Priority

[0001] This application claims priority to provisional U.S. Patent Application Ser. No.

62/877,348 filed July 23, 2019, and provisional U.S. Patent Application Ser. No. 62/976,066 filed on February 13, 2020. The disclosure of both are herein incorporated by reference in its entirety.

Technical Field

[0002] The present teachings relate generally to the field of medical devices and, more particularly, to a wireless auricular point stimulation device and method to stimulate auricular points for pain management in a non-invasive method.

Background

[0003] Pain has been a major health issue, and it is most commonly treated with analgesics and opioids as part of the patients’ pain management strategy. The drug-based treatment, however, has many adverse lasting effects that results in, for example, the developing opioid epidemic. Health care providers have been looking into alternative treatments for pain that would involve less drug intake, with the goal to reduce overall opioid use by patients.

[0004] One of the alternative pain treatment methods that has been developed include transcutaneous electrical nerve stimulation (TENS) methods. The TENS methods involve electrically stimulating various muscles of a human body using electrical pulsing to treat musculoskeletal pain disorders. The TENS methods are typically used on large body parts that involve sticking a large gel pad directly to the symptomatic area, such as attaching an electrical stimulation pad to the shoulders for treating pain at that particular location in the shoulders.

[0005] Indirect alternative pain treatments that have been studied include using needles to perform acupuncture methods under Chinese medicinal methods, and electrical stimulations of auricular peripheral nerve fields by inserting needles to the nerves in the human ear as probes. These auricular methods are intrusive to the patient and requires well-trained professionals to ensure that the needles are inserted properly without causing further pain. Other pain treatment alternatives are continuously being actively researched.

Summary

[0006] The following presents a simplified summary in order to provide a basic understanding of some aspects of one or more embodiments of the present teachings. This summary is not an extensive overview, nor is it intended to identify key or critical elements of the present teachings, nor to delineate the scope of the disclosure. Rather, its primary purpose is merely to present one or more concepts in simplified form as a prelude to the detailed description presented later.

[0007] In an embodiment, there is a auricular point stimulation device comprising an earpiece that includes a receiver and a battery, an electrical wire having a first end that is connected to the earpiece; and a gel pad connected to a second end of the electrical wire. The gel pad includes at least one electrode, and the earpiece sends electrical output to the at least one electrode.

[0008] In an embodiment, there is a method of treating pain comprising receiving information on a controller that relates to pain symptoms and symptomatic location of pain; identifying a treatment protocol that relates to the symptomatic locations from a pre-loaded list of treatment protocols based on the information received; based on the identified treatment protocol, providing directions on at least one location of at least one corresponding ear acupoint for a gel pad of an earpiece to be attached for treatment; sending electrical signal from the controller to at least one electrodes in the gel pad to execute the treatment protocol for electrical stimulation of the ear acupoint for pain treatment; and recording the protocol parameters.

[0009] In another embodiment, there is a method of treating pain comprising diagnosing a symptomatic body location to be treated using a controller, wherein the controller includes a signal transmitter and receiver, and a processor; choosing a treatment protocol from a pre-loaded list of treatment protocols identified by the controller based on the symptomatic body location diagnosed; locating at least one corresponding ear acupoint associated with the treatment protocol as provided by the directions shown on the controller; attaching at least one gel pad from an earpiece onto the corresponding ear acupoint shown; executing the treatment protocol by sending electrical signals from the controller to the earpiece, and the earpiece sends electrical stimulation to the ear acupoint via at least one electrodes in the gel pad; and recording treatment data from the execution of the treatment protocol.

[0010] The auricular point stimulation device is believed to deliver electrical acupuncture like stimulation to acupoints that correspond to the specific symptomatic parts of the body of a user without inserting an invasive needle to the acupoints like traditional methods. The device is a novel, non-intrusive, user-friendly, non-pharmacological alternative method that has great potential to improve pain management and reduce overall drug use as the most common pain management treatment. Brief Description of the Drawings

[0011 ] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present teachings and together with the description, serve to explain the principles of the disclosure. In the figures:

[0012] FIG. 1 is a drawing of an embodiment auricular point stimulation device that can connect wirelessly to a controller according to the descriptions herein;

[0013] FIG. 2A is a schematic drawing of a gel pad of an embodiment auricular point stimulation device, and an enlargement of the schematic drawing;

[0014] FIG. 2B is a schematic drawing of an embodiment auricular point stimulation device;

[0015] FIG. 3 is a flow chart of a method of using an embodiment auricular point stimulation device according to the descriptions herein;

[0016] FIG. 4 is a depiction of a human ear shown with auricular master points locations;

[0017] FIG. 5 is a depiction of a human ear shown with auricular master points locations and active points location that corresponds to the lower back;

[0018] FIG. 6 is a depiction of a human ear shown with auricular master points locations and active points location that corresponds to the middle back;

[0019] FIG. 7 is a depiction of a human ear shown with auricular master points locations and active points location that corresponds to the upper back;

[0020] FIG. 8 is a depiction of a human ear shown with auricular master points locations and active points location that corresponds to the shoulder;

[0021 ] FIG. 9 is a depiction of a human ear shown with auricular master points locations and active points location that corresponds to the neck; [0022] FIG. 10 is a depiction of a human ear shown with auricular master points locations and active points location that corresponds to the pelvic;

[0023] FIG. 11 is a depiction of a human ear shown with auricular master points locations and active points location that corresponds to the head;

[0024] FIG. 12 is a depiction of a human ear shown with auricular master points locations and active points location that corresponds to the knee;

[0025] FIG. 13 is a depiction of a human ear shown with auricular master points locations and active points location that corresponds to the leg;

[0026] FIG. 14 is a depiction of a human ear shown with auricular master points locations and active points location that corresponds to the foot;

[0027] FIG. 15 is a depiction of a human ear shown with auricular master points locations and active points location that corresponds to the ankle;

[0028] FIG. 16 is a depiction of a human ear shown with auricular master points locations and active points location that corresponds to the hand;

[0029] FIG. 17 is a depiction of a human ear shown with auricular master points locations and active points location that corresponds to the wrist;

[0030] FIG. 18 is a depiction of a human ear shown with auricular master points locations and active points location that corresponds to the arm;

[0031 ] FIG. 19 is a depiction of a human ear shown with auricular master points locations and active points location that corresponds to the temporomandibular joint; and

[0032] FIG. 20 is a flow chart of a method of using a controller to execute treatment protocols using an embodiment auricular point stimulation device according to the descriptions herein. [0033] It should be noted that some details of the FIGS have been simplified and are drawn to facilitate understanding of the present teachings rather than to maintain strict structural accuracy, detail, and scale.

Detailed Description

[0034] Alternative treatments for pain are being studied to avoid long term adverse effects that result from the use of analgesics and opioids, which are currently the most common pain management strategies. An alternative treatment described herein is auricular point stimulation therapy. Originated from traditional Chinese medicine, Paul Nogier, MD, in the 1980s started to develop auricular therapy when he found that specific points of the ear corresponded to specific organs and areas of the body. Dr. Nogier mapped a somatotopic representation of the human body onto the ear, and believed that by stimulating the ear acupoints, the corresponding symptomatic parts of the body could be treated. Starting from Dr. Nogier’ s somatotopic representation, the location of acupoints on the ear that correspond to the symptomatic body parts can be confirmed by electrodermal response, such as using a point finder. Once identified, the acupoints can be stimulated, such as using acupuncture needles, to treat the corresponding symptomatic body parts.

[0035] Auricular point acupressure (APA) is one of the alternative treatments that has been derived from auricular acupuncture, mainly to manage pain in patients. APA applies acupuncture like stimulation on a specific ear acupoint by using small plant seeds as stimulant when pressed against the ear acupoint without the use of needles that are traditionally used to stimulate acupoints in acupuncture. However, APA relies on the patient to manually press on the seeds throughout the day, and self-administer appropriate pressure that is sufficient in relieving the pain symptoms. A patient may not be able to manually deliver the level of stimulation at a frequency that would effectively provide the stimulation needed for treatment.

[0036] Other auricular therapy methods include electrical stimulations such as vagus nerve stimulation (VNS) and transcutaneous auricular vagus nerve stimulation (taVNS) methods. The taVNS treatment involves electrically stimulating the auricular vagus nerve located at the cymba conchae region of a human ear. However, the VNS and taVNS methods have only been used in studies to treat neuropsychiatric disorders (e.g. epilepsy or depression), chronic tinnitus, learning, decrease inflammatory response, migraine, and gastroparesis disorders.

[0037] As an alternative to the conventional methods, the embodiments and methods herein provides an auricular point stimulation device that provides patients/users with electrical stimulation that can be controlled and monitored by another wireless device, such as a smartphone with a software application that corresponds to the auricular point stimulation device, to treat physical pain that are located at different parts of the human body, such as shoulders, head, foot, hand, ankle, etc.

[0038] In an embodiment, such as shown in Figure 1 , a wireless auricular point stimulation device 100 includes an earpiece 101 that can be attached to a human ear 150. The earpiece 101 is connected via wires 103 to gel pads 105 that includes at least one electrode in the gel pad 105. The device 100 can be connected to a single gel pad 105 via one wire 103, or connected to numerous gel pads 105 via numerous wires 103 that correspond to each gel pad 105. In an embodiment, there are four gel pads 105 that are placed on the ear 150, and the four gel pads 105 are each attached to the earpiece 101 via each respective wire 103. The earpiece 101 sends electrical signals to the electrodes in the gel pad 105 for electrical stimulation on the human ear 150. The earpiece 101 can include a rechargeable battery with a charging port, or can have a battery compartment that can be opened to insert and replace with disposable batteries.

[0039] The earpiece 101 can be wirelessly connected to a controller 130, such as a smartphone that is shown in the embodiment in Figure 1. The earpiece 101 can be a wireless receiver that is connected to the controller 130 via Bluetooth or other wireless radio wave methods. A user of the auricular point stimulation device 100 can use an app on a smartphone 109 (or other wireless devices, such as an ipad, a tablet, a laptop, etc.) to control the amount of electrical stimulation that is exerted by the electrodes in the gel pad 105. Alternatively, the auricular point stimulation device 100 can have an earpiece that is connected to a control device via physical wires that sends electrical signals via wires to the earpiece, which in turn sends the electrical signals towards the gel pads via each respective wire to the pads.

[0040] Details of the gel pads are shown in the enlarged schematic drawings in Figure 2.

The gel pads 205, attached to a wire 203, include a gel 221, at least one or more high-performance miniaturized electrodes 223 that are attached to the gel 221, and a backing 225 that acts as a support for the electrode 223 and gel 221. Alternatively, the at least one electrode 223 can be embedded into the gel 221, such that the electrode 223 is protected by the gel 221 and not exposed to the external environment. Although only one electrode 223 is shown in Figure 2, each gel pad 205 may have one or more electrodes 223, and a different number of electrodes 223 can be provided in each of the numerous gel pads that are attached to an earpiece via wires 203. The wires 203 can be a medical electrode cable, and have a length of between about 5 cm to about 20 cm, preferably between about 8 cm to about 15 cm, and most preferably between about 10 inches to about 12 inches. Each of the wire 203 can be of a different length from other wires attached to the same earpiece. [0041 ] The gel pad 205 can have a backing 225 that has a maximum rectangular surface area having a length 225L of between about 1.5 cm and about 0.3 cm, preferably between about 1 cm and about 0.5 cm, and most preferably about 0.7 cm, and can have a width of between about 1.5 cm and about 0.3 cm, preferably between about 1 cm and about 0.5 cm, and most preferably about 0.7 cm. The ratio of length to width can be between about 1:0.2 and about 1:5, preferably between about 1:0.5 and about 1:3, and most preferably between about 1: 1 and about 1: 1.2. Alternatively the backing 225 can have a circular surface area that has a diameter of between about 1.5 cm and about 0.3 cm, preferably between about 1 cm and about 0.5 cm, and most preferably about 0.7 cm. Nonetheless, the backing 225 can be of any shape that would be appropriate for attaching to desired locations on a human ear.

[0042] As shown in Figure 2, the backing 225 has two major surfaces: a first major surface that is adjacent to the electrode 223. The electrode 223 can be directly attached to the first major surface of the backing 225 as shown, or can alternatively be embedded in gel 221 and the gel 221 is directly attached to the first major surface of the backing 225. The first major surface of the backing 225 will also be adjacent to the human ear when the gel pad 205 is attached to the human ear by a user. The second major surface of the backing 225 face away from the electrode 223 and gel 221. The second major surface

[0043] The gel 221 can be made of any type of non-latex adhesive, including having a smooth gel like surface for comfort. The gel 221 can have a shape that is rectangular, circular, oval, etc., and the length 221L of the gel 221 can be between about 1.5 cm and about 0.3 cm, preferably between about 1 cm and about 0.5 cm, and most preferably about 0.7 cm.

[0044] The at least one electrode 223 can also have a size with a length 223L of between about 0.7 cm and about 0.05 cm, preferably between about 0.5 cm and about 0.1 cm, and most preferably about 0.3 cm. The electrode 223 can be placed between the gel 221, or can be embedded into the gel 221 while the gel 221 is directly attached to the backing 225. The electrode 223 receives electronic signals via wire 203, which can be directly connected to the electrode 223.

[0045] Figure 3 shows a schematic drawing of an auricular point stimulation device 300, having an earpiece 301 that is attached to wires 303 and gel pads 305. The earpiece 301 can be in a curved shape that is selected to match the contour of a human ear for ease and comfort of the ear. The earpiece 301 has a front tip 307 and a curved tip 309. The earpiece 301 can be attached to a human ear, for example, in a position that places the front tip 307 at the top of the ear and places the curved tip 309 at a lower position at the back of the ear. A battery and an electronic wave receiver can be provided in either the front tip 307 or the curved tip 309, and the wires 303 are attached to the front tip 307 of the earpiece 301.

[0046] The auricular point stimulation device can have pain management treatment parameters. Parameters for the auricular point stimulation device includes frequency, pulse width, and intensity. Frequency of the stimulation can have a range between about 0.5 Hz and about 100 Hz, preferably between about 10 Hz and about 60 Hz, and most preferably between about 25 Hz and about 40 Hz. Frequency settings may also be provided as pre-programmed frequencies for the user to choose from. The pulse width can be provided in a range of between about 100 ps to about 750 ps. Intensity is also provided in a range of between about 1 mA to about 10 mA for users to choose from to accommodate differences in each person’s pain relieve levels and nerve tolerances. The duration of each cycle of electrical stimulation, also called a duty cycle, can be in the range of less than about 2 ms, preferably less than about 1.5 ms, and more preferably less than about 1 ms. Durations of the treatment sessions can range from less than 1.5 hours, less than 1 hour, and between about 0 minutes to about 40 minutes. [0047] A software application that corresponds to the auricular point stimulation device can be provided on a controller, such as the smartphone 130 shown in Figure 1, so that users can select protocols and interact with the auricular point stimulation device to provide pain treatment. The software application can include many treatment protocols and tracking functions, including information about the locations of the acupoints that corresponds to specific symptomatic body parts, and automatic tracking of parameters used during treatment session, device usage per day, duration, and intensity for each session. The software application can also include a Pulse Width Modulation function that enables the software application to send a digital signal from the controller as a wireless signal to the electrodes via the receiver on the earpiece, such as a square wave that allows an oscillation of electrical signals, and the oscillation is configured according to the parameters set in the software application based on the predetermined auricular point stimulation treatment protocols.

[0048] The software application can display graphs and charts of the usage data for statistical viewing. The software application can also include data input capabilities for users to note additional drug use, pain intensity changes and sensitivity levels for each session, physical function, and other criteria that aids the user in documenting effects of the pain management treatment plan. The primary goals of pain management is to decrease pain and improve physical function. Thus, the software application will also include capabilities for users to input and record physical function to determine effectiveness in treatment.

[0049] As shown in Figure 3, a method 300 of using the auricular point stimulation device involves, first, determining a user’s need in pain management and pinpointing a symptomatic body location to be treated 301. This is achieved by diagnosing the symptomatic body location and noting the user’s pain level. The user then chooses the appropriate predetermined treatment protocols 303 that have been developed based on the traditional acupuncture auricular therapy to locate the ear acupoints that correspond to the symptomatic body locations 305, and positions the electrodes in the gel pads to stick on the located ear acupoints accordingly 307.

[0050] The predetermined treatment protocols can be pre-loaded onto the software application such that the user can self-diagnosing the symptomatic body locations and can choose a predetermined treatment protocol according to the diagnosis, for example, using step-by-step instructions in words, drawings, simulations, and videos. Some of the example acupoints for treatment protocols are shown in Figures 4 to 19.

[0051 ] First, the treatment protocol will show the three“Master Points” that applies to all treatments, as shown in Figure 4 as point X, the shenmen point, point Y, the sympathic point, and point Z, the nervous subcortex point. These three master points are the basic points for all treatment protocols. After locating the three Master Points and attaching gel pads to these locations, the treatment protocol will show the“Active Points” on the front and the back of a human ear that correspond to the specific symptomatic body locations that the user may want to treat. The active points for some example common symptomatic locations are shown in Figures 5 to 19:

[0052] Figure 5 shows the 3 specific acupoint locations on the front side of the ear 550 for the active points AA of the lower back, provided in a triangular shaped grouping that is close to the shenmen point X, and in a location on the back side of the ear 560 that corresponds to the front side of the ear 550;

[0053] Figure 6 shows the 3 specific acupoint locations on the front side of the ear 650 for the active points BB of the middle back, provided in a triangular shaped grouping that is lower on the ear than the active points for the lower back, and in a location on the back side of the ear 660 that corresponds to the front side of the ear 650; [0054] Figure 7 shows the 3 specific acupoint locations on the front side of the ear 750 for the active points CC of the upper back, provided in a triangular shaped grouping that is lower on the ear than the active points for the middle back, and in a location on the back side of the ear 760 that corresponds to the front side of the ear 750;

[0055] Figure 8 shows the 3 specific acupoint locations on the front side of the ear 850 for the active points DD of the shoulder, provided in a substantially vertical grouping following the contour of the ear that is lower on the ear than the active points for the upper back, and in a location on the back side of the ear 860 that corresponds to the front side of the ear 1850;

[0056] Figure 9 shows the 3 specific acupoint locations on the front side of the ear 950 for the active points EE of the neck, provided in a line grouping following the contour of the ear that is lower on the ear than the active points for the shoulder, and in a location on the back side of the ear 960 that corresponds to the front side of the ear 950;

[0057] Figure 10 shows the one specific acupoint location on the front side of the ear 1050 for the active point FF of the pelvic, provided close to but lower than the shenmen point X on the ear, and in a location on the back side of the ear 1060 that corresponds to the front side of the ear 1050;

[0058] Figure 11 shows the 4 specific acupoint locations on the front side of the ear 1150 for the active points GG of the head, provided in a line grouping following the contour of the ear that is lower on the ear than the nervous subcortex point Z, and in a location on the back side of the ear 1160 that corresponds to the front side of the ear 1150;

[0059] Figure 12 shows the 3 specific acupoint locations on the front side of the ear 1250 for the active point HH of the knee, provided in a triangular shaped grouping that is close to but higher than the shenmen point X on the ear, and in a location on the back side of the ear 1260 that corresponds to the front side of the ear 1250;

[0060] Figure 13 shows the 3 specific acupoint locations on the front side of the ear 1350 for the active point II of the leg, provided in a line grouping that is close to but higher than the shenmen point X on the ear, and in a location on the back side of the ear 1360 that corresponds to the front side of the ear 1350;

[0061] Figure 14 shows the 2 specific acupoint locations on the front side of the ear 1450 for the active point JJ of the foot, provided in a line grouping that is close to but higher than the shenmen point X on the ear and higher than the active points of the leg on the ear, and in a location on the back side of the ear 1460 that corresponds to the front side of the ear 1450;

[0062] Figure 15 shows the one specific acupoint location on the front side of the ear 1550 for the active point KK of the ankle, provided higher than the shenmen point X on the ear, and in a location on the back side of the ear 1560 that corresponds to the front side of the ear 1550;

[0063] Figure 16 shows the 2 specific acupoint locations on the front side of the ear 1650 for the active points LL of the hand, provided in a line higher than the shenmen point X on the ear along the contour of the ear, and in a location on the back side of the ear 1660 that corresponds to the front side of the ear 1650;

[0064] Figure 17 shows the one specific acupoint location on the front side of the ear 1750 for the active point MM of the wrist, provided higher than the shenmen point X and on the contour of the ear that is lower than the active points for the hand, and in a location on the back side of the ear 1760 that corresponds to the front side of the ear 1750;

[0065] Figure 18 shows the 3 specific acupoint location on the front side of the ear 1850 for the active points NN of the arm, provided in a line on the contour of the ear that is lower than the active point for the wrist and higher than the active points for the shoulder, and in a location on the back side of the ear 1860 that corresponds to the front side of the ear 1850; and

[0066] Figure 19 shows the one specific acupoint location on the front side of the ear 1950 for the active point OO of the temporomandibular joint (TMJ), provided lower than the nervous subcortex point Z and on the contour of the ear that is higher than the ear lobe but lower than the active points for the neck, and in a location on the back side of the ear 1960 that corresponds to the front side of the ear 1950.

[0067] After positioning the electrodes onto the master points and the appropriate active points on the ear according to the treatment protocols, using the software application, the user can choose a frequency level with a pulse width that stays constant throughout the treatment session, and with the ability to control the intensity and duration of the electrical stimulation during the treatment session. Alternatively, the frequency level and pulse width can also vary during the treatment session. The user can execute the treatment protocol via the software application 309 to send wireless electrical signals to the receiver in the earpiece, and the receiver sends the electrical signals to the electrodes according to the treatment parameters set in the software application. The software application can automatically record the returned data from the auricular point stimulation device with the frequency level, the pulse width, the intensity, and the duration as part of the software’s usage data 311. After the session, the user can put in additional data such as recording the pain level after the treatment session (as compared to the pain level prior to the treatment session), drug intake, physical activity, sleep quality, etc.

[0068] Any type of controller that can execute a software application, can transmit and receive electrical signals, and can control the strength and frequency of electrical signals transmitted, can be used as a controller for the auricular point stimulation device described herein. The controller is preferably wirelessly connected to the earpiece of the auricular point stimulation device, but can also be directly connected to the device via a physical wire. The controller can be any device that includes a screen and a processor that is preloaded with predetermined treatment protocols in a software application. The software application can be, for example, a non-transitory computer readable medium storing instructions, that when executed by a hardware processor, performs a method of pain treatment according to pre-loaded treatment protocols as discussed herein.

[0069] The controller can be any type of mobile devices, such as smart telephones, laptop computers, tablet computers, cellular telephones, and personal digital assistants. The controller can also include one or more memory devices that serve as a main memory during the operation of the controller. For example, during operation, the pre-loaded treatment protocols can be stored in the one or more memory devices. The controller can also include one or more peripheral interfaces, such as keyboards, mice, touchpads, computer screens, touchscreens, etc., for enabling human interaction with and manipulation of software application pre-loaded onto the controller.

[0070] The controller can also include a data bus, one or more storage devices of varying physical dimensions and storage capacities, such as flash drives, hard drives, random access memory, etc., for storing data, such as images, files, and program instructions for execution by the one or more processors. The controller can also include one or more network interfaces 608 for communicating via one or more networks, such as Ethernet adapters, wireless transceivers, or serial network components, for communicating over wired or wireless media using protocols.

[0071 ] Additionally, the controller can include one or more software applications that enable the functionality described above. The one or more software applications can include instructions that cause the one or more processors to perform the processes, functions, and operations described herein. Copies of the one or more software applications can be stored in the one or more memory devices and/or on in the one or more storage devices. Likewise, the data utilized by one or more software programs can be stored in the one or more memory devices and/or on in the one or more storage devices.

[0072] The data received and implemented in the software application can be stored on or transmitted over a computer-readable medium as one or more instructions or code. Computer- readable media includes both tangible, non-transitory computer storage media and

communication media including any medium that facilitates transfer of a computer program from one place to another. A storage media can be any available tangible, non-transitory media that can be accessed by a computer. By way of example, and not limitation, such tangible, non- transitory computer-readable media can comprise RAM, ROM, flash memory, or EEPROM. Also, any connection is properly termed a computer-readable medium. For example, if the software is transmitted from a website, server, or other remote source using a coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technologies such as infrared, radio, and microwave, then the coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technologies such as infrared, radio, and microwave are included in the definition of medium. Combinations of the above should also be included within the scope of computer-readable media.

[0073] The software application described herein can be implemented with modules

(e.g., procedures, functions, subprograms, programs, routines, subroutines, modules, software packages, classes, and so on) that perform the functions described herein. A module can be coupled to another module or a hardware circuit by passing and/or receiving information, data, arguments, parameters, or memory contents. Information, arguments, parameters, data, or the like can be passed, forwarded, or transmitted using any suitable means including memory sharing, message passing, token passing, network transmission, and the like. The software codes can be stored in memory units and executed by processors. The memory unit can be

implemented within the processor or external to the processor, in which case it can be

communicatively coupled to the processor via various means as is known in the art.

[0074] In an exemplary method of treatment, as shown in Figure 20, a controller for an embodiment auricular point stimulation device can receive information 2001 from user input to diagnose the symptomatic body locations for pain treatment. Alternatively, the controller can also receive information 2001 from a feedback loop from a previous treatment protocol records to diagnose the symptomatic body locations that need additional pain treatment. Using the information inputted, the controller can calculate and identify the appropriate treatment protocol to treat the symptomatic body locations 2003, and then provide directions for attaching gel pads to the master points and active points locations that correspond to the treatment protocol 2005. After the gel pads are attached to the correct acupoints, the controller can execute the treatment protocol 2007 and send electrical signal from the controller to the earpiece to provide electrical stimulation to the acupoints through the electrodes in the gel pads. While the treatment protocol is executed, the receiver in the earpiece can record 2011 and/or send data back to the controller, wirelessly or wired, to record the treatment and provide feedback loop for the next treatment session.

[0075] In an exemplary treatment session, the auricular point stimulation device can be used at low frequency and high intensity to achieve an acupuncture-like treatment session. In another treatment session, the auricular point stimulation device can also be used at medium or high frequency and low intensity. It is believed that the auricular point stimulation device use will decrease pain intensity, improve physical function and/or drug use for the users that commonly use drug-based pain management treatments, such as opioids. It is believed that it will also improve health-related quality of life and sleep after, for example, one month of consistent treatment sessions.

[0076] Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the present teachings are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Moreover, all ranges disclosed herein are to be understood to encompass any and all sub-ranges subsumed therein. For example, a range of "less than 10" can include any and all sub-ranges between (and including) the minimum value of zero and the maximum value of 10, that is, any and all sub-ranges having a minimum value of equal to or greater than zero and a maximum value of equal to or less than 10, e.g., 1 to 5. In certain cases, the numerical values as stated for the parameter can take on negative values. In this case, the example value of range stated as“less than 10” can assume negative values, e.g. - 1, -2, -3, -10, -20, -30, etc.

[0077] While the present teachings have been illustrated with respect to one or more implementations, alterations and/or modifications can be made to the illustrated examples without departing from the spirit and scope of the appended claims. For example, it will be appreciated that while the process is described as a series of acts or events, the present teachings are not limited by the ordering of such acts or events. Some acts may occur in different orders and/or concurrently with other acts or events apart from those described herein. Also, not all process stages may be required to implement a methodology in accordance with one or more aspects or embodiments of the present teachings. It will be appreciated that structural components and/or processing stages can be added or existing structural components and/or processing stages can be removed or modified. Further, one or more of the acts depicted herein may be carried out in one or more separate acts and/or phases. Furthermore, to the extent that the terms“including,”“includes,” “having,”“has,”“with,” or variants thereof are used in either the detailed description and the claims, such terms are intended to be inclusive in a manner similar to the term“comprising.” The term“at least one of’ is used to mean one or more of the listed items can be selected. Further, in the discussion and claims herein, the term“on” used with respect to two materials, one“on” the other, means at least some contact between the materials, while“over” means the materials are in proximity, but possibly with one or more additional intervening materials such that contact is possible but not required. Neither“on” nor“over” implies any directionality as used herein. The term“conformal” describes a coating material in which angles of the underlying material are preserved by the conformal material. The term“about” indicates that the value listed may be somewhat altered, as long as the alteration does not result in nonconformance of the process or structure to the illustrated embodiment. Finally,“exemplary” indicates the description is used as an example, rather than implying that it is an ideal. Other embodiments of the present teachings will be apparent to those skilled in the art from consideration of the specification and practice of the disclosure herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the present teachings being indicated by the following claims.