

[0096] Alternatively or additionally, in some embodiments, the memory of the wearable oxygen monitor stores instructions for causing the processor to detect that the wearer has interacted (e.g., pressed) with an alert mechanism of the wearable oxygen monitor (i.e., a manual alert), and in response to detecting that the alert mechanism has been interacted with, generate and send (via a wireless transceiver) a message to one or more emergency contacts stored in the memory (e.g., as part of an emergency plan stored therein). The memory may also store instructions for causing the processor to, in response to detecting that the alert mechanism has been interacted with, initiate a phone call to emergency services (911), activate a speaker, activate a microphone, emit a sound to indicate an alert, emit a light to indicate an alert, generate and send (via a wireless transceiver) an alert message to a mobile application for presentation to a user via a GUI of the user's computing device, and cause a warning record to be stored to the memory, the warning record including a date stamp, a time stamp, and measurement data collected from components of the wearable oxygen monitor (e.g., air quality sensor, photodetector, (one or more) body temperature sensor, (one or more) internal measurement sensor, etc.) at the time of the warning.

[0097] Alternatively or additionally, the memory may store instructions for causing the processor to compare a predetermined threshold stored in the memory with one or more measurements collected by one or more components of the wearable oxygen monitor. When the processor determines that one or more measurements are unexpectedly below or unexpectedly above the predetermined threshold, the processor may detect that an alarm condition exists. The memory may also store instructions for causing the processor to generate and send (via a wireless transceiver) a message to one or more emergency contacts stored in the memory in response to detecting the alarm condition (e.g., as part of an emergency plan stored therein). The memory may also store instructions for causing the processor to perform, in response to detecting the alarm condition: initiating a phone call to emergency services (911), activating a speaker, activating a microphone, emitting a sound to indicate an alarm, emitting light to indicate an alarm, generating and sending (via a wireless transceiver) a warning message to a mobile application for presentation to a user via a GUI of the user's computing device, and causing a warning record to be stored in the memory, the warning record including a date stamp, a time stamp, and measurement data collected from components of the wearable oxygen monitor (e.g., air quality sensor, photodetector, (one or more) body temperature sensor, (one or more) internal measurement sensor) at the time of the warning.

[0098] In some embodiments, to begin using the wearable oxygen monitor, the wearer positions the wearable oxygen monitor around a portion of the wearer's ear (e.g., an upper ear, such as the helix, scaphoid, or pinna of the ear) in a wearing configuration. In a first example wearing configuration, a first housing portion of the wearable oxygen monitor is in contact with or adjacent to an anterior surface or front surface of the ear, and a second housing portion of the wearable oxygen monitor is in contact with or adjacent to a posterior surface or back surface / rear surface of the ear. In a second example wearing configuration, a second housing portion of the wearable oxygen monitor is in contact with or adjacent to an anterior surface or front surface of the ear, and a first housing portion of the wearable oxygen monitor is in contact with or adjacent to a posterior surface or back surface / rear surface of the ear. In other words, when the wearable oxygen monitor is worn, the first housing portion and the second housing portion are positioned on opposite sides of the wearer's ear.

[0099] In some embodiments, a first light emitting diode of the wearable oxygen monitor may be configured to emit light having a first wavelength, and a second light emitting diode of the wearable oxygen monitor may be configured to emit light having a second wavelength different from the first wavelength.

[0100] Figure 12-Figure 48 is a wireframe of a user interface screen (for GUI display) of a mobile application (e.g., running on a mobile computing device) that interacts with a wearable oxygen monitor (e.g., with any of the wearable oxygen monitors described herein) in accordance with some embodiments. Fig.12 As shown in , a user of the mobile application (optionally, also a wearer of an associated wearable oxygen monitor, as shown and described herein) can create a user profile in the mobile application. Creation of a user profile can include specifying one or more medications that the user is currently taking or has taken in the past. The user interface can include a search bar in which the user can enter search criteria related to one or more medications, and by pressing ENTER, a search can be performed to match the search criteria. The results identified via the search can then be displayed for selection via the user interface. The user can "add" a medication to their user profile by clicking the "+" symbol next to the relevant medication. Fig.12 Also shown in FIG. 1 are available / navigable screens: Dashboard, Reports, Medical ID, Progress, and Log.

[0101] Fig.13It is shown that the creation of a user profile may also include specifying one or more symptoms that the user is currently experiencing or has experienced in the past. The user interface may include a search bar in which the user may enter search criteria related to one or more symptoms, and by pressing ENTER, a search may be performed to match the search criteria. The results identified via the search may then be displayed for selection via the user interface. The user may "add" a symptom to their user profile by clicking on the "+" symbol next to the relevant symptom. The user interface also includes an "Emergency" button that the user may select to trigger one or more warnings to be generated and / or sent. For example, selecting an “Emergency” button, similar to pressing the warning mechanism of the wearable oxygen monitor described herein, can trigger one or more of: generating and sending a message to one or more emergency contacts (e.g., stored as part of an emergency plan), initiating a telephone call to emergency services (911), activating a speaker phone on the mobile computing device, emitting a sound to indicate an alarm, emitting light (e.g., of a predetermined color and / or in a predetermined pattern) to indicate an alarm, displaying a warning message via a user interface, and causing storage of a warning record in a memory that includes a date stamp, a time stamp, and measurement data collected from components of the wearable oxygen monitor. Fig.14 An alert and notification user interface is shown, via which a user can use a slider to turn alerts and notifications on or off.

[0102] Figure 15-19 A welcome screen describing the functionality of the mobile application is shown, and the user can register for the service via the welcome screen (see Fig.16 ), log in, set up and personalize the mobile application. The mobile application can be personalized, for example to include a representation of one or more safe blood oxygen saturation (SpO2) thresholds, so that when the wearer's SpO2 is detected as too low by the wearable oxygen monitor, an alert or warning is generated. Fig. 20 A synchronous request is shown, where the mobile application requests the user's input ("OK") to authorize the mobile application to establish Connect and via Connect with the Wearable Oxygen Monitor Sync ("Sync") mobile app. The UI during sync looks like this: Fig.21 Shown in. Fig. 22 The login screen is shown, and Fig.23 An option is shown for the user to "get started", such as after the user's first login event. Figure 24-Figure 36A user interface for a questionnaire is shown that requests input from the user regarding whether they are from the United States, what the emergency thresholds for oxygen levels, heart rate, altitude, and air quality should be, settings (alerts and notifications, location services, unit preferences, language preferences, app sync, and other personalization), profile data (name, age, sex, weight, pulmonary hypertension (PH) classification (e.g., pulmonary arterial hypertension (PAH), PH due to left heart disease, COPD, chronic thromboembolic pulmonary hypertension (CTEPH), or PH with unclear multifactorial mechanisms), safety thresholds, medications, and allergies / reactions), diary personalization, emergency information (emergency contacts, doctor instructions, EMS instructions), sex, month and year of birth, weight, whether they have cardiovascular disease, and whether they have PH (and if so, what the World Health Organization (WHO) classification is). Fig.34 shows a login screen, which can be accessed by a user Figure 24-Figure 33 and Figure 35-Figure 36 Before you complete any of the following, or after you set up your user account or complete Fig. 22 After the "registration" process referred to in (e.g. by answering Figure 24-Figure 33 and Figure 35-Figure 36 The questionnaire questions shown in the ) were completed.

[0103] Fig.37 A developer test module screen is shown with a battery level indication and current oxygen level (percentage) and heart rate (beats per minute, BPM) readings. Fig.38 The current blood oxygen saturation level (percent) and heart rate (beats per minute, BPM) readings are shown, as well as the current altitude (feet), humidity (percent), air quality index (e.g., good, moderate, poor), and barometric pressure (inches of mercury (Hg)). Fig.39 A user interface is shown via which a user can select which metrics they wish to display on their dashboard page. Fig.40 An example log entry for the day is shown, with date, time, SpO2, heart rate, altitude, air quality index, barometric pressure, and humidity values ​​(e.g., average, high, etc.), as well as medications taken that day (if any), symptoms experienced that day (if any), and a user-entered note (if any). Fig.41 A location services user interface is shown via which a user can use a slider to turn location services (eg, GPS location) on or off. Fig.42 A user interface is shown that is accessible to a user with a premium account, or that provides a user with the option to register for a premium account, for example. A premium account may provide the user with access to features such as predictive analytics, detailed report generation, and presentation of weekly and monthly vital signs via a mobile application dashboard. Fig.43 is a user interface showing a populated Medical ID tab. Fig.44 is a user interface showing current oxygen level (percentage) and heart rate (BPM) readings as well as a resettable timer. Fig.45 is a user interface showing user-selectable options for report generation, including time frame, vital signs of interest, and report format (e.g., or ). Fig.46 A safety threshold user interface is shown via which a user can use a slider to set a threshold percentage SpO2 value and select "Done" when finished. Fig.47 is a user interface showing settings after the security threshold has been set and the premium account has been established (with Fig.26 , which does not include safety thresholds or OxiWear advanced line items). Fig.48 is a user interface showing an example landing screen that may be displayed when a mobile application is first launched / opened (ie, the first screen a first time user will see and via which he / she may register an account).

[0104] Fig.49 A user interface is shown that includes a warning sub-window disposed on a control panel window, the warning sub-window being displayed in response to one or more SpO2 indicators being below a predetermined threshold. In at least some embodiments, the predetermined threshold is specified by a user, such as Fig.60 . The alert subwindow includes a user interface that includes one or more buttons with which a user can interact. For example, a user can interact with a snooze button to suppress the alert subwindow (e.g., for a predefined time period, such as 5 minutes, 10 minutes, 30 minutes, etc.). A user can also interact with a "Call 911" button that is configured to initiate a telephone call to an emergency dispatch office. Fig.50 A control panel depicting multiple measurements is shown, including biometric measurements of the user and factors associated with or contributing to the user's oxygen level. For example, the multiple measurements may include one or more live biometric readings of SpO2 blood oxygen level and / or heart rate. The multiple measurements may also include one or more environmental measurements of altitude, air quality index, humidity, and / or air pressure. The control panel may also depict a record of one or more previous measurements in graphical form. For example, multiple SpO2 and heart rate measurements sampled within the previous hour (or any other desired previous time period) may be plotted on a graph, and the graph may be updated in real time or approximately real time in response to new measurements of oxygen level and heart rate.

[0105] Fig.51 A user interface is shown that includes a monthly / calendar view of a user's diary entries. The user can use e.g. Fig.40 , to enter a log entry for a particular day using the interface shown in . The log entry may include the date, time, SpO2, heart rate, altitude, air quality index, barometric pressure and humidity values ​​(e.g., average, high, etc.), as well as medications taken that day (if any), symptoms experienced that day (if any), exercises and / or physical activities completed (if any), and user-entered instructions (if any). The user can interact with the calendar for a given month to view any log entries entered on a day in the given month. The user can also use the calendar to select a day to enter a new log entry by interacting with the "+" icon or similar interface / GUI element. The user can also use the calendar to search for previous log entries (e.g., using a keyword search, interacting with a magnifying glass icon or similar interface / GUI element).

[0106] Fig.52 A user interface is shown that includes views of detected oxygen level and heart rate. The views may be in the form of, for example, graphs, drawings, or charts. One view may depict real-time readings that may be dynamically updated in real time or approximately real time in response to new measurements of oxygen level and heart rate. A second view may depict a plurality of detected oxygen levels, heart rates, and / or other measurements measured over a period defined by a user via the GUI. The period may include past time periods and / or past dates / ranges (i.e., historical data / readings) for which measurements were recorded.

[0107] Fig.53 A user interface for viewing and configuring reports is shown. The report may include measurements collected over a period defined by a user. The report may include at least one of a plurality of vital / biometric measurements and / or a plurality of environmental measurements. For example, the report may include a plurality of SpO2, heart rate, and altitude measurements recorded or otherwise captured over a given period. The time period may include a past date (or date range) and / or time (or time range) defined by the user via the GUI. The user may download the report (e.g., as a file for viewing and / or local storage) and / or may generate and send an email containing the report via the user interface.

[0108] Fig.54 A user interface is shown through which a user can access multiple settings. The settings may include, for example, ID security settings, warning and notification toggles, location access settings, wireless communication protocol related and similar device connection settings, threshold settings, and / or SOS / emergency notification settings. The user interface may be configured to provide the user with access to a GUI to edit the user's profile, such as Fig.59 The user interface may also provide a button that the user may use to delete the user's account.

[0109] Fig.55 A user interface is shown through which a user can configure one or more connections between two or more devices. The devices may include, for example, one or more wearable oxygen devices and a mobile device (e.g., a smartphone, tablet computer, laptop computer, smart watch, or similar computing device). The mobile device may be a device that displays Fig.55 The one or more connections may include, for example, using one or more wireless communication protocols (e.g., One or more network connections (such as Fig.54 Interact with the interface shown in to access the user interface.

[0110] Fig.56 A user interface for configuring SOS / emergency notification alerts is shown. The SOS alert may include a text alert sent to one or more contacts defined by the user using the user interface. The text alert may include an SMS text message. The user may use, for example, Fig.54 to access the user interface.

[0111] Fig.57 A user interface for configuring ID security is shown. A user may use the user interface to configure / specify a user's email address, which may be used to contact and / or identify the user. A user may also use the user interface to update a password for account access and / or update a subscription plan associated with the user's account. A user may use, for example, Fig.54 to access the user interface.

[0112] Fig.58 A user interface for configuring location access associated with a mobile application configured for use with one or more wearable oxygen devices is shown. A user can configure location access to provide data indicating the user's geographic location to one or more programs associated with the wearable oxygen device. The user can use, for example, Fig.54 to access the user interface.

[0113] Fig.59A user interface for configuring a user profile is shown. The user interface may include a name field, a gender field, a birthday field, a weight field, and / or a height field. The user interface may also be used to populate information about the primary user of one or more wearable oxygen devices. The user may use, for example, Fig.54 to access the user interface.

[0114] Fig.60 A user interface for configuring an SpO2 threshold to trigger an alert is shown. A user may set the SpO2 threshold between, for example, 92% and 97%. The threshold may trigger, for example Fig.49 The user interface may include interactive elements, such as sliders, drop-down menus, radio buttons, or any other graphic or text-based elements, with which the user can interact to set the SpO2 threshold. The user can use, for example, Fig.54 to access the user interface.

[0115] Figure 61A-Figure 61N A flexible electronic assembly for a wearable oxygen monitor according to some embodiments (e.g., Figure 7A-7C Presentation of various configurations of the electronic device 760) illustrating the foldability / flexibility of the assembly and its components.

[0116] In some embodiments, a method of manufacturing an ear wearable device includes bonding an electronic board to an ear pad using at least one of silicone or epoxy such that the electronic board is secured to the ear pad within a cavity defined in a surface of the ear pad, and attaching the ear pad to a chassis.

[0117] Additional details regarding embodiments of the wearable oxygen monitor described herein can be found, for example, in Appendices A through D appended to this disclosure.

[0118] Wearable Oxygen Monitor Applications - COVID-19

[0119] The novel coronavirus (coronavirus disease 2019 (COVID-19)) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that disrupts the function of many organ systems and has caused hundreds of deaths to date. COVID-19 affects the respiratory system, with effects ranging from mild upper respiratory tract symptoms to pneumonia and acute respiratory distress syndrome. One potential symptom caused by COVID-19 is silent hypoxia, in which patients experience below-average (or "low") tissue and blood oxygen saturation but do not experience dyspnea. Although the mechanism of silent hypoxia is unclear, the phenomenon deserves high clinical and public health attention. In terms of public health, silent hypoxia presents at least two problems: 1) infected individuals may develop more severe disease states but may not know that they are COVID-positive; 2) infected silent hypoxic patients may become vectors for infecting those around them ("asymptomatic transmission"). For patients with hypoxia, continuous blood oxygen saturation monitoring is important. Therefore, it is desirable to have a smart, portable, and wearable device that can provide real-time SpO2 monitoring and alert the user when the user's SpO2 level drops below an acceptable level.

[0120] One or more embodiments of the wearable blood oxygen monitor described herein can perform robust blood oxygen saturation level monitoring for a variety of applications, including: identifying patients with silent hypoxia; helping to alert healthcare providers to patients at risk for serious disease progression; enhancing existing COVID-19 diagnostic platforms such as nasopharyngeal swabs; preventing the spread of COVID-19; assisting healthcare providers in coordinating care; and monitoring one or more of the multiple health conditions described in detail below. Normal blood oxygen saturation levels are approximately 95%. When a patient's blood oxygen saturation falls below this threshold, the patient's organ systems (especially the brain) may not receive enough oxygen, which can cause confusion or drowsiness. If oxygen levels drop below 80%, there is a risk of severe damage to vital organs that may result in death.

[0121] Silent hypoxia has been reported in patients with COVID-19. According to Dr. Richard Levitan, an emergency physician at Bellevue Hospital in New York City, those with silent hypoxia from COVID did not have difficulty breathing until the day they arrived at the hospital. This suggests that despite a period of COVID-induced hypoxia, some COVID-19 patients are completely asymptomatic, suggesting that silent hypoxia patients may be able to spread the infection to others and also progress to more severe stages of COVID-19.

[0122] Continuous oximetry monitoring is desirable to protect vulnerable populations and facilitate the early detection of low oxygen saturation. High-sensitivity monitoring can help ensure that patients receive medical assistance before their condition worsens, thereby improving patient outcomes and helping healthcare systems manage the current pandemic burden.

[0123] COVID-19 symptoms and risk factors

[0124] Fever, defined by the Centers for Disease Control and Prevention as a temperature above 100.4 degrees Celsius, is the most common symptom associated with COVID-19 among the public. However, an analysis of clinical observations at Northwell Health, New York's largest provider system, showed that only 30.7% of patients diagnosed with COVID-19 were clinically febrile. The weak correlation between fever and infection suggests that the presentation of COVID-19 is very variable and that providers should screen patients for multiple parameters when assessing the presence or severity of infection.

[0125] Although the relationship between fever and infection is unclear, clinical studies have defined specific risk factors that may make patient populations more susceptible to severe infection. Based on observations of COVID-19 positive patients at Northwell Health, 56.6% had a history of hypertension, 41.7% had a history of obesity, and 33.8% had diabetes. The strong association between chronic pre-existing conditions and COVID-19 hospitalization emphasizes the desirability of robust surveillance, particularly in high-risk populations.

[0126] Clinical observations also raise the desirability of prognostic markers for COVID-19, which could help ensure that patients are treated earlier and more aggressively and help prevent progression to mechanical ventilation, which is associated with significantly higher mortality. In conjunction with the planned reopening of workplaces and schools, some entities are planning to use thermal scanners to flag febrile individuals. However, afebrile individuals, despite not displaying the baseline symptoms of COVID-19, may still serve as vectors for infection transmission. More expensive symptom tracking may help curb the spread of COVID-19.

[0127] Risk of COVID-19 and the significance of hypertension in older adults

[0128] Individuals aged ≥65 years are overrepresented in the composition of COVID-19 infections, hospitalizations, ICU admissions, and deaths. The greater toll of COVID-19 on older adults has greatly facilitated the implementation of social distancing and other public health measures aimed at slowing the spread of the disease. The strong association between COVID-19 and hypertension is thought to play a central role in the overrepresentation of older patients among infected patients. 63.1% of adults aged ≥60 years have hypertension, and many in this patient population use angiotensin-converting enzyme (ACE) inhibitors to lower blood pressure. Continued use of ACE inhibitors may contribute to increased expression of ACE-2 receptors in cardiovascular, renal, gastrointestinal, and pulmonary organ systems. Because SARS-CoV-2 is thought to enter cells via the ACE-2 receptor, upregulation of ACE-2 in disproportionately older hypertensive patients may increase their disease burden.

[0129] Nosocomial transmission of COVID-19 in high-risk patients

[0130] Dr. Shu-Yuan Xiao, a gastroenterologist affiliated with the University of Chicago Medicine, studied two patients at Zhongnan Hospital in Wuhan, China. The patients who underwent lung resection for adenocarcinoma were found to have COVID-19 during surgery. Pathology reports showed that both patients had pulmonary edema and alveolar inflammation characteristic of pneumonia. At the time of surgery, neither patient had symptoms of pneumonia, suggesting that the patients were still in the early stages of disease progression. The unexpected cases of pneumonia in a patient population reported for surgical procedures in non-COVID settings illustrates the risk of asymptomatic patients becoming carriers to healthcare providers and other patients in the hospital. To combat the spread of COVID-19 in healthcare settings, it is desirable to actively monitor for symptoms to isolate patients suspected of being positive.

[0131] Silent hypoxia: a clinical dilemma

[0132] Hypoxemia refers to below-average blood oxygenation, while hypoxia is a clinical state of reduced tissue oxygen tension. Clinically, normal arterial oxygen saturation is designated as between 94% and 100%. Reduced blood and tissue oxygenation disrupts cellular metabolism, growth, and development. Healthcare professionals routinely consider hypoxia to be consistent with symptoms of respiratory distress such as shortness of breath. However, the clinical presentation of COVID-19 partially contradicts this understanding. Dr. Richard Levitan, a volunteer emergency medical provider at Bellevue Hospital in New York, reported cases in which patients did not report respiratory discomfort in the days prior to hospital admission despite imaging-confirmed viral pneumonia and below-average blood oxygen saturation. These cases document a phenomenon known as "silent hypoxia." The following table lists the above-mentioned category levels of hypoxemia:

[0133]

[0134] COVID-19 binds to receptors on alveolar cells, which produce surfactant. Surfactants disrupt the surface tension of water within the alveoli, thereby preventing the alveolar spaces from collapsing after exhalation. The infection leads to a decrease in surfactant production and collapse of the air spaces. White blood cells, or leukocytes, produce an inflammatory response within the alveoli. Leukocytes also release cytokines that promote fluid leakage from the lung microvasculature into the spaces surrounding the alveoli. The accumulation of fluid also leads to alveolar collapse. Alveolar collapse reduces the interface for oxygen to diffuse into the bloodstream, leading to hypoxemia. At this stage in the progression of the disease, the compliance of the lungs may remain unchanged. Therefore, patients may still be able to exhale normal amounts of carbon dioxide, which prevents the onset of dyspnea—making them “silently hypoxic.” In some cases, the accumulation of fluid and inflammation progresses to the point where total lung capacity is reduced, which impedes the removal of carbon dioxide and leads to dyspnea. This transition can be rapid and necessitate ventilatory assistance, which can be a burden on the healthcare system overall.

[0135] COVID-19 and ARDS

[0136] Acute respiratory distress syndrome (ARDS) is characterized by the acute development of pulmonary edema, hypoxia, and subsequent dependence on mechanical ventilation. ARDS is an important cause of respiratory failure and was evident in 10% of patients in the ICU before the advent of COVID-19. Unlike conditions of silent hypoxia, ARDS is associated with decreased exhalation of carbon dioxide resulting in increased shortness of breath. Severe damage to the alveolar cells of the lungs leads to ARDS. Alveolar damage results in increased permeability of the alveoli to fluid, a process mediated by inflammatory signals called cytokines. Disease progression may lead to extensive lung scarring and adverse changes in lung compliance.

[0137] ARDS is of particular relevance to COVID-19. A retrospective clinical study of 107 patients in Wuhan, China, showed that 26.2% of all COVID patients had ARDS. Among COVID patients who died, 78.9% reported ARDS. Another Wuhan clinical study showed that patients developed ARDS between 8 and 15 days after onset. Seemingly benign hypoxia in "silent hypoxia" may progress to ARDS, which can be fatal for COVID patients. Therefore, robust monitoring of blood oxygen saturation can alert patients to hypoxia before the onset of ARDS, potentially improving outcomes and helping providers organize care.

[0138] Clinical management of ARDS

[0139] Severe inflammation and fluid accumulation within the lungs of ARDS patients can lead to advanced pulmonary fibrosis, which may eventually cause the lung to collapse completely. According to the American Thoracic Society, ARDS is associated with a 30-40% mortality rate. In patients who recover, lung function may gradually recover over a process that takes between six months and a year. However, this recovery is only partial as surviving patients will have below-average lung capacity and residual lung fibrosis. According to Dr. Gregory Cosgrove, chief medical officer of the Pulmonary Fibrosis Foundation, patients who survive ARDS may have a reduced quality of life, which may lead to anxiety, depression, and / or PTSD. Therefore, it is desirable that clinical workflows include symptom monitoring to rapidly identify patients with mild COVID-19 symptoms who may progress to a more serious condition such as ARDS.

[0140] Coagulation and silent hypoxia

[0141] As awareness of silent hypoxia in COVID-19 patients has increased, theories about the origins of the phenomenon have emerged that seem to contradict medical practice. Dr. Elnara Marcia Negri, a pulmonologist in Sao Paulo, Brazil, has highlighted the role of coagulation in inducing the silent hypoxic state in COVID-19 patients. According to Negri, an inflammatory response within the lung vessels may lead to blood clot formation in COVID-19 patients. Increased blood clot formation interferes with the diffusion of oxygen from the alveoli into the bloodstream, leading to hypoxia. Negri gave heparin, a common anticoagulant, to patients with hypoxia, regardless of whether they showed symptoms. According to Negri, 24 of the 27 patients have recovered, which supports her theory. Negri recommends that patients monitor their blood oxygen saturation levels regularly and go to the hospital if their blood oxygen saturation levels drop below 93%.

[0142] Anoxic stroke in COVID-19

[0143] A large vessel stroke is a condition in which blood flow to one of the major arteries that perfuse the brain is interrupted. The interruption in blood flow reduces the availability of oxygen to the brain. Doctors affiliated with Mount Sinai Health System in New York reported five strokes in COVID-19 positive patients under the age of 50. And a retrospective review of data from Wuhan showed that the incidence of stroke among COVID-19 patients is about 5%.

[0144] Furthermore, the average age of COVID-19 patients with stroke in Wuhan was 55 years, suggesting that COVID-19-related stroke poses a distinct risk to a slightly younger patient population. Doctors attribute the incidence of stroke in COVID-19 patients to the role of the infection in inducing dysfunction of the endothelial cells that line the inside of blood vessels. The association of COVID-19 with other serious pathologies such as large vessel stroke underscores the desirability of robust monitoring of blood oxygen saturation.

[0145] Known flaws in COVID-19 diagnostics

[0146] Cleveland Clinic researchers have investigated the efficacy of existing diagnostic technologies for identifying COVID-19 positive patients. These diagnostic tests include Abbot's ID NOW machine, which is said to produce results in 15 minutes. According to the study, the false negative rate of ID NOW was 14.8% and the true positive rate was 85.2%. The results of the study suggest that about 15% of positive patients would be incorrectly labeled as not infected using the ID NOW test. The study also investigated the DiaSorin Simplexa test, which had a true positive rate of 89.3%. According to Dr. Gary Procop, the head of COVID-19 testing at Cleveland Clinic, diagnostic tests should have a true positive rate of at least 95% to assure the public of the effectiveness of the test. While the diagnostic platforms made by Roche and Cepheid have an accuracy rate higher than 95%, the sub-threshold accuracy of the DiaSorin Simplexa and ID NOW platforms shows that there are still gaps that continue to remain in the field of COVID-19 diagnosis. The challenges of COVID-19 testing make the monitoring of other clinical variables such as blood oxygen saturation more important. It is possible that robust oxygen monitoring could be used to supplement conventional nasopharyngeal swab testing to produce higher accuracy in COVID-19 diagnosis, thereby rapidly identifying patients who require medical assistance.

[0147] Known monitoring options to combat silent hypoxia: pulse oximetry

[0148] Given the possibility that patients could experience severe hypoxia before they develop breathing difficulties, some medical providers have called for widespread use of pulse oximeters. Pulse oximeters can provide patients with a noninvasive way to monitor their oxygen saturation levels, alerting them to hypoxia even if they report no other symptoms. Pulse oximeters include a light-emitting sensor that can be clipped onto a patient's finger. Patients who use pulse oximeters at home can consult with their healthcare provider to help them understand their oxygen saturation levels. Noting the case of silent hypoxia, Dr. Levitan, an emergency physician at Bellevue Hospital, called for all COVID-19-positive patients to have their oxygen saturation checked routinely within two weeks of diagnosis. It may also be prudent to monitor oxygenation in patients who have not yet been diagnosed but have symptoms of cough, fatigue and / or fever.

[0149] Known pulse oximeters (such as finger clips) may be useful for patient assessment, but are often difficult to transport and / or use. Some pulse oximeters (such as the Nonin Onyx) are bulky and may fall off during patient transportation or due to daily activities (such as getting up, sitting down, and wiggling fingers). In addition, some patients may have a weak pulse or tissue damage, which may distort the measurement results. Other known wearable devices only provide measurements at the wrist, and such devices generally do not provide oxygen monitoring or related alerts. Instead, such devices measure pulse and health-related measurements such as steps and sleep time.

[0150] In the case of COVID-19, pulse oximeter cuffs are often not provided and / or used for continuous monitoring. In cases of silent hypoxia, when the patient does not feel any respiratory distress, the patient may not check their blood oxygen saturation level and be unaware of their hypoxia for a long time.

[0151] As described above, blood oxygen saturation is a valuable biomarker for COVID-19 for both symptomatic and asymptomatic individuals. Embodiments of the wearable oxygen monitor described herein facilitate continuous monitoring of blood oxygen saturation levels via measurements taken on the wearer's ears (e.g., helix, scaphoid, pinna, etc.) using relevant measurement data displayed via a mobile software application. When the wearer's SpO2 level drops below an acceptable level, an alarm is generated and transmitted to the wearer (e.g., via one or more of an audio indication, a light indication, a GUI display, etc.). In addition, the wearer can trigger an emergency services call by clicking a button on the wearable oxygen monitor.

[0152] All combinations of the above concepts and additional concepts discussed herein (provided that these concepts are not mutually inconsistent) are considered part of the subject matter disclosed herein. The meanings given to the terms explicitly used herein (which may also appear in any disclosure incorporated by reference) should be most consistent with the specific concepts disclosed herein.

[0153] The drawings are primarily for illustrative purposes and are not intended to limit the scope of the subject matter described herein. The drawings are not necessarily drawn to scale; in some instances, various aspects of the subject matter disclosed herein may be exaggerated or enlarged in the drawings to facilitate understanding of different features. In the drawings, like reference numerals generally refer to like features (e.g., functionally similar and / or structurally similar elements).

[0154] The entire content of this application (including cover page, title, title, background, content of the invention, description of the drawings, specific implementation, embodiment, summary, drawings, appendix, etc.) shows various embodiments in an explanatory manner, wherein the embodiment can be put into practice. The advantages and features of the present application are only representative examples of embodiments, and are not exhaustive and / or exclusive. On the contrary, they are presented to help understand and teach the embodiments, and they do not represent all embodiments. Therefore, some aspects of the present disclosure are not discussed herein. Alternative embodiments may not be presented for a specific part of the innovation, or other alternative embodiments not described may be used for a certain part, and should not be considered to exclude such alternative embodiments from the scope of the present disclosure. It should be understood that many of these undescribed embodiments combine the same principles of innovation, and others are equivalent. Therefore, it should be understood that other embodiments can be utilized, and functional, logical, operational, organizational, structural and / or topological modifications can be performed without departing from the scope and / or spirit of the present disclosure. Therefore, throughout the present disclosure, all examples and / or embodiments are considered to be non-restrictive.

[0155] Furthermore, embodiments discussed herein should not be inferred relative to embodiments not discussed herein, except for the purpose of reducing space and repetition. For example, it should be understood that the logic and / or topology of any combination of any program component (assembly of components), other components, and / or any existing feature set as described in the drawings and / or throughout the text is not limited to a fixed order of operations and / or configuration, but rather, any disclosed order is exemplary, and all equivalents, regardless of their order, are contemplated by the present disclosure.

[0156] The term "automatically" is used herein to modify actions that occur without direct input or prompting from an external source (such as a user). Automatically occurring actions may occur periodically, sporadically, in response to a detected event (e.g., user login), or according to a predetermined schedule.

[0157] As used herein, the term "substantially" has a meaning similar to "mostly" or "to a large extent." For example, the phrase "substantially uniform thickness" refers to a thickness value with a range of plus or minus 10%.

[0158] The term "determining" includes a variety of actions, and thus, "determining" may include calculating, figuring out, processing, deriving, investigating, searching (e.g., searching in a table, database, or other data structure), and confirming, etc. Also, "determining" may include receiving (e.g., receiving information) and accessing (e.g., accessing data in a memory), etc. Also, "determining" may include resolving, selecting, choosing, and establishing, etc.

[0159] Unless expressly specified otherwise, the phrase “based on” does not mean “based only on.” In other words, the phrase “based on” describes both “based only on” and “based at least on.”

[0160] The term "processor" should be interpreted broadly to include general-purpose processors, central processing units (CPUs), microprocessors, digital signal processors (DSPs), controllers, microcontrollers, state machines, etc. In some cases, a "processor" may refer to an application-specific integrated circuit (ASIC), a programmable logic device (PLD), a field-programmable gate array (FPGA), etc. The term "processor" may refer to a combination of processing devices, for example, a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0161] The term "memory" should be interpreted broadly to include any electronic component capable of storing electronic information. The term memory may refer to various types of processor-readable media, such as random access memory (RAM), read-only memory (ROM), nonvolatile random access memory (NVRAM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable PROM (EEPROM), flash memory, magnetic or optical data storage, registers, and the like. A memory is said to be in electronic communication with a processor if the processor can read information from and / or write information to the memory. Memory that is integrated into a processor is in electronic communication with the processor.

[0162] The terms "instructions" and "code" should be broadly interpreted to include any type of (one or more) computer-readable statements. For example, the terms "instructions" and "code" may refer to one or more programs, routines, subroutines, functions, procedures, etc. "Instructions" and "code" may include a single computer-readable statement or many computer-readable statements.

[0163] Some embodiments described herein relate to computer storage products with non-transitory computer-readable media (also referred to as non-transitory processor-readable media) having instructions or computer codes thereon for performing various computer-implemented operations. Computer-readable media (or processor-readable media) are non-transitory because they do not themselves include transient propagating signals (e.g., propagating electromagnetic waves that carry information on a transmission medium such as space or cables). The media and computer code (also referred to as code) may be codes designed and constructed for a specific purpose. Examples of non-transitory computer-readable media include, but are not limited to: magnetic storage media such as hard disks, floppy disks, and magnetic tapes; optical storage media such as compact disks / digital video disks (CD / DVD), compact disk read-only memories (CD-ROMs), and holographic devices; magneto-optical storage media such as optical disks; carrier signal processing modules; and hardware devices specifically configured to store and execute program codes, such as application specific integrated circuits (ASICs), programmable logic devices (PLDs), read-only memories (ROMs), and random access memory (RAM) devices. Other embodiments described herein relate to computer program products, which may include, for example, instructions and / or computer codes discussed herein.

[0164] Some embodiments and / or methods described herein may be implemented by software (implemented on hardware), hardware, or a combination thereof. Hardware modules may include, for example, general purpose processors, field programmable gate arrays (FPGAs), and / or application specific integrated circuits (ASICs). Software modules (implemented on hardware) may be implemented in languages ​​including C, C++, Java, and the like. TM , Ruby, Visual Basic TM The computer code may be expressed in various software languages ​​(e.g., computer code) of object-oriented, procedural or other programming languages ​​and development tools. Examples of computer code include, but are not limited to, microcode or microinstructions, machine instructions such as those generated by a compiler, codes for generating web services, and files containing higher-level instructions executed by a computer using an interpreter. For example, embodiments may be implemented using imperative programming languages ​​(e.g., C, Fortran, etc.), functional programming languages ​​(Haskell, Erlang, etc.), logical programming languages ​​(e.g., Prolog), object-oriented programming languages ​​(e.g., Java, C++, etc.), or other suitable programming languages ​​and / or development tools. Other examples of computer code include, but are not limited to, control signals, encryption codes, and compression codes.

[0165] Various concepts can be embodied as one or more methods providing at least one example. The actions performed as part of the method can be sorted in any suitable manner. Therefore, embodiments that perform actions in a sequence different from that shown can be constructed, and these embodiments can include performing some actions simultaneously, even if shown as sequential actions in the illustrative embodiments. In other words, it should be understood that these features are not necessarily limited to a specific execution order, but any number of threads, processes, services and / or servers, etc. can be performed serially, asynchronously, concurrently, in parallel, simultaneously and / or synchronously in a manner consistent with the present disclosure. Therefore, some of these features may contradict each other because they cannot appear in a single embodiment at the same time. Similarly, some features are applicable to an aspect of innovation and are not applicable to other aspects.

[0166] In addition, the present disclosure may include other innovations not currently described. Applicants reserve all rights to such innovations, including the right to implement such innovations, submit additional applications, their continuations, partial continuations and / or divisions, etc. Therefore, it should be understood that the advantages, embodiments, examples, functions, features, logic, operations, organizations, structures, topologies and / or other aspects of the present disclosure should not be regarded as limitations on the present disclosure defined by the embodiments or limitations on the equivalents of the embodiments. Depending on the specific expectations and / or characteristics of individual and / or business users, database configurations and / or relational models, data types, data transmission and / or network frameworks, grammatical structures, etc., the various embodiments of the technology disclosed herein can be implemented in a manner that enables a large amount of flexibility and customization as described herein.

[0167] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0168] As used herein, in particular embodiments, the term "about" or "approximately" preceding a numerical value indicates a range of plus or minus 10% of that value. Where a range of values ​​is provided, it is understood that each intervening value to one-tenth of a unit of the lower limit between the upper and lower limits of the range and any other stated or intermediate values ​​within the stated range are included in the disclosure unless the context clearly dictates otherwise. The upper and lower limits of these smaller ranges may be independently included in the smaller ranges, which are also included in the disclosure, subject to any explicitly excluded limitations in the stated ranges. Where the stated range includes one or both of the limits, ranges excluding one or both of those included limits are also included in the disclosure.

[0169] Unless expressly stated to the contrary, the indefinite articles "a", "an" and "a" used in the specification and the examples are to be understood to mean "at least one".

[0170] The phrase "and / or" as used herein in the specification and examples should be understood to mean "either or both" of the elements so connected (i.e., elements that appear in conjunction in some cases and separately in other cases). Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" of the elements so connected. In addition to the elements explicitly identified by the "and / or" clause, other elements may optionally be present, whether or not related to the explicitly identified elements. Thus, as a non-limiting example, when used in conjunction with open language such as "comprising", reference to "A and / or B" may mean: in one embodiment, only A (optionally including elements other than B); in another embodiment, only B (optionally including elements other than A); in yet another embodiment, A and B (optionally including other elements); and so on.

[0171] As used herein in the specification and the embodiments, "or" should be understood to have the same meaning as "and / or" defined above. For example, when separating the items in the list, "or" or "and / or" should be interpreted as including, i.e. including at least one of several elements or element lists but also including more than one, and, optionally including additional unlisted items. Only explicitly indicated as opposite terms (such as "only one of" or "exactly one of" or "consisting of when used in the embodiments) refer to including exactly one of several elements or element lists. Generally speaking, when the front is an exclusive term such as "any one", "one of" or "exactly one of", the term "or" used herein should only be interpreted as indicating exclusive alternatives (i.e. "one or another, but not both"). "Substantially consisting of" used in the embodiments should have the general meaning used in the field of patent law.

[0172] As used herein in the specification and in the examples, with respect to a list of one or more elements, the phrase "at least one" should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but does not necessarily include at least one of each element specifically listed in the list of elements, nor does it exclude any combination of elements in the list of elements. This definition also allows that elements other than the elements specifically identified in the list of elements mentioned by the phrase "at least one" may optionally be present, whether or not they are related to those specifically identified elements. Thus, as a non-limiting example, "at least one of A and B" (or, equivalently, "at least one of A or B", or equivalently "at least one of A and / or B") may mean: in one embodiment, at least one, optionally including more than one A, without the presence of B (and optionally including elements other than B); in another embodiment, at least one, optionally including more than one B, without the presence of A (and optionally including elements other than A); in yet another embodiment, at least one, optionally including more than one A, and at least one, optionally including more than one B (and optionally including other elements); and so on.

[0173] In the embodiments, as well as in the above description, all transitional phrases (such as "includes," "comprising," "carrying," "having," "containing," "involving," "holding," "consisting of," etc.) should be understood as open-ended, i.e., meaning including but not limited to. Only the transitional phrases "consisting of" and "consisting substantially of" shall be closed or semi-closed transitional phrases, respectively, as described in Section 2111.03 of the Manual of Patent Examining Procedures of the United States Patent Office.

Claims

1. A device comprising: The first main part includes: processor, a memory operatively coupled to the processor, at least one light emitting diode operably coupled to the processor, and at least one optical sensor configured to detect a reflected portion of light emitted from the at least one light emitting diode during operation; a second body portion, the second body portion comprising a collar; and a connecting portion, the connecting portion being arranged between the first main body portion and the second main body portion, The memory stores instructions for causing the processor to: causing light to be emitted from the at least one light emitting diode when the device is positioned on the ear of a wearer and during operation of the device, and The wearer's blood oxygen saturation level is calculated based on the reflected portion of the light.

2. The device according to claim 1, wherein: The second body portion also includes flexible ear pads.

3. The device according to claim 1, wherein: The first body portion includes a flexible ear pad.

4. The apparatus of claim 1 further comprising a vibration motor operably coupled to the processor, the memory further storing instructions for operating the vibration motor in response to detecting an event.

5. The device according to claim 4, wherein: The event includes at least one of the following: An alarm condition is detected; A low battery condition is detected; or Successful positioning of the device on the wearer's ear is detected.

6. The device according to claim 1, wherein: The connecting member includes nylon.

7. The device according to claim 1, wherein: The first body portion includes a flexible ear pad, and the at least one optical sensor is positioned within a cavity defined in the flexible ear pad.

8. The device according to claim 7, wherein: The at least one optical sensor is fixed within the cavity by epoxy resin.

9. The device according to claim 1, wherein: The processor and the memory are positioned on a circuit board, and the at least one optical sensor is electrically coupled to the circuit board via a flexible conductor.

10. The device according to claim 9, wherein: The flexible conductor is substantially S-shaped.

11. The apparatus of claim 1 , further comprising at least one of a microphone or a speaker operably coupled to the processor, the memory further storing instructions for causing the processor to activate at least one of the microphone or the speaker in response to detecting an alarm condition.

12. The apparatus of claim 1 further comprising a wireless transceiver operably coupled to the processor and configured to communicate with a mobile software application, the memory further storing instructions for causing the processor to send a signal representing measurement data to the mobile software application via the wireless transceiver.

13. The device according to claim 1, wherein: The memory also stores instructions for causing the processor to send signals to a mobile software application according to a predetermined schedule, the signals representing measurement data.

14. The device according to claim 1 further includes at least one sensor operably coupled to the processor, the at least one sensor including at least one of a body temperature sensor, an air quality sensor, a humidity sensor, an altimeter, or an air pressure sensor, and the memory also stores instructions for causing the processor to store data collected by the at least one sensor in the memory.

15. The apparatus of claim 1 , further comprising at least one sensor operably coupled to the processor, the at least one sensor comprising at least one of a body temperature sensor, an air quality sensor, a humidity sensor, an altimeter, or an air pressure sensor, the memory further storing instructions for causing the processor to send a signal to a mobile software application according to a predetermined schedule, the signal representing data collected by the at least one sensor.

16. The device according to claim 1, wherein The reflected portion of light is a first reflected portion of light, and the instructions for causing the processor to calculate the wearer's blood oxygen saturation level include instructions for causing the processor to calculate the wearer's blood oxygen saturation level based on the first reflected portion of light and the second reflected portion of light.

17. The apparatus of claim 1 further comprising a warning mechanism operably coupled to the processor, the memory further storing instructions for causing the processor to generate and transmit a signal representative of a warning in response to detecting a user interaction with the warning mechanism.

18. The device according to claim 1, wherein: The device is waterproof.

19. The device according to claim 1, wherein: The second body portion does not include any electronic components.

20. A kit comprising: a device configured to be positioned on an ear of a wearer, the device comprising a first body portion, a second body portion, and a connecting member mechanically coupled to each of the first body portion and the second body portion, the first body portion having a processor, a memory operably coupled to the processor, at least one light emitting diode, and at least one optical sensor, the at least one optical sensor configured to detect a reflected portion of light emitted from the at least one light emitting diode during operation, the reflected portion of light being reflected from a surface of the wearer's ear, the memory storing instructions for causing the processor to calculate a blood oxygen saturation level of the wearer based on the reflected portion of light; a charger housing configured to receive the device and to provide power to the device; as well as A plurality of flexible ear pads, each flexible ear pad from the plurality of flexible ear pads being configured to be mechanically coupled to the second body portion.

21. The kit of claim 20, wherein: The second body portion includes an annular opening, and each flexible ear pad from the plurality of flexible ear pads is configured to be mechanically coupled to the second body portion via the annular opening.

22. The kit of claim 20, wherein: The device and the charger housing are configured to enable data to be exchanged between the device and the charger housing.

23. The kit of claim 20, wherein: The device and the charger housing are configured to enable at least one of data or power to be exchanged between the device and the charger housing via a pair of electrical contacts.

24. A method comprising: bonding the electronic board to the ear pad using at least one of silicone or epoxy such that the electronic board is secured to the ear pad within a cavity defined in a surface of the ear pad; as well as The ear pads are attached to the chassis.

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