Abstract:
A mountable transducer assembly with removable sleeve provides for efficient and versatile implantation of transducers that are part of an implantable hearing assistance system. The invention provides for a universal connector and bracket where the universal connector can be removed from the bracket without the necessity of unmounting the bracket from its implanted location, for example, attached to the mastoid bone in the middle ear region. Further, the invention provides for three-dimensional movement of a transducer assembly attached to a removable column which further extends the flexibility and options for an implantation surgeon when implanting an implantable hearing-assistance device requiring one or more transducers. The sleeve, with attached transducer assembly, is further slidably adjustable in a longitudinal manner, to further extend the options and flexibility for the implantation surgeon to achieve good contact between a transducer and a target anatomical structure within the middle ear. There are further options for the implantation surgeon to use non-functioning replicas of the transducer assembly that can be both pliable and transparent to further aid in sizing the transducer and transducer assembly for successful implantation within a hearing-impaired subject.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This is a Continuation-in-Part application and is directed to subject matter that is related to the subject matter of commonly assigned U.S. application Ser. No. 08/908,233, filed Aug. 7, 1997, now U.S. Pat. No. 6,001,129 which is incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates to mounting implantable transducers for use in a hearing aid system within the middle ear. 
     2. Description of Related Art 
     In a patient with normally functioning anatomical hearing structures, sound waves are directed into an ear canal by the outer ear and into contact with a tympanic membrane. The tympanic membrane is located at the terminus of the ear canal. The pressure of the sound waves vibrates the tympanic membrane resulting in the conversion to mechanical energy. This mechanical energy is communicated through the middle ear to the inner ear by a series of bones located in the middle ear region. These bones of the middle ear are generally referred to as the ossicular chain, which includes three primary components, the malleus, the incus and the stapes. These three bones must be in functional contact in order for the mechanical energy derived from the vibration of the tympanic membrane to be transferred through the middle ear to the inner ear. 
     In a patient possessing normal hearing capacity, the tympanic vibrations are mechanically conducted through the malleus, incus, and stapes to the oval window and then into the fluid in the cochlea of the inner ear. Within the cochlea, the mechanical vibrations generate fluidic motion. This fluidic motion is converted into neural impulses and the brain interprets these impulses and derives the patient&#39;s perception of sound. A variety of disorders, however, can disrupt or impair normal hearing. These disorders include disorders of the tympanic membrane as well as disorders of the ossicular chain and/or inner ear. 
     Implantable devices are often useful for assisting with hearing. Such devices include partial middle ear implantable (P-MEI) or total middle ear implantable (T-MEI) devices, cochlear implants, and other hearing assistance systems that use components disposed in the middle or inner ear regions. These components may include an input transducer for receiving sound vibrations or an output stimulator for providing mechanical or electrical output stimuli based on the received sound vibrations. 
     The cochlear implant, for instance, is an electronic device that allows profoundly deaf people to hear by electrical stimulation of the auditory nerve fibers within the inner ear. Typically, an external microphone will transpond sound waves into electrical energy. A processor will amplify the electrical energy, filter it, and send it to a transmitter which changes the electrical signals into magnetic signals. An implanted receiver transcutaneously senses the magnetic currents, transforms it to an electrical signal, which travels to the cochlea via a wire electrode. This electrode directly stimulates nerve fibers present in the cochlea. The brain perceives this stimulation as sound (see also U.S. Pat. No. 3,764,748). 
     Some types of partial middle ear implantable (P-MEI), total middle ear implantable (T-MEI), cochlear implant, or other hearing assistance systems utilize components disposed within the middle ear or inner ear regions. Such components may include an input transducer for receiving sound vibrations or an output stimulator for providing mechanical or electrical output stimuli based on the received sound vibrations. 
     An example of one such device is disclosed in U.S. Pat. No. 4,729,366, issued to D. W. Schaefer on Mar. 8, 1988. In the &#39;366 patent, a mechanical-to-electrical piezoelectric input transducer is associated with a malleus bone in the patient&#39;s middle ear. The malleus vibrates in response to sounds received at the patient&#39;s tympanic membrane (eardrum). The piezoelectric input transducer transduces a mechanical energy of the malleus vibrations into an electrical signal, which is amplified and further processed by an electronics unit. A resulting electrical signal is provided to an electrical-to-mechanical piezoelectric output transducer that generates a mechanical vibration that is coupled to a stapes bone in the ossicular chain or to an oval window or round window of a cochlea. In the &#39;366 patent, the ossicular chain is interrupted by removal of an incus bone. Removal of the incus prevents the mechanical vibrations delivered by the piezoelectric output transducer from mechanically feeding back to the piezoelectric input transducer. 
     Piezoelectric transducers are one example of a class of electromechanical transducers that require contact to sense or provide mechanical vibrations. For example, the piezoelectric input transducer in the &#39;366 patent contacts the malleus for detecting mechanical vibrations. In another example, the piezoelectric output transducer in the &#39;366 patent contacts a stapes bone or the oval or round window of the cochlea. 
     Devices for assisting the hearing impaired patient range from miniaturized electronic hearing devices which can be adapted to be placed entirely within the auditory canal, or implantable devices which can be completely or partially implanted within the skull. For those hearing systems, or portions of hearing systems, that require complete subcranial implantation, a challenge has existed to adapt the implantable device for optimal mounting to the unique patient morphologies (including both naturally occurring as well as those created by surgical processes) among patients. The access site for accessing the implantation area for hearing systems is normally posterior to the flap (or pinna) of the outer ear. The precise morphology of the implantation area of any given patient is normally not determinable until surgical entry into the implantation area is achieved. Thus, it is difficult to fabricate a device that will operably fit within the implantation area prior to surgically accessing the implantation site. 
     Known implantable devices that have elements which perform a support or mounting function are typically rigidly mounted to a bone within the middle ear region. However, once such systems are positioned and mounted, the devices are not removable from the implantation area without disengaging the support device and any attached apparatus from the bone. As can be readily appreciated removal of previously mounted supporting brackets from tissue and bone creates undesirable trauma as well as stripping of the bone screw holes rendering the holes nearly useless if remounting is necessary. 
     Further difficulties have arisen with the use of implantable devices in facilitating the fine adjustments necessary to properly position and configure the support assembly and attached transducers so as to contact an auditory element and thus vibrate a portion of the ossicular chain, e.g., the stapes. Such devices present a particular problem in that positioning, or docking, of the transducer against the auditory element in a stable configuration requires extremely fine adjustments that are difficult given the location of the auditory elements and the attendant lack of maneuvering room. 
     SUMMARY OF THE INVENTION 
     To address the difficulties noted above, it is an object of this invention to provide an apparatus and method of use for more efficiently and accurately positioning and mounting an implantable hearing aid system transducer support assembly within a patient&#39;s middle ear or adjacent cavity. A transducer is coupled to a mounting support and positioned in the middle ear with an accompanying electronics unit being separately inserted for ease of implantation. Because the transducer support and electronics units are not attached, repair or maintenance of the electronics unit does not necessitate the need to remove or adjust the support. 
     It is yet another object of this invention to promote a single mounting flange with a plurality of apertures is mounted in the middle ear. The mounting flange is flexible to allow positioning of the apertures substantially flush with the mounting area of the mastoid bone. A flexible neck connects the mounting flange with a hanger portion. The hanger is configured to accept a sleeve with an attached transducer assembly at one end, and the retaining nut at the other end. The hanger is devised so that the sleeve with the attached transducer assembly can be removed and reinserted without removing the mounting flange attached to the mastoid bone. Further, different lengths of the support assembly are interchangeable to address anatomical differences among patients. The sleeve is both rotationally and pivotally coupled with the hanger to allow adjustments to be made within the implantation area while the sleeve is coupled with the hanger. The retaining nut is received into the top of the hanger portion and engages the top of the sleeve. When sufficient pressure is exerted upon the sleeve by the retaining nut, the sleeve is secured in its proper position. The attached transducer assembly can move slidably within the sleeve to either lengthen or shorten the overall length of the sleeve and transducer assembly, further allowing adjustment of the transducer within the implantation area. 
     Yet another object of this invention is to provide a transducer with a flexible connection to its support member allowing for fine adjustment of the transducer by bending. A further preferred embodiment of the subject invention contemplates multiple, bendable mounting flanges connected to the hanger via multiple flexible necks to increase the number of potential mounting positions and sites within the implantation area. 
     Another object of this invention is to provide a support comprising a single component mounted at one end to a bone mass within the middle ear region. The support is adjustable at a plurality of locations along its length to facilitate positioning of the support at a suitable position in the middle ear. A transducer is positioned at and extending from a second end of the support. The plurality of adjustment mechanisms enable proper placement of the transducer so as to engage a portion of the ossicular chain. 
     A further object of this invention is to provide a support comprising a single component mounted at one end to a bone mass within the middle ear region. The support is adjustable at a plurality of locations along its length to facilitate positioning of the support at a suitable position in the middle ear. A sensor is positioned at and extending from a second end of the support. The plurality of adjustment mechanisms further enable proper placement of the sensor so as to engage a portion of a disarticulated ossicular chain, such as the stapes. 
     Still another object of this invention is to provide a support that is adjustable at a plurality of locations along its length to enable a near full range of motion to the support assembly and to facilitate positioning of the support at a suitable position in the middle ear. A driver is positioned at and extends from a second end of the support. The plurality of adjustment mechanisms enable proper placement of the driver so as to engage a predetermined portion of the ossicular chain, such as the malleus. 
     The transducers referred to above may be input transducers (sensors or microphones) or output transducers (drivers), depending on the particular embodiment of the invention. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     Embodiments of the invention will be described with reference to the Figures, in which like reference numerals denote like elements and in which: 
     FIG. 1 illustrates a frontal section of an anatomically normal human right ear in which the invention operates. 
     FIG. 2 is a more enlarged view of the ossicular chain within the middle ear as shown in FIG.  1 . 
     FIG. 3 depicts one embodiment of the invention with a single mounting flange. 
     FIG. 4 depicts a side view of one embodiment of the invention with the sleeve engaged in the hanger. 
     FIG. 5 shows a further view of the embodiment of FIG. 4 of the invention. 
     FIG. 6 depicts another embodiment of the invention wherein multiple mounting flanges and multiple neck portions are attached to the hanger along with a further embodiment of the transducer portion. 
     FIG. 7 shows another view of the embodiment depicted in FIG.  6 . 
     FIG. 8 is an enlarged view of a portion of the structures shown in FIG. 7, showing the construction of the transducer and the electrical contacts. 
     FIG. 9 shows yet another view of a portion of FIG. 7 wherein the sleeve and the transducer assembly are shown engaged with one another. 
     FIG. 10 is a detailed view of the engagement of the transducer assembly and the sleeve. 
     FIG. 11 is a representative view of the transducer engaging the stapes as viewed through a facial recess. 
     FIG. 12 is a view similar to that of FIG. 11, but depicting the transducer at an angle of introduction different from that of FIG.  11 . 
     FIG. 13 is a detailed view depicting placement of a transducer against an auditory element while avoiding contact with a separate bone structure of the patient. 
     FIG. 14 is a perspective view of a further embodiment of the present invention. 
     FIG. 15 is a view of a particular embodiment of the invention placed in operational position against an auditory element of the middle ear. 
     FIG. 16 is a detailed view of FIG. 15 illustrating the mounting of an embodiment of the invention to a portion of the temporal bone structure. 
     FIG. 17 is a perspective view of an embodiment of the present invention. 
     FIG. 18 is a perspective view of a further embodiment of the present invention. 
     FIG. 19 is a perspective view of still another embodiment of the present invention. 
     FIG. 20 is a view of an embodiment of the invention positioned in a human ear engaging a portion of the ossicular chain thereof. 
     FIG. 21 is a detailed view of an embodiment of the invention mounted in a human ear. 
     FIG. 22A is a cross-sectional view of FIG. 19 along line X—X. 
     FIG. 22B is a cross-sectional view of FIG. 22A along line Y—Y. 
     FIG. 23 is a view of a burr used in mastoidectomy. 
     FIG. 24 is a view of the middle ear region after mastoidectomy. 
     FIG. 25 is a view of an embodiment of the invention placed in operational position within a middle ear, exhibiting deformation of the mounting support. 
     FIG. 26 is a view of two embodiments of the invention utilized as components of a hearing assistance system. 
     FIG. 27 is a perspective view of a further embodiment of the present invention. 
     FIG. 28 is a perspective view of a further embodiment of the present invention. 
     FIG. 29 is a perspective view of a further embodiment of the present invention. 
     FIG. 30 shows a further embodiment of the present invention configured with dual transducers. 
     FIG. 31 shows another embodiment of the present invention configured with dual transducers. 
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
     Referring to FIG. 1, ear  20  includes outer ear  22 , middle ear  24 , and inner ear  26 . Outer ear  22 , in turn, includes pinna  30  and exterior auditory canal (external acoustic meatus)  32 . The exterior auditory canal extends through mastoid  34 . 
     Middle ear  24  begins at tympanic membrane  36 , the interior terminus of exterior auditory canal  32 , and includes tympanic membrane  36  and ossicular chain  38 . Ossicular chain  38 , in turn, includes malleus  42 , incus  44 , and stapes  46 . 
     FIG. 1 illustrates a frontal section of a human ear. Sound waves are directed into external auditory canal  32  by pinna  30 . Frequency characteristics of the sound waves are preferably modified by the resident characteristics of external auditory canal  32 . The sound waves impinge upon tympanic membrane  36 , interposed at the terminus of external auditory canal  32 , thereby producing mechanical tympanic vibrations. The mechanical energy of the tympanic vibrations is communicated by a series of articulating bones located in middle ear  24  to inner ear  26 , comprising cochlea  88 , vestibule  90 , and semicircular canals  92 . The series of articulating bones is referred to generally as ossicular chain  38 . Thus, tympanic membrane  36  transforms acoustic energy in external auditory canal  32  to mechanical energy and ossicular chain  38  conveys the mechanical energy to cochlea  88 . The hearing aid system comprising this invention assists the human auditory system in converting acoustic energy contained within sound waves into electrochemical signals delivered to the brain and interpreted as sound. 
     As best seen from FIG. 2, malleus  42  includes head  52 , lateral process  54 , anterior process  56 , and manubrium  58 . Malleus  42  attaches to tympanic membrane  36  at manubrium  58 . Incus  44  articulates with malleus  42  at incudomalleolar joint  62  and includes body  64 , short crus  66 , and long crus  68 . Stapes  46  articulates with incus  44  at incudostapedial joint  72  and includes posterior crus  74 , anterior crus  75 , capitulum  76 , and base (front plate)  79 . Capitulum  76  of stapes  46 , in turn, includes head  77  and neck  78 . 
     Base  79  of stapes  46  is disposed in and against a portion of inner ear  26 . Inner ear  26  includes cochlea  88 , vestibule  90 , and semicircular canals  92 . Base  79  of stapes  46  attaches to a membrane covered opening between cochlea  88  and middle ear  24  referred to as oval window  98 . Oval window  98  is considered part of cochlea  88 . 
     Normally, prior to implantation of the invention, tympanic vibrations are mechanically conducted through malleus  42 , incus  44 , and stapes  46  to oval window  98 . Vibrations at oval window  98  are conducted into the fluid filled cochlea  88 . Pressure is generated in cochlea  88  by fluidic motion accompanied by a second membrane covered opening in cochlea  88 . The second membrane covered opening between cochlea  88  and middle ear  24  is referred to as round window  102 . Round window  102  is also considered part of cochlea  88 . Receptor cells in cochlea  88  translate the fluidic motion into neural impulses which are transmitted to the brain and perceived as sound. However, various disorders of tympanic membrane  36 , ossicular chain  38 , and/or cochlea  88  can disrupt or impair normal hearing. 
     For example, hearing loss due to damage in cochlea  88  is referred to as sensorineural hearing loss. Hearing loss due to an inability to conduct mechanical vibrations through middle ear  24  is referred to as conductive hearing loss. Other problems occur for some patients who have ossicular chains  38  which lack resiliency. Ossicular chains  38  with insufficient resiliency are either inefficient or totally fail to transmit mechanical vibrations between tympanic membrane  36  and oval window  98 . As a result, fluidic motion in cochlea  88  is attenuated and receptor cells in cochlea  88  fail to receive adequate mechanical stimulation. Damaged or missing elements of ossicular chain  38 , of course, may further interrupt transmission of mechanical vibrations between tympanic membrane  36  and oval window  98 . 
     Various techniques have been developed to remedy hearing loss resulting from conductive or sensorineural hearing loss. For example, tympanoplasty is used to surgically reconstruct tympanic membrane  36  and establish ossicular continuity from tympanic membrane  36  to oval window  98 . Various passive mechanical prostheses and implantation techniques have been developed in connection with reconstructive surgery of middle ear  24  for patients with damaged elements of ossicular chain  38 . Two basic forms of prostheses are available: total ossicular replacement prosthesis, which is connected between tympanic membrane  36  and oval window  98 ; and partial ossicular replacement prosthesis, which is positioned between tympanic membrane  36  and stapes  46 . 
     Different types of hearing aids have been developed to compensate for hearing disorders. A conventional “air conduction” hearing aid is sometimes used to overcome hearing loss due to sensorineural cochlear damage or mild conductive impediments to ossicular chain  38 . Conventional hearing aids utilize microphones which transduce sound into an electrical signal. Amplification circuitry amplifies the electrical signal. A speaker transduces the amplified electrical signal into acoustic energy transmitted to tympanic membrane  36 . In such systems, however, some of the transmitted acoustic energy is typically detected by the microphone, resulting in a feedback signal which degrades sound quality. Conventional hearing aids also often suffer from a significant amount of signal distortion. 
     Implantable hearing aid systems have also been developed, utilizing various approaches to compensate for hearing disorders. A variety of inner ear and middle ear implantable hearing aid systems have been designed. Implantation of a hearing aid system within the middle ear is particularly advantageous for various reasons. Importantly, placement of the system within the middle ear serves the purpose of shielding the device from damage caused by an impact to the head in general, or the ear specifically. Such a blow may have deleterious effects on the operability of the system or worse, such as when such a blow induces mechanical or vibratory consequences causing damage to one or more components of the inner ear. Another advantage of middle ear implantation is the ability to provide the patient with a system having no external components to address the issue of cosmetic concerns, including the lessening of any feelings of embarrassment or self-consciousness. Other advantages of middle ear implantation exist and can be readily appreciated by one skilled in the art. 
     A cochlear implant is an electronic device that allows profoundly deaf people to “hear” by electrical stimulation of the auditory nerve fibers within the inner ear. A typical system includes an external microphone, signal processor, and transmitter, and an implanted receiver and electrode. The microphone transponds normal sound waves, converting this mechanical sound energy into electrical energy representative thereof. The processor amplifies the electrical energy, filters it and sends it to the transmitter, which changes the electrical signals into magnetic signals. Transcutaneous magnetic currents cross the skin and are received by the implanted receiver, a coil for example, and the signal travels to the cochlea via a wire electrode. Current flows between this active electrode and a nearby ground electrode, preferably disposed in the eustachian tube, to stimulate nerve fibers present in the cochlea. The brain interprets this stimulation as sound. 
     A particularly interesting class of hearing assistance systems includes those that are configured for disposition principally within middle ear  24 . In middle ear implantable hearing aids, an electrical-to-mechanical output transducer couples mechanical vibration to ossicular chain  38 , which is optionally interrupted to allow coupling of the mechanical vibrations to ossicular chain  38 . Both electromagnetic and piezoelectric output transducers have been used to effect mechanical vibrations upon ossicular chain  38 . 
     One example of a partial middle ear implantable hearing aid system having an electromagnetic output transducer comprises: an external microphone transducing sound into electrical signals; external amplification and modulation circuitry; and an external radio frequency (RF) transmitter for transdermal RF communication of an electrical signal. An implanted receiver detects and rectifies the transmitted signal, driving an implanted coil in constant current mode. A resulting magnetic field from the implanted drive coil vibrates an implanted magnet that is permanently affixed only to incus  44 . Such electromagnetic output transducers have relatively high power consumption, which severely limits their usefulness in total middle ear implantable hearing aid systems. 
     A piezoelectric output transducer is also capable of affecting mechanical vibrations to ossicular chain  38 . An example of such a device is disclosed in U.S. Pat. No. 4,729,366, issued to Schaefer. Therein, a mechanical-to-electrical piezoelectric input transducer is associated with malleus  42 , transducing mechanical energy into an electrical signal, which is amplified and further processed. A resulting electrical signal is provided to an electrical-to-mechanical piezoelectric output transducer that generates a mechanical vibration coupled to a separate element of ossicular chain  38  or to oval window  98  or round window  102 . Ossicular chain  38  is interrupted by removal of incus  44 . Removal of part of the ossicular chain prevents the mechanical vibrations delivered by the piezoelectric output transducer from mechanically feeding back to the piezoelectric input transducer. 
     Piezoelectric transducers have several advantages over electromagnetic transducers. The smaller size of the piezoelectric transducer advantageously eases implantation into middle ear  24 . The lower power consumption of the piezoelectric transducer is particularly attractive for total middle ear implantation hearing aid systems, which may include a limited-longevity implanted battery as a power source. 
     A piezoelectric transducer is typically implemented as a ceramic piezoelectric bi-element transducer, which is frequently a cantilevered double-plate ceramic element in which two plates are bonded together such that they amplify a piezoelectric action in a direction approximately normal to the bonding plane. Such a bi-element transducer vibrates according to a potential difference applied between two bonded plates. A proximal end of such a bi-element transducer is typically cantilevered from a transducer mount which is secured at a reference point to a non-ossicular chain bone within the middle ear. A distal end of such a bi-element transducer couples mechanical vibrations to an ossicular element such as stapes  46 . 
     Securing a bi-element transducer mount to the temporal bone adds invasive complexity to the surgical implantation procedure. Given the delicate nature of the middle ear, placement of the system at its proper position and with the appropriate level of pressure on the auditory element is critical. Failure to account for small dimensional anatomical variations among patients can have considerable consequences, supplying the difference between acceptable and poor hearing ability for a patient. Although piezoelectric transducers provide many advantages, the invention contemplates use of other types (e.g., electromechanical) of transducers. 
     Implantation of components of an implantable or partially implantable hearing assistance system typically involves gaining physical access to middle ear  24 . This access is necessary for the purpose of implanting the transducers. These transducers can be sensors, drivers, microphones, or other components. Sensors and drivers commonly contact at least one of the bones of ossicular chain  38  within middle ear  24 . The contact must be secure to insure that during the life of the hearing assistance system, appropriate physical contact is maintained between the transducer and the bone. Thus, the anchoring of a transducer within middle ear  24  is vital to the operation of this type of hearing assistance system. If physical contact between the target bone and the transducer is either lost or sporadic, the hearing assistance system cannot perform adequately. This poses a challenge for the surgeon, created not only by the surgical procedure, but by the anatomical differences found among patients. Because of both surgically created and naturally occurring morphological variations likely to be encountered within any given implantation area, flexibility and adaptability in the mounting and adjusting of the transducer is important for safe and effective implantation. 
     The surgical procedure commonly used to gain physical access to middle ear  24  is called a basic or simple mastoidectomy. Because this procedure gives only limited access to middle ear  24 , it is common to follow the mastoidectomy with a procedure to further open facial recess  15 . These procedures are performed with various surgical tools, which include burr  12  and diamond burr (not shown). Burr  12 , as depicted in FIG. 23, is a spherical boring instrument that removes bone and bony structures. As can be appreciated, the shape of the instrument dictates the shape of the area of the bone that remains after bone is removed. Often the mastoidectomy commences with the largest burr  12  available. As the implantation area becomes smaller, burr  12  size decreases accordingly. Diamond burr (not shown) is used for fine removal of anatomical structure. The use of different size burrs  12  creates layers of bone with a series of concave layers, with the shape of each layer generally dependent upon the size and shape of burr  12  used. 
     The mastoidectomy is initially performed with a large cutting burr  12 , as well as suction, irrigation and other devices. The size of the burr typically decreases as depth into mastoid bowl  35  increases. During the initial steps of the procedure, the primary goal is to identify landmarks that allow the surgeon to maintain orientation while drilling. An initial cut with burr  12  is normally made along the temporal line while a subsequent cut is made substantially perpendicular to the first cut, and toward mastoid tip  33 . These two lines intersect just posterior to the spine of henle  27 . Initially, this region, called the supra medial triangle of Macewen  29 , is the deepest part of the dissection and actually overlies the mastoid atrium  37 . Using these first two cuts with the burr as general boundaries, the mastoid cortex bone is then removed in a systematic fashion referred to as saucerization. Saucerization of the cortex continues while landmarks are identified to maintain orientation. Wide saucerization is important in this procedure because insufficiently wide saucerization may result in inadequate recognition of landmarks and thus perhaps a less desirable exposure to the implantation area upon deeper dissection. It is this initial wide saucerization, followed by the narrowing of the dissection area, that creates one of the many challenges faced by the surgeon in mounting transducers and transducer support brackets, and which contributes to the need for minimizing any further tissue trauma beyond that necessary. 
     Important landmarks that the surgeon is looking for, during progressive cavity saucerization, are posterior bony canal wall  40 , tegman  48  and sigmoid sinus  50 . Care must be taken in this region because of the presence of facial nerve  17 . Typically, digastic ridge  60  is identified and preserved as a landmark to facial nerve  17 . Facial nerve  17  lies roughly on a line between the anterior tip of digastic ridge  60  and the lateral extent of the horizontal canal. In normal anatomy, facial nerve  17  lies directly inferior and medial to fossa incudis  70  as it finishes its tympanic segment. Once facial nerve  17  is identified, the air cells near facial nerve  17  can be safely removed with the smaller-sized diamond burr (not shown). 
     Mastoid  34  contains air cells that will be encountered during the dissection. The air cells, as mentioned above, are also typically present in the area of facial nerve  17 , as well as in other areas of the dissection. In some countries, the above described procedure typically attempts to achieve the removal of all, or a significant amount of, the air cells so that a more firm bony structure is revealed. The more firm bony structure is a preferred mounting area for a transducer, or transducer support member. However, in other areas of the world, removal of a significant amount of the air cells of mastoid  34  are not typically effected during the simple mastoidectomy, resulting in further challenges to finding a secure mounting site. 
     The air cells, particularly near facial nerve  17 , are removed; and the bone overlying sigmoid sinus  50  and tegmen  48  is thinned, which typically completes the mastoidectomy. Structures visible at this juncture normally include, among others, the head of incus  44  and a narrow buttress supporting the short process of incus  44 . 
     Drilling of facial recess  15  is then normally performed, as the simple mastoidectomy typically does not expose sufficient areas of middle ear  24  to allow for transducer implantation. Again, burr  12  is used initially, with finer dissection performed by diamond burr (not shown). Facial recess  15  is opened until access to middle ear  24  is achieved. The use of burr  12  and diamond burr (not shown) and the gradual dissection of the bony areas in and around middle ear  24  result in irregularly shaped surfaces when the procedure is complete. A small generally triangular space is the result with the main trunk of facial nerve  17  forming the medial wall to this area. This area is normally large enough to attempt implantation, however, it is not uncommon for further surgical dissection to occur to optimally configure the area for access. 
     The initial wide saucerization is followed by a more narrow saucerization of the area to accommodate facial nerve  17  and other vital structures within the implantation area. A slight widening out of the area once middle ear  24  is exposed, results in the formation of substantially convex-shaped walls within the implantation area. Further, these walls have been formed, as described above, by sweeping motions of spherical burr  12 , thus creating concave layers in the walls of the implantation area. FIG. 24 depicts a view of one possible wall topography within the middle ear region, subsequent to completion of a mastoidectomy. The surgeon, then, with the goal of mounting a transducer within this area, faces multiple challenges. The irregular shape and non-planar of the walls of the implantation area make the connection between the apparatus and the target bone problematic. The naturally occurring differences in the anatomy found at the implantation site requires adaptability on the part of the surgeon, as well as the devices to be implanted. The promontory bone  175 , for example, which is formed by the intrusion of the first turn of the cochlea  88  into the middle ear, yet is an obstacle the surgeon typically must work around to successfully implant a transducer and support member. The size and location of the promontory bone  175  is not identical in every patient. The variable surgically created shape of the implantation area, as well as the limited number of available implantation sites pose further challenges to the implantation surgery. 
     If the mounting of the transducer or support members thereof are to be completed successfully, the surgeon must be able to adapt to the conditions as discovered or created within the implantation area. It is this challenge that the various embodiments of the present invention address. 
     The invention provides a support assembly  10 , shown in FIG. 3, and method for mounting a transducer within middle ear  24  or adjacent region. Different embodiments of the invention facilitate mounting to the surface of the cranium or, alternatively, to a bone mass adjacent to middle ear  24 . In a preferred embodiment, support assembly  10  is mounted to a bone mass adjacent to the middle ear to shorten the mounting arm, thereby increasing the stability of support assembly  10  over a surface mount assembly. Through the many and varied features, the invention seeks to optimize proper positioning, adjustment, and placement of the device within middle ear  24 . 
     The output transducer herein is referred to generally as a transducer  162 . However, it should be recognized that transducer  162  may, alternatively, be either a driver (output transducer) or a sensor (input transducer). Referring to FIG. 3, one preferred embodiment of the invention consists of mounting flange  145  that is connected by neck  148  to hanger  150 . Mounting flange  145  defines a plurality of apertures  142  for mounting the flange  145  within the implantation area. Mounting flange  145  is further characterized by offset  146  that enables different portions of mounting flange  145  to be disposed in different planes from one another, thereby facilitating mounting of support assembly  10  to irregular surfaces and enabling limited gross depth adjustments to be made at the mounting location. For example, variable contours of the implantation site might require one set of apertures  142  to be on a different plane than another set of apertures to get the desired mounting configuration. Offset  146  facilitates the resolution of this problem by providing a step-like feature in mounting flange  145 . 
     Although references to bone screws and bone screw holes are made throughout this application, it should be recognized that these terms should not be taken as limiting the means by which the present invention can be attached in the implantation area. Alternative means of attachment include clips, staples, adhesives, rivets, or any other method known by one skilled in the art. Thus, though reference is generally made to mounting via bone screws, it is contemplated that other methods may be utilized to secure the invention within the implantation area. 
     Mounting flange  145  is bendable so that the portions of mounting flange  145  defining apertures  142  can be sufficiently positioned against mastoid  34 , or other location within the ear, for secure mounting. Mounting flange  145  is preferably constructed such that excess material surrounding apertures  142  is removed. Construction of mounting flange  145  in this manner ameliorates obstruction, shaping, and fit problems associated with mounting support assembly  10  to irregular surfaces. Hanger  150  is preferably cylindrical in nature and is designed to accept retaining nut  120  at one end and ball end  139  of sleeve  135  at the other end. In the embodiment depicted in FIG. 3, sleeve  135  also defines sleeve bore  132  designed to mate with spinner  165  of transducer assembly  168 . In one embodiment, transducer assembly  168  consists of threaded spinner  165 , adjustable slide post  170 , transducer support  160 , and transducer  162 . In this embodiment, hanger threads  157  are designed to accept retaining nut  120  that has external nut threads  125 . Retaining nut  120  also defines bore  126  that has an inner spherical radius designed to mate with ball end  139  of sleeve  135 . Retaining nut  120  is screwed into hanger  150  by engaging external nut threads  125  with hanger threads  157 . The spherical inner radius of bore  126  of retaining nut  120  engages ball end  139  of sleeve  135 . By tightening retaining nut  120  using slots  129 , retaining nut  120  is forced down upon ball end  139  of sleeve  135 , disposing ball end  139  against socket  152  of hanger  150 , and securing ball end  139  of sleeve  135  in position. The design of retaining nut  120 , hanger  150 , and sleeve  135  are such that retaining nut  120  can be torqued down upon to stably secure sleeve  135  within the implantation area, providing security so that retaining nut  120  does not back out after implantation. It is contemplated that a number of torque settings would be available depending upon multiple factors—including the length of time the retaining nut would be required to perform its function. This torquing feature of retaining nut  120  is useful to obviate a screw-loose scenario in the implantation area of the patient. 
     In one embodiment of the invention, to facilitate engagement of ball end  139  of sleeve  135  with hanger  150  at its receptacle opening  154 , and to facilitate the rotating and pivoting of sleeve  135  once engaged in socket  152  of hanger  150 , the surfaces of ball end  139  of sleeve  135 , receptacle opening  154 , and socket  152  of hanger  150  are coated with a material to reduce the coefficient of friction, such as polytetrafluoroethylene (PTFE) or other appropriate bio-compatible material. This feature facilitates proper positioning of transducer  162  against a bone of ossicular chain  38 , such as stapes  46 . 
     One preferred embodiment of the invention allows for the adjustment of the overall length of the portion of the invention formed by sleeve  135  and engaged transducer assembly  168 . In this embodiment, spinner  165  is threaded to match the threaded portion of sleeve bore  132 . Further, the inner diameter of bore  132 , beginning at the second end of sleeve  135 , is constructed with a predetermined number of V-cuts or notches  137 , preferably four, to receive adjustable slide post  170 , as depicted in FIG.  10 . Spinner  165  can be moved through sleeve bore  132 , and as it does so, adjustable slide post  170  can slide within sleeve  135 , making the overall length of sleeve  135  and transducer assembly  168  adjustable. Because sleeve  135  and attached transducer assembly  168  can be removed from hanger  150 , approximate adjustments can be made before mounting sleeve  135  within hanger  150 . Further adjustment can be made while ball end  139  of sleeve  135  is engaged with socket  152  via retaining nut  120 . Bore  126  allows access to the top portion of spinner  165  through sleeve bore  132  with the use of an appropriate tool. Thus, the overall length of sleeve  135  and transducer assembly  168  may be adjusted by rotating spinner  165 , even while retaining nut  120  and sleeve  135  are attached to hanger  150 . Linear adjustments made at transducer assembly  168  and transducer  162  are properly viewed as fine adjustments. 
     In one embodiment of the invention, transducer assembly  168  is coated with a material, such as a plastic or other suitable coating known to one of skill in the art, to restrain any wobbling motion that might be present when transducer assembly  168  and sleeve  135  are at, or near, full extension. The presence of the coating introduces a friction into the interface between sleeve  135  and transducer assembly  168  to aid in maintaining the spatial relationship therebetween without a backlash, subsequent to fine adjustment and positioning. 
     A further embodiment of the preferred invention facilitates rotational and angular adjustments of transducer  162  by virtue of the “ball-and-socket” nature of the coupling between sleeve  135  and hanger  150 . As stated above, linear movement of transducer  162  within the implantable area is also possible by adjusting the length of adjustable slide post  170  within sleeve  135 , by means of adjusting spinner  165 . This angling feature is depicted in FIG. 4 where depicted angle  115  is greater than 90 degrees. 
     In a further embodiment of the invention, sleeve  135  is available in a selectable variety of lengths, to accommodate the surgical and natural morphological differences encountered within the implantation area. Further, adjustable slide post  170  comprises a selectable number of assemblies of different sizes and configurations to facilitate in the mounting and adjustment of this invention. The interchangeability of the variety of different-sized sleeves  135  and adjustable slide posts  170  serves to increase flexibility for the surgeon during implantation in response to morphological variations among patients. 
     Another embodiment of the invention is depicted in FIG.  6 . This embodiment possesses multiple mounting flanges  149  each being connected by neck  147  to hanger  150 . Mounting flanges  149  are flexible to allow for bending and to position apertures  144 , facilitating ease of placement of the invention by the surgeon in the implantation area. A representation of the flexible nature of mounting flanges  149  is depicted in FIG. 6, in which the flanges are shown as not co-planar. Alternatively, mounting flanges  149  and necks  147  may be removed, for example by snipping off or otherwise removing one or more of flange  149  and neck  147 , if unnecessary for mounting support assembly  10 . Further, neck  147  and neck  148  may also be flexible or semi-rigid to allow even more options to the implantation surgeon in mounting the support members and transducers. 
     One embodiment of the invention possesses a feature to allow for the adjustment of transducer  162  by means of semi-rigid bendable member  164 , shown in FIG.  7  and FIG.  8 . Bendable member  164  is affixed to transducer support  160  at a first end, and is firmly affixed to and supports transducer  162  at a second end. By means of bendable member  164 , transducer  162  can be angled to permit alignment of the distal end of transducer  162  with the target anatomical structure within ear  20 . FIGS. 11 and 12 illustrate this feature of the invention. As depicted in FIG. 11, facial recess  15  requires transducer  162  to be placed at a steeper angle with respect to adjustable slide post  170 . FIG. 12 depicts facial recess  15  that requires a more shallow angle between adjustable slide post  170  and transducer  162  to make operable contact with stapes  46 . In each instance, bendable member  164  facilitates this task. 
     A variation of this embodiment includes adjustable slide post  170  which is selectable from a plurality of adjustable slide posts, and wherein post  170  may have a bendable member  164  positioned at a different preset angle at the connection point between post  170  and transducer  162 . This feature enables fine adjustments for positioning transducer  162  against a bone of ossicular chain  38 , such as stapes  46 , rather than relying on merely crude adjustment mechanisms and methods to achieve functional relation between the transducer and the ossicle. Further, post  170  can be constructed from a material with sharable properties to allow the end of post  170 , where the transducer support  160  is attached, to be shared to allow another means to anole transducer  162  for proper positioning. 
     Another instance wherein it is necessary to position transducer  162  at an angle from its engagement with sleeve  135  is when promontory bone  175  is positioned particularly close to stapes  46 . In this situation, it is necessary to mount transducer  162  angularly from adjustable slide post  170 . An angle of descent near or at 15° from the plane defining the distal end of post  170  is preferable to ensure that transducer  162  does not engage promontory bone  175 , as shown in FIG.  13 . 
     Referring now to FIG. 8, a close-up view is depicted of transducer assembly  168  with bendable member  164  and electrical contacts  111  configured to receive or send electrical signals. Further depicted is a detailed view of the construction of transducer  162 , comprising driving board portion  113  and bendable portion  164 . 
     In one preferred embodiment of the subject invention, spinner  165 , sleeve  135  and other portions of support assembly  10  are constructed from biocompatible materials known to one of skill in the art, such as grade-5 titanium, gold or stainless steel 316-L, or other functional material. It is also anticipated that other materials, for example, an acetal resin, such as that manufactured under the trade name DELRIN®, may be used in construction of components of this invention. 
     A useful feature of the various embodiments of this invention is the ability to remove sleeve  135  with attached transducer assembly  168  from hanger  150  while mounting flange  145  or, alternatively, flanges  149  remain attached to bone. This feature allows for general sizing of transducer assembly  168  and sleeve  135  without the necessity of complete removal of support assembly  10 , thus avoiding excess trauma, such as the possibility of stripping out the bone screw holes, thereby making remounting more difficult. This feature is also useful when replacing a previously mounted transducer assembly. The invention allows for the removal of sleeve  135  and transducer assembly  168  without disruption of mounting flange  145  or, alternatively, mounting flanges  149 , thus preserving the mounting area from damage. The replacement of a transducer assembly  168  therefore is simplified. 
     Because sleeve  135  and transducer assembly  168  may be detached from hanger  150 , a further embodiment of the invention contemplates temporary replacement of transducer assembly  168  with a sizing and positioning model (not shown) that may be substantially transparent, pliable, or both. Upon initial placement of transducer assembly  168  for sizing, the model facilitates placement of transducer  162  in relation to stapes  46  or other target bones within middle ear  24  of the patient. The transparent feature aids visualization during placement and allows the surgeon performing the implantation to better view potential obstructions in the implantation area and make necessary adjustments. The pliability of the model is advantageous from a safety perspective. The safety of the patient is maintained by protecting the delicate structure of middle ear  24  during positioning in general and during gross positioning specifically. Preservation of the integrity of transducer  162  is also maintained as any obstructions can be avoided based on information learned during the trial placement with the model. After general sizing has taken place, the model can then be replaced by an operable transducer assembly  168 , and thereafter further adjustments can be made as described above. 
     A further embodiment of this invention provides a support assembly  205  for disposing an output transducer  310  within middle ear  24  for use in an implantable hearing aid system. Support assembly  205  is capable of two- and three-directional movement at a plurality of locations along its length. 
     Accompanying output transducer  310  as components of the hearing aid system are electronics unit  360  and input transducer (not illustrated), each of which is known in the art. Electronics unit  360  and input transducer may be implanted separately from output transducer  310 . This further eases implantation, repair, and maintenance or adjustment to electronics unit  360 , such as changing a battery, without the need for removing support assembly  205 . 
     For implantation of system components, an access hole  85  is created in a region of the temporal bone, known as mastoid  34  through a mastoidectomy. An incision is made in the skin covering mastoid  34 , and the underlying access hole  85  is created through mastoid  34 , allowing external access to middle ear  24 . The access hole is located approximately posterior and superior to external auditory canal  32 . By placing access hole  85  in this region, output transducer  310 , affixed to support assembly  205 , can be placed on approximately the same planar level as the auditory element, such as stapes  46 , which it engages. 
     In one embodiment, as shown in FIG. 14, support assembly  205  is implanted into middle ear  24  for mounting. Support assembly  205  is mounted to a region of the temporal bone, preferably mastoid  34 , by multiposition mounting plate  210 . Mounting plate  210  is capable of being deformed to substantially conform to the anatomical features of the particular patient. As such, multiple configurations are possible, depending upon patient anatomy and other relevant factors. Mounting plate  210  has a number of apertures  220  positioned along its length, capable of receiving at least one bone screw  320 . Bone screw  320  secures support assembly  205  to mastoid  34 . The ability of mounting plate  210  to be deformed to substantially conform to the patient morphology enables the surgeon to place bone screw  320  at a preferred angle. In the event of a mastoidectomy, when the internal bone mass assumes a concave character with an attendant ledge, the bone screws  320  can be recessed and secured within the mastoidectomy topography. Bone screw  320  comprises any suitable biocompatible material, and preferably is self-tapping. Two preferred diameters for bone screw  320  are 1.2 mm and 1.7 mm. Support assembly  205  also comprises any suitable biocompatible material as is well-known to one skilled in the art. Bone screw  320  can also be any type of screw well-known to one skilled in the art, such as an orthopedic bone screw, a torx head screw, a single- or double-slotted head screw. To reduce the number of components handled during implantation and mounting of the invention, support assembly  205  is preferably adapted to receive and hold bone screw  320  such that the combination can be placed against mastoid  34  as a single unit. Any known technique, such as pre-threading or otherwise shaping support assembly  205  in accordance with known practices is suitable. 
     Positioned at one end of mounting plate  210  is extendible frame member  230 . Frame member  230  is designed to be readily bendable at various positions along its length, as illustrated in FIG. 14 or otherwise. Bendable frame member  230  facilitates mounting of support assembly  205  to irregular surfaces and enables gross depth and positioning adjustments to be effected at the mounting site. Use of multiposition mounting plate  210  and bendable frame member  230  may obviate or limit the need for grinding the patient&#39;s mastoid  34  to effect placement of support assembly  205 . Housing  240  is attached to the distal end of frame member  230 . In one embodiment, the outer jacket of housing  240  encases a captured ball  260 , which is free to rotate within housing  240 . Captured ball  260  extends partially through a first housing orifice  250  located on a first side of housing  240  and connects to mounting rod  300  externally from housing  240 . Captured ball  260  functions as a joint  290 , or universal connector, such as a ball-and-socket-type joint, in conjunction with mounting rod  300 . Utilization of a ball-and-socket-type joint allows three-way positioning of output transducer  310 , including linear, rotational, and angular movement. Captured ball  260  may be an intact sphere or, alternatively, may be split into two substantially hemispherical portions operatively coupled to one another. A second housing orifice  280  is located on a second side of housing  240 , through which locking screw  270  enters housing  240 . Locking screw  270  may be advanced to a point where engagement with captured ball  260  is effected, thereby restricting movement of the ball-and-socket joint assembly. Mounting rod  300  extends outward from captured ball  260  and, at a distal end, is attached to output transducer  310 . Mounting rod  300  is capable of linear movement to further assist in positioning output transducer  310 . Output transducer  310 , as a result of the angular, rotational, and linear movement, may be positioned with precision in a near-full range of positions in three-dimensional space. 
     As best shown in FIGS. 15-16, support assembly  205  is mounted to mastoid  34 , or other suitable temporal bone, and is then adjusted and manipulated at frame member  230 , captured ball  260 , and mounting rod  300 , as necessary. Adjustments made at mounting plate  210  and frame member  230  may be characterized as gross adjustments. Adjustments made at captured ball  260  and mounting rod  300  are fine adjustments used to effect final placement, or docking, of output transducer  310  against a suitable auditory element, such as stapes  46  or malleus  42 . In positioning output transducer  310  against an auditory element, it is important to join the two components against one another gently and carefully so as to avoid damage to anatomical structure or the hearing aid system. Failure to exercise proper care in positioning support assembly  205  may result in mechanical or electrical damage to output transducer  310  or physical trauma to the auditory element. As a result, the multiple adjustment mechanisms of support assembly  205 , comprising both gross and fine adjustment mechanisms, play a substantial role in the overall effectiveness of the hearing aid system. 
     Referring now to FIG. 15, electrical lead wires  340 ,  350  extend from output transducer  310  and connect to electronics unit  360  at a separate location. Of course, an input transducer (not illustrated) must also be coupled to electronics unit  360  to receive incoming acoustical vibrations which are processed and forwarded to output transducer  310  to effect proper hearing. 
     In one particular embodiment, the invention is used in conjunction with a disarticulated ossicular chain  38 . For example, incus  44  is removed from ossicular chain  38  to prevent feedback of mechanical vibration from output transducer  310  to the input transducer. By affixing support assembly  205  to mastoid  34  by bone screw  320  or other suitable fastener, mechanical vibrations of output transducer  310  are not transmitted back through support assembly  205 . 
     FIG. 17 illustrates an alternative embodiment of support assembly  205  in accordance with the present invention. Adjustable mounting bridge  440  and rigid mounting arm  450  operate in tandem to effectively mount support assembly  205 . Mounting bridge  440  is linearly adjustable to effect a tension fit in middle ear  24  or adjacent cavity. Attached to mounting arm  450  and extending therefrom is mounting plate  455 . Plate  455  has positioned along its length one or more apertures  465  adapted for receipt of a mechanical fastener. Importantly, plate  455  provides a tertiary affixation point with which to secure support assembly  205 . The presence of plate  455  is preferable to obviate exertion of excessive pressure by mounting arm  450  against tegman  48 , as such pressure is transferred directly to brain sacs posterior to tegman  48 . Encasement  380  of housing  370  is positioned between bridge  440  and arm  450 . Encasement  380  is further coupled to joint  390 , preferably a three-way positional member, such as a ball-and-socket joint, to enable linear, angular and rotational positioning of transducer  330  against an auditory element of middle ear  24 . Retaining nut  410  and set screw  420  function as adjustment/locking mechanisms and may be engaged with joint  390  to restrict angular and rotational movement of joint  390 . Extension shaft  430  depends from joint  390  and is adapted for linear movement toward and away from housing  370  at joint  390 . A third adjustment/locking mechanism, such as lead screw  400 , is positioned about joint  390  to restrict linear movement of shaft  430  during positioning. Joint  390 , like captured ball  260 , may be intact or split. 
     In the embodiment as shown in FIG. 18, support assembly  505  is comprised of a pair of bendable, multiposition mounting tabs  510  by which support assembly  505  is mounted to mastoid  34 , or other suitable temporal bone. Mounting tabs  510  are characterized by two or more apertures  520  for acceptance of mounting screw  525  or other suitable mechanical fastener as illustrated in FIG.  21 . It is contemplated that either or both of the two apertures  520  on each of the two tabs  510  may be utilized to facilitate mounting support assembly  505  to irregular surfaces, thereby providing multiple mounting positions. 
     Mounting tabs  510  are attached to bendable mounting arms, such as frame members  530 , which are commonly joined at shoulder  540 . Frame members  530  are constructed to be readily bendable in order to facilitate positioning of the hearing aid system and provide still further configurations for support assembly  505 . In one embodiment, as shown in FIG. 18, frame members  530  are characterized by offset  535  to allow support assembly  505  to be located below the outer surface of the head, thereby preventing damage to the assembly or the elements of the ear from an impact to the head or ear area. Mounting tabs  510  and frame members  530  are constructed of any suitable biocompatible material known in the art and are constructed to be readily deformed at multiple positions along their respective lengths. Again, the multiplicity of positioning adjustments may obviate or lessen the need for grinding the patient&#39;s mastoid  34  to effect placement of support assembly  505 . 
     Shoulder  540  engages joint  570 , preferably a three-way positional member such as a ball-and-socket joint, to allow further angular and rotational movement of support assembly  505  to facilitate positioning of output transducer  545  against an auditory element of middle ear  24 . Again, as with captured ball  260  and joint  390 , joint  570  may assume the form of an intact sphere or two substantially hemispherical components operatively engaged. At the top portion of shoulder  540 , a first retaining mechanism such as lead screw  550 , is positioned which engages inner sleeve  590  to restrict or allow linear movement thereof. As shown in FIGS. 22A and 22B, inner sleeve  590  is housed within outer sleeve  580  and may be positioned to extend beyond the length of outer sleeve  580  by retraction of lead screw  550 . Outer sleeve  580  and inner sleeve  590 , in part, maintain their spacial relationship via slot  600  running a portion of the length of inner sleeve  590 , which engages a pin  608  positioned toward the distal end of outer sleeve  580 . Additionally, outer sleeve  590  and inner sleeve  580  may engage one another via mating internal-external threads (not shown). Angular and rotational movement of outer sleeve  580  and inner sleeve  590  is controlled at joint  570 . Such movement may be limited or restricted by adjustment of a second retaining mechanism, such as retaining/locking nut  560 , which may be positioned to engage joint  570  and is located atop shoulder  540 . 
     Inner and outer sleeves  580 ,  590  together comprise a connector assembly or spacing shaft, from which pivot base  700  is positioned at the distal end of inner sleeve  580 . Base  700  is free to rotate about the longitudinal axis of outer and inner sleeves  580 ,  590 . Additionally, base  700  engages mounting rod  610  at pivot joint  620  to allow further rotational movement of mounting rod  610  about the axis of pivot joint  620 . Positioned atop base  700  is rotational mounting rod set screw  615  to restrict and maintain the spacial position of mounting rod  610  during positioning of support assembly  505 . Mounting rod  610  is capable of linear movement toward and away from base  700  at pivot joint  620 . Linear mounting rod set screw  625  positioned atop pivot joint  620  restricts linear movement of mounting rod  610  during positioning of support assembly  505 . 
     Output transducer  545  is affixed to the distal end of mounting rod  610 . Upon mounting support assembly  505  at mounting tabs  510  to mastoid  34  or other suitable temporal bone, output transducer  545  is moved into position against an auditory element of middle ear  24 , such as malleus  42 , through a series of adjustments made to frame members  530 , outer and inner sleeves  580 ,  590 , base  700 , and mounting rod  610 . 
     Alternatively, in lieu of base  700 , a further embodiment has flange  720  positioned between inner sleeve  590  and output transducer  545 , as seen in FIG.  19 . Output transducer  545  is capable of rotational movement about the longitudinal axis of outer and inner sleeves  580 ,  590 . Due to the linear movement of inner sleeve  590  within outer sleeve  580 , output transducer  545  may be further positioned in a linear manner. 
     A particular advantage of one embodiment of the present invention is the small volumetric profile of support assembly  505 . Given the compact dimensions and the multiplicity of anatomical structures present in and around middle ear  24  and adjacent cavities, a small-volume profiled device is particularly advantageous. Because support assembly  505  may be deformed at mounting tabs  510  (refer to FIG.  25 ), frame member  530 , about joint  570  and along outer and inner sleeves  580  and  590 , support assembly  505  is able to assume a volumetric profile no larger than a volume defined by the widest cross-sectional area and length of support assembly  505 . In the embodiment illustrated in FIG. 18, that profile would be defined in part by the cross-sectional area of shoulder  540 . 
     Dimensional considerations are of great importance to address morphologic variations among patients. It is preferable to limit the dimensions of support assembly  505  as a whole and subparts thereof to enable implantation of assembly  505  within the small dimension of the middle ear region, and to account for varied anatomical requirements of the individual patient. For example, in a patient who has had a mastoidectomy, it is desirable to have a small-diameter outer sleeve  580  to prevent interference with the resulting bone side wall. Reduction of the footprint of transducer  545  would further assist in preventing such interference. In one embodiment, transducer  545  is reduced to dimensions such that transducer  545  extends only slightly beyond the profile defined by outer sleeve  580  at its distal end, thus minimizing the profile of support assembly  505 . 
     Support assembly  505  is mounted to mastoid  34 , or other suitable temporal bone, and is then adjusted and manipulated at frame members  530 , joint  570 , outer and inner sleeves  580 ,  590 , base  700 , and mounting rod  610 , as necessary. Adjustments made at mounting tabs  510  and frame members  530  may be characterized as gross adjustments. Adjustments made elsewhere are more properly characterized as fine adjustments used to effect final placement, or docking, of output transducer  545  against a suitable auditory element, such as stapes  46  or malleus  42 . In positioning output transducer  545  against an auditory element, it is important to adjoin the two components gently and carefully so as to avoid damage to anatomical structure or the hearing aid system. Failure to exercise proper care in positioning support assembly  505  may result in mechanical or electrical damage to output transducer  545  or physical trauma to the auditory element. The multiple adjustment mechanisms of support assembly  505 , comprising both gross and fine adjustments, play an important role in the overall system effectiveness. 
     In particular patients, such as those who have had a mastoidectomy, frame members  530 , mounting tabs  510 , or both may need to be of extended length to facilitate proper positioning of support assembly  505 . Frame members  530  may be further characterized by large sloping radii to provide sufficient support and to account for the additional space within middle ear  24  and adjacent regions as a result of the surgical removal of a portion of mastoid  34 . Such an embodiment of the invention could be accomplished in a number of other ways readily apparent to one of skill in the art, including the introduction of a separate extension plate (not illustrated) at the proximal end of support assembly  505 . 
     Referring now to FIG. 20, electrical lead wires  640 ,  650  extend from transducer  545  and connect to electronics unit  660  at a separate location. Of course, a second transducer (not illustrated) may also be coupled to electronics unit  660  to facilitate receipt and delivery of information within the system to impart hearing to the patient. 
     In yet a further embodiment of the invention, as pictured in FIGS. 27-28, support assembly  805  is comprised of a pair of bendable, multiposition mounting tabes  810  by which support assembly  805  is mounted to mastoid  34 , or other suitable bone. Mounting tabs  810  are characterized by multiple apertures  830  adapted for acceptance of a mechanical fastener. Depending from mounting tabs  810  are bendable frame members  820  which are commonly joined at collar  840 . Mounting tabs  810  and members  820  may be deformed to aid in positioning a transducer within middle ear  24 . 
     Collar  840  is constructed for receipt of a joint mechanism, such as joint  390  previously disclosed herein. Additional means extending from collar  840  may be utilized in unique circumstances to provide additional fastening capabilities. These additional means may optionally include apertures suitable for receiving fastening means; however, other structures are contemplated within the context of this invention. 
     In one embodiment of the invention, support system or assembly  905  is comprised of mounting plate  910 , which is further characterized by two apertures  920 . Depending from plate  910  is bendable primary member  930 , of a predetermined width, which is connected to bendable secondary member  940  having a width smaller than primary member  930 . Primary and secondary members  930 ,  940  comprise multiple width strengthening means for customized bending within a particular patient. Further, cut-out  950  may be optionally removed at mounting plate  910  to aid in mounting support assembly  905  to irregular surfaces. The remainder of the hearing assistance device (not pictured) is operatively coupled to primary and/or secondary members  930 ,  940 . 
     In the above-described embodiments, a variety of transducers are contemplated. The invention is useful in a partial middle ear implantation hearing aid system, and particular useful in a total middle ear implantation hearing aid system. In one such total middle ear implantation system, an input transducer is associated with stapes  46 , transducing mechanical energy into an electrical signal which is amplified. It is further contemplated that the support assemblies, as described herein, may each also function as a component part of a larger system, such as a system wherein a second transducer is associated with malleus  42  and an embodiment of the invention as described herein is associated with stapes  46 , the two transducers being coupled through an electronics unit. Refer to FIG.  26 . 
     In one such embodiment, the system includes a programmer (not shown). The programmer includes an external (i.e., not implanted) programmer communicatively coupled to an external or implantable portion of the hearing assistance system, such as electronics unit  360 . The programmer includes hand-held, desktop or a combination of hand-held and desktop embodiments for use by a surgeon or the patient in which the hearing assistance system is implanted. 
     In one embodiment, each of the programmer and the hearing assistance system includes an inductive element, such as coil, for inductively-coupled bi-directional transdermal communication between the programmer and the hearing assistance system. Inductive coupling is jus tone way to communicatively couple the programmer and the hearing assistance system, any other suitable technique of communicatively coupling the programmer and the hearing assistance system may also be used, including, but not limited to, radio-frequency (RF) coupling, infrared (IR) coupling, ultrasonic coupling, and acoustic coupling. 
     In one embodiment, the signals are encoded using pulse-code modulation (PCM), such as pulse-width telemetry or pulse-interval telemetry. In pulse-width telemetry, communication is by short bursts of a carrier frequency at fixed intervals, wherein the width of the burst indicates the presence of a “ 1 ” or a “ 0 .” In pulse-interval telemetry, communication is by short fixed-length bursts of a carrier frequency at variable time intervals, wherein the length of the time interval indicates the presence of a “1” or a “0.” The data can also be encoded by any other suitable technique, including, but not limited to, amplitude modulation (AM), frequency modulation (FM), or other communication technique. 
     The data stream is formatted to indicate that data is being transmitted, where the data should be stored in memory (in the programmer or the hearing assistance system), and also includes the transmitted data itself. In one embodiment, for example, the data includes a wake-up identifier (e.g., 8 bits), followed by an address (e.g., 6 bits) indicating where the data should be stored in memory, followed by the data itself. 
     In a further embodiment, such communication includes programming of the hearing assistance system by a programmer (not shown) for adjusting hearing assistance parameters in the hearing assistance system to the programmer, such as for parameter verification or diagnostic purposes. Programmable parameters include, but are not limited to: on/off, standby mode, type of noise filtering for a particular sound environment, frequency response, volume, gain range, maximum power output, delivery of a test stimulus on command, and any other adjustable parameter. In one embodiment, certain ones of the programmable parameters (e.g., on/off, volume) are programmable by the patient, while others are of the programmable parameters (e.g., gain range, filter frequency responses, maximum power output, etc.) are programmable only by the physician. 
     FIG. 30 shows an embodiment of the present invention configured with two transducers  162  that comprise adapters  1001  for fitting the transducers to an auditroy element such as the oval window or the stapes  46 . The transducers are mounted on connectors  1002  and attached to mounting portions  1004  of support member  1005  by universal joints  1003 . The mounting portions are fixably attached by connector  1006 , which joins the mounting portions via ball-and-socket joints  1007 . A bendable neck  1008  joins the support member to conformable mounting flange  210 . Electrical leads  1009  electrically connect transducers  162  to the electronic unit  360 , which is equipped with electrical signal processing elements  1011 . 
     FIG. 31 shows another embodiment of the present invention that comprises dual transducers. The transducers  162  are in contact with different auditory elements such as the stapes  46  and the malleus  44 . The transducers are mounted on mounting portions  1004  of support member  1005 . A universal connector  1003  is employed to position one of the transducers. The support member is attached to conformable mounting flange  210  by bendable neck  1008 . 
     The embodiments of FIGS. 30 and 31 exemplify mounting means. The transducers may be electromagnetic or employ piezoelectric materials. A transducer may be either an input transducer, an output transducer, or an input-output transducer. A bendable portion is not limited to the position shown, but may be used elsewhere; for instance, between the mounting portions or between a transducer and a mounting portion. The mounting means for the transducers may also use other means disclosed herein; for instance, a removably couplable hangers-and-sleeve means. The conformable mounting flange is also not limited to the illustrated embodiment; for instance, more than one may be used, one may have more mounting holes, be shaped as a rectangle, comprise an offset, or be attached with a pivotable means, or attached to another portion of the apparatus. 
     While the present invention has been described with reference to the preferred embodiments, the invention is not limited to the specific examples given. Various other modifications will occur to those of ordinary skill in the art, and other embodiments and modification can be made by those skilled in the art without departing from the spirit and scope of the invention as defined in the following claims.