Abstract: Systems and methods can be employed for facilitating access and procedures in the outer, middle, and inner ear in order to diagnose or treat ear disorders including, but not limited to hearing loss and excessive ear wax. In some examples, the systems and methods include instruments and techniques that facilitate trans-tympanic membrane or trans-fibrous ring access to the middle ear. The systems and methods can also be used to improve accessibility for various otological surgical procedures, such as, but not limited to, cholesteatoma removal, tympanic membrane repair and ossicular chain repair.

Abstract: Intra-tympanic injections of therapeutics into the inner ear can be used to treat conditions such as hearing loss. One or more stabilizing devices that define working channels can be temporarily implanted in the tympanic membrane. Purpose-built instruments such as endoscopes, forceps, and injections instruments can be passed through the working channels of the stabilizer devices to access the inner ear where the therapy can be administered. Afterwards, the stabilizing devices can be removed from the tympanic membrane and the tympanic membrane can heal, typically without the need for sutures.

Abstract: A system for delivering one or more therapeutics to a region of the ear, the region being internal to a tympanic membrane. The system includes a canal guide configured to be inserted within and fittingly engaged with walls of the ear canal and needle assembly having a flexible shaft sized to extend through the canal guide. The canal guide provides alignment of the needle assembly within the ear canal relative to the tympanic membrane. The canal guide includes a viewing lumen extending between a proximal end to a distal-most end of the canal guide and is sized to remain external to the tympanic membrane. The canal guide includes a guide lumen extending to a distal opening near the distal-most end of the canal guide. The guide lumen curves from a first axis to a second axis. Related devices, systems, and methods are provided.

Abstract: An implantable device for delivering a therapeutic agent to treat an ear of a patient includes a body having a distal end region and a proximal end region. The body defines, at least in part, a reservoir configured to contain the therapeutic agent. The device includes a shaft attached to the distal end region of the body and a lumen extending through the shaft having at least one inlet at a proximal end region in fluid communication with the reservoir and at least one outlet at a distal end region. Upon implantation of the body in a region of the ear, a length of the shaft is sufficient to extend from the body to at least the round window membrane of the ear. The device is configured to deliver the therapeutic agent to the ear from the reservoir via passive diffusion. Related devices and methods are described.

Abstract: Systems and methods can be employed for trans-tympanic membrane access to the middle ear for delivery of a formulation or implant device to a target location under direct visualization. The systems and methods can also be used to improve accessibility and visualization for various otological surgical procedures, such as, but not limited to, cholesteatoma removal, tympanic membrane repair and ossicular chain repair.

Abstract: Devices, systems, and methods can be employed to facilitate indirect viewing into cavities such as, but not limited to, the middle ear space. Some embodiments have uses such as, but not limited to, facilitating visualization and procedures in the outer, middle, and/or inner ear in order to diagnose and/or treat disorders including, but not limited to, hearing loss and other ear disorders. In particular implementations, a surgical microscope is used in conjunction with an inverter lens and a distal lens. In some cases, the distal lens transverses a membrane or septum such as, but not limited to, the tympanic membrane. The distal lens can be an assembly combining two or more lenses, in some embodiments. For example, in some cases wide angle lenses, zoom lenses, lenses of other various shapes and/or prisms can be used in the distal lens.

Abstract: Systems and methods can be employed for trans-tympanic membrane access to the middle ear for delivery of a therapeutic agent, for example, to the round window niche adjacent to the cochlea under direct visualization. The systems and methods can also be used to improve accessibility and visualization for various otological surgical procedures, such as, but not limited to, cholesteatoma removal, tympanic membrane repair and ossicular chain repair.

Abstract: Systems and methods can be employed for trans-tympanic membrane access to the middle ear for delivery of a therapeutic agent, for example, to the round window niche adjacent to the cochlea under direct visualization. The systems and methods can also be used to improve accessibility and visualization for various otological surgical procedures, such as, but not limited to, cholesteatoma removal, tympanic membrane repair and ossicular chain repair.

Abstract: An implantable device for delivering a therapeutic agent to treat an ear of a patient includes a body having a distal end region and a proximal end region. The body defines, at least in part, a reservoir configured to contain the therapeutic agent. The device includes a shaft attached to the distal end region of the body and a lumen extending through the shaft having at least one inlet at a proximal end region in fluid communication with the reservoir and at least one outlet at a distal end region. Upon implantation of the body in a region of the ear, a length of the shaft is sufficient to extend from the body to at least the round window membrane of the ear. The device is configured to deliver the therapeutic agent to the ear from the reservoir via passive diffusion. Related devices and methods are described.

Abstract: A formulation for sustained release of an apoptosis inhibitor in the inner ear to protect from hearing loss, especially due to exposure to chemotherapy with drugs such as cisplatin. The formulation can be injected through a small gauge needle into the inner ear, where it gels to form a sustained release depot for controlled delivery of drug over a few days. In the preferred embodiment, the formulation includes a thermoresponsive sol-gel polymer such as POLOXAMER 407 and an apoptosis inhibitory agent, preferably an inhibitor of apoptotic protease activating factor-1 (APAF-1), in an effective amount to prevent hearing loss, for example, due to the administration of platinum-based chemotherapeutic agents. As demonstrated by the examples, the hydrogel provides sustained release of an apoptosis inhibitory agent, LPT99, an anti-apoptosis agent that inhibits apoptotic protease activating factor-1 (APAF-1), as well as safety and efficacy in in vitro and in vivo models.