System and method for electro-optical therapy with capacitive monitoring of the skin

Abstract

An electrotherapy apparatus and method comprising an electrode configured to be adhered to a recipient's skin and to apply electrical fields to an underlying portion of the recipient's tissue is disclosed. The electrode comprises a first electrically conductive portion and a second electrically conductive portion electrically isolated from the first electrically conductive portion. Circuitry is configured to detect at least one signal indicative of an electrical conductivity, an electrical capacitance, and / or an electrical impedance between the first and second electrically conductive portions and to evaluate an electrical contact of the electrode with the recipient's skin based on the signal without increasing electrical current applied to the recipient. In certain implementations, the electrode comprises an optically transmissive portion in optical communication with a light source. The circuitry can control the light source based on the electrical contact to prevent unintended light exposure when the electrode detaches from the skin.

Description

SYSTEM AND METHOD FOR ELECTRO-OPTICAL THERAPY WITH CAPACITIVE MONITORING OF THE SKINCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 790,290, filed April 17, 2025, entitled “ SYSTEM AND METHOD FOR ELECTRO-OPTICAL THERAPY WITH CAPACITIVE MONITORING OF THE SKIN,” the entire disclosure of which is hereby incorporated by reference in its entirety.FIELD[00021 This application relates generally to systems and methods of treating a recipient’s body using electrotherapy.BACKGROUND

[0003] Electrotherapy (e.g., transcutaneous electrical nerve stimulation or TENS; electrical muscle stimulation or EMS; neuromuscular electrical stimulation of NMES; pulsed electromagnetic field therapy or PEMF) uses disposable electrodes to apply electrical voltages to a recipient’s body. These electrotherapy electrodes can be low cost and designed to be disposable after a single use. See, e.g., D.E. Akgtin et al., “Design of TENS electrodes using conductive yarn,” Inf 1 J. of Clothing Sci. and Tech., Vol. 28, Issue 3, (2016); PALS neurostimulation electrodes available from Compex Technologies of New Brighton, MN.

[0004] The skin’s electrical impedance is a barrier to efficient electrotherapy, prompting the use of relatively high field strengths (e.g., intensities) to produce clinically meaningful responses.BRIEF DESCRIPTION OF THE DRAWINGS

[0005] The detailed description is set forth with reference to the accompanying drawings. The use of the same reference numerals may indicate similar or identical items. Various embodiments may utilize elements and / or components other than those illustrated in the drawings, and some elements and / or components may not be present in various embodiments.Elements and / or components in the figures are not necessarily drawn to scale. Throughout this disclosure, depending on the context, singular and plural terminology may be used interchangeably.0006] FIG. 1 schematically illustrates a conventional electrotherapy electrode.

[0007] FIG. 2 schematically illustrates an example electrode comprising flexible circuitry with a plurality of light sources in accordance with one or more embodiments of the present disclosure.

[0008] FIG. 3 schematically illustrates an example electrode in accordance with one or more embodiments of the present disclosure.

[0009] FIGs. 4A-4E schematically illustrate example configurations of first and second electrically conductive portions in accordance with one or more embodiments of the present disclosure.

[0010] FIG. 5 depicts a flow diagram of an exemplary method for controlling electrotherapy based on electrical contact evaluation in accordance with one or more embodiments of the present disclosure.[00111 FIG. 6 depicts a flow diagram of an exemplary method for controlling a light source during combined electro-optical therapy based on electrical contact evaluation in accordance with one or more embodiments of the present disclosure.DETAILED DESCRIPTION

[0012] An electrode (e.g., biocompatible; disposable) for electrotherapy is configured to be adhered to a recipient’s body (e.g., a patient’s skin) and to apply electric fields to an underlying portion of the recipient’s tissue (e.g., skin; muscle). Although the electrode can have various shapes (e.g., square; rectangular; having at least partially rounded corners) and / or can be generally small so that the electrode can fit on a portion of a recipient’s body (e.g., having a length and / or width in a range of 1-4 inches). The electrode can comprise a hydrogel layer configured to be in electrical communication with the underlying skin. In certain implementations, the hydrogel layer is supplemented with one or more electrically conductive materials (e.g., nanoparticles; carbon nanotubes; metal-coated silicon nanoparticles; metal-atomclusters; graphene; graphite flakes; graphite sheets) configured to increase electrical conduction between the electrode and the underlying skin.

[0013] Electrotherapy electrodes are conventionally optically opaque and not suitable for integration with photobiomodulation therapy (PBMT). PBMT uses optical elements, such as one or more light sources (e.g., LEDs) and lens structures, to apply electromagnetic radiation to the recipient’s body. In certain implementations described herein, the electrode comprises at least one optically transmissive portion (e.g., transparent; translucent; orifice) configured to receive light from at least one light source and to allow the light to propagate through the at least one optically transmissive portion to impinge the recipient’ s body. By allowing the transmission of light from the at least one light source to the recipient’s skin, the electrode of certain implementations enables the application of electrotherapy and photobiomodulation therapy together (e.g., simultaneously). The electrode, being optically transparent, enables electrotherapy (e.g., TENS; EMS; NMES; PEMF) via electric and / or optical fields (e.g., light). In certain implementations, the electrode can comprise an optically transmissive and electrically conductive material. For example, the electrode can comprise an optically transmissive layer of graphene or any other suitably optically transmissive and electrically conductive material. In certain further implementations, an optically transmissive and electrically conductive material can have a varying thickness. For example, the electrode can comprise a layer of graphene, the layer of graphene having a thickness of 1.0 pm, 1.5 pm, 2.0 pm, 2.5 pm, 3.0 pm, or any thickness therebetween. In certain implementations, the thickness of the optically transmissive and electrically conductive material enables transmission of electromagnetic radiation therethrough, including but not limited to visible light, infrared light, and / or near-infrared light. In certain implementations, the optically transmissive and electrically conductive material can be transmitted through the electrode without attenuating the clinical effectiveness of the electromagnetic radiation.

[0014] In certain implementations, the optically transmissive and electrically conductive material can comprise materials other than graphene. In certain implementations, the optically transmissive and electrically conductive material can have a sheet resistance in a range of 1 Q / sq to 1000 Q / sq, 10 Q / sq to 500 Q / sq, or 50 Q / sq to 200 Q / sq. In certain implementations, theoptically transmissive and electrically conductive material can have an optical transmittance of at least 70%, at least 80%, at least 90%, or at least 95% for wavelengths in a range of 400 nm to 1100 nm (e.g., visible light and near-infrared light).|0015] In certain implementations, the electrode is in optical communication with at least one light source via at least one optical conduit (e.g., fiber optic cable; optical fiber; light guide). The at least one optical conduit is configured to transmit light from the at least one light source through the at least one optically transmissive portion of the electrode to impinge the recipient’s skin. In certain implementations, the at least one light source comprises a laser (e.g., laser diode). In certain implementations, the at least one light source is configured to emit infrared light and / or near-infrared light for photobiomodulation therapy.[0016| In certain implementations, the circuitry is configured to control the at least one light source based on the electrical contact between the electrode and the recipient’s skin. For example, the circuitry can be configured to disable the at least one light source when the electrical contact is less than a predetermined threshold (e.g., when the electrode peels off or partially detaches from the recipient’s skin). By disabling the at least one light source when the electrical contact is insufficient, the system can prevent unintended exposure of the recipient or user to the light (e.g., laser light) from the at least one light source.[0017) Because PBMT sources such as lasers may present a safety risk when not properly coupled to tissue (e.g., when the electrode is partially or fully detached from the recipient’s skin), monitoring the electrical contact between the electrode and the recipient’s skin provides a proxy for determining whether the light source is properly positioned relative to the recipient’s body. In certain implementations, the circuitry can use electrical conductivity, electrical capacitance, and / or electrical impedance measured as an indicator of whether the electrode is sufficiently adhered to the recipient’s skin to safely deliver light therapy. In this way, the system can automatically disable or attenuate the light source when the electrical contact indicates that the electrode has been compromised, thereby reducing the risk of unintended light exposure to the recipient or nearby persons.

[0018] In certain implementations, the electrode is configured to allow for combination electro-optical therapies (e.g., TENS; EMS; NMES; PEMF; PBMT), to reduce the power levelsused for any of the therapeutic modalities alone, and / or to synergistically improve the clinical efficiencies of the electro-optical therapies while reducing or eliminating fields at nerves and tissues that are not to be stimulated. In certain such implementations, electrotherapy (e.g., TENS / EMS / NMES / PEMF) and photobiomodulation therapy are applied to the recipient’s body in conjunction with one another (e.g., concurrently or contiguously with one another; in a sequence in which the two therapies are alternatively applied) to produce a synergistic combination that produces more benefits than do the sum of the benefits of the two separate therapies (e.g., the combination of the two therapies produces a clinical benefit that is greater than the sum of the individual clinical benefits). Examples of such electrodes are described below with reference to FIGs. 1 and 2.

[0019] FIG. 1 schematically illustrates a conventional electrotherapy electrode. FIG. 2 schematically illustrates an example electrode comprising flexible circuitry in accordance with certain implementations described herein. As schematically illustrated by FIG. 2, the electrode can comprise flexible circuitry 210 (e.g., flexible circuit board) configured to be placed on the patient's body, a plurality of light sources 220 (e.g., point-of-application light sources) mounted on the flexible circuitry. The optically transmissive portion can comprise optically clear, electrically conductive circuitry 230 (e.g., conduits; traces) configured to be in electrical communication with an electric power source. The circuitry is affixed (e.g., attached; deposited; overlaid) onto an optically clear, electrically insulating material. In certain implementations, the electrode can further comprise optically clear hydrogel layers 240 configured to be in electrical communication with the underlying skin while allowing light from the plurality of light sources to propagate therethrough to impinge the patient's skin.

[0020] In certain implementations, the circuitry of the optically transmissive portion comprises graphene and are arranged in patterns configured to format the applied electrical field. For example, the geometry and pattern of the traces of the circuitry can be configured to shape the electrical field intensity distribution at the skin (e.g., to maximize the electrical field intensity at a predetermined tissue volume / depth below the skin and / or the target nerves and tissues). In this way, the electrode of certain implementations provides greater optical energy coupling efficiency (e.g., from the power source to the target tissue) than would be otherwiseavailable. For example, the electrode can be configured to reduce (e.g., prevent; limit; eliminate) the electrical field intensity applied to non-target nerves and tissues (e.g., nerves and tissues not to be stimulated), and / or to reduce (e.g., prevent; limit; eliminate) the overall field intensity applied to the skin to affect the electrotherapy (e.g., TENS; EMS; NMES).

[0021] In certain implementations, the electrically conductive circuitry of the electrode comprises micro-needles configured to penetrate the skin for percutaneous electrical nerve stimulation (PENS), thereby bypassing local skin resistance to deliver electrical stimulation in proximity to the nerve endings. Certain such implementations combine the advantages of electroacupuncture and TENS.

[0022] In certain implementations, the power source is modulated (e.g., modulations of voltage and / or current amplitudes) with temporal parameters (e.g., pulsing frequency; pulsing duty cycle) based on nerve conduction velocity measurements to minimize the nerve conduction velocity of the nerve being stimulated.

[0023] The electrode of certain implementations described herein is electrically conductive and is configured to be in electrical communication (e.g., via conduits, wires, and / or traces) with an electric power source of the electrotherapy device. The power source is configured to be modulated (e.g., modulations of voltage and / or current amplitudes) with temporal parameters (e.g., pulsing frequency; pulsing duty cycle) to optimize the electrotherapy treatment. In certain implementations, the electrode comprises flexible circuitry (e.g., flexible circuit board) configured to be placed on the recipient’s body and is configured to be affixed (e.g., attached; pressed; overlaid) onto the recipient’s skin. In certain implementations, the electrode comprises an electrically conductive “disposable pad” (e.g., made of biocompatible materials) that is configured to be detachably affixed (e.g., using adhesive) to securely attach to and to detach from the recipient’s skin.

[0024] In certain implementations described herein, the electrode is configured to minimize the skin-applied electric field intensity to decrease the risk of tissue damage and to increase the energy efficiency of transdermal nerve stimulation devices. In certain implementations described herein, the electrode is configured to significantly increase electrical efficiency (e g.,longer battery life) and / or clinical effectiveness (e.g., more effective pain management and muscle contraction control) of the electrotherapy (e.g., TENS, EMS, NEMS, and PENS) device.

[0025] In certain implementations, the electrode (e.g., “smart” electrode) is configured to apply electrotherapy that provides an analgesic effect on the recipient’s body. One or more electrodes can be built in an assembly (e.g., brace; wrap) configured such that when the assembly is worn on the recipient’s body, the one or more electrodes are correctly positioned relative to one or more targeted nerves for the electrotherapy. The assembly can be configured to apply sufficient pressure to the one or more electrodes (e.g., to press the one or more electrodes against the recipient’s skin) to ensure that sufficiently good electrical contact by the one or more electrodes with the recipient’s skin is maintained during the electrotherapy.

[0026] In certain implementations, the one or more electrodes monitor the electrical contact between the one or more electrodes and the recipient’s skin. For example, the one or more electrotherapy electrodes can comprise at least one sensor configured to detect the electrical contact between the electrotherapy electrode and the recipient’s skin. The contact area of the at least one sensor with the recipient’s skin can be significantly smaller than the contact area of the electrotherapy electrode (e g., hundreds of square millimeters). Various shapes and configurations of the at least one sensor across the contact area of the electrotherapy electrode are compatible with certain implementations described herein. In certain implementations, the at least one sensor is unaffected by the electrotherapy, while in certain other implementations, the non-zero effect on the at least one sensor by the electrotherapy is used to monitor the electrotherapy.

[0027] In certain implementations, the one or more electrodes comprises at least one biosensor configured to provide information relevant to the efficacy of the electrotherapy treatment. The at least one biosensor can be configured to measure at least one biomarker (e.g., blood flow; heart rate variability; nerve conduction; sweat; galvanic response; electromyography) indicative of the efficacy of the electrotherapy treatment. For example, muscle spasms detected by the at least one biosensor can be indicative of too much stimulation being applied during the electrotherapy. By way of further example, nerve conduction detectedby the at least one biosensor can be indicative of excessive administration of electrotherapy to the recipient.

[0028] In certain implementations described herein, the system (e.g., comprising the electrotherapy device and the electrode) is configured to monitor at least one attribute of the electrical contact between the electrode and the recipient’s skin. For example, the system can comprise circuitry (e.g., microcontroller; microprocessor) configured to be in electrical communication with the electrode, to detect at least one signal indicative of an electrical contact between the electrode and the underlying skin, and to control the electrical power source in response to the at least one signal. In response to the detected at least one signal, the circuitry can determine if the electrical contact between the electrode and the recipient’s skin is sufficient for electrotherapy. For example, if the detected at least one signal is indicative of an electrical contact that is less than a predetermined amount (e.g., due to an air bubble between the electrode and the skin; due to a corner portion of the electrode not physically contacting the skin), the circuitry can modify the electrotherapy voltage drive signals provided to the electrode (e.g., increased amplitude to account for the reduced electrical contact), generate a corresponding communication signal (e.g., warning message; error light) to the user (e.g., recipient; medical practitioner) and / or disable the electrotherapy process until the electrical contact equals or is greater than the predetermined amount.

[0029] In certain implementations, the circuitry can execute stored instructions comprising a lookup table or control algorithm correlating measured electrical conductivity, electrical capacitance, and / or electrical impedance values with predetermined ranges of stimulation parameters. For example, the circuitry can reference a lookup table that maps ranges of measured electrical capacitance to corresponding voltage amplitudes, pulse widths, and / or pulse frequencies for the electrotherapy. In certain implementations, the control algorithm can comprise a feedback control mechanism configured to dynamically adjust the electrotherapy parameters based on the measured electrical contact. In certain implementations, the stored instructions can be updated or customized based on the recipient’s attributes (e.g., skin type; body part; treatment history). In certain implementations, the circuitry is configured to implement closed-loop control of the electrotherapy based on the electrical contact between the electrodeand the recipient’s skin. For example, the circuitry can be configured to continuously or periodically monitor the electrical contact and dynamically adjust electrotherapy parameters (e.g., voltage amplitude; current amplitude; pulse width; pulse frequency; duty cycle) in response to changes in the electrical contact. In certain implementations, the circuitry can increase the voltage amplitude when the electrical contact decreases (e.g., due to perspiration, movement, or partial detachment of the electrode) to maintain a consistent therapeutic effect. In certain implementations, the circuitry can decrease the voltage amplitude when the electrical contact increases to prevent overstimulation. In certain implementations, the circuitry can store a history of electrical contact measurements and use the history to predict changes in electrical contact and proactively adjust electrotherapy parameters.[0030| FIG. 3 schematically illustrates an example electrode 300 in accordance with certain implementations described herein. In certain implementations, the electrode 300 comprises a first electrically conductive portion 310 (e.g., electrical trace) and a second electrically conductive portion 320 (e.g., electrical trace) electrically isolated from the first electrically conductive portion 310, the first and second electrically conductive portions 310, 320 in electrical communication with circuitry 350 of electrotherapy device 360. In certain implementations, the at least one signal detected by the circuitry 350 is indicative of an electrical conductivity between the first and second portions 310, 320, an electrical capacitance between the first and second portions 310, 320, and / or an electrical impedance between the first and second portions 310, 320. The circuitry 350 can be configured to, in response to the electrical conductivity between the first and second portions 310, 320, the electrical capacitance between the first and second portions 310, 320, and / or the electrical impedance between the first and second portions 310, 320, evaluate the electrical contact of the electrode 300 with the recipient’s skin. In certain implementations, the capacitance can be measured without increasing electrical current. For example, one or more electrical traces of the electrode 300 can be configured to modulate the electric field to increase capacitance without requiring an increase in electrical current.

[0031] In certain implementations, the first portion 310 and the second portion 320 can comprise an electrically conductive material that is configured to contour and stretch to fit ontothe recipient’s skin. Examples of materials for the first portion 310 and the second portion 320 that are compatible with certain implementations described herein include but are not limited to: knit conductive fabric which is stretchable to an amount greater than its original dimensions without loss of conductivity. The first portion 310 and the second portion 320 are electrically insulated from one another (e.g., having a resistance between the first portion 310 and the second portion 320 that is greater than 10 k at a frequency of 100 kHz or greater than 1 MQ at a frequency of 100 kHz). In certain implementations, the first and second portions 310, 320 are substantially planar and are substantially coplanar with one another.

[0032] In certain implementations, the electrode 300 further comprises an electrically insulative substrate 330 in mechanical communication with the first and second portions 310, 320. For example, the electrically insulative substrate 330 can be substantially planar and configured to contour and stretch to fit onto the recipient’s skin. Examples of materials for the substrate 330 that are compatible with certain implementations described herein include but are not limited to: knit insulative fabric which is stretchable to an amount greater than its original dimensions while keeping the first portion 310 and the second portion 320 electrically insulated from one another. In certain implementations, the electrode 300 further comprises at least one electrically conductive adhesive configured to adhere the electrode 300 to the recipient’s skin.

[0033] In certain implementations, when the electrode 300 is not in contact with the skin, the first and second portions 310, 320 have a first electrical conductivity therebetween (e.g., zero electrical conductivity since the first and second portions 310, 320 are electrically insulated from one another) and when the electrode 300 is in contact with the skin, the first and second portions 310, 320 have a second electrical conductivity therebetween (e.g., via the skin) that is nonzero. The magnitude of the electrical conductivity can be indicative of the amount of electrical contact of the electrode 300 with the skin. In certain other implementations, when the electrode 300 is not in contact with the skin, the first and second portions 310, 320 have a first electrical capacitance with one another and when the electrode is in contact with the skin, the first and second portions 310, 320 have a second electrical capacitance with one another. The magnitude of the electrical capacitance can be indicative of the amount of electrical contact of the electrode 300 with the skin. In certain other implementations, when the electrode 300 is not in contactwith the skin, the first and second portions 310, 320 have a first electrical impedance with one another and when the electrode is in contact with the skin, the first and second portions 310, 320 have a second electrical impedance with one another. The magnitude of the electrical impedance can be indicative of the amount of electrical contact of the electrode 300 with the skin. For example, the second electrical impedance can be substantially equal to the skin impedance (e.g., 220 at a frequency of 100 kHz; in a range of 1 k to 1 MQ at a frequency of 1 Hz).

[0034] In certain implementations, the electrode 300 further comprises at least a portion of the circuitry 350 (e.g., resistors; capacitors; amplifiers; other electrical elements) configured to facilitate measurements of the electrical conductivity, the electrical capacitance, and / or the electrical impedance between the first and second portions 310, 320. In certain other implementations, the circuitry 350 is spaced from the electrode 300 but is in electrical communication with the electrode 300 (e.g., via one or more electrical conduits 340, such as wires or cables). For example, the circuitry 350 can be configured to passively measure the electrical conductivity, electrical capacitance, and / or the electrical impedance between the first and second portions 310, 320 (e.g., by applying low voltage signals to the electrical traces) and comparing the measured electrical conductivity, electrical capacitance, and / or electrical impedance to a predetermined threshold. Such passive measurements are different from measurements in which a voltage amplitude applied to a portion of the electrode 300 is increased until electrical breakdown occurs. Example techniques for making such measurements in accordance with certain implementations described herein are disclosed by S.F. Khalil et al., “The Theory and Fundamentals of Bioimpedance Analysis in Clinical Status Monitoring and Diagnosis of Diseases,” Sensors, Vol. 14, pp. 10895-10928 (2014); T. Yilmaz et al., “Detecting Vital Signs with Wearable Wireless Sensors,” Sensors, Vol. 10, pp. 10837-10862 (2010); E. Alonso et al., “A Novel Passive Method for the Assessment of Skin-Electrode Contact Impedance in Intraoperative Neurophysiological Monitoring Systems,” Nature Sci. Reports, Vol. 10, p. 2819 (2020); D. Wang, “FDC1004: Basics of Capacitive Sensing and Applications,” Texas Instruments Application Report, SNOA927A, pp. 1-12, Dec. 2014, revised June 2021.

[0035] In certain implementations, the predetermined threshold is selected and / or adjusted to correspond to at least one attribute of the recipient (e.g., recipient’s size, skin type, skinthickness; amount and color of hair; skin hydration; etc.). In certain implementations, the measured electrical conductivity, electrical capacitance, and / or electrical impedance while the electrode 300 is applied to the recipient’s skin can be compared to measured values of the electrical conductivity, electrical capacitance, and / or electrical impedance measured while the electrode 300 is spaced away from the recipient’s skin, and differences between the measurements can be indicative of the electrical contact of the electrode 300 with the recipient’s skin (e.g., analogous to operation of a touch control lamp). In certain implementations, the measured electrical conductivity, electrical capacitance, and / or electrical impedance can be indicative of degradation of the electrode 300.0036] The threshold values to be used to distinguish good electrical contact (e.g., sufficient for performing the electrotherapy) from poor electrical contact (e.g., insufficient for performing the electrotherapy) depend on the frequency of the electrical voltages and / or currents applied to the first and second portions 310, 320 to detect the electrical conductivity, electrical capacitance, and / or electrical impedance (e.g., the therapeutic frequency used during the electrotherapy) and other factors (e.g., electrode contact area size; electrode conductive trace pattern). In certain implementations, more than one threshold value can be used to distinguish excellent electrical contact, good electrical contact, and bad electrical contact. For example, excellent electrical conductivity or electrical capacitance can correspond to values less than 100 ms, good electrical conductivity or electrical capacitance can correspond to values between 100 ms and 250 ms, and poor electrical contact can correspond to values greater than 250 ms. For another example, while the contact impedance at the therapeutic frequency is ideally as low as possible (e.g., zero), the predetermined threshold used for distinguishing good electrical impedance from bad electrical impedance (e.g., at frequencies of 1 Hz or 100 kHz) can be in a range of less than 10 Q, less than 100 , or less than 1 MQ.

[0037] In certain implementations, the circuitry 350 controls both the sensing by the electrode 300 and the electrotherapy applied using the electrode 300. In certain such implementations, the circuitry 350 protects (e.g., shields) the portions of the circuitry 350 that controls the sensing from the relatively larger electrical voltages for applying the electrotherapy. In certain implementations, the circuitry 350 can sense a type of electrode 300connected to the electrotherapy device 360. For example, an electrode 300 configured to administer electrotherapy to a predetermined portion of a recipient’s body can be detected by the circuitry 350, the circuitry 350 configured to administer a predetermined electrotherapy regime that is clinically effective for the predetermined portion of a recipient’s body. By way of further example, an electrode 300 can be preconfigured for electrotherapy of a desired body structure of the recipient, the electrode 300 being in electrical communication with the circuitry such that the circuitry 350 receives a signal from the electrode 300 to execute an electrotherapy regime that is clinically effective and / or customized for application to the desired body structure of the recipient. It will be understood that the preconfiguration of an electrode 300 for an electrotherapy regime can be for any desired portion, structure, tissue, etc. of the recipient. In certain implementations, the electrode 300 can be preconfigured for an electrotherapy regime of a joint. In certain implementations, the electrode can be preconfigured for an electrotherapy regime of a desired tissue type. For example, the electrotherapy regime can be customized for a soft tissue (e.g., a muscle, adipose tissue, connective tissue, nervous tissue, blood, lymph, organs, and any other human tissue). In certain implementations, the electrotherapy regime can be preconfigured for a hard tissue (e.g. bone, cartilage, and any other human hard tissue). In certain implementations, the electrotherapy regime can be customized for a body part (e.g., an elbow, a knee, a shoulder, or any other human body part). In some implementations, the electrode 300 can comprise an anatomical shape for electrotherapy of a desired body structure of the recipient. For example, an electrode can be shaped to fit an elbow, a knee, a shoulder etc. such as to ensure that sufficient and / or clinically effective electrical contact of an electrode 300 with the recipient’s skin is maintained during the electrotherapy. In certain implementations, the electrode can comprise conductive portion 310, 320 (e.g., electrical trace) shaped to maximize clinical effectiveness of the electrotherapy being administered to a desired body structure of the recipient. For example, an electrical trace can be shaped to ensure that sufficient and / or clinically effective electrical contact with the recipient’s skin is maintained during the electrotherapy. |0038] In certain implementations, the electrode 300 comprises a fuse configured to be burned out once the electrotherapy has been completed. For example, the last step of the electrotherapy can comprise applying a sufficiently high electrical voltage and / or current suchthat the fuse bums out and creates an open circuit which prevents the electrode 300 from being used in a subsequent electrotherapy session (e.g., the electrode 300 is a “one-time-use” electrode). In certain implementations, the electrode 300 comprises a fuse configured to be in electrical communication with the circuitry 350 such that the circuitry 350 is preconfigured to generate a signal to the electrode 300 to administer electrotherapy if, and only if, the electrode 300 is recognized as suitable for use with the circuitry 350. For example, the electrode 300 and the circuitry 350 can be configured to execute an electronic “handshake” such only a suitable electrode 300 can be connected to the circuitry 350. In some implementations, the electrode can comprise a microcontroller that is configured to determine if a successful electronic handshake has been established between the electrode 300 and the circuitry 350. In certain implementations, a microcontroller can determine whether an electrode 300 has been previously used. In certain implementations, a microcontroller can record data associated with the type, duration, etc. of use of an electrode 300. In certain implementations, a microcontroller can log data associated with a serial number of an electrode. For example, the circuitry 350 can register a serial number of an electrode and further store data associated with the type and duration of use of the electrode with the serial number.

[0039] FIGs. 4A-4E schematically illustrate example configurations of the first and second portions 410, 420 in accordance with certain implementations described herein. In certain implementations, the first and second portions 410, 420 are substantially planar and are substantially coplanar with one another, and at least one first edge 412 of the first portion 410 and at least one second edge 422 of the second portion 420 are substantially parallel to one another.

[0040] In certain implementations, the electrical isolation between the first portion 410 and the second portion 420 can be characterized by a resistance value that depends on the frequency of the applied electrical signals. For example, the resistance between the first portion 410 and the second portion 420 can be greater than 1 MQ at a frequency of 100 kHz, greater than 10 MQ at a frequency of 1 kHz, or greater than 100 M at a frequency of 1 Hz. In certain implementations, the electrical isolation is provided by an air gap, an insulative material (e g., polymer; ceramic; glass), or a combination thereof. In certain implementations, the thirdelectrically conductive portion (e.g., for applying electrotherapy voltages) is electrically isolated from the first and second portions by a resistance that is greater than 100 kQ at a frequency of 100 kHz, greater than 1 MQ at a frequency of 100 kHz, or greater than 10 M at a frequency of 100 kHz.

[0041] For example, as schematically illustrated by FIG. 4A, the at least one first edge 412 can comprise at least a portion of an outer perimeter of the first portion 410 and the at least one second edge 422 comprises at least a portion of an inner perimeter of the second portion 420. In certain such implementations, the first portion 410 can be used to apply the electrotherapy voltages and / or currents to the recipient. In certain other implementations in which neither the first nor second electrically conductive portions 410, 420 are used to apply the electrotherapy voltages to the recipient, the electrode 300 comprises a third electrically conductive portion for applying the electrotherapy voltages to the recipient. The first and second portions 410, 420 can decrease the fraction of the surface area of the electrode 300 that is used to apply the electrotherapy voltages and / or currents to the recipient. The third electrically conductive portion can be electrically insulated from both the first portion 410 and the second portion 420. For example, a resistance between the first or second portions 410, 420 and the third portion can be greater than 10 k at a frequency of 100 kHz or greater than 1 MQ at a frequency of 100 kHz.

[0042] For another example, as schematically illustrated by FIGs. 4B and 4C, the first portion 410 can comprise at least one first trace and the second portion 420 can comprise at least one second trace, at least a portion of the at least one second trace substantially parallel to at least a portion of the at least one first trace.

[0043] In certain such implementations, the spacing between the at least one first edge 412 and the at least one second edge 422 is substantially equal at all points along the first and second portions 410, 420 (e g., the first and second portions 410, 420 are concentric with one another), while in certain other implementations, the spacing between the at least one first edge 412 and the at least one second edge 422 varies at various points along the first and second portions 410, 420.

[0044] FIG. 4D schematically illustrates an example configuration in which the electrode comprises an optically transmissive portion positioned within an inner perimeter of the firstelectrically conductive portion 410. In certain implementations, the optically transmissive portion provides an opening 440 configured to allow light to propagate through the electrode to impinge the recipient’s skin. For example, the optically transmissive portion can comprise a transparent or translucent material (e.g., hydrogel; optically clear adhesive) or an orifice through which light can pass. As illustrated in FIG. 4D, a light source 450 can be in optical communication with the opening 440 and is configured to transmit light through the opening 440 to impinge the recipient’s skin.0045] FIG. 4E schematically illustrates another example configuration in which the electrode comprises an opening 440 configured to receive an electro-optical device. In certain implementations, the opening 440 provides an empty space where the electro-optical device can fit. In certain implementations, the electro-optical device is configured to provide both light (e.g., infrared light; near-infrared light; laser light) and electrical stimulation signals to the electrode. For example, the electro-optical device can be inserted into or positioned within the opening 440 such that the electro-optical device is in optical and electrical communication with the electrode and the recipient’s skin. In certain implementations, the electro-optical device comprises the light source 450 (e.g., LED; laser diode) and electrical contacts configured to deliver electrical stimulation to the recipient via the electrode. As illustrated in FIG. 4E, the electrode has a circular shape with the first and second electrically conductive portions 410, 420 being concentric with one another and the opening 440 positioned within the inner perimeter of the second electrically conductive portion 420.

[0046] Although FIGs. 4A-4E illustrate example configurations having generally rectangular shapes, the electrode and the first and second electrically conductive portions can have various other shapes (e.g., circular; oval; polygonal; square) in accordance with certain implementations described herein. The configurations illustrated in FIGs. 4A-4E are not intended to be limiting. In certain implementations, such as those illustrated in FIGs. 4D and 4E, the first and second electrically conductive portions 410, 420 are concentric with one another. In certain implementations, the electrode can have various sizes depending on the intended application. For example, the electrode can have a length and / or width in a range of 1 inch to 4 inches, 4 inches to 8 inches, or 8 inches to 12 inches. In certain implementations, the electrodecan have a square shape with dimensions of approximately 10 inches by 10 inches or larger for applications requiring coverage of larger body areas (e.g., back; thigh; torso).

[0047] The configurations of the openings 440 illustrated in FIGs. 4D and 4E are not intended to be limiting. In certain implementations, the electrode can comprise multiple openings 440 configured to receive light from one or more light sources 450. In certain implementations, the one or more openings 440 can be positioned within the inner perimeter of the second electrically conductive portion 420 (e.g., as illustrated in FIGs. 4D and 4E), between the first and second electrically conductive portions 410, 420, or outside of the first and second electrically conductive portions 410, 420. In certain implementations, the size and shape of the one or more openings 440 can vary depending on the intended application. In certain implementations, the electrically insulative substrate can comprise an optically transmissive material configured to allow light from the light source 450 to penetrate therethrough to impinge the recipient's skin.

[0048] In a representative implementation, the electrode 300 is adhered to the recipient’s skin and the circuitry 350 detects at least one signal indicative of an electrical capacitance between the first and second electrically conductive portions 310, 320. The circuitry 350 compares the measured electrical capacitance to a predetermined threshold to evaluate the electrical contact of the electrode 300 with the recipient’s skin. If the electrical contact is sufficient (e.g., the measured electrical capacitance meets or exceeds the predetermined threshold), the circuitry 350 enables the electrotherapy device 360 to apply electrotherapy to the recipient’s tissue via the electrode 300. During the electrotherapy, the circuitry 350 continuously or periodically monitors the electrical contact and dynamically adjusts the electrotherapy parameters as needed. If the electrical contact falls below the predetermined threshold (e.g., due to movement or perspiration), the circuitry 350 can modify the electrotherapy parameters, generate a communication signal to the user, and / or disable the electrotherapy. In implementations comprising a light source 450, the circuitry 350 can also disable the light source 450 when the electrical contact falls below the predetermined threshold to prevent unintended light exposure.

[0049] FIG. 5 depicts a flow diagram of an exemplary method 500 for controlling electrotherapy based on electrical contact evaluation in accordance with certain implementations described herein. Different implementations of the method 500 may include additional, fewer, or different steps.

[0050] At block 510, the method 500 comprises providing an electrotherapy device comprising at least one electrode configured to be adhered to a recipient’s skin and to apply electrical fields to an underlying portion of the recipient’s tissue, the at least one electrode comprising a first electrically conductive portion and a second electrically conductive portion electrically isolated from the first electrically conductive portion.

[0051] At block 520, the method 500 comprises generating, using the at least one electrode, at least one signal indicative of an electrical conductivity between the first and second electrically conductive portions, an electrical capacitance between the first and second electrically conductive portions, and / or an electrical impedance between the first and second electrically conductive portions. In certain implementations, generating the at least one signal comprises measuring the electrical conductivity, the electrical capacitance, and / or the electrical impedance without increasing electrical current applied to the recipient.

[0052] At block 530, the method 500 comprises evaluating, in response to the at least one signal, an electrical contact of the at least one electrode with the recipient’s skin. In certain implementations, evaluating the electrical contact comprises comparing a measured value of the electrical conductivity, the electrical capacitance, and / or the electrical impedance to a predetermined threshold. In certain implementations, the predetermined threshold is selected and / or adjusted to correspond to at least one attribute of the recipient (e.g., recipient’s size, skin type, skin thickness; amount and color of hair; skin hydration). In certain implementations, evaluating the electrical contact comprises comparing a measured first value of the electrical conductivity, the electrical capacitance, and / or the electrical impedance to a measured second value of the electrical conductivity, the electrical capacitance, and / or the electrical impedance, the first value measured while the at least one electrode is applied to the recipient’s skin and the second value measured while the at least one electrode is spaced away from the recipient’s skin.

[0053] At block 540, the method 500 comprises controlling electrotherapy applied by the at least one electrode based on the electrical contact evaluation. In certain implementations, controlling the electrotherapy comprises modifying electrotherapy parameters (e.g., voltage amplitude; current amplitude; pulse width; pulse frequency; duty cycle) when the electrical contact is below a predetermined threshold. In certain implementations, controlling the electrotherapy comprises disabling the electrotherapy when the electrical contact is below a predetermined threshold. In certain implementations, controlling the electrotherapy comprises generating a communication signal (e.g., warning message; error light) to a user (e.g., recipient; medical practitioner).

[0054] FIG. 6 depicts a flow diagram of an exemplary method 600 for controlling a light source during combined electro-optical therapy to underlying tissue through a recipient’s skin based on electrical contact evaluation in accordance with certain implementations described herein. Different implementations of the method 600 may include additional, fewer, or different steps, or steps performed in a different order than illustrated in FIG. 6.

[0055] At block 610, the method 600 comprises providing at least one electrode configured to be adhered to a recipient’s skin and to apply electrical fields to an underlying portion of the recipient’s tissue, the at least one electrode comprising at least one optically transmissive portion, a first electrically conductive portion, and a second electrically conductive portion electrically isolated from the first electrically conductive portion.

[0056] At block 620, the method 600 comprises transmitting light from at least one light source through at least one optical conduit and through the at least one optically transmissive portion of the at least one electrode to impinge the recipient’s skin. In certain implementations, the at least one light source comprises a laser (e.g., laser diode). In certain implementations, the at least one light source is configured to emit infrared light and / or near-infrared light for photobiomodulation therapy.

[0057] At block 630, the method 600 comprises generating at least one signal indicative of an electrical conductivity between the first and second electrically conductive portions, an electrical capacitance between the first and second electrically conductive portions, and / or an electrical impedance between the first and second electrically conductive portions.

[0058] At block 640, the method 600 comprises evaluating an electrical contact of the at least one electrode with the recipient’s skin based on the at least one signal.

[0059] At block 650, the method 600 comprises controlling the at least one light source based on the at least one signal. In certain implementations, controlling the at least one light source comprises disabling the at least one light source when the electrical contact is less than a predetermined threshold (e.g., when the electrode peels off or partially detaches from the recipient’s skin). By disabling the at least one light source when the electrical contact is insufficient, the method 600 can prevent unintended exposure of the recipient or user to the light (e g., laser light) from the at least one light source. Tn certain implementations, the method 600 further comprises applying electrotherapy and photobiomodulation therapy simultaneously to the recipient. For example, the method 600 can comprise applying electrotherapy between the first and second electrically conductive portions of the at least one electrode and applying photobiomodulation therapy through the at least one optically transmissive portion of the at least one electrode simultaneously to the recipient.[0060j Although commonly used terms are used to describe the systems and methods of certain implementations for ease of understanding, these terms are used herein to have their broadest reasonable interpretations. Although various aspects of the disclosure are described with regard to illustrative examples and implementations, the disclosed examples and implementations should not be construed as limiting. Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain implementations include, while other implementations do not include, certain features, elements, and / or steps. Thus, such conditional language is not generally intended to imply that features, elements, and / or steps are in any way required for one or more implementations. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a nonexclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.[0061 Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is to be understood within the context used in general to convey that an item, term, etc. may be either X, Y, orZ. Thus, such conjunctive language is not generally intended to imply that certain implementations require the presence of at least one of X, at least one of Y, and at least one of Z.[0(162 j Language of degree, as used herein, such as the terms “approximately,” “about,” “generally,” and “substantially,” represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” may refer to an amount that is within ± 10% of, within ± 5% of, within ± 2% of, within ± 1% of, or within ± 0.1% of the stated amount. As another example, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by ± 10 degrees, by ± 5 degrees, by ± 2 degrees, by ± 1 degree, or by ± 0.1 degree, and the terms “generally perpendicular” and “substantially perpendicular” refer to a value, amount, or characteristic that departs from exactly perpendicular by ± 10 degrees, by ± 5 degrees, by ± 2 degrees, by ± 1 degree, or by ± 0.1 degree. The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” less than,” “between,” and the like includes the number recited. As used herein, the meaning of “a,” “an,” and “said” includes plural reference unless the context clearly dictates otherwise. While the structures and / or methods are discussed herein in terms of elements labeled by ordinal adjectives (e.g., first, second, etc.), the ordinal adjectives are used merely as labels to distinguish one element from another, and the ordinal adjectives are not used to denote an order of these elements or of their use.[0063j Various configurations have been described above. It is to be appreciated that the implementations disclosed herein are not mutually exclusive and may be combined with one another in various arrangements. Although this invention has been described with reference to these specific configurations, the descriptions are intended to be illustrative of the invention and are not intended to be limiting. Various modifications and applications may occur to those skilled in the art without departing from the true spirit and scope of the invention. Thus, forexample, in any method or process disclosed herein, the acts or operations making up the method / process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Features or elements from various implementations and examples discussed above may be combined with one another to produce alternative configurations compatible with implementations disclosed herein. Various aspects and advantages of the implementations have been described where appropriate. It is to be understood that not necessarily all such aspects or advantages may be achieved in accordance with any particular implementation. Thus, for example, it should be recognized that the various implementations may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may be taught or suggested herein.L

Claims

CLAIMSTHAT WHICH IS CLAIMED IS:

1. An apparatus for monitoring electrical contact between an electrode and a recipient’s skin, the apparatus comprising:an electrical power source;circuitry in electrical communication with the electrical power source and configured to control the electrical power source; andat least one electrode in electrical communication with the electrical power source and with the circuitry, the at least one electrode comprising a first electrically conductive portion and a second electrically conductive portion electrically insulated from the first electrically conductive portion, the at least one electrode configured to be adhered to the recipient’s skin and to apply electrical fields to an underlying portion of the recipient’s tissue,wherein the circuitry is configured to detect at least one signal indicative of an electrical conductivity between the first and second electrically conductive portions, an electrical capacitance between the first and second electrically conductive portions, and / or an electrical impedance between the first and second electrically conductive portions and evaluate an electrical contact of the at least one electrode with the recipient’ s skin based on the at least one signal, andwherein the electrical conductivity, the electrical capacitance, and / or the electrical impedance is measured without increasing electrical current applied to the recipient.

2. The apparatus of claim 1, wherein the circuitry is further configured to modify electrotherapy parameters provided to the at least one electrode when the electrical contact is below a predetermined threshold.

3. The apparatus of claim 1, wherein the circuitry is configured to disable electrotherapy when the electrical contact is below a predetermined threshold.

4. The apparatus of claim 1, wherein the circuitry is configured to generate a communication signal to a user when the electrical contact is insufficient for electrotherapy.

5. The apparatus of claim 1, wherein the first electrically conductive portion comprises at least one first trace and the second electrically conductive portion comprises at least one second trace, at least a portion of the at least one second trace substantially parallel to at least a portion of the at least one first trace.

6. The apparatus of claim 1, wherein the first and second electrically conductive portions are concentric.

7. The apparatus of claim 1, wherein the first electrically conductive portion and the second electrically conductive portion are electrically insulated from one another by a resistance that is greater than 10 kQ at a frequency of 100 kHz.

8. The apparatus of claim 1, wherein the at least one electrode further comprises a third electrically conductive portion configured to apply electrotherapy voltages and / or currents to the recipient, the third electrically conductive portion electrically insulated from both the first electrically conductive portion and the second electrically conductive portion by a resistance that is greater than 10 kQ at a frequency of 100 kHz.

9. The apparatus of claim 1, wherein the circuitry is configured to passively measure the electrical conductivity, the electrical capacitance, and / or the electrical impedance by applying low voltage signals to the first and second electrically conductive portions and comparing the measured electrical conductivity, electrical capacitance, and / or electrical impedance to a predetermined threshold.

10. The apparatus of claim 9, wherein the predetermined threshold is adjusted to correspond to at least one attribute of the recipient.

11. The apparatus of claim 1, wherein the at least one electrode comprises an electrically insulative substrate in mechanical communication with the first and second electrically conductive portions, the electrically insulative substrate configured to contour and stretch to fit onto the recipient’s skin.

12. The apparatus of claim 1, wherein the at least one electrode comprises at least one electrically conductive adhesive configured to adhere the at least one electrode to the recipient’s skin.

13. A method for monitoring electrical contact between an electrode and a recipient’ s skin, the method comprising:providing an electrotherapy device comprising at least one electrode configured to be adhered to the recipient’s skin and to apply electrical fields to an underlying portion of the recipient’s tissue, the at least one electrode comprising a first electrically conductive portion and a second electrically conductive portion electrically isolated from the first electrically conductive portion;generating, using the at least one electrode, at least one signal indicative of an electrical conductivity between the first and second electrically conductive portions, an electrical capacitance between the first and second electrically conductive portions, and / or an electrical impedance between the first and second electrically conductive portions;evaluating, in response to the at least one signal, an electrical contact of the at least one electrode with the recipient’s skin; andcontrolling electrotherapy applied by the at least one electrode based on the electrical contact evaluation.

14. The method of claim 13, wherein generating the at least one signal comprises measuring the electrical conductivity, the electrical capacitance, and / or the electrical impedance without increasing electrical current applied to the recipient.

15. The method of claim 13, wherein evaluating the electrical contact comprises comparing a measured value of the electrical conductivity, the electrical capacitance, and / or the electrical impedance to a predetermined threshold.

16. The method of claim 15, wherein the predetermined threshold is selected and / or adjusted to correspond to at least one attribute of the recipient.

17. The method of claim 13, wherein evaluating the electrical contact comprises comparing a measured first value of the electrical conductivity, the electrical capacitance, and / or the electrical impedance to a measured second value of the electrical conductivity, the electrical capacitance, and / or the electrical impedance, the first value measured while the at least one electrode is applied to the recipient’s skin and the second value measured while the at least one electrode is spaced away from the recipient’s skin.

18. The method of claim 13, wherein controlling the electrotherapy comprises modifying electrotherapy parameters when the electrical contact is below a predetermined threshold.

19. The method of claim 13, wherein controlling the electrotherapy comprises disabling the electrotherapy when the electrical contact is below a predetermined threshold.

20. The method of claim 13, wherein controlling the electrotherapy comprises generating a communication signal to a user.

21. An apparatus for providing light therapy to underlying tissue through a recipient’ s skin, the apparatus comprising:at least one electrode configured to be adhered to a recipient’s skin and to apply electrical fields to an underlying portion of the recipient’ s tissue, the at least one electrode comprising at least one optically transmissive portion, a first electrically conductive portion, and a second electrically conductive portion electrically isolated from the first electrically conductive portion;at least one light source;at least one optical conduit in optical communication with the at least one light source and configured to transmit light from the at least one light source through the at least one optically transmissive portion of the at least one electrode to impinge the recipient’s skin; andcircuitry configured to detect at least one signal indicative of an electrical conductivity between the first and second electrically conductive portions, an electrical capacitance between the first and second electrically conductive portions, and / or an electrical impedance between the first and second electrically conductive portions, to evaluate an electrical contact of the at least one electrode with the recipient’s skin based on the at least one signal, and to control the at least one light source based on the at least one signal.

22. The apparatus of claim 21, wherein the circuitry is configured to disable the at least one light source when the electrical contact is below a predetermined threshold.

23. The apparatus of claim 21, wherein the at least one optically transmissive portion comprises an optically transmissive and electrically conductive material.

24. The apparatus of claim 23, wherein the optically transmissive and electrically conductive material comprises graphene.

25. The apparatus of claim 24, wherein the graphene comprises a layer having a thickness of 1.0 pm to 3.0 pm.

26. The apparatus of claim 21, wherein the at least one light source comprises a laser.

27. The apparatus of claim 21, wherein the at least one optically transmissive portion is configured to transmit infrared light and / or near-infrared light.

28. The apparatus of claim 21, wherein the at least one electrode comprises an opening configured to receive an electro-optical device, the electro-optical device configured to provide light and electrical stimulation signals to the at least one electrode.

29. The apparatus of claim 21, wherein the circuitry is configured to apply electrotherapy between the first and second electrically conductive portions of the at least one electrode and photobiomodulation therapy through the at least one optically transmissive portion of the at least one electrode simultaneously to the recipient.

30. The apparatus of claim 21, wherein the circuitry is configured to apply electrotherapy and photobiomodulation therapy in a sequence.

31. A method for providing light therapy to underlying tissue through a recipient’s skin, the method comprising:providing at least one electrode configured to be adhered to the recipient’s skin and to apply electrical fields to an underlying portion of the recipient’s tissue, the at least one electrode comprising at least one optically transmissive portion, a first electrically conductive portion, and a second electrically conductive portion electrically isolated from the first electrically conductive portion;transmitting light from at least one light source through at least one optical conduit and through the at least one optically transmissive portion of the at least one electrode to impinge the recipient’s skin;generating at least one signal indicative of an electrical conductivity between the first and second electrically conductive portions, an electrical capacitance between the first and second electrically conductive portions, and / or an electrical impedance between the first and second electrically conductive portions;evaluating an electrical contact of the at least one electrode with the recipient’s skin based on the at least one signal; andcontrolling the at least one light source based on the at least one signal.

32. The method of claim 31, wherein controlling the at least one light source comprises disabling the at least one light source when the electrical contact is less than a predetermined threshold.

33. The method of claim 31, further comprising applying electrotherapy between the first and second electrically conductive portions of the at least one electrode and photobiomodulation therapy through the at least one optically transmissive portion of the at least one electrode simultaneously to the recipient.

34. The method of claim 31, wherein the at least one light source comprises a laser.

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