Abstract:
The present invention is directed to a wearable system wherein elements of the system, including various sensors adapted to detect biometric and other data and/or to deliver drugs, are positioned proximal to, on the ear or in the ear canal of a person. In embodiments of the invention, elements of the system are positioned on the ear or in the ear canal for extended periods of time. For example, an element of the system may be positioned on the tympanic membrane of a user and left there overnight, for multiple days, months, or years. Because of the position and longevity of the system elements in the ear canal, the present invention has many advantages over prior wearable biometric and drug delivery devices.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application Nos. 62/236,295, filed Oct. 2, 2015, and 62/395,667, filed Sep. 16, 2016, which applications are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The present invention is related to wearable devices and methods for their use. The present invention is further related to hearing devices. The present invention is further related to methods for the use of wearable devices and hearing devices. 
       SUMMARY OF THE INVENTION 
       [0003]    The present invention is directed to a wearable system wherein elements of the system, including various sensors, are adapted to detect biometric and other data and/or to deliver drugs. In this invention, the elements of the system are positioned proximal to, on, or in the ear canal of a person. In embodiments of the invention, elements of the system are positioned external to, on or in the ear canal and may reside there for extended periods of time. For example, an element of the system may be positioned on the tympanic membrane of a user and left there overnight, for multiple days, months or years. Because of the position and longevity of the system elements in the ear canal, the present invention has many advantages over prior wearable biometric devices. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0004]    The foregoing and other objects, features and advantages of embodiments of the present inventive concepts will be apparent from the more particular description of preferred embodiments, as illustrated in the accompanying drawings in which like reference characters refer to the same or like elements. The drawings are not necessarily to scale; emphasis instead being placed upon illustrating the principles of the preferred embodiments. 
           [0005]      FIG. 1  shows a hearing system configured in accordance with embodiments of the present invention. 
           [0006]      FIG. 2  shows an isometric view of the medial ear canal assembly of the hearing system of  FIG. 1  in accordance with embodiments of the present invention. 
           [0007]      FIG. 3  shows a top view of the medial ear canal assembly of the hearing system of  FIG. 1  in accordance with embodiments of the present invention. 
           [0008]      FIG. 4  shows an exploded view of a medial ear canal assembly and its method of assembly, in accordance with embodiments of the present invention. 
           [0009]      FIG. 5A  is an isometric Top view of a medial ear canal assembly in accordance with embodiments of the present invention. 
           [0010]      FIG. 5B  is an isometric bottom view of a medial ear canal assembly in accordance with embodiments of the present invention. 
           [0011]      FIG. 6  shows a medial ear canal assembly in accordance with embodiments of the present invention. 
           [0012]      FIG. 7  shows an isometric view of a medial ear canal assembly including a drug delivery reservoir in accordance with embodiments of the present invention. 
           [0013]      FIG. 8  shows an isometric view of a lateral ear canal assembly in accordance with embodiments of the present invention. 
           [0014]      FIG. 9  is an isometric top view of a medial ear canal assembly in accordance with embodiments of the present invention. 
           [0015]      FIG. 10  is an isometric bottom view of a medial ear canal assembly in accordance with embodiments of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0016]    In embodiments of the present invention, biometric sensors and other devices may be placed in proximity to, on or in the ear canal resulting in a system with the ability to collect information on the user&#39;s environment, including information on the user&#39;s location, the time of day, and the activity the user is engaged in. In embodiments of the present invention, drug delivery devices may be placed in proximity to, on or in the ear canal resulting in a system with the ability to deliver drugs to a user through the ear and/or components of the ear. In embodiments of the present invention, the combination of a superior hearing system with biometric sensors and other devices, such as drug delivery devices, in a single system which may be placed in proximity to, on or in the ear canal may result in a system with the ability to collect information on the user&#39;s environment, including information on the user&#39;s location, the time of day, and the activity the user is engaged in. 
         [0017]    The system may further provide access to highly vascular sections of ear canal, including the pars tensa and manubrium vessels and the information that may be gathered from such locations. The system may further provide the ability to gather data, monitor health, send alerts and deliver drugs through a device that is in place 24 hours a day for years on end, without interfering with or changing the wearer&#39;s day to day activities. The system may further provide the ability to ensure user compliance without the need for user interaction, other than, in some cases, normal upkeep. In some embodiments, the current invention may be used to replace halter monitors, event recorders and/or Sub-Cutaneous (Sub-Q) monitors (e.g. injectable monitors). The system may further provide the ability to mount sensors directly against the skin and ensure that they stay in place over long periods of time, by, for example, using system components that are custom fit to the ear canal wall and/or to the tympanic membrane. The system may further provide the user with feedback, instructions or warnings which go directly to the wearer&#39;s tympanic membrane in a manner which is imperceptible to any third party. 
         [0018]    A system according to the present invention may further enable a user to take advantage of characteristics of the ear canal of the user to make measurements of the user&#39;s biometric data, including: positioning of sensors in a place, which is undetectable to both the user and third parties; positioning of sensors in a place where they are well protected from the environment, and from external forces (not subject to false alarms, such as, for example, the type of false alarms that result from the dropping or shaking of externally worn devices); positioning of sensors in a very vascular environment; positioning sensors in an environment which may be highly conducive to the measurement of biometric data (an environment where a better signal to noise ratio is achievable—enclosed and dark to facilitate optical measurements; and positioning sensors in an environment where an extensive range of biometric data is available and can be measured, including blood pressure, heart rate, glucose levels, respiration rate, temperature, blood flow and other biometric data. 
         [0019]    A system according to the present invention may further provide: the ability to deliver drugs to a user, including sustained, timed and/or algorithm controlled drug delivery; the ability to ensure compliance with drug regimens by automating drug delivery in an easily accessible region such as the ear canal; the ability to limit the amount of drug delivered without compromising efficacy by delivering to highly vascular tissue in or around the ear canal, such as, for example, the pars tensa and manubrium vessels; the ability to deliver drugs to regions of the body where the vasculature is easily accessible, for example, where the tissue covering the vasculature is very thin, such as, for example, over the manubrium vessels; the ability to locally deliver drugs which are normally delivered systemically, thereby reducing the amount of drugs delivered and the related side effects; and the ability to deliver drugs and treat diseases using a novel platform in the ear canal. Drugs which may be delivered using the present invention include antibiotics (neomycin/quinolenes), dexamethasone, steroids (prednisolone), acetic acid, aluminum acetate, boric acid, betnesol, prednisolone sodium phosphate, clotrimazole, Ceruminolytic agents (sodium chloride/chlorbutanol/paradichlorobenzene), amoxicillin, flucloxacillin; ciprofloxacillin, penicillin, betahistine dopamine antagonists (prochlorperazine), antihistamines (cinnarizine and cyclizine), antiviral drugs (acyclovir), sodium fluoride, nicotine and insulin. Diseases which may be treated using the present invention include acute otitis media, furunculosis of external auditory canal, perichondritis of pinna, acute mastoiditis, and malignant otitis externa, vertigo, herpes zoster oticus and cancer. Embodiments of the invention may be used to deliver drugs in which systemic or local drug delivery would be beneficial. 
         [0020]      FIG. 1  shows a hearing system  10  configured to transmit electromagnetic energy EM to a medial ear canal assembly  100  positioned in the ear canal EC of the user. The ear comprises an external ear, a middle ear ME and an inner ear. The external ear comprises a Pinna P and an ear canal EC and is bounded medially by a tympanic membrane (also referred to as an eardrum) TM. Ear canal EC extends medially from pinna P to tympanic membrane TM. Ear canal EC is at least partially defined by a skin SK disposed along the surface of the ear canal. The tympanic membrane TM comprises a tympanic membrane annulus TMA that extends circumferentially around a majority of the eardrum to hold the eardrum in place. The middle ear ME is disposed between tympanic membrane TM of the ear and a cochlea CO of the ear. The middle ear ME comprises the ossicles OS to couple the tympanic membrane TM to cochlea CO. The ossicles OS comprise an incus IN, a malleus ML and a stapes ST. The malleus ML is connected to the tympanic membrane TM and the stapes ST is connected to an oval window OW, with the incus IN disposed between the malleus ML and stapes ST. Stapes ST is coupled to the oval window OW so as to conduct sound from the middle ear to the cochlea. 
         [0021]    The hearing system  10  may include an input transducer assembly  20  and a medial ear canal assembly  100  to transmit sound to the user. Hearing system  10  may comprise a sound processor  24 , which may be, for example, a behind the ear unit (BTE). Sound processor  24  may comprise many components of hearing system  10  such as a speech processor, battery, wireless transmission circuitry, and input transducer assembly  20 . The input transducer assembly  20  can be located at least partially behind the pinna P or substantially or entirely within the ear canal EC. Input transducer assembly  20  may further comprise a Bluetooth™ connection to couple to a cell phone or other external communication device  26 . The medial ear canal assembly  100  of hearing system  10  may comprise components to receive the light energy or other energy, such as RF energy and vibrate the eardrum in response to such energy. 
         [0022]    The input transducer assembly  20  can receive a sound input, for example an audio sound or an input from external communication device  26 . With hearing aids for hearing impaired individuals, the input can be ambient sound. The input transducer assembly may comprise at least one input transducer, for example a microphone  22 . The at least one input transducer may comprise a second microphone located away from the first microphone, in the ear canal or the ear canal opening, for example positioned on sound processor  24 . Input transducer assembly  20  may also include can include a suitable amplifier or other electronic interface. In some embodiments, the input may comprise an electronic sound signal from a sound producing or receiving device, such as a telephone, a cellular telephone, a Bluetooth connection, a radio, a digital audio unit, and the like. 
         [0023]    Input transducer assembly  20  may include a lateral ear canal assembly  12  which may comprise a light source such as an LED or a laser diode for transmitting data (including audio data) and energy to medial ear canal assembly  100 . In other embodiments, lateral ear canal assembly  12  may comprise an electromagnetic coil, an RF source, or the like for transmitting data (including audio data) and energy to medial ear canal assembly  100 . In embodiments of the invention, lateral ear canal assembly  12  may further comprise a receiver adapted to receive data transmitted from medial ear canal assembly  100 , such as, for example, biometric data from sensors positioned on or near medial ear canal assembly  100 . 
         [0024]    In embodiments of the invention, medial ear canal assembly  100  is adapted to receive the output from input transducer assembly  20  and produce mechanical vibrations in response to the received information, which may be, for example, in the form of a light signal generated by lateral ear canal assembly  12 . In embodiments of the invention, medial ear canal assembly  100  comprises a sound transducer, wherein the sound transducer may comprise at least one of a microactuator, a coil, a magnet, a magnetostrictive element, a photostrictive element, or a piezoelectric element. In embodiments of the invention, input transducer assembly  20  may comprise a light source coupled to sound processor  24  by a fiber optic cable and positioned on lateral ear canal assembly  12 . In embodiments of the invention, input transducer assembly  20  may comprise a laser diode coupled to sound processor  24  and positioned on lateral ear canal assembly  12 . In embodiments of the invention, the light source of the input transducer assembly  20  may be positioned in the ear canal along with sound processor  24  and microphone  22 . When properly coupled to the subject&#39;s hearing transduction pathway, the mechanical vibrations caused by medial ear canal assembly  100  can stimulate the cochlea CO, which induces neural impulses in the subject which can be interpreted by the subject as a sound input. 
         [0025]      FIG. 2  and  FIG. 3  show isometric and top views, respectively, of an embodiment of medial ear canal assembly  100  according to the present invention. In the illustrated embodiments, medial ear canal assembly  100  may comprise a retention structure  110 , a support structure  120 , a transducer  130 , at least one spring  140 , and a photodetector  150 . Medial ear canal assembly  100  may include data processor  200  and transmitter  210  which may be positioned on transducer  130 . Retention structure  110 , which may be a resilient retention structure, may be sized to couple to the tympanic membrane annulus TMA and at least a portion of the anterior sulcus AS of the ear canal EC. Retention structure  110  may comprise an aperture  110 A. Aperture  110 A is sized to receive transducer  130  and to allow for normal transduction of sound through the subjects hearing transduction pathway. 
         [0026]    The retention structure  110  can be sized to the user and may comprise one or more of an O-ring, a C-ring, a molded structure, or a structure having a shape profile so as to correspond to the user&#39;s ear canal anatomy, or to a mold of the ear canal of the user. Retention structure  110  may comprise a resilient retention structure such that the retention structure can be compressed radially inward as indicated by arrows  102  from an expanded wide profile configuration to a narrow profile configuration when passing through the ear canal and subsequently expand to the wide profile configuration when placed on one or more of the eardrum, the eardrum annulus, or the skin of the ear canal. The retention structure  110  may comprise a shape profile corresponding to anatomical structures that define the ear canal. For example, the retention structure  110  may comprise a first end  112  corresponding to a shape profile of the anterior sulcus AS of the ear canal and the anterior portion of the tympanic membrane annulus TMA. The first end  112  may comprise an end portion having a convex shape profile, for example a nose, so as to fit the anterior sulcus and so as to facilitate advancement of the first end  112  into the anterior sulcus. The retention structure  110  may comprise a second end  114  having a shape profile corresponding to the posterior portion of tympanic membrane annulus TMA. 
         [0027]    The support structure  120  may be positioned in aperture  110 A and may comprise a frame, or chassis, so as to support the components connected to support structure  120 . Support structure  120  may comprise a rigid material and can be coupled to the retention structure  110 , the transducer  130 , the at least one spring  140 , which may support transducer  130 , and the photodetector  150 . The support structure  120  may comprise an elastomeric bumpers  122  extending between the support and the retention structure, so as to couple the support to the retention structure  110  with the elastomeric bumpers  122 . The support structure  120  may define an aperture  120 A formed thereon. The aperture  120 A can be sized so as to receive transducer  130 , which may be, for example, a balanced armature transducer. When positioned in aperture  120 A, housing  139  of the balanced armature transducer  130  may extend at least partially through the aperture  120 A when transducer  130  is coupled to the tympanic membrane TM. Aperture  120 A may be further sized to allow normal sound conduction through medial ear canal assembly  100 . 
         [0028]    Transducer  130  may, in embodiments of the invention, comprise structures to couple to the eardrum when the retention structure  110  contacts one or more of the eardrum, the eardrum annulus, or the skin of the ear canal. The transducer  130  may, in embodiments of the invention, comprise a balanced armature transducer having a housing  139  and a vibratory reed  132  extending out one end of housing  139 . Housing  139  may also, in embodiments of the invention, be a part of a flux return path for transducer  130 . In embodiments of the invention, the housing may be a fully integrated part of the transducer, including, for example, the magnetic flux path. The vibratory reed  132  may be affixed to a post  134  and an umbo pad  136 . The umbo pad  136  may have a convex surface that contacts the tympanic membrane TM and may move the TM in response to signals received by medial ear canal assembly  100 , causing the TM to vibrate. The umbo pad  136  can be anatomically customized to the anatomy of the ear of the user. 
         [0029]    At least one spring  140  may be connected to the support structure  120  and the transducer  130 , so as to support the transducer  130  in aperture  120 A. The at least one spring  140  may comprise a first spring  142  and a second spring  144 , in which each spring is connected to opposing sides of a first end of transducer  130 . The springs may comprise coil springs having a first end attached to support structure  120  and a second end attached to transducer  130  or a mount affixed to transducer  130 , such that the coil springs pivot the transducer about axes  140 A of the coils of the coil springs and resiliently urge the transducer toward the eardrum when retention structure  110  contacts one or more of the eardrum, the eardrum annulus, or the skin of the ear canal. The support structure  120  may comprise a tube sized to receiving an end of the at least one spring  140 , so as to couple the at least one spring to support structure  120 . 
         [0030]    In embodiments of the invention, a photodetector  150  may be coupled to support structure  120  of medial ear canal assembly  100 . A bracket mount  152  can extend substantially around photodetector  150 . An arm  154  may extend between support structure  120  and bracket mount  152  so as to support photodetector  150  with an orientation relative to support structure  120  when placed in the ear canal EC. The arm  154  may comprise a ball portion so as to couple to support structure  120  with a ball-joint  128 . The photodetector  150  may be electrically coupled to transducer  130  so as to drive transducer  130  with electrical energy in response to the light energy signal radiated to medial ear canal assembly  100  by input transducer assembly  20 . In embodiments of the invention, medial ear canal assembly  100  may include an electronics package  215  mounted on a back surface of photodetector  150 . Electronics in electronics package  215  may be used to, for example, condition or modulate the light energy signal between photodetector  150  and transducer  130 . Electronics package  215  may comprise, for example, an amplifier to amplify the signal from photodetector  150 . 
         [0031]    Resilient retention structure  110  can be resiliently deformed when inserted into the ear canal EC. The retention structure  110  can be compressed radially inward along the pivot axes  140 A of the coil springs such that the retention structure  110  is compressed as indicated by arrows  102  from a wide profile configuration having a first width  110 W 1  as illustrated in  FIG. 3  to an elongate narrow profile configuration having a second width  110 W 2 . Compression of retention structure  110  may facilitate advancement of medial ear canal assembly  12  through ear canal EC in the direction illustrate by arrow  104  in  FIG. 2  and when removed from the ear canal in the direction illustrated by arrow  106  in  FIG. 2 . The elongate narrow profile configuration may comprise an elongate dimension extending along an elongate axis corresponding to an elongate dimension of support structure  120  ( 120 W) and aperture  120 A. The elongate narrow profile configuration may comprise a shorter dimension corresponding to a width of the support structure  120  and aperture  120 A. The retention structure  110  and support structure  120  may be passed through the ear canal EC for placement on, for example, the tympanic membrane TM of a user. To facilitate placement, vibratory reed  132  of the transducer  130  can be aligned substantially with the ear canal EC while medial ear canal assembly  100  is advanced along the ear canal EC in the elongate narrow profile configuration having second width  110 W 2 . 
         [0032]    When properly positioned, retention structure  110  may return to a shape conforming to the ear canal adjacent to tympanic membrane TM, wherein the medial ear canal assembly is held in place, at least in part, by the interaction of retention structure  110  with the walls of ear canal EC. The medial ear canal assembly  100 , including support structure  120 , may apply a predetermined amount of force to the tympanic membrane TM when the umbo pad  136  is in contact with the eardrum. When medial ear canal assembly  100  is positioned the support structure  120  can maintain a substantially fixed shape and contact with the tympanic membrane TM is maintained, at least in part, by the force exerted by at least one spring  140 . 
         [0033]      FIG. 4  is an exploded view of a medial ear canal assembly  100  according to embodiments of the present invention which shows an assembly drawing and a method of assembling medial ear canal assembly  100 . The retention structure  110  as described herein can be coupled to the support structure  120 , for example, with elastomeric bumpers  122  extending between the retention structure  110  and the support structure  120 . The retention structure  110  may define an aperture  110 A having a width  110 AW corresponding to the wide profile configuration. The support structure  120  may define an aperture  120 A having a width  120 AW that remains substantially fixed when the resilient retention structure is compressed. The aperture  110 A of the resilient retention structure can be aligned with the aperture  120 A of the support. Support structure  120  may comprise ball joint  128 , and ball joint  128  can be coupled to arm  154  and bracket mount  152 , such that the support is coupled to the photodetector  150 . 
         [0034]    The transducer  130  may comprise a housing  139  and a mount  138  attached to housing  139 , in which the mount  138  is shaped to receive the at least one spring  140 . The transducer  130  may comprise a vibratory reed  132  extending from housing  139 , in which the vibratory reed  132  is attached to a post  134 . The post  134  can be connected to the umbo pad  136 . 
         [0035]    The support structure  120  can be coupled to the transducer  130  with the at least one spring  140  extending between the coil and the transducer such that the umbo pad  136  is urged against the tympanic membrane TM when the medial ear canal assembly  100  is placed to transmit sound to the user. The support structure  120  may comprise mounts  126 , for example tubes, and the mounts  126  can be coupled to a first end of at least one spring  140 , and a second end of the at least one spring  140  can be coupled to the transducer  130  such that the at least one spring  140  extends between the support and the transducer. Umbo sensor  220  may be attached to umbo pad  136  such that umbo sensor  220  is positioned against tympanic membrane TM when medial ear canal assembly  100  is positioned in the ear canal. Umbo sensor may be positioned against any portion of the tympanic membrane and may be referred to as a tympanic membrane sensor. 
         [0036]      FIG. 5A  is an isometric top view of a medial ear canal assembly  100  according to embodiments of the invention.  FIG. 5B  is an isometric bottom view of a medial ear canal assembly  100  according to embodiments of the invention. In  FIGS. 5A and 5B , medial ear canal assembly  100  has a retention structure  110  comprising a stiff support  121  extending along a portion of retention structure  110 . The stiff support  121  may be connected to resilient member  141  and coupled to intermediate portion  149 . In many embodiments, resilient member  141  and stiff support structure  120  comprise an integrated component such as an injection molded (or 3-D Printed) unitary component comprising a modulus of elasticity and dimensions so as to provide the resilient member  141  and the stiff support  121 . 
         [0037]    In the embodiments of  FIGS. 5A and 5B , stiff support  121  and resilient member  141  can be configured to support output transducer  130  such that output transducer  130  is coupled to the tympanic membrane TM when the medial ear canal assembly  100 , including retention structure  110  is placed in the ear canal EC. The resilient member  141  can be attached to the stiff support  121 , such that the resilient member  141  directly engages the stiff support  121 . The stiff support  121  can be affixed to the resilient member  141  so as to position the umbo pad  136  below the retention structure  110 , such that the umbo pad  136  engages the tympanic membrane TM when the retention structure  110  is placed, for example on the tympanic membrane annulus TMA. The resilient member  141  can be configured to provide a predetermined force to the eardrum when the medial ear canal assembly  100  is placed in the Ear Canal. 
         [0038]    In the embodiments of  FIGS. 5A and 5B , resilient member  141  may comprise a resilient cantilever beam. In these embodiments, photodetector  150  may be attached to the output transducer  130  with a mount  153 . Photodetector  150  and output transducer  130  can deflect together when the biasing structure  149 , for example a spacer, is adjusted to couple the output transducer  130  and the umbo pad  136  to the tympanic membrane TM. 
         [0039]    Sulcus sensors  230  may be positioned on layer  115  of retention structure  110  such that sulcus sensors  230  are in contact with the tympanic membrane TM and/or other portions of the ear canal EC when medial ear canal assembly  100  is positioned in the ear canal. Sulcus sensors  230  may also be positioned on sulcus flanges  235  to optimize their position in ear canal EC, such as, for example, to optimize their position against the tissue of tympanic membrane TM and/or against the tissue of the tympanic membrane annulus TMA. Sulcus flanges  235  may be used to, for example, position sulcus sensors  230  over regions of highly vascular tissue in the ear canal EC, such as on the tympanic membrane TM. Sulcus flanges  235  may be used to, for example, position sulcus sensors  230  over the pars tensa. 
         [0040]      FIG. 6  shows an isometric view of the medial ear canal assembly  100 . Medial ear canal assembly  100  comprises a retention structure  110 , a support structure  120 , a transducer  130 , at least one spring  140  and a photodetector  150 . Medial ear canal assembly  100  may include data processor  200  and transmitter  210  which may be positioned on transducer  130 . Medial ear canal assembly  100  may further include non-contact sensors  260  and tethered sensors  250 . Non-contact sensors  260  and tethered sensors  250  may be connected to data processor  200  to provide data to data processor  200 . Alternatively, or in combination, one or more of data processor  200 , transmitter  210 , non-contact sensor(s)  260  and tethered sensors  250  may be part of, located on, or connected to electronics package  215  on photodetector  150 . Tethered sensors  250  may be positioned against the skin SK in the ear canal EC where umbo sensors  220  (not shown in  FIG. 6 ) and sulcus sensors  230  (not shown in  FIG. 6 ) cannot contact. Alternatively or in combination, one or more of non-contact sensors  260  may be positioned loosely in ear canal EC to gather data. Retention structure  110  is sized to couple to the tympanic membrane annulus TMA and at least a portion of the anterior sulcus AS of the ear canal EC. With respect to the remaining elements of the retention structure and their function, see the discussion of  FIGS. 2 and 3 . 
         [0041]      FIG. 7  shows and isometric view of the medial ear canal assembly  100  including retention structure  110 , support structure  120 , springs  140 , a photodetector  150 , and at least one drug delivery device. In embodiments of the invention, medial ear canal assembly  100  may include reservoir  400  and delivery tube  410  which are adapted to deliver drugs to the wearer. In embodiments of the invention, reservoir  400  may be used to store drugs for delivery to, for example, the tympanic membrane. In embodiments of the invention, delivery tube  410  may be used to transport drugs from reservoir  400  to umbo pad  136  which may be constructed to transmit the drugs to or through at least a portion of the tympanic membrane TM. In embodiments of the invention, umbo pad  136  may be constructed to include, for example, needles or microneedles through which drugs may be transported into the tissue of, for example, the tympanic membrane. 
         [0042]    In embodiments of the invention, the medial ear canal assembly  100  may include sensors, such as, for example, umbo sensors  220 , sulcus sensors  230  and tethered sensors  250 , such as those shown in  FIGS. 4, 5, and 6 . In embodiments of the invention, sensors located on medial ear canal assembly  100  may be used to collect data on the user, which user data may be used to regulate the flow of drugs from the at least one drug delivery device which is incorporated into medial ear canal assembly  100 . 
         [0043]      FIG. 8  shows a lateral ear canal assembly  12 , including a retention structure  310  (which may also be referred to as an eartip retention structure) configured for placement in the ear canal. Retention structure  310  may comprise a molded tubular structure having the shape of the ear canal. Retention structure  310  may be configured to retain lateral ear canal assembly  12  in the ear canal. Lateral ear canal assembly  12  may include a signal source  320  such as a laser diode. An outer surface  340  of retention structure  310  may include ear tip sensors  240 , which may be positioned against the skin SK of the ear canal EC and, alternatively or in combination, sensors (not shown) which are positioned on the medial or lateral ends of lateral ear canal assembly  12 , such as, for example, a body temperature sensor. 
         [0044]      FIG. 9  is an isometric Top view of a medial ear canal assembly in accordance with embodiments of the present invention. In  FIG. 9 , medial ear canal assembly  100  comprises transducer  130 , photodetector  150 , spring  140 , support structure  120  and retention structure  110 . In the embodiment of  FIG. 9 , sulcus sensors  230  may be positioned on retention structure  110 , which may be, for example a flexible material adapted to conform to the anatomy of the user&#39;s ear canal. Retention structure  110  may comprise a material such as Parylene or Silicone. 
         [0045]      FIG. 10  is an isometric bottom view of a medial ear canal assembly in accordance with embodiments of the present invention. In  FIG. 10 , medial ear canal assembly  100  may comprise transducer  130 , photodetector  150 , spring  140 , support structure  120 , retention structure  110  and umbo pad  136 . In the embodiment of  FIG. 10 , sulcus sensors  230  may be positioned on retention structure  110 , which may be, for example a flexible material adapted to conform to the anatomy of the user&#39;s ear canal. In the embodiment of  FIG. 10 , umbo sensors  220  may be positioned on umbo pad  136 . Retention structure  110  may comprise a material such as Parylene or Silicone. 
         [0046]    In embodiments of the invention, umbo sensors  220 , sulcus sensors  230 , eartip sensors  240 , and tethered sensors  250  may comprise sensors that contact the skin to detect biometric data. Alternatively or in combination, umbo sensors  220 , sulcus sensors  230 , eartip sensors  240 , and tethered sensors  250  may comprise sensors that do not require skin contact to detect biometric data. Non-contact sensors may also be sensors which do not require skin contact to detect biometric data. 
         [0047]    Skin contacting sensors adaptable for use in embodiments of the present invention may include: micro-sensors, electrochemical sensors; thin film sensors; pressure sensors; micro-needle sensors, capacitive sensors thermometers, thermocouples, trigeminal nerve monitors; piezoelectric sensors; electrodes, pulse oximetry sensors, glucose meters, oxygen sensors and iontophoresis electrodes. 
         [0048]    Non-skin contacting sensors adaptable for use in embodiments of the present invention may include: light sensors (e.g. optical sensors or infrared sensors); sound sensors (e.g. a microphone to pick up sounds in the ear canal); vibration sensors; heat sensors, micro-sensors; electrochemical sensors; thin film sensors; liquid (e.g. oil) sensors; accelerometers, microphones; gyroscopes, including 3-axis accelerometers, 3 axis gyroscopes; MEMS sensors, including 3 axis MEMS sensors; GPS circuitry; pedometers; reservoir monitors; walking gait sensors; battery state monitors; energy level monitors; and strain gauges. 
         [0049]    In embodiments of the present invention, a suitable microphone might be transducer  130  wired to measure back electromagnetic fields (back EMF) which is generated when post  134  is moved independent of any drive signal provided to transducer  130 , such as by vibrations in the tympanic membrane TM resulting from, for example the user speaking or snoring. The back EMF could then be provided to data processor  200  where it could be analyzed and transmitted to a receiver in lateral ear canal assembly  12  or in a remote receiver (e.g. a smart phone) by transmitter  210 . In one embodiment of the invention, data processor  200  could include circuitry used to separate sounds coming from sources other than the user from sounds generated by the user to provide filtered data, which filtered feedback data may represent, for example, the user&#39;s voice. 
         [0050]    In embodiments of the invention, a suitable optical sensor may comprise an infrared transmitter and infrared receiver. In embodiments of the invention, a suitable optical sensor may include an optical receiver tuned to the same frequency as signal source  320 . 
         [0051]    In embodiments of the invention, sensors may be 3D printed on or as an integral part of structures in the components of hearing system  10 . In embodiments of the invention, non-skin contacting sensors may be mounted on, for example, the back side of photodetector  150 . 
         [0052]    In embodiments of the invention, a light may be mounted on medial ear canal assembly  100  and positioned to shine through tympanic membrane TM to illuminate the middle ear and the contents thereof. In embodiments of the invention, a sensor may be further included on medial ear canal assembly  100  to measure light reflected from the middle ear. 
         [0053]    In embodiments of the invention, sensors on medial ear canal assembly  100  may be used to sense the position of transducer assembly with respect to structural features of the ear canal EC, such as the tympanic membrane TM. The data from such sensors may be used to position the medial ear canal assembly  100  to ensure it is properly placed and aligned in the user&#39;s ear. 
         [0054]    In embodiments of the invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure environmental factors which are related to the proper functioning of the medial ear canal assembly  100 , such as, degradation in photodetector output, earwax buildup, whether the user is compliant with the required oiling regimen. In embodiments of the invention, sensors may be used to ensure that the user is properly oiling by, for example, measuring the amount and regularity of oiling. In embodiments of the invention, sensors on the eartip may be used to guide and/or detect proper medial ear canal assembly insertion. In embodiments of the invention, pressure sensors and/or fluid sensors may be positioned on a medial ear canal assembly, including on the umbo pad  136  or sulcus platform to assist in the preceding tasks. 
         [0055]    In embodiments of the invention, strain gauges may be included in the medial ear canal assembly  100  to provide feedback on the proper placement of medial ear canal assembly  100 . For example, post  134  may include strain gauges which indicate when displacement starts and/or the degree of displacement by registering the lateral force on umbo pad  136 . Further, the placement of one or more strain gages on retention structure  110  may provide an indication that the medial ear canal assembly  100  has lifted off of the tympanic membrane TM. In embodiments of the invention, medial ear canal assembly  100  may include features which interact with physical features of the wearer to maintain medial ear canal assembly  100  in a predetermined position in the ear canal EC, such as, for example against the tympanic membrane TM. In embodiments of the invention, such physical features may create strain on the medial ear canal assembly  100 , which strain may be measured by strain gauges positioned on medial ear canal assembly  100  to ensure proper placement of medial ear canal assembly  100 . 
         [0056]    In embodiments of the invention, a feedback signal representative of the average power received by photodetector  150  may be provided, which signal may be used to quantify the coupling efficiency between photodetector  150  and signal source  320 . In embodiments of the invention, the power level of signal source  320  may be adjusted to reflect the degree of coupling and the coupling efficiency indicated by the feedback signal. In embodiments of the invention, the position of lateral ear canal assembly  12  and/or medial ear canal assembly  100  may be modified to increase or decrease the level of the feedback signal, thus improving the coupling efficiency between the lateral ear canal assembly  12  and the medial ear canal assembly  100 . 
         [0057]    In embodiments of the invention, noise cancelation may be implemented by, for example, incorporating a microphone onto the back of photodetector  150 . Sound signals received by the microphone could be converted into drive signals which move the tympanic membrane in opposition to the received signals such that the received signals are not perceived by the user. Such noise cancelation may be implemented such that the microphone is turned on only when the output from the photodetector exceeds a predetermined voltage, such as, for example, approximately 300 millivolts. Alternatively or in combination, the microphone may be turned on when the photodetector output voltage exceeds approximately 1 volt. In one embodiment of the invention, the sound signals may be measured by measuring the back EMF of transducer  130  and generating a signal to the transducer which causes the transducer to vibrate the tympanic membrane in a way which cancels the movement which generated the measured back EMF. 
         [0058]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure bodily fluids, such as sweat, interstitial fluid, blood and/or cerumen (ear wax). Sensors suitable for making these measurements include electrochemical sensors, micro-needles and capacitive sensors. 
         [0059]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure sweat for the purpose of, for example, measuring hydration levels, electrolyte balance, lactate threshold, glucose levels, calories burned, respiration rate, drug levels, metabolites, small molecules (e.g. amino acids, DHEA, cortisol, pH levels and various proteins. Sensors suitable for making these measurements include electrochemical sensors, micro-needles and capacitive sensors. 
         [0060]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure the temperature, including the core body temperature of a user. Sensors suitable for making these measurements include thermometers, thermocouples, and optical temperature sensors. 
         [0061]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure and/or monitor blood pressure, blood flow, heart rate, pulse, and arrhythmia. Sensors suitable for making these measurements include electrodes, PPG (Photoplethysmography) sensors and pulse oximetry sensors. 
         [0062]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure and/or monitor the oxygen level in a user&#39;s blood. Sensors suitable for making these measurements include optical sensors PPG (Photoplethysmography) sensors, and/or pulse oximetry sensors. 
         [0063]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure and/or monitor drug delivery and/or medication use by monitoring the drug content in blood or interstitial fluid of a user. Sensors suitable for making these measurements include micro-needles and/or iontophoresis electrodes. 
         [0064]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure and/or monitor body fat. Sensors suitable for making these measurements include electrodes. 
         [0065]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to monitor and/or measure sleep, including the duration and/or quality of such sleep. Sensors suitable for making these measurements include accelerometers, microphones and gyroscopes. 
         [0066]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure and/or monitor snoring and/or sleep apnea. Sensors suitable for making these measurements include accelerometers, microphones; gyroscopes; head position monitors (3 axis gyroscope); vibration sensor (microphone, TMT microactuator); oxygen sensors and trigeminal nerve monitors. 
         [0067]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC and/or on the tympanic membrane may be used to measure and/or monitor the location of a user. Sensors suitable for making these measurements include GPS circuitry. 
         [0068]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure and/or monitor the movement of a user. Sensors suitable for making these measurements include an accelerometer and/or a pedometer. 
         [0069]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure and/or monitor calorie intake. Sensors suitable for making these measurements include microphones and piezoelectric sensors. 
         [0070]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure and/or monitor posture, head position and/or body position. Sensors suitable for making these measurements include gyroscopes, accelerometers (including 3-axis accelerometers) and MEMS sensors (including 3 axis MEMS sensors). 
         [0071]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure and/or monitor seizure disorders, including epilepsy, by making electroencephalogram (EEG) measurements. Sensors suitable for making these measurements include electrodes and/or electroencephalograph. 
         [0072]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure and/or monitor electrical activities of the heart by making an electrocardiogram (ECG/EKG). Sensors suitable for making these measurements may include electrodes and/or electrocardiographs. 
         [0073]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure and/or monitor the electrical activity produced by skeletal muscles by making an electromyogram using Electromyography (EMG). Sensors suitable for making these measurements may include electrodes and/or electromyographs. 
         [0074]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure and/or monitor the glucose in a user&#39;s blood and/or interstitial fluid. Sensors suitable for making these measurements include glucose meters, electrochemical sensors, microneedles, and/or iontophoresis electrodes. 
         [0075]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure and/or monitor neurological function. Sensors suitable for making these measurements may include sensors for measuring the walking gait of a user. 
         [0076]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to measure and/or monitor the position and/or orientation of a user&#39;s eye. 
         [0077]    Many other physical characteristics may be measured by sensors on medial ear canal assembly  100  or positioned in the ear canal EC, including: multi-axis acceleration; multi-axis angle; skin capacitance; infrared absorption, (e.g. pulse ox), chemical reactions; and strains. 
         [0078]    In embodiments of the present invention, devices on medial ear canal assembly  100  or positioned in the ear canal EC may be used in combination with sensors to deliver medication to a user. Devices suitable for making these delivers may include drug reservoirs, patches, microneedles, polymers designed to elute over time and/or drug eluting materials. 
         [0079]    In embodiments of the invention, drugs may be delivered through, for example, iontophoresis, direct skin contact, needles, drugs in the platform, drug infused silicon or other structural materials or holes or pores in the tympanic membrane structure to hold drugs prior to dispensing or weep over time. 
         [0080]    In embodiments of the present invention, devices on medial ear canal assembly  100  or positioned in the ear canal EC may be used to stimulate serotonin production in a user by, for example, shining light in the ear canal EC for predetermined periods of time. Alternatively, such devices may be adapted to increase the production of vitamin D. 
         [0081]    In embodiments of the present invention, devices, including sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to recognize the speech of a user. Devices suitable for making these delivers may include microphones and speech recognition/signal processing chips and software. 
         [0082]    In embodiments of the present invention, sensors on medial ear canal assembly  100  or positioned in the ear canal EC may be used to control the function of hearing system  10 . The function of hearing system  10  may be controlled by, for example, sensing control instructions from the user, including, verbal instructions and/or instructions conveyed by finger snapping, bone conduction and/or bringing a hand or finger into proximity with the sensors on medial ear canal assembly  100 . Sensors suitable for such control functions may include touch sensors, bone conduction sensors and proximity sensors. 
         [0083]    In embodiments of the present invention, the power required to operate sensors, drug delivery, and/or other devices located on medial ear canal assembly  100  may be supplied by one or more of the following: AC or DC current from photodetector  150 ; AC or DC current from an RF antenna located on or connected to medial ear canal assembly  100 ; Energy from a battery, micro-battery and/or super capacitor on or connected to medial ear canal assembly  100 . In further embodiments of the present invention, circuitry on medial canal assembly  100  may be obtained by, for example: harvesting power from the motion of the user, including the dynamic motion of the wall of an outer ear, using, for example, a spring located on or connected to medial ear canal assembly  100 ; harvesting power from the motion of the tympanic membrane, including harvesting sound energy which vibrates the tympanic membrane; harvesting power from the motion of the tympanic membrane, including harvesting sound energy below approximately 100 Hz; harvesting power from the action of muscles in or near the ear canal, such as, for example muscles used in chewing food; harvesting power from the temporomandibular joint; using the movement of the eardrum (such as, for example, driven by music) to act as a pump. In embodiments of the invention circuitry on medial ear canal assembly  100  may be powered by, for example, the use of light based earplugs which transmits energy to medial ear canal assembly  100  to power the assembly when lateral ear canal assembly  12  is not being used. In embodiments of the invention, such light based earplugs may be used to recharge batteries or super capacitors located on or connected to medial ear canal assembly  100 . In embodiments of the invention circuitry on medial ear canal assembly  100  may be powered by, for example, a wand which radiates, for example, RF energy to an antenna located on or connected to medial ear canal assembly  100  to power sensors on medial ear canal assembly  100  and/or in the ear canal EC for the purpose of making measurements. 
         [0084]    In embodiments of the present invention, sensors located on medial ear canal assembly  100  may communicate data to any one of a number of devices, including lateral ear canal assembly  12 , a smartphone, a smart watch, a cellular network, a ZigBee network, a Wi-Fi network, a WiGi-G network, and/or a Bluetooth enabled device. In embodiments of the present invention, such information may be transmitted from medial ear canal assembly  100  to lateral ear canal assembly  12  and from lateral ear canal assembly  12  to a smartphone, a smart watch, a cellular network, a ZigBee network, and/or a Bluetooth enabled device. In embodiments of the invention, such sensors a part of a closed loop communication network. In embodiments of the invention, communication to medial ear canal assembly  100  may be facilitated by the positioning of an antenna on or connected to medial ear canal assembly  100 . In embodiments of the invention, such antennas may be printed on or formed as part of a chassis of medial ear canal assembly  100 . In embodiments of the present invention, communication of data may be facilitated by the inclusion of transmitter  210  on medial ear canal assembly  100 . 
         [0085]    In embodiments of the invention, removable portions of hearing system  10  may sense emergency situations, such as fire alarms, and communicate with the user wearing medial ear canal assembly  100  using an antenna located on or connected to medial ear canal assembly  100  to warn the user of danger. 
         [0086]    In embodiments of the invention, data collected from sensors located on medial ear canal assembly  100  or in the ear canal EC of a user may be communicated to the user&#39;s physician and/or family. In embodiments of the invention, data collected from sensors located on medial ear canal assembly  100  or in the ear canal EC of a user may be used to generate data or reports which may be communicated to the user&#39;s physician and/or family. 
         [0087]    In embodiments of the present invention, information, data or reports which may be communicated to the user, the user&#39;s physician and/or family may include information on the user&#39;s environment, including time of day, activity, surrounding sounds. In embodiments of the present invention, information, data or reports which may be communicated to the user, the user&#39;s family physician, and/or family may include information on biometric date related to the user, including blood pressure, heart rate, glucose levels, and other biometric data. In embodiments of the present invention, information, data or reports which may be communicated to the user, the user&#39;s family physician and/or family may include information on specific events related to the user or the user&#39;s physical condition, including, falls, blood pressure spikes, heart attacks, temperature spikes, impending or actual seizures, changes in specific biomarkers, or other metrics. In embodiments of the present invention, information, data or reports which may be communicated to the user, the user&#39;s family physician and/or family may include algorithm results transmitted when trends or parameters in the user&#39;s biometric data become concerning. In embodiments of the present invention, information, including warnings may be communicated to the user may include, sleep apnea warnings, drowsiness warnings (e.g. when driving), warnings of impending seizures, migraine headaches warnings, and/or cluster headache warnings. 
         [0088]    In embodiments of the invention, medial ear canal assembly  100  may be used to communicate with the user to, for example, remind the user when to drink or when the user&#39;s sugar levels are spiking or dropping. 
         [0089]    In embodiments of the present invention, data or other information may be transmitted by a user to the hearing system  10  of a second user. In embodiments of the invention, a user may transmit data or other information to a network of hearing systems  10 . 
         [0090]    In embodiments of the present invention, data collected by sensors positioned on medial ear canal assembly  100  or in the ear canal of a user may be collected and analyzed, by, for example, an Application on the user&#39;s smart phone. Such data may be used for many purposes, including predicating changes in the user&#39;s health and generating event alarms. Event alarms generated from the collected data might include alarms related to epilepsy seizures, migraines, cluster headaches, or predetermined changes in key biometric data or trends. Such data may be further processed to allow the user to, for example, view the data which is most important to the user, perform trend analysis on the data, correlate specific data with activities or environment, provide a dashboard of data or chart specific data. Data may also be stored for review at future doctor&#39;s appointments. Data trends may also be stored and analyzed over time. 
         [0091]    Embodiments of the present invention are directed to a hearing system comprising a medial ear canal assembly including a transducer configured to be positioned on the tympanic membrane of a user; a lateral ear canal assembly including a signal source configured to be positioned in the ear canal of a user; and sensors connected to the medial ear canal assembly, the sensors being connected to a transmitter. In embodiments of the invention, the sensors may include sensors adapted to detect biometric data. In embodiments of the invention, the sensors may include sensors adapted to detect one or more physical characteristics of the user. In embodiments of the invention, at least one of the sensors may comprise a microphone. In embodiments of the invention, the microphone may comprise a micro-actuator. In embodiments of the invention, sound received by the micro-actuator is configured to be converted to a back EMF signal. In embodiments of the invention, the hearing system may include a data processor which is configured to convert the back EMF to a signal representative of the sound received by the micro-actuator. In embodiments of the invention the hearing system may be configured to transmit the signal representative of the sound received by the microactuator to a receiver external to the hearing system. In embodiments of the invention, the receiver comprises a smart phone, a wireless network, or a peripheral device. In embodiments of the invention, at least one of the sensors comprises a skin contacting sensor or a non-skin contacting sensor. In embodiments of the invention, at least one of the sensors comprises an umbo sensor, an eartip sensor, or a tethered sensor. 
         [0092]    Embodiments of the present invention are directed to a method of sensing physical characteristics of a hearing system user, the hearing system comprising a medial ear canal assembly positioned on or near the tympanic membrane, the medial ear canal assembly comprising transducer sensors and a transmitter, the method comprising the steps of: using the sensors to measure biometric data of the user; and transmitting the measured biometric data using the transmitter. In embodiments of the invention the method further comprising using the sensors to measure one or more physical characteristics of the user. In embodiments of the invention at least one of the sensors comprises a microphone the method further comprising the steps of measuring sound in the user&#39;s ear canal. In embodiments of the invention the microphone comprises a micro-actuator, the method further comprising measuring the back EMF signal. In embodiments of the invention the hearing system includes a data processor, the method further including the step of converting the back EMF signal to an electrical signal and transmitting the electrical signal to the data signal processor. In embodiments of the invention the back EMF signal includes a first signal portion representative of the signal received from the hearing system and a second signal representative of at least one physical characteristic of the user, the method further including the step of separating the first signal from the second signal. In embodiments of the invention the method further includes the step of transmitting the signal to a receiver external to the hearing system. In embodiments of the invention the receiver comprises a smart phone. In embodiments of the invention at least one of the sensors comprises a skin contacting sensor or a non-skin contacting sensor. In embodiments of the invention at least one of the sensors comprises an umbo sensor, an eartip sensor, or a tethered sensor. In embodiments of the invention the output transducer is used as a sensor. In embodiments of the invention the sensor is used as a microphone to measure received sound at the tympanic membrane. In embodiments of the invention the signal from the microphone is coupled to the transmitter. 
         [0093]    Embodiments of the present invention are directed to an ear canal platform comprising: a medial ear canal assembly positioned on or over the tympanic membrane of a user; and sensors connected to the signal output transducer, the sensors being connected to a transmitter. In embodiments of the invention the sensors include sensors adapted to detect biometric data. In embodiments of the invention the sensors include sensors adapted to detect one or more physical characteristics of the user. In embodiments of the invention at least one of the sensors comprises a microphone. In embodiments of the invention the microphone comprises a micro-actuator. In embodiments of the invention sound received by the micro-actuator is configured to be converted to a voltage representative of the back EMF generated in the microactuator by the sound received by the microactuator. In embodiments of the invention the hearing system includes a data processor which is configured to convert the voltage to a signal representative of the sound received by the micro-actuator. In embodiments of the invention the signal is configured to be transmitted by the hearing system to a receiver external to the hearing system. In embodiments of the invention the receiver comprises a smart phone, a wireless network, or a peripheral device. In embodiments of the invention at least one of the sensors comprises a skin contacting sensor or a non-skin contacting sensor. In embodiments of the invention at least one of the sensors comprises an umbo sensor, an eartip sensor, or a tethered sensor. 
         [0094]    Embodiments of the present invention are directed to a method of sensing physical characteristics of a user having a medial ear canal assembly positioned on or near the tympanic membrane, the medial ear canal assembly comprising sensors and a transmitter, the method comprising the steps of: using the sensors to measure biometric data of the user; and transmitting the measured biometric data using the transmitter. In embodiments of the invention the method further comprising using the sensors to measure one or more physical characteristics of the user. In embodiments of the invention at least one of the sensors comprises a microphone the method further comprising the steps of measuring sound in the user&#39;s ear canal. In embodiments of the invention the microphone comprises a micro-actuator, the method further comprising measuring and transmitting the output of the microphone. In embodiments of the invention the hearing system includes a data processor, the method further including the step of sending the transmitted signal to the data processor. the transmitted signal includes a first signal portion representative of the signal received from the hearing system and a second signal representative of a physical characteristic of the user, the method further including the step of separating the first signal from the second signal. In embodiments of the invention the method further includes the step of transmitting the signal to a receiver external to the hearing system. In embodiments of the invention the receiver comprises a smart phone. In embodiments of the invention at least one of the sensors comprises a skin contacting sensor or a non-skin contacting sensor. In embodiments of the invention at least one of the sensors comprises an umbo sensor, an eartip sensor, or a tethered sensor. In embodiments of the invention the output transducer is used as a sensor. In embodiments of the invention the sensor is used as a microphone to measure received sound at the tympanic membrane. In embodiments of the invention the signal from the microphone is coupled to the transmitter. 
         [0095]    Embodiments of the present invention are directed to an ear canal platform comprising: a medial ear canal assembly positioned on the tympanic membrane of a user; a drug delivery device mounted on the ear canal assembly. In embodiments of the invention an ear canal assembly further includes sensors connected to the ear canal assembly, the sensors being connected to a transmitter. In embodiments of the invention the sensors include sensors adapted to detect biometric data. In embodiments of the invention the sensors include sensors adapted to detect one or more physical characteristics of the user. In embodiments of the invention at least one of the sensors is a microphone. In embodiments of the invention the microphone is a micro-actuator. In embodiments of the invention sound received by the micro-actuator is converted to a transmitted signal. In embodiments of the invention the hearing system includes a data processor which converts the transmitted signal to a signal representative of the sound received by the micro-actuator. In embodiments of the invention the signal is transmitted by the hearing system to a receiver external to the hearing system. In embodiments of the invention the receiver is a smart phone, a wireless network, or a peripheral device. In embodiments of the invention at least one of the sensors comprises a skin contacting sensor, or a non-skin contacting sensor. In embodiments of the invention at least one of the sensors comprises an umbo sensor, an eartip sensor, or a tethered sensor. 
         [0096]    Embodiments of the present invention are directed to a method of delivering drugs to a user having a medial ear canal assembly positioned on or near the user&#39;s tympanic membrane, the medial ear canal assembly comprising a drug delivery device, the method comprising the steps of: delivering drugs to the user through the drug delivery device. In embodiments of the invention the medial ear canal assembly further includes sensors and a transmitter, the method comprising the steps of: using the sensors to measure biometric data of the user; and transmitting the measured biometric data using the transmitter. In embodiments of the invention the method further includes the step of activating the drug delivery device using the biometric data measured by the sensors. In embodiments of the invention the method further comprises using the sensors to measure one or more physical characteristics of the user. In embodiments of the invention the method further comprises the step of activating the drug delivery device using the measured physical characteristics of the user. In embodiments of the invention, the step of activating drug delivery includes activating drug delivery when needed and/or at predetermined times or over predetermined time periods. In embodiments of the invention at least one of the sensors comprises a skin contacting sensor or a non-skin contacting sensor. In embodiments of the invention at least one of the sensors comprises an umbo sensor, an eartip sensor, or a tethered sensor. In embodiments of the invention, the system may comprise a reservoir and mechanisms for drug delivery. 
         [0097]    While the preferred embodiments of the devices and methods have been described in reference to the environment in which they were developed, they are merely illustrative of the principles of the present inventive concepts. Modification or combinations of the above-described assemblies, other embodiments, configurations, and methods for carrying out the invention, and variations of aspects of the invention that are obvious to those of skill in the art are intended to be within the scope of the claims. In addition, where this application has listed the steps of a method or procedure in a specific order, it may be possible, or even expedient in certain circumstances, to change the order in which some steps are performed, and it is intended that the particular steps of the method or procedure claim set forth herein below not be construed as being order-specific unless such order specificity is expressly stated in the claim.