Abstract: Methods are taught for treating chronic wounds and skin and soft tissue infections with antibiotic tumescent injection. In such methods, the region of tumescent drug delivery is monitored and expanded by the infusate in order to be 2×-5× larger in area and volume in the region of the wound or infection, the drug in the infusate creates a tissue concentration greater than the MIC in the tumescent volume for selected period of time, and the high concentration has a residence lifetime in the tissue long enough to kill the bacteria. Typically, the methods are performed without the use of vasoconstrictors such as epinephrine and in a manner that avoids physical manipulation of the wound.

Abstract: A device, kit, and method for producing medically-deliverable intravenous solution may include supplying a liquid to a housing, pumping the liquid through the housing while purifying the liquid, metering concentrated intravenous solution into the liquid to create a medically-deliverable intravenous solution, and dispensing the medically-deliverable intravenous solution.

Abstract: A medical device includes a first housing portion (FHP) and a second housing portion (SHP) configured to be to be movable relative to each other from a first position to operatively engage at a second position to couple at least one of a drive device and a needle-inserting device supported by one of the FHP and the SHP to a reservoir supported by the other of the FHP and the SHP. Electronic circuitry configured to detect at least one of a first magnetic interaction between a magnet and at least one of a first magnetically attractive material and a first magnet-responsive device and a second magnetic interaction between the magnet and at least one of a second magnetically attractive material and a second magnet-responsive device, and to provide a signal or a change in state in response to detecting at least one of the interactions.

Abstract: An infusion pump system and method with common line auto flush, wherein the infusion pump system has a first reservoir, a second reservoir, a junction, a common line having one end in fluid connection with the junction and having a terminal fluid delivery end, and an infusion pump. The method includes infusing the first fluid at a first rate along a first flow path; entering a common line flush volume value for the common line; switching from the first flow path to a second flow path; driving the second fluid at the first rate along the second flow path; monitoring volume of the second fluid driven at the first rate; and driving the second fluid at a second rate along the second flow path when the monitored volume is equal to or greater than the common line flush volume value.

Abstract: The subject matter disclosed herein relates to systems, methods and/or devices for calibrating sensor data to be used in estimating a blood glucose concentration. A relationship between sensor measurements and reference readings may be used to estimate a relationship between sensor measurements and blood glucose concentration. Such sensor measurements may be weighted according to a decreasing function of uncertainty associated with sensor values.

Abstract: An injection device (100) including a tubular body (3) within which a cartridge is inserted (10) equipped with a bottom (14) and a back chamber (8) containing one first substance (SI). The device (100) also has a front chamber (9) containing one second substance (S2) intended to be mixed inside the tubular body (3) with the first substance (SI) to reconstitute the injectable substance (S). The device (100) is characterized in that the cartridge (10) has a flexible body (13) suitable for tearing as a result of the increase of pressure inside the cartridge (10) in order to put in communication the back chamber (8) with the front chamber (9) and to allow the reconstitution of the injectable solution (S).

Abstract: This disclosure relates to devices and kits for delivery of a fluid. In some embodiments, the fluid is useful in facilitating and maintaining hemostasis.

Abstract: The present disclosure relates to an injector device having a container and a plunger. The plunger is movable into the container to dispense medicament during operation of the injector device. The injector device also has a switch arranged to interact with a structural element of the plunger to detect movement of the plunger during operation of the injector device.

Abstract: An injection device with a dose delivering mechanism being adapted to provide a non-visual, e.g. audible and/or tactile, feedback signal when a set dose has been at least substantially injected. A first and a second part of the injection device are adapted to perform a relative rotational movement with respect to each other. The relative rotational movement causes at least two parts of the injection device to abut or engage, and this abutment or engagement causes the non-visual feedback signal to be generated. A very distinct and precise feedback is provided as compared to prior art axial solutions because the generation of the feedback signal is initiated by the relative rotational movement. Feedback signal may be generated by a change in a rotational velocity of at least one part, e.g. by changing the pitch of a threaded portion or by engaging a non-rotating part and a rotating part, thereby causing the non-rotating part to start rotating.

Abstract: An apparatus includes a housing, a medicament container, an actuator, and a biasing member. The actuator is configured to move the medicament container within the housing when the actuator is moved from a first configuration to a second configuration. The actuator includes a gas container and a puncturer. When the actuator is in the first configuration, a portion of the puncturer is disposed apart from the gas container. When the actuator is in the second configuration, the portion of the puncturer is disposed within the gas container. The gas container has a longitudinal axis offset from a longitudinal axis of the medicament container. The biasing member is configured to bias the actuator toward the second configuration.

Abstract: A medicine dispensing device configured with an overdose indicator. The medicine dispensing device includes a substantially transparent vessel for holding a drug therein and a series of zones visible on the vessel. Each of the zones corresponds to a pre-determined dose of the drug. A first of the zones may correspond to a minimum dose of the drug for a patient population, a second of the zones may correspond to an average dose of the drug for the patient population, and a third of the zones may correspond to a maximum dose of the drug for the patient population and is marked or colored to serve as an overdose indicator. The series of zones may be printed on a label affixed to an outer surface of the vessel. Each zone may be of a different color.

Abstract: The present invention relates to a medicament delivery device comprising a generally tubular distal housing part (10; 110) having opposite proximal and distal ends, wherein third mechanically coded interface means (11; 111) are arranged on its proximal end; a generally tubular proximal housing (20; 120) part having opposite proximal and distal ends and being releasibly connected to said distal housing part, wherein with fourth mechanically coded interface means (22; 122) are arranged on its distal end; a medicament container having a slidable stopper, wherein said container is arranged to be positioned within said proximal housing part; a plunger rod (60; 160) arranged within said distal housing; drive means arranged within said distal housing and being operably connected to said plunger rod for driving said plunger rod and thereby said stopper towards the proximal end of the device; wherein said device further comprises an interface member (50; 150) comprising first (51; 151) and second (52; 152) mechanicall

Abstract: A drug delivery device comprising; a housing; a cylindrical member configured to be rotatably supported inside the housing, wherein the outer surface of the cylindrical member is provided with at least first and second tracks together forming an encoder, each track comprising conductive segments and non-conductive segments; and at least first and second groups of contacts configured to engage the first and second tracks respectively at predetermined intervals along the length of the track.

Abstract: The invention relates to a prefilled injection pen for apportioning multiple set doses of a liquid drug. The injection pen comprises a housing assembly with a removable cap rotatable coupled to the housing assembly such that the user has to rotate the removable cap upon mounting and dismounting the removable cap. Rotation of the removable cap initiates a process in which the proximal end of a needle cannula is first inserted into a cartridge permanently embedded in the housing assembly and thereafter moves the cartridge proximally to thereby pump a predetermined amount of the preservative containing liquid drug from the cartridge and into a cleaning chamber carried by an axially movable shield. The needle cannula is mounted in a needle hub which is arranged to follow rotation of the removable cap and guided helically in relation to the housing assembly such that the needle hub is moved proximally upon rotation of the removable cap.

Abstract: A pen needle, comprising a reusable adapter configured for attachment to a distal end of a medication pen, the adapter having a proximal needle for accessing the interior of the pen injector and a fitting on the distal side for mating with a patient end needle assembly, and a disposable patient-end needle assembly having a base configured for mating with the fitting on the distal side of the adapter and a patient-end needle extending from a distal end of the base.

Abstract: An inhaler article includes a body extending along a longitudinal axis from a mouthpiece end to a distal end and a capsule cavity defined within the body. The capsule cavity has a length extending along the longitudinal axis. A mouthpiece air channel extends from the capsule cavity to the mouthpiece end. An end cap is disposed within the distal end and extends to the capsule cavity. The end cap includes an air channel extending from the end cap distal end to the end cap inner end. A capsule is disposed within the capsule cavity and has a capsule length. The capsule length is in a range from about 25% to about 99% of the cavity length, or about 50% to about 95% of the cavity length, or about 70% to about 90% of the cavity length, or from about 75% to about 85% of the cavity length, or about 80% of the cavity length.

Abstract: An electronic cigarette includes a container for storing a tobacco flavored liquid, an atomizer connected to the container to atomize the tobacco flavored liquid by an electric heating, a battery tube to power the atomizer, and an actuating film movably positioned in the battery tube to control the atomizer.

Abstract: A fluid control device includes a case including an internal space that is partitioned by a partition wall into an air blowing chamber and a control chamber. A dividing wall is disposed inside the air blowing chamber to partition an internal space of the air blowing chamber into a first air blowing chamber and a second air blowing chamber. A fan unit is housed in the second air blowing chamber. A differential pressure sensor senses a differential pressure between a pressure inside the first air blowing chamber and a pressure inside the second air blowing chamber. A controller controls a fan based on the sensed differential pressure.

Abstract: A positive airway pressure apparatus is disclosed and includes a mask, a micro pump and a processor. The mask is fastened on a user's face and is spatially corresponding to an airway opening of the user, so as to form a closed space. The micro pump is assembled with the cover and is in fluid communication with the exterior of the mask. The processor transmits an actuation control signal to the micro pump so as to actuate the micro pump. Consequently, air is transported into the closed space from the exterior of the mask, and a positive pressure airflow is formed and flows into the airway of the user. A pressure sensor is disposed within the closed space to detect the pressure of the closed space, so that the processor can determine the respiratory state of the user and control the air pressure output of the micro pump correspondingly.

Abstract: In accordance with the present invention, there is provided an adaptor or attachment which is suitable for integration into the patient circuit of a ventilation system, such as a non-invasive open ventilation system, is configured for attachment to any standard ventilation mask, and is outfitted with a jet pump which creates pressure and flow by facilitating the entrainment of ambient air. The adaptor comprises a base element and a nozzle element which are operatively coupled to each other. The base element further defines a throat and at least one entrainment port facilitating a path of fluid communication between the throat and ambient air. The nozzle element includes a jet nozzle, and a connector which is adapted to facilitate the fluid coupling of the nozzle element to a bi-lumen tube of the patient circuit. The connector includes both a delivery port and a sensing port.

Abstract: A laryngeal mask airway (LMA) device includes a backplate, an inflatable balloon, an airway tube, and a non-inflatable skeleton, which extends anteriorly from the backplate, and which is shaped so as to define a skeleton anterior side that has a pre-formed shape. A distal end of an inflation tube is coupled in fluid communication with (i) an interior of the inflatable balloon for supplying air to the inflatable balloon, and (ii) at least a portion of the skeleton anterior side. The inflatable balloon is shaped so as to define an inflatable annular cuff which (a) covers at least a portion of the skeleton anterior side, and (b) has a cuff anterior side that is configured to form a seal around a laryngeal inlet of a patient when the inflatable annular cuff is disposed at an LMA-insertion location within a throat of the patient. Other embodiments are also described.

Abstract: The present invention relates to a tracheal ventilation apparatus (1), in particular a tracheostomy cannula or an endotracheal tube, having a cannula tube (2), which has a proximal tube portion (3) with a proximal opening (3a) and a distal tube portion (4) with a distal opening (4a). In order to provide an easy-to-handle tracheal ventilation apparatus that can easily be inserted and that impedes a swallowing process as little as possible, in which tracheal ventilation apparatus the risk of injuring the tracheal wall is reduced, it is proposed, according to the invention, that the proximal tube portion (3) and the distal tube portion (3) are connected to one another by way of an axially air-permeable joint (7) that facilitates at least restricted mobility and, in particular, pivotability of the axis of the distal tube portion (4) with respect to the axis of the proximal tube portion (3).

Abstract: An oral or nasal endotracheal tube includes a tube part, a first balloon and a second balloon. The tube part extends along a direction with a tube shape and an end portion of the tube part is intubated into trachea. The first balloon extends with passing through the tube part, and expands or contracts a block cuff. The second balloon extends with passing through the tube part, and expands or contracts a guide cuff. The block cuff uniformly expands around the tube part and blocks the trachea after the tube part is intubated into the trachea. The guide cuff ununiformly expands around the tube part and guides the tube part to be intubated into the trachea.

Abstract: A patient interface includes a sealing arrangement adapted to provide an effective seal with the patient's nose, an inlet conduit arrangement adapted to deliver breathable gas to the sealing arrangement, and a cover that substantially encloses the sealing arrangement and/or the inlet conduit arrangement.

Abstract: The present invention is directed to a therapeutic device that enables the user to effectively treat cortical visual impairment. The therapeutic device comprises a base; a light source within the base capable of generating light in a variety of colors; a light diffusing layer positioned above the light source such that the light diffusing layer is substantially uniform in color when illuminated by the light source; a substantially opaque grid located above the light diffusing layer; an upper light source located above the substantially opaque grid at a sufficient distance to allow physical items to be placed on top of the opaque grip; and the upper light source further positioned such that the upper light source illuminates the upper surface of the substantially opaque grid.

Abstract: Systems and methods for applying binaural beats to a person are disclosed in a way to prevent the listener from becoming acclimatized to the binaural beats. The system administers varying binaural beat frequencies according to varying progressions of binaural beats from a base binaural beat to a target binaural beat in an irregular manner.

Abstract: The sleep inducing device includes: an input receiving unit for receiving an input of a user; a background sound output unit for outputting a first signal corresponding to a background music having a melody and a rhythm according to the input of the user; a sleep inducing sound output unit for outputting a second signal having a maximum amplitude at a sleep inducing frequency and corresponding to a sleep inducing sound having a pitch varying to produce a consonance with the melody of the background music; and a mixing unit mixing the first signal and the second signal to output a mixing signal. The user can feel more comfortable while sleeping by changing the pitch of the sleep inducing sound to coincide with the melody of the background music.

Abstract: Systems, devices, and methods are provided for transseptal access of septa within a patient. The device can be advanced to a septum, e.g., towards a fossa ovalis. Instead of applying positive pressure to “tent” the septum, a negative pressure is applied to a lumen within a sheath, e.g., within an elongated member slidable within the sheath, via a negative pressure source such as a syringe on the proximal end of the sheath. This results in the septum pulling inward. The sheath employs a stationary needle-like central core component contained within the lumen of the sheath that punctures the septum when the same is pulled passed it by the negative pressure. The stationary needle-like central core component may be hollow and may form a portion of the elongated member or may be coupled to a distal end thereof.

Abstract: A packaged closed intermittent urinary catheter system equipped with a dispensing system and method of dispensing a packaged catheter using the dispensing system. The dispensing system is a pair of separately translatable movement control devices, each operably engaging the catheter for permitting unidirectional movement of the catheter in a first axial direction relative to the movement control devices. The movement control devices may be mounted to a hand-grippable assembly with a sliding or pivoting movable member reciprocal to a base member. Alternatively, the movement control devices are mounted to a coupling member and a spring member biases them apart.

Abstract: Systems, devices, and methods for using an intraluminal sensing device are provided. The intraluminal sensing device may include a ferrous element disposed at a distal portion of an elongate flexible member configured to be placed in a body lumen of a patient. An external electromagnetic field device may be used to produce an electromagnetic field that may be used to direct the movement of the flexible elongate member within the body lumen.

Abstract: A safety needle system operable with a medical device includes: a housing with a needle mount having a needle; and a sheath telescopically engaged with the housing and surrounding the needle such that the sheath operates in a retracted position, in which the sheath exposes the needle, and an extended position, in which the sheath surrounds the needle. The sheath is coupleable to the medical device such that removal of the needle from the medical device draws the sheath over the needle, transitioning the sheath from the retracted position to the extended position. In one embodiment, the system includes a slider engaged with the sheath and/or housing and including a restraint that engages and disengages the sheath to respectively reinforce and weaken the coupling of the sheath and medical device. In another embodiment, the sheath includes a longitudinal track that slidingly engages a setting of the housing between sheath positions.

Abstract: Provided is a medical needle that reduces a user's discomfort feeling while securely housing a needle tip into a case. Medical needle 1 includes needle portion 10 including needle tip 14 at the head thereof; case 30 configured to be capable of exposing needle portion 10 from the head thereof and housing the needle portion; movement mechanism 50 including spring member 60, which is located in case 30, configured to move needle portion 10 from a first position at which needle tip 14 protrudes from case 30 by a predetermined length to a second position at which needle tip 14 is housed in case 30; and curved portion 90 provided in a portion which is in movement mechanism 50 and faces case 30.

Abstract: A cannula is provided that includes a core and a peelable outer layer. The core includes multiple longitudinal cannula body segments that collectively define a lumen and are generally maintained in position by the peelable outer layer. To remove the cannula from a patient, the outer peelable layer may be peeled and removed, thereby enabling the cannula segments to be separated and removed from the patient.

Abstract: One aspect is a medical guidewire having a first wire section of a first material and a second wire section having a second material different from the first material. A joining section is adjacent both the first and second wire sections, and the joining section has a feature configured hold the first wire section to the second wire section.

Abstract: A device for one-handed insertion of a guidewire into a vessel or cavity is provided. The device has a body, an actuator carriage, a guidewire feed, and a syringe. The body has a handle, a guideway, and a clip to retain the syringe. The syringe has a barrel and a plunger with a flange and a guidewire passage. The actuator carriage has a trigger and a clip to grasp the syringe plunger flange. The actuator carriage slides along the body guideway. The guidewire feed has a wire feed surface. The thumb engages wire at the wire feed surface to advance and retract the wire through the guidewire passage and a finger moves the trigger to move the syringe plunger rearwardly and/or forwardly, while the remaining fingers of the one hand grasp the handle. The device allows the user to sense resistance encountered by the tip of the wire.

Abstract: The present application regards examples of a fluid delivery device including a spike including a base end and a pointed end, an inlet opening located along the shaft of the spike between the base end and the pointed end, and an outlet opening located on the pointed end. In an example, the fluid delivery device includes an inner flexible layer, wherein the base end of the spike is attached to the inner flexible layer. The fluid delivery device includes an outer flexible layer, wherein the spike punctures the outer flexible layer in response to the inner flexible layer moving towards the outer flexible layer in response to inflation of a volume of space enclosed by the inner flexible layer.

Abstract: Systems and method for using a sleeve for enhanced drug delivery are described. The sleeve may incorporate porous materials and may be coated or treated with various drugs and/or therapeutic agents. The sleeve may be utilized in cooperation with balloon catheters and/or other devices. When acting as a reservoir for holding various drugs and/or therapeutic agents, the drug delivery sleeve provides a means of reducing drug losses as well as a controlled mechanism for drug release. The materials for the sleeve, constructed by various techniques, may be circumferentially distensible, may be elastic, and may have varying degrees of recoil as needed for any particular purpose.

Abstract: Ingestible devices with a relatively large payload volume or sample volume, as well as related components, systems and methods, are disclosed.

Abstract: Described herein is the use of CSF or a CSF-like agent for increasing or promoting glymphatic system clearance in the optic nerve and/or retina for the treatment and/or prevention of retinal diseases, such as age-related macular degeneration, retinal vasculitis and commotio retinae. Also described herein is the use of a therapeutic agent for increasing or promoting glymphatic system clearance in the optic nerve and/or retina for the treatment and/or prevention of retinal diseases. The application further provides adjusted methods for the treatment and/or prevention of glaucoma.

Abstract: A clamp for retaining an IV tube having a pair of clamp sections configured to be selectively secured together. Each clamp section includes a semi-cylindrical surface, and the semi-cylindrical surfaces are positioned to mirror one another when the clamp sections are secured together to frictionally engage around the IV tube. Each clamp section has a finger grip on an outer surface which is positioned on an opposite side of the clamp section from the semi-cylindrical surface. Each finger grip also has an arched surface which includes a medial portion positioned between each end of the finger grips, and at least one end of the finger grip flares away from the semi-cylindrical surface. The finger grip can have a finger shield which extends laterally beyond the semi-cylindrical surface. At least one of the finger grips may be symmetrical.

Abstract: A connector system (47, 48, 49, 50) for a medical application including a male single channel fluid connector (X) designed with an outer collar (M2) arranged concentric with an inner tube (3) and extending beyond a center collar (M1), and a female single channel fluid connector (Y) is designed with an outer collar (F1) arranged concentric with a tube (13), wherein the male single channel fluid connector (X) is interconnectable with the female single channel fluid connector (Y) to thereby form a fluid tight single channel connection for passage of fluid, and to a luer type female single channel fluid connector (YS), and wherein the female single channel fluid connector (Y) is interconnectable with a luer type male single channel fluid connector (XS). Also a system including a plurality of the connector systems is disclosed.

Abstract: Antiseptic caps that can be used to disinfect and/or protect medical connectors are disclosed herein. In some embodiments, the antiseptic cap can include a first chamber configured to be removably attached to the medical connector. Delivery systems for use with medical articles are also disclosed herein. In some embodiments, the delivery system comprises various dispensing systems for antiseptic caps and/or antiseptic cap holder assemblies. In some embodiments, the delivery system can be configured to permit the medical articles to be individually removable from the delivery system.

Abstract: Methods for cleaning and antiseptically maintaining patient fluid line access valves to minimize the risk of infection via catheters. The methods include cleaning patient fluid line access valves devices with a cap that may contain a dry pad impregnated with an antimicrobial agent. Covering the access portion of the access valve when not in use with the cap. The devices have a hood that contains a wet pad impregnated with a cleaning solution and, optionally, an antimicrobial agent. The methods include wet pad cleaning the access portion of the access valve prior to and optionally, after the access valve is utilized to access the patient fluid line.

Abstract: A body-fluid-and-medication leak-proof and closed medical connector has a first connecting assembly and a second connecting assembly. The first connecting assembly has a first sleeve and a first resilient valve. The first resilient valve tends to seal a first opening of the first sleeve. The second connecting assembly has a second sleeve and a second resilient valve. The second resilient valve tends to seal a second opening of the second sleeve. The two resilient valves can avoid leakage of the medication remaining in an injector and a vial, or remaining in a fluid infusion tube and a catheter. The two resilient valves also can seal in two directions to avoid leakage during connecting or separating the two connecting assemblies after supplying medication. Therefore, the transfer of the medication is more hygienic and safe, and the waste of medical resources is effectively reduced.

Abstract: A pumping system comprising a pump comprising a door for access within a housing of the pump, a pump segment configured for conveying a fluid based on compression of the pump segment, a pump segment frame for preventing said pump segment from stretching, a visual placement indicator configured for facilitating in a proper placement of the pump segment frame in the housing, and a non-pinching valve configured to be disposed in the housing and to control a flow of the fluid without requiring pinching of a tube.

Abstract: The exemplified systems and methods facilitate a nerve conduction block at a target nerve using electrical stimulation applied from one or more electrodes located on a percutaneous lead that are placed in parallel, or substantially in parallel, and without direct contact, to a long axis of the peripheral nerve over an overlapping nerve region of greater than about 3 millimeters. The exemplified system and method can be further configured to block nerve condition without eliciting onset activity and co-excitation of non-targeted structures. The exemplified method and system can be performed using conventional percutaneous leads, though an improved percutaneous lead design is disclosed herein. In an aspect, an introducer is disclosed that facilitates accurate and consistent insertion of the percutaneous lead to the specified or intended position relative to the target nerve. In another aspect, a treatment kit comprising the various system components to treat pain is disclosed.

Abstract: Systems, methods and devices, for stimulating one or more esophageal muscle contractions are provided. The system, methods, and devices may be designed to evoke motion and/or restore function in one or more organs that are located distal to the lower esophageal sphincter. A controller and a generator may be used to transmit signals to one or more electrodes in a tube placed in a patient's GI tract. In some aspect, the generator is configures to generate a series of pulses for one or more periods of time. In some aspects, a preliminary pulse is transmitted to narrow and esophageal portion such that an esophageal wall is in contact with at least one electrode thus lowering the nominal stimulation threshold.

Abstract: Systems and methods for the treatment of head pain are provided. Systems for the treatment of head pain may include implantable neuromodulator devices configured for to provide non-contacting neuromodulation energy to one or more nerves transmitting head pain. Neuromodulation energy may be applied to one or more nerves to cause neural inhibition, blocking a head pain signal. Systems for the treatment of head pain may further include external devices configured to communicate with implantable devices.

Abstract: A kit or arrangement for securing a burr hole plug that includes a guide base having an upper flange, a lower flange, and a connecting member coupling the upper flange to the lower flange, each of the upper flange and the lower flange defining one or more guide holes, wherein the one or more guide holes of the upper flange are aligned with the one or more guide holes of the lower flange; a drill shank including a cutting element and a main shaft that are configured to pass through any one of the one or more guide holes in the upper flange; and one or more guide collets including a collet shaft and a fastener tube extending from the collet shaft to receive a fastener, where the collet shaft and fastener tube are configured for insertion into any one of the guide holes in the upper flange.

Abstract: The present embodiment is an implantable device capable of controlling cochlear implant electrode insertion and positioning. The embodiment uses an implanted mechanical positioning unit to advance position and monitor an electrode array. The device can be controlled via an external controller to reposition or advance an electrode array at any point after implantation with no surgical re-intervention. A cochlear implant electrode array whose position can be advanced and modified over time to best fit a patient's evolving hearing pattern would improve functional outcomes and significantly expand the candidacy range for cochlear implantation to include patients with substantial residual hearing.