Patent Description:
The present invention is related to hearing systems. The present invention is further related to drug delivery devices. The present disclosure is further related to methods not forming part of the claimed invention for the use of wearable devices, hearing devices and drug delivery devices.

<CIT> provides systems, methods, devices, and kits for treating a patient's ear comprising a guide block including a foam block or disk at its distal end. The foam block is configured to fit within the ear canal near the tympanic membrane. The foam block holds in alignment a guide tube. The guide tube extends through the foam block and is configured to be located near the tympanic membrane. The guide tube has a soft tip at its distal end. The foam block also holds in alignment a tube that can be used to deliver medication into the space between the foam block.

Aspects of the invention are as set out in the independent claim, and optional features in the dependent claims.

The present disclosure 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 disclosure, the elements of the system are positioned proximal to, on, or in the ear canal of a person. In embodiments of the disclosure, 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, including drug delivery devices, 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 drug delivery devices.

The foregoing and other objects, features and advantages of embodiments of the disclosure 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.

In embodiments of the present disclosure, 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's environment, including information on the user's location, the time of day, and the activity the user is engaged in. In embodiments of the present. disclosure, 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 disclosure, 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's environment, including information on the user's location, the time of day, and the activity the user is engaged in. 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 <NUM> hours a day for years on end, without interfering with or changing the wearer'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. Some embodiments 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's tympanic membrane in a manner which is imperceptible to any third party.

A system according to the present disclosure may further enable a user to take advantage of characteristics of the ear canal of the user to make measurements of the user'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.

A system according to the present disclosure 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.

<FIG> shows a hearing system <NUM> configured to transmit electromagnetic energy EM to a medial ear canal assembly <NUM> 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.

The hearing system <NUM> may include an input transducer assembly <NUM> and a medial ear canal assembly <NUM> to transmit sound to the user. Hearing system <NUM> may comprise a sound processor <NUM>, which may be, for example, a behind the ear unit (BTE). Sound processor <NUM> may comprise many components of hearing system <NUM> such as a speech processor, battery, wireless transmission circuitry, and input transducer assembly <NUM>. The input transducer assembly <NUM> can be located at least partially behind the pinna P or substantially or entirely within the ear canal EC. Input transducer assembly <NUM> may further comprise a Bluetooth™ connection to couple to a cell phone or other external communication device <NUM>. The medial ear canal assembly <NUM> of hearing system <NUM> may comprise components to receive the light energy or other energy, such as RF energy and vibrate the eardrum in response to such energy.

The input transducer assembly <NUM> can receive a sound input, for example an audio sound or an input from external communication device <NUM>. 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 <NUM>. 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 <NUM>. Input transducer assembly <NUM> 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.

Input transducer assembly <NUM> may include a lateral ear canal assembly <NUM> 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 <NUM>. In other embodiments, lateral ear canal assembly <NUM> may comprise an electromagnetic coil, an RF source, or the like for transmitting data (including audio data) and energy to medial ear canal assembly <NUM>. In embodiments of the invention, lateral ear canal assembly <NUM> may further comprise a receiver adapted to receive data transmitted from medial ear canal assembly <NUM>, such as, for example, biometric data from sensors positioned on or near medial ear canal assembly <NUM>.

In embodiments of the disclosure, medial ear canal assembly <NUM> is adapted to receive the output from input transducer assembly <NUM> 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 <NUM>. In embodiments of the disclosure, medial ear canal assembly <NUM> 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 disclosure, input transducer assembly <NUM> may comprise a light source coupled to sound processor <NUM> by a fiber optic cable and positioned on lateral ear canal assembly <NUM>. In embodiments of the disclosure, input transducer assembly <NUM> may comprise a laser diode coupled to sound processor <NUM> and positioned on lateral ear canal assembly <NUM>. In embodiments of the disclosure, the light source of the input transducer assembly <NUM> may be positioned in the ear canal along with sound processor <NUM> and microphone <NUM>. When properly coupled to the subject's hearing transduction pathway, the mechanical vibrations caused by medial ear canal assembly <NUM> can stimulate the cochlea CO, which induces neural impulses in the subject which can be interpreted by the subject as a sound input.

<FIG> and <FIG> show isometric and top views, respectively, of an embodiment of medial ear canal assembly <NUM> according to the present disclosure. In the illustrated embodiments, medial ear canal assembly <NUM> may comprise a retention structure <NUM>, a support structure <NUM>, a transducer <NUM>, at least one spring <NUM>, and a photodetector <NUM>. Medial ear canal assembly <NUM> may include data processor <NUM> and transmitter <NUM> which may be positioned on transducer <NUM>. Retention structure <NUM>, 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 <NUM> may comprise an aperture 110A. Aperture 110A is sized to receive transducer <NUM> and to allow for normal transduction of sound through the subjects hearing transduction pathway.

The retention structure <NUM> 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's ear canal anatomy, or to a mold of the ear canal of the user. Retention structure <NUM> may comprise a resilient retention structure such that the retention structure can be compressed radially inward as indicated by arrows <NUM> 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 <NUM> may comprise a shape profile corresponding to anatomical structures that define the ear canal. According to the claimed invention, the retention structure <NUM> comprises a first end <NUM> 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 <NUM> comprises 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 <NUM> into the anterior sulcus. The retention structure <NUM> may comprise a second end <NUM> having a shape profile corresponding to the posterior portion of tympanic membrane annulus TMA.

The support structure <NUM> may be positioned in aperture 110A and may comprise a frame, or chassis, so as to support the components connected to support structure <NUM>. Support structure <NUM> may comprise a rigid material and can be coupled to the retention structure <NUM>, the transducer <NUM>, the at least one spring <NUM>, which may support transducer <NUM>, and the photodetector <NUM>. The support structure <NUM> may comprise an elastomeric bumpers <NUM> extending between the support and the retention structure, so as to couple the support to the retention structure <NUM> with the elastomeric bumpers <NUM>. The support structure <NUM> may define an aperture 120A formed thereon. The aperture 120A can be sized so as to receive transducer <NUM>, which may be, for example, a balanced armature transducer. When positioned in aperture 120A, housing <NUM> of the balanced armature transducer <NUM> may extend at least partially through the aperture 120A when transducer <NUM> is coupled to the tympanic membrane TM. Aperture 120A may be further sized to allow normal sound conduction through medial ear canal assembly <NUM>.

Transducer <NUM> may, in embodiments of the disclosure, comprise structures to couple to the eardrum when the retention structure <NUM> contacts one or more of the eardrum, the eardrum annulus, or the skin of the ear canal. The transducer <NUM> may, in embodiments of the invention, comprise a balanced armature transducer having a housing <NUM> and a vibratory reed <NUM> extending out one end of housing <NUM>. Housing <NUM> may also, in embodiments of the invention, be a part of a flux return path for transducer <NUM>. 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 <NUM> may be affixed to a post <NUM> and an umbo pad <NUM>. The umbo pad <NUM> 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 <NUM>, causing the TM to vibrate. The umbo pad <NUM> can be anatomically customized to the anatomy of the ear of the user.

At least one spring <NUM> may be connected to the support structure <NUM> and the transducer <NUM>, so as to support the transducer <NUM> in aperture 120A. The at least one spring <NUM> may comprise a first spring <NUM> and a second spring <NUM>, in which each spring is connected to opposing sides of a first end of transducer <NUM>. The springs may comprise coil springs having a first end attached to support structure <NUM> and a second end attached to transducer <NUM> or a mount affixed to transducer <NUM>, such that the coil springs pivot the transducer about axes 140A of the coils of the coil springs and resiliently urge the transducer toward the eardrum when retention structure <NUM> contacts one or more of the eardrum, the eardrum annulus, or the skin of the ear canal. The support structure <NUM> may comprise a tube sized to receiving an end of the at least one spring <NUM>, so as to couple the at least one spring to support structure <NUM>.

In embodiments of the disclosure, a photodetector <NUM> may be coupled to support structure <NUM> of medial ear canal assembly <NUM>. A bracket mount <NUM> can extend substantially around photodetector <NUM>. An arm <NUM> may extend between support structure <NUM> and bracket mount <NUM> so as to support photodetector <NUM> with an orientation relative to support structure <NUM> when placed in the ear canal EC. The arm <NUM> may comprise a ball portion so as to couple to support structure <NUM> with a ball-joint <NUM>. The photodetector <NUM> may be electrically coupled to transducer <NUM> so as to drive transducer <NUM> with electrical energy in response to the light energy signal radiated to medial ear canal assembly <NUM> by input transducer assembly <NUM>. In embodiments of the disclosure, medial ear canal assembly <NUM> may include an electronics package <NUM> mounted on a back surface of photodetector <NUM>. Electronics in electronics package <NUM> may be used to, for example, condition or modulate the light energy signal between photodetector <NUM> and transducer <NUM>. Electronics package <NUM> may comprise, for example, an amplifier to amplify the signal from photodetector <NUM>.

Resilient retention structure <NUM> can be resiliently deformed when inserted into the ear canal EC. The retention structure <NUM> can be compressed radially inward along the pivot axes 140A of the coil springs such that the retention structure <NUM> is compressed as indicated by arrows <NUM> from a wide profile configuration having a first width 110W1 as illustrated in <FIG> to an elongate narrow profile configuration having a second width 110W2. Compression of retention structure <NUM> may facilitate advancement of medial ear canal assembly <NUM> through ear canal EC in the direction illustrate by arrow <NUM> in <FIG> and when removed from the ear canal in the direction illustrated by arrow <NUM> in <FIG>. The elongate narrow profile configuration may comprise an elongate dimension extending along an elongate axis corresponding to an elongate dimension of support structure <NUM> (120W) and aperture 120A. The elongate narrow profile configuration may comprise a shorter dimension corresponding to a width of the support structure <NUM> and aperture 120A. The retention structure <NUM> and support structure <NUM> 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 <NUM> of the transducer <NUM> can be aligned substantially with the ear canal EC while medial ear canal assembly <NUM> is advanced along the ear canal EC in the elongate narrow profile configuration having second width 110W2.

When properly positioned, retention structure <NUM> 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 <NUM> with the walls of ear canal EC. The medial ear canal assembly <NUM>, including support structure <NUM>, may apply a predetermined amount of force to the tympanic membrane TM when the umbo pad <NUM> is in contact with the eardrum. When medial ear canal assembly <NUM> is positioned the support structure <NUM> 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 <NUM>.

<FIG> is an exploded view of a medial ear canal assembly <NUM> according to embodiments of the present disclosure which shows an assembly drawing and a method of assembling medial ear canal assembly <NUM>. The retention structure <NUM> as described herein can be coupled to the support structure <NUM>, for example, with elastomeric bumpers <NUM> extending between the retention structure <NUM> and the support structure <NUM>. The retention structure <NUM> may define an aperture 110A having a width 110AW corresponding to the wide profile configuration. The support structure <NUM> may define an aperture 120A having a width 120AW that remains substantially fixed when the resilient retention structure is compressed. The aperture 110A of the resilient retention structure can be aligned with the aperture 120A of the support. Support structure <NUM> may comprise ball joint <NUM>, and ball joint <NUM> can be coupled to arm <NUM> and bracket mount <NUM>, such that the support is coupled to the photodetector <NUM>.

The transducer <NUM> may comprise a housing <NUM> and a mount <NUM> attached to housing <NUM>, in which the mount <NUM> is shaped to receive the at least one spring <NUM>. The transducer <NUM> may comprise a vibratory reed <NUM> extending from housing <NUM>, in which the vibratory reed <NUM> is attached to a post <NUM>. The post <NUM> can be connected to the umbo pad <NUM>.

The support structure <NUM> can be coupled to the transducer <NUM> with the at least one spring <NUM> extending between the coil and the transducer such that the umbo pad <NUM> is urged against the tympanic membrane TM when the medial ear canal assembly <NUM> is placed to transmit sound to the user. The support structure <NUM> may comprise mounts <NUM>, for example tubes, and the mounts <NUM> can be coupled to a first end of the at least one spring <NUM>, and a second end of the at least one spring <NUM> can be coupled to the transducer <NUM> such that the at least one spring <NUM> extends between the support and the transducer. Umbo sensor <NUM> may be attached to umbo pad <NUM> such that umbo sensor <NUM> is positioned against tympanic membrane TM when medial ear canal assembly <NUM> 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.

<FIG> is an isometric top view of a medial ear canal assembly <NUM> according to embodiments of the disclosure. <FIG> is an isometric bottom view of a medial ear canal assembly <NUM> according to embodiments of the disclosure. In <FIG> and <FIG>, medial ear canal assembly <NUM> has a retention structure <NUM> comprising a stiff support <NUM> extending along a portion of retention structure <NUM>. The stiff support <NUM> may be connected to resilient member <NUM> and coupled to intermediate portion <NUM>. In many embodiments, resilient member <NUM> and stiff support structure <NUM> comprise an integrated component such as an injection molded (or <NUM>-D Printed) unitary component comprising a modulus of elasticity and dimensions so as to provide the resilient member <NUM> and the stiff support <NUM>.

In the embodiments of <FIG> and <FIG>, stiff support <NUM> and resilient member <NUM> can be configured to support output transducer <NUM> such that output transducer <NUM> is coupled to the tympanic membrane TM when the medial ear canal assembly <NUM>, including retention structure <NUM> is placed in the ear canal EC. The resilient member <NUM> can be attached to the stiff support <NUM>, such that the resilient member <NUM> directly engages the stiff support <NUM>. The stiff support <NUM> can be affixed to the resilient member <NUM> so as to position the umbo pad <NUM> below the retention structure <NUM>, such that the umbo pad <NUM> engages the tympanic membrane TM when the retention structure <NUM> is placed, for example on the tympanic membrane annulus TMA. The resilient member <NUM> can be configured to provide a predetermined force to the eardrum when the medial ear canal assembly <NUM> is placed in the Ear Canal.

In the embodiments of <FIG> and <FIG>, resilient member <NUM> may comprise a resilient cantilever beam. In these embodiments, photodetector <NUM> may be attached to the output transducer <NUM> with a mount <NUM>. Photodetector <NUM> and output transducer <NUM> can deflect together when the biasing structure <NUM>, for example a spacer, is adjusted to couple the output transducer <NUM> and the umbo pad <NUM> to the tympanic membrane TM.

Sulcus sensors <NUM> may be positioned on layer <NUM> of retention structure <NUM> such that sulcus sensors <NUM> are in contact with the tympanic membrane TM and/or other portions of the ear canal EC when medial ear canal assembly <NUM> is positioned in the ear canal. Sulcus sensors <NUM> may also be positioned on sulcus flanges <NUM> 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 <NUM> may be used to, for example, position sulcus sensors <NUM> over regions of highly vascular tissue in the ear canal EC, such as on the tympanic membrane TM. Sulcus flanges <NUM> may be used to, for example, position sulcus sensors <NUM> over the pars tensa.

<FIG> shows an isometric view of the medial ear canal assembly <NUM>. Medial ear canal assembly <NUM> comprises a retention structure <NUM>, a support structure <NUM>, a transducer <NUM>, at least one spring <NUM> and a photodetector <NUM>. Medial ear canal assembly <NUM> may include data processor <NUM> and transmitter <NUM> which may be positioned on transducer <NUM>. Medial ear canal assembly <NUM> may further include non-contact sensors <NUM> and tethered sensors <NUM>. Non-contact sensors <NUM> and tethered sensors <NUM> may be connected to data processor <NUM> to provide data to data processor <NUM>. Alternatively, or in combination, one or more of data processor <NUM>, transmitter <NUM>, non-contact sensor(s) <NUM> and tethered sensors <NUM> may be part of, located on, or connected to electronics package <NUM> on photodetector <NUM>. Tethered sensors <NUM> may be positioned against the skin SK in the ear canal EC where umbo sensors <NUM> (not shown in <FIG>) and sulcus sensors <NUM> (not shown in <FIG>) cannot contact. Alternatively or in combination, one or more of non-contact sensors <NUM> may be positioned loosely in ear canal EC to gather data. Retention structure <NUM> 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 <FIG> and <FIG>.

<FIG> shows and isometric view of the medial ear canal assembly <NUM> including retention structure <NUM>, support structure <NUM>, springs <NUM>, a photodetector <NUM>, and at least one drug delivery device. In embodiments of the invention, medial ear canal assembly <NUM> may include reservoir <NUM> and delivery tube <NUM> which are adapted to deliver drugs to the wearer. In embodiments of the invention, reservoir <NUM> may be used to store drugs for delivery to, for example, the tympanic membrane. In embodiments of the invention, delivery tube <NUM> may be used to transport drugs from reservoir <NUM> to umbo pad <NUM> 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 <NUM> may be constructed to include, for example, microneedles through which drugs may be transported into the tissue of, for example, the tympanic membrane.

In embodiments of the invention, the medial ear canal assembly <NUM> may include sensors, such as, for example, umbo sensors <NUM>, sulcus sensors <NUM> and tethered sensors <NUM>, such as those shown in <FIG>, <FIG>, and <FIG>. In embodiments of the invention, sensors located on medial ear canal assembly <NUM> 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 <NUM>. In embodiments of the disclosure, the drug delivery device on medial ear canal assembly <NUM> may include power supply <NUM> adapted to provide power to medial ear canal assembly <NUM>, including pump <NUM>.

<FIG> is an isometric view of the medial ear canal assembly <NUM> including retention structure <NUM>, a photodetector <NUM>, and at least one drug delivery device. In embodiments of the invention, medial ear canal assembly <NUM> may include reservoir (not shown) and delivery tube <NUM> which are adapted to deliver drugs to the wearer. In embodiments of the invention, the reservoir may be used to store drugs for delivery to, for example, the tympanic membrane or the region surrounding the tympanic membrane. In embodiments of the invention, delivery tube <NUM> may be used to transport drugs from the reservoir to umbo pad <NUM> 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 <NUM> may be constructed to include, for example, microneedles <NUM> through which drugs may be transported into the tissue of, for example, the tympanic membrane. In embodiments of the invention, umbo pad <NUM> may be constructed to include, for example, needles <NUM> through which drugs may be transported into the tissue of, for example, the tympanic membrane. In embodiments of the disclosure, retention structure <NUM> may be constructed to include, for example, microneedles <NUM> through which drugs may be transported into the tissue of, for example, the tympanic membrane. In embodiments of the disclosure, the drug delivery device on medial ear canal assembly <NUM> may include pump <NUM> adapted to pump drugs from the reservoir to microneedles <NUM>. In embodiments of the disclosure, the drug delivery device on medial ear canal assembly <NUM> may include pump <NUM> adapted to pump drugs from the reservoir to needle <NUM>. In embodiments of the disclosure, the drug delivery device on medial ear canal assembly <NUM> may include power supply <NUM> adapted to provide power to medial ear canal assembly <NUM>, including pump <NUM>.

<FIG> shows a lateral ear canal assembly <NUM>, including a retention structure <NUM> (which may also be referred to as an eartip retention structure) configured for placement in the ear canal. Retention structure <NUM> may comprise a molded tubular structure having the shape of the ear canal. Retention structure <NUM> may be configured to retain lateral ear canal assembly <NUM> in the ear canal. Lateral ear canal assembly <NUM> may include a signal source <NUM> such as a laser diode. An outer surface <NUM> of retention structure <NUM> may include ear tip sensors <NUM>, 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 <NUM>, such as, for example, a body temperature sensor.

<FIG> is an isometric Top view of a medial ear canal assembly in accordance with embodiments of the present disclosure. In <FIG>, medial ear canal assembly <NUM> comprises transducer <NUM>, photodetector <NUM>, spring <NUM>, support structure <NUM> and retention structure <NUM>. In the embodiment of <FIG>, sulcus sensors <NUM> may be positioned on retention structure <NUM>, which may be, for example a flexible material adapted to conform to the anatomy of the user's ear canal. Retention structure <NUM> may comprise a material such as Parylene or Silicone.

<FIG> is an isometric bottom view of a medial ear canal assembly in accordance with embodiments of the present disclosure. In <FIG>, medial ear canal assembly <NUM> may comprise transducer <NUM>, photodetector <NUM>, spring <NUM>, support structure <NUM>, retention structure <NUM> and umbo pad <NUM>. In the embodiment of <FIG>, sulcus sensors <NUM> may be positioned on retention structure <NUM>, which may be, for example a flexible material adapted to conform to the anatomy of the user's ear canal. In the embodiment of <FIG>, umbo sensors <NUM> may be positioned on umbo pad <NUM>. Retention structure <NUM> may comprise a material such as Parylene or Silicone.

In embodiments of the disclosure, umbo sensors <NUM>, sulcus sensors <NUM>, eartip sensors <NUM>, and tethered sensors <NUM> may comprise sensors that contact the skin to detect biometric data. Alternatively, or in combination, umbo sensors <NUM>, sulcus sensors <NUM>, eartip sensors <NUM>, and tethered sensors <NUM> 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.

Skin contacting sensors adaptable for use in embodiments of the present disclosure, 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.

Non-skin contacting sensors adaptable for use in embodiments of the present disclosure 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 <NUM>-axis accelerometers, <NUM> axis gyroscopes; MEMS sensors, including <NUM> axis MEMS sensors; GPS circuitry; pedometers; reservoir monitors; walking gait sensors; battery state monitors; energy level monitors; and strain gauges.

In embodiments of the present disclosure, a suitable microphone might be transducer <NUM> wired to measure back electromagnetic fields (back EMF) which is generated when post <NUM> is moved independent of any drive signal provided to transducer <NUM>, 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 <NUM> where it could be analyzed and transmitted to a receiver in lateral ear canal assembly <NUM> or in a remote receiver (e.g. a smart phone) by transmitter <NUM>. In one embodiment of the disclosure, data processor <NUM> 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's voice.

In embodiments of the disclosure, a suitable optical sensor may comprise an infrared transmitter and infrared receiver. In embodiments of the disclosure, a suitable optical sensor may include an optical receiver tuned to the same frequency as signal source <NUM>.

In embodiments of the disclosure, sensors may be 3D printed on or as an integral part of structures in the components of hearing system <NUM>. In embodiments of the disclosure, non-skin contacting sensors may be mounted on, for example, the back side of photodetector <NUM>.

In embodiments of the disclosure, a light may be mounted on medial ear canal assembly <NUM> and positioned to shine through tympanic membrane TM to illuminate the middle ear and the contents thereof. In embodiments of the disclosure, a sensor may be further included on medial ear canal assembly <NUM> to measure light reflected from the middle ear.

In embodiments of the disclosure, sensors on medial ear canal assembly <NUM> 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 <NUM> to ensure it is properly placed and aligned in the user's ear.

In embodiments of the disclosure, sensors on medial ear canal assembly <NUM> 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 <NUM>, such as, degradation in photodetector output, earwax buildup, whether the user is compliant with the required oiling regimine. In embodiments of the disclosure, 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 disclosure, sensors on the eartip may be used to guide and/or detect proper medial ear canal assembly insertion. In embodiments of the disclosure, pressure sensors and/or fluid sensors may be positioned on a medial ear canal assembly, including on the umbo pad <NUM> or sulcus platform to assist in the preceding tasks.

In embodiments of the disclosure, strain gauges may be included in the medial ear canal assembly <NUM> to provide feedback on the proper placement of medial ear canal assembly <NUM>. For example, post <NUM> may include strain gauges which indicate when displacement starts and/or the degree of displacement by registering the lateral force on umbo pad <NUM>. Further, the placement of one or more strain gages on retention structure <NUM> may provide an indication that the medial ear canal assembly <NUM> has lifted off of the tympanic membrane TM. In embodiments of the disclosure, medial ear canal assembly <NUM> may include features which interact with physical features of the wearer to maintain medial ear canal assembly <NUM> in a predetermined position in the ear canal EC, such as, for example against the tympanic membrane TM. In embodiments of the disclosure, such physical features may create strain on the medial ear canal assembly <NUM>, which strain may be measured by strain gauges positioned on medial ear canal assembly <NUM> to ensure proper placement of medial ear canal assembly <NUM>.

In embodiments of the disclosure, a feedback signal representative of the average power received by photodetector <NUM> may be provided, which signal may be used to quantify the coupling efficiency between photodetector <NUM> and signal source <NUM>. In embodiments of the disclosure, the power level of signal source <NUM> may be adjusted to reflect the degree of coupling and the coupling efficiency indicated by the feedback signal. In embodiments of the disclosure, the position of lateral ear canal assembly <NUM> and/or medial ear canal assembly <NUM> may be modified to increase or decrease the level of the feedback signal, thus improving the coupling efficiency between the lateral ear canal assembly <NUM> and the medial ear canal assembly <NUM>.

In embodiments of the disclosure, noise cancelation may be implemented by, for example, incorporating a microphone onto the back of photodetector <NUM>. 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 <NUM> millivolts. Alternatively, or in combination, the microphone may be turned on when the photodetector output voltage exceeds approximately <NUM> volt. In one embodiment of the disclosure, the sound signals may be measured by measuring the back EMF of transducer <NUM> 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.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> 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.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> 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.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> 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.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> 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.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> or positioned in the ear canal EC may be used to measure and/or monitor the oxygen level in a user's blood. Sensors suitable for making these measurements include optical sensors PPG (Photoplethysmography) sensors, and/or pulse oximetry sensors.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> 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.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> 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.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> 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.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> 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 (<NUM> axis gyroscope); vibration sensor (microphone, TMT microactuator); oxygen sensors; and trigeminal nerve monitors.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> 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.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> 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.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> 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.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> 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 <NUM>-axis accelerometers) and MEMS sensors (including <NUM> axis MEMS sensors).

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> 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.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> 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.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> 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.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> or positioned in the ear canal EC may be used to measure and/or monitor the glucose in a user's blood and/or interstitial fluid. Sensors suitable for making these measurements include glucose meters, electrochemical sensors, microneedles, and/or iontophoresis electrodes.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> 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.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> or positioned in the ear canal EC may be used to measure and/or monitor the position and/or orientation of a user's eye.

Many other physical characteristics may be measured by sensors on medial ear canal assembly <NUM> 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.

In embodiments of the present disclosure, devices on medial ear canal assembly <NUM> or positioned in the ear canal EC may be used 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.

In embodiments of the disclosure, 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.

In embodiments of the present disclosure, devices on medial ear canal assembly <NUM> 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.

In embodiments of the present disclosure, devices, including sensors on medial ear canal assembly <NUM> 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.

In embodiments of the present disclosure, sensors on medial ear canal assembly <NUM> or positioned in the ear canal EC may be used to control the function of hearing system <NUM>. The function of hearing system <NUM> 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 <NUM>. Sensors suitable for such control functions may include touch sensors, bone conduction sensors and proximity sensors.

In embodiments of the present disclosure, the power required to operate sensors, drug delivery, and/or other devices located on medial ear canal assembly <NUM> may be supplied by one or more of the following: AC or DC current from photodetector <NUM>; AC or DC current from an RF antenna located on or connected to medial ear canal assembly <NUM>; Energy from a battery, micro-battery and/or super capacitor on or connected to medial ear canal assembly <NUM>. In further embodiments of the present disclosure, circuitry on medial canal assembly <NUM> 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 <NUM>; 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 <NUM>; 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 disclosure circuitry on medial ear canal assembly <NUM> may be powered by, for example, the use of light based earplugs which transmits energy to medial ear canal assembly <NUM> to power the assembly when lateral ear canal assembly <NUM> is not being used. In embodiments of the disclosure, such light based earplugs may be used to recharge batteries or super capacitors located on or connected to medial ear canal assembly <NUM>. In embodiments of the disclosure circuitry on medial ear canal assembly <NUM> 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 <NUM> to power sensors on medial ear canal assembly <NUM> and/or in the ear canal EC for the purpose of making measurements.

In embodiments of the present disclosure, sensors located on medial ear canal assembly <NUM> may communicate data to any one of a number of devices, including lateral ear canal assembly <NUM>, 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 disclosure, such information may be transmitted from medial ear canal assembly <NUM> to lateral ear canal assembly <NUM> and from lateral ear canal assembly <NUM> to a smartphone, a smart watch, a cellular network, a ZigBee network, and/or a Bluetooth enabled device. In embodiments of the disclosure, such sensors a part of a closed loop communication network. In embodiments of the disclosure, communication to medial ear canal assembly <NUM> may be facilitated by the positioning of an antenna on or connected to medial ear canal assembly <NUM>. In embodiments of the disclosure, such antennas may be printed on or formed as part of a chassis of medial ear canal assembly <NUM>. In embodiments of the present disclosure, communication of data may be facilitated by the inclusion of transmitter <NUM> on medial ear canal assembly <NUM>.

In embodiments of the disclosure, removable portions of hearing system <NUM> may sense emergency situations, such as fire alarms, and communicate with the user wearing medial ear canal assembly <NUM> using an antenna located on or connected to medial ear canal assembly <NUM> to warn the user of danger.

In embodiments of the disclosure, data collected from sensors located on medial ear canal assembly <NUM> or in the ear canal EC of a user may be communicated to the user's physician and/or family. In embodiments of the disclosure, data collected from sensors located on medial ear canal assembly <NUM> or in the ear canal EC of a user may be used to generate data or reports which may be communicated to the user's physician and/or family. In embodiments of the present disclosure, information, data or reports which may be communicated to the user, the user's physician and/or family may include information on the user's environment, including time of day, activity, surrounding sounds. In embodiments of the present disclosure, information, data or reports which may be communicated to the user, the user'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 disclosure, information, data or reports which may be communicated to the user, the user's family physician and/or family may include information on specific events related to the user or the user'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 disclosure, information, data or reports which may be communicated to the user, the user's family physician and/or family may include algorithm results transmitted when trends or parameters in the user's biometric data become concerning. In embodiments of the present disclosure, 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.

In embodiments of the disclosure, medial ear canal assembly <NUM> may be used to communicate with the user to, for example, remind the user when to drink or when the user's sugar levels are spiking or dropping.

In embodiments of the present disclosure, data or other information may be transmitted by a user to the hearing system <NUM> of a second user. In embodiments of the invention, a user may transmit data or other information to a network of hearing systems <NUM>.

In embodiments of the present disclosure, data collected by sensors positioned on medial ear canal assembly <NUM> or in the ear canal of a user may be collected and analyzed, by, for example, an Application on the user's smart phone. Such data may be used for many purposes, including predicating changes in the user'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's appointments. Data trends may also be stored and analyzed over time.

Embodiments of the present disclosure 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 disclosure, the sensors may include sensors adapted to detect biometric data. In embodiments of the disclosure, the sensors may include sensors adapted to detect one or more physical characteristics of the user. In embodiments of the disclosure, at least one of the sensors may comprise a microphone. In embodiments of the disclosure, the microphone may comprise a micro-actuator. In embodiments of the disclosure, sound received by the micro-actuator is configured to be converted to a back EMF signal. In embodiments of the disclosure, 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 disclosure 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 disclosure, the receiver comprises a smart phone, a wireless network, or a peripheral device. In embodiments of the disclosure, at least one of the sensors comprises a skin contacting sensor or a non-skin contacting sensor. In embodiments of the disclosure, at least one of the sensors comprises an umbo sensor, an eartip sensor, or a tethered sensor.

Embodiments of the present disclosure are directed to a method not forming part of the claimed invention 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 not forming part of the claimed invention 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 disclosure the method not forming part of the claimed invention further comprising using the sensors to measure one or more physical characteristics of the user. In embodiments of the disclosure at least one of the sensors comprises a microphone the method not forming part of the claimed invention further comprising the steps of measuring sound in the user's ear canal. In embodiments of the disclosure the microphone comprises a micro-actuator, the method not forming part of the claimed invention further comprising measuring the back EMF signal. In embodiments of the disclosure the hearing system includes a data processor, the method not forming part of the claimed invention 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 disclosure the back EMF signal includes a first signal portion representative of the signal received from the hearing system and a second signal the method not forming part of the claimed representative of at least one physical characteristic of the user, invention further including the step of separating the first signal from the second signal. In embodiments of the disclosure the method not forming part of the claimed invention further includes the step of transmitting the signal to a receiver external to the hearing system. In embodiments of the disclosure the receiver comprises a smart phone. In embodiments of the disclosure at least one of the sensors comprises a skin contacting sensor or a non-skin contacting sensor. In embodiments of the disclosure at least one of the sensors comprises an umbo sensor, an eartip sensor, or a tethered sensor. In embodiments of the disclosure the output transducer is used as a sensor. In embodiments of the disclosure the sensor is used as a microphone to measure received sound at the tympanic membrane. In embodiments of the disclosure the signal from the microphone is coupled to the transmitter.

Embodiments of the present disclosure are directed to an ear canal platform comprising: a medial ear canal assembly positioned on or over the tyinpanic membrane of a user; and sensors connected to the signal output transducer, the sensors being connected to a transmitter. In embodiments of the disclosure the sensors include sensors adapted to detect biometric data. In embodiments of the disclosure the sensors include sensors adapted to detect one or more physical characteristics of the user. In embodiments of the disclosure at least one of the sensors comprises a microphone. In embodiments of the disclosure the microphone comprises a micro-actuator. In embodiments of the disclosure 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 disclosure 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 disclosure the signal is configured to be transmitted by the hearing system to a receiver external to the hearing system. In embodiments of the disclosure the receiver comprises a smart phone, a wireless network, or a peripheral device. In embodiments of the disclosure at least one of the sensors comprises a skin contacting sensor or a non-skin contacting sensor. In embodiments of the disclosure at least one of the sensors comprises an umbo sensor, an eartip sensor, or a tethered sensor.

Embodiments of the present disclosure are directed to a method not forming part of the claimed invention 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 not forming part of the claimed invention 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 disclosure the method not forming part of the claimed invention further comprising using the sensors to measure one or more physical characteristics of the user. In embodiments of the disclosure at least one of the sensors comprises a microphone the method not forming part of the claimed invention further comprising the steps of measuring sound in the user's ear canal. In embodiments of the disclosure the microphone comprises a micro-actuator, the method not forming part of the claimed invention further comprising measuring and transmitting the output of the microphone. In embodiments of the disclosure the hearing system includes a data processor, the method not forming part of the claimed invention 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 not forming part of the claimed invention further including the step of separating the first signal from the second signal. In embodiments of the disclosure the method not forming part of the claimed invention further includes the step of transmitting the signal to a receiver external to the hearing system. In embodiments of the disclosure the receiver comprises a smart phone. In embodiments of the disclosure at least one of the sensors comprises a skin contacting sensor or a non-skin contacting sensor. In embodiments of the disclosure at least one of the sensors comprises an umbo sensor, an eartip sensor, or a tethered sensor. In embodiments of the disclosure the output transducer is used as a sensor. In embodiments of the disclosure the sensor is used as a microphone to measure received sound at the tympanic membrane. In embodiments of the disclosure the signal from the microphone is coupled to the transmitter.

Embodiments of the present disclosure 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 disclosure an ear canal assembly further includes sensors connected to the ear canal assembly, the sensors being connected to a transmitter. In embodiments of the disclosure the sensors include sensors adapted to detect biometric data. In embodiments of the disclosure the sensors include sensors adapted to detect one or more physical characteristics of the user. In embodiments of the disclosure at least one of the sensors is a microphone. In embodiments of the. disclosure the microphone is a micro-actuator. In embodiments of the disclosure sound received by the micro-actuator is converted to a transmitted signal. In embodiments of the disclosure 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 disclosure the signal is transmitted by the hearing system to a receiver external to the hearing system. In embodiments of the disclosure the receiver is a smart phone, a wireless network, or a peripheral device. In embodiments of the disclosure at least one of the sensors comprises a skin contacting sensor, or a non-skin contacting sensor. In embodiments of the disclosure at least one of the sensors comprises an umbo sensor, an eartip sensor, or a tethered sensor.

Embodiments of the present disclosure are directed to a method not forming part of the claimed invention of delivering drugs to a user having a medial ear canal assembly positioned on or near the user's tympanic membrane, the medial ear canal assembly comprising a drug delivery device, the method not forming part of the claimed invention comprising the steps of: delivering drugs to the user through the drug delivery device. In embodiments of the disclosure the medial ear canal assembly further includes sensors and a transmitter, the method not forming part of the claimed invention 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 disclosure the method not forming part of the claimed invention furth includes the step of activating the drug delivery device using the biometric data measured by the sensors. In embodiments of the disclosure the method not forming part of the claimed invention further comprises using the sensors to measure one or more physical charactenstics of the user. In embodiments of the disclosure the method not forming part of the claimed invention further comprises the step of activating the drug delivery device using the measured physical characteristics of the user. In embodiments of the disclosure, 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 disclosure at least one of the sensors comprises a skin contacting sensor or a non-skin contacting sensor. In embodiments of the disclosure at least one of the sensors comprises an umbo sensor, an eartip sensor, or a tethered sensor. In embodiments of the disclosure, the system may comprise a reservoir and mechanisms for drug delivery.

Claim 1:
A hearing system (<NUM>), comprising:
a medial ear canal assembly (<NUM>) adapted to be positioned on the tympanic membrane of a user, the medial ear canal assembly (<NUM>) comprising a retention structure (<NUM>) adapted to conform to the anatomy of the user's ear canal, wherein the retention structure (<NUM>) includes a first end (<NUM>) corresponding to a shape profile of the anterior sulcus and the anterior portion of the tympanic membrane annulus; wherein the first end (<NUM>) comprises an end portion having a convex shape profile to facilitate the advancement of the first end (<NUM>) into the anterior sulcus; and
a drug delivery device mounted on the ear canal assembly (<NUM>).