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Ossiculoplasty

Editor: Matthew Ng Updated: 12/11/2024 5:56:31 PM

Introduction

Ossicular discontinuity or fixation occurs in approximately 55% of cases of conductive hearing loss.[1] The mechanics of sound conduction rely on various factors, including an individual patient's anatomy, which is difficult to predict and simulate in ossiculoplasty. Reconstruction of the ossicular chain is often suboptimal because it consists of 2 joints: one between the malleus and incus and another between the incus and stapes. These joints allow for freedom of movement, which helps prevent excessive footplate displacement and protects the inner ear.[2]

Modern ossiculoplasty techniques involve replacing these 2 ossicular joints with partial (PORP) or total (TORP) ossicular prostheses. These procedures effectively transform the ossicular chain into a single piston, transmitting forces from the tympanic membrane directly to the stapes superstructure or oval window. However, using PORPs and TORPs carries risks, including sensorineural hearing loss due to perilymph leakage and potential prosthetic extrusion.[3] 

Most ossicular chain disorders affect the incus. The causes of ossicular chain disorders include:

  • Cholesteatoma (80%) [4]
  • Otitis media
    • Acute [5]
    • Chronic
  • Trauma
    • Blunt
    • Penetrating
  • Congenital
    • Aural atresia [6]
    • Congenital ossicular fixation
    • Malformation
    • Absence
  • Idiopathic
    • Otosclerosis
  • Neoplasms

The first attempt at ossiculoplasty was in 1901, involving a case of absent ossicles. The goal was to connect the tympanic membrane to the oval window.[7] A classification of ossicular defects was created to distinguish between the presence or absence of the malleus handle and the stapes superstructure.[8] Classification schemes were subsequently refined to account for factors such as ossicular chain integrity, malleus head fixation, and stapes fixation.[9]

The ideal middle ear implant remains elusive. Both autogenous and alloplastic prostheses have been used with similar hearing reconstruction results. Homographs have largely been abandoned to reduce the risk of transmitting diseases, such as HIV and Creutzfeld-Jakob disease. Most otologic surgeons use one of the following or a combination, depending on personal preference and experience:

  • Biologic materials
    • Ossicles (autogenous)
    • Cartilage
  • Synthetic prostheses
    • Hydroxyapatite
    • Plastipore
    • Titanium
    • Ceramics

Sound energy is created by disturbances in the density of particles in air, an elastic medium that allows sound to travel. The speed of sound is slower in air than in fluids in the inner ear. Repetitive patterns produce musical tones, whereas sound that lacks these patterns is perceived as noise.

Ossicular coupling is the primary sound transmission pathway and is facilitated by the ossicular chain and, to a lesser extent, the stapedius and tensor tympani muscles.[10] Middle ear mechanics play a crucial role in transmitting sound energy from the air to the fluid within the inner ear, addressing the impedance mismatch. Impedance refers to the resistance encountered by sound energy as it travels through different media. Without the ossicles to resolve this mismatch, sound would be largely deflected upon entering the inner ear due to the significantly higher impedance of the inner ear fluids than air. This pathway is called "acoustic coupling." The difference between ossicular and acoustic coupling represents the maximal conductive hearing loss expected with ossicular discontinuity, typically 50 to 60 dB.[11][12]

The key factor in the middle ear's ability to match impedance is the "area ratio" between the tympanic membrane and the stapes footplate. The surface area of the tympanic membrane (69 mm²) is about 20 times larger than that of the stapes footplate (3.4 mm²).[13] If sound energy were transmitted directly to the stapes footplate instead of the tympanic membrane, the force per unit area would be 20 times greater, or approximately 26 dB.

The other impedance-matching mechanism is the lever ratio, specifically referring to the difference in length between the malleus's manubrium and the incus's long process. This lever ratio is estimated to be 1.3:1 because the manubrium is slightly longer than the long process of the incus, which results in a gain of approximately 2 dB.[14] The middle ear sound pressure gain is less than expected because the tympanic membrane's ability to vibrate in different areas may be affected by tympanosclerosis or middle ear disease.[15]

The biomechanics of ossiculoplasty is faced with significant challenges, including:

  • Prosthesis biocompatibility, materials, and characteristics
  • Middle ear environment, including the status of middle ear mucosa, pathology, and malleus
  • Tension

Ossiculoplasty has evolved by utilizing various techniques, materials, and prostheses, each with advantages and limitations. The success of this procedure is influenced by factors such as the underlying disease, particularly cholesteatoma, the durability and functionality of the prosthesis, the surgical technique employed, and the surgeon's level of experience. Staging ossiculoplasty alongside tympanomastoidectomy may be preferable. Hearing outcomes have improved only slightly over the past 50 years, and achieving complete closure of the air-bone gap with ossiculoplasty is still rare.[16]

Anatomy and Physiology

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Anatomy and Physiology

The ossicles—the malleus, incus, and stapes—are 3 bones in the middle ear that assist in the mechanical transduction of sound energy. The tympanic membrane collects sound energy, transmitted across the middle ear, through the 3 ossicles, and into the fluid-filled cochlea. The middle ear bones collectively form the ossicular chain.

Embryologically, the malleus and incus develop from the Meckel cartilage of the 1st pharyngeal arch, the stapes from the Reichert cartilage of the 2nd pharyngeal arch, and the footplate and annular ligament from the otic capsule.[17] The malleus is divided into the head, neck, manubrium, and anterior and lateral processes. The incus is divided into the body, short crus, long crus, and lenticular process. The stapes consist of the head (capitulum), neck, anterior crus, posterior crus, and footplate. The ossicles are held in position and suspended within the middle ear by various ligaments, muscles, and structural attachments. Laterally, the malleus is attached to the tympanic membrane at the lateral process, manubrium, and umbo.

Medially, the stapes footplate is secured to the otic capsule by an annular ligament. The incus, positioned between the malleus and stapes, is connected to the other 2 ossicles by the incudomalleolar and incudostapedial joints, both synovial diarthrodial joints. When sound energy is transmitted across the ossicular chain, it causes vibratory motion of the stapes within the oval window, transmitting sound to the cochlea. The classic description of stapes movement is similar to that of a piston, although other vibration patterns and characteristics for the stapes footplate have been observed. Differential pressure and impedance at the oval and round windows are required to move cochlear fluid, which forms the basis of neural stimulation for hearing.[18]

The middle ear muscles, including the tensor tympani and stapedius, play a role in suspending and stabilizing the ossicular chain and protecting the inner ear from potentially injurious loud sounds. The tensor tympani attaches to the manubrium of the malleus near the neck and retracts it medially to stiffen the tympanic membrane, reducing vibratory transmission. The stapedius attaches to the posterior aspect of the stapes head, damping vibrations in the oval window during the acoustic reflex triggered by loud sounds.[19] If these muscles are detached from their respective ossicles or lose function due to disease or surgery, their protective effects cannot be restored during ossiculoplasty.

Human hearing relies on 2 key factors: sound processing and hearing protection. Sound processing converts acoustic energy into mechanical energy, which influences the electrochemical processes in the organ of Corti. This process ultimately generates electrical signals that are sent to the brain. Hearing protection prevents excessive sound energy from damaging the physical structures of the middle ear and cochlea.

The biomechanics of ossiculoplasty involve a complex interplay of several factors to accomplish sound processing and hearing protection. These factors include:

  • Biologic factors
    • Biocompatibility of the prosthesis: inert versus nidus of infection
    • Environment of the postoperative middle ear, including tympanic membrane repair, mucosal status, and presence of drainage
    • Healing process and possible scarring
    • Restoration of middle ear aeration
    • Patient comorbidities such as diabetes
  • Mechanical elements
    • Tension of reconstruction—a prosthesis that is too tight may distend the stapes footplate and annular ligament, risking a perilymphatic fistula
    • Angle of the prosthetic vector of motion
    • Remaining ossicular remnants
    • Use of interposed cartilage and its characteristics
    • Biomechanics of the prosthesis
  • Staging of surgery
    • Delaying an ossiculoplasty after primary tympanomastoidectomy remains controversial.
    • Indications for delaying reconstruction include the following:
      • A canal wall-down procedure is used.
      • A TORP is used.
      • Concerns for recurrent cholesteatoma or extensive disease and resection persist.

An impedance mismatch occurs if sound energy travels through the air and enters the external auditory canal directly to the stapes footplate, bypassing the tympanic membrane, middle ear, and ossicles. Acoustic energy must be transmitted from the air to the fluid-filled cochlea. Otherwise, only about 0.1% of the acoustic energy reaches the inner ear.[20] The ossicular chain is essential for overcoming the impedance mismatch between the air in the outer ear and the fluid in the inner ear, allowing more than 90% of the acoustic energy to reach the cochlea. The chain amplifies the force of sound vibrations by at least 25 times, resulting in a pressure gain of approximately 25 to 30 dB.[21]

The middle ear compensates for the impedance change mainly through the following mechanisms:

  • The effective vibratory area of the tympanic membrane is 17 to 20 times greater than that of the stapes footplate.
  • The lever action of the ossicular chain encompasses the following:
    • The long process of the incus is shorter (by a factor of 1.3) than the length of the manubrium and neck of the malleus, providing a mechanical advantage.
    • The incudostapedial joint acts as a small, synovial ball-and-socket joint, allowing only a limited, linear range of motion
  • The curved shape of the tympanic membrane and its characteristics contribute to the catenary lever effect.

When considering both the area and lever effects, the mechanical advantage of the middle ear is 22 to 1. This advantage results from the combined effects of the area and lever ratios. The tympanic membrane is crucial in transferring sound energy, protecting the middle ear from infection and foreign materials, and providing an air cushion that facilitates communication with the Eustachian tube. During an ossiculoplasty procedure, the continuity of the ossicular chain and the integrity of the tympanic membrane can be surgically restored. However, the lever effect cannot be replicated with current technology, and no 3-dimensional reconstructions of ossicular chains are currently available.

Indications

Ossiculoplasty is a surgical procedure aimed at restoring the continuity of the ossicular chain and improving hearing in individuals with conductive hearing loss. The primary goal is to enhance the patient's overall hearing, especially for conversational speech, while maintaining realistic expectations since complete closure of the air-bone gap is unlikely, even in the most skilled surgical hands. Maintaining continuity in the ossicular chain is crucial because extended conductive hearing loss can impair language development, cognitive abilities, and learning processes.[22][23] 

Ossiculoplasty has the highest success rate when a patient's perceived hearing improvement matches their better-hearing ear. Special considerations include:

  • Bilateral hearing loss
  • Considerations in the pediatric population
    • Conditions manifesting with congenital conductive hearing loss
    • Effects on growth and vice versa
    • Higher susceptibility to head trauma and otitis media
    • Smaller anatomy [24]

The decision to perform ossiculoplasty should be based on a careful evaluation of the patient's clinical condition and the extent of the disease. Prioritizing the removal of cholesteatoma and achieving a dry, healthy ear should come before efforts to restore hearing. If a patient has previously undergone unsuccessful ossiculoplasty, waiting at least 6 months before considering revision surgery allows for proper healing and management of any residual or recurrent cholesteatoma. Furthermore, hearing assistive devices, such as conventional hearing aids and bone-conduction devices, should be offered to all patients as alternatives to ossiculoplasty, not just those with prior unsuccessful surgeries.

Chronic otitis media and its complications, including cholesteatoma and ossicular erosion, are responsible for more than 80% of cases involving ossicular chain disruption.[25] The remaining cases are due to blunt and penetrating trauma causing disarticulation, congenital ossicular fixation, acquired ossicular fixation from tympanosclerosis, congenital malformations, congenital absence of ossicles, otosclerosis, and middle ear neoplasms.[26] The incus is primarily involved in these cases, especially the long process, with the stapes following closely behind.[27][28] Around half of the cases involve more than 1 ossicle.[29][30]

Ossicular discontinuity or fixation was found to be responsible for up to 55% of conductive hearing loss cases.[1] Reduced stapes footplate mobility, absence of stapes superstructure, or an improperly aligned stapes superstructure may produce suboptimal ossicular coupling, increased prosthesis displacement risk, and surgical failure.[31][32]

Establishing a stable, well-aerated middle ear environment is critical for ossiculoplasty success. A contracted middle ear space can restrict the movement of the tympanic membrane, ossicular chain, and round window, resulting in a 35- to 55-dB conductive hearing loss.[33] Middle ear pathology resulting from poor ventilation is significantly more detrimental to ossiculoplasty success than surgical technique and prosthetic factors.[34][35] Additionally, conditions such as negative middle ear pressure, inadequate mastoid pneumatization, fluid accumulation, ongoing Eustachian tube dysfunction, granulation tissue, middle ear fibrosis, adhesive disease, and tympanic membrane perforations can all impact the effectiveness of sound transmission.

Residual or recurrent cholesteatoma may undermine any successes achieved through hearing reconstruction via ossiculoplasty. Therefore, the skilled otologic surgeon needs to address these issues either before or during the ossiculoplasty procedure.[36]

Contraindications

Acute otitis media is the only absolute contraindication for ossicular chain reconstruction. Ossiculoplasty must be postponed until after the acute infection resolves. Otherwise, acute otitis media may—

  • cause poor healing because of fluid or pus accumulation, granulation tissue formation, or scarring.
  • alter middle ear mucosa integrity.
  • be associated with Eustachian tube dysfunction.
  • cause prosthesis extrusion.

Chronic otitis media and middle ear cholesteatoma may justify delaying ossiculoplasty, but they are not contraindications. Relative contraindications include factors resulting in suboptimal hearing improvement, such as reduced middle ear space, repeated surgical failures using similar prostheses, stapes fixation or malformation, and having only one functional hearing ear.

Other contraindications may relate to patient comorbidities and age. If a patient has a high risk of surgical or anesthetic complications, ie, patients risk-stratified as American Society of Anesthesiologists class III or above, ossiculoplasty may be deferred with a recommendation for hearing aids or watchful waiting.[37]

Equipment

Ossiculoplasty improves hearing with a success rate of 75% for PORP and 68% for TORP at 12 to 18 months. The success at 5 years for PORP is 66%, and for TORP is 33%. The use of autologous versus artificial synthetic materials for prostheses has been debated since the 1950s.

The following equipment may be needed:

  • Operating microscope
  • Otologic drill with drill bits designed for sculpting autografts.
  • Ossicle holder
  • Otologic instrumentation tray, including self-retaining retractors
  • Ossicular prosthesis

Hall first used autografts in ossicular reconstruction in 1957.[38] Using autografts from ossicles, cortical bone, and cartilage has the advantage of a low risk of extrusion. The sculpted incus body is the most commonly utilized autograft, often with or without an interposition of cartilage. The incus is advantageous because it is readily available and can be used immediately. However, autografts also have some disadvantages. For instance, the available ossicular body mass may be insufficient if significant erosion has occurred due to disease. Additionally, the process of sculpting the graft can prolong the intraoperative time. Future resorption may also occur due to osteitis, fixation issues, and the potential for residual cholesteatoma.

Artificial synthetic prostheses have largely replaced autograft and homograft prostheses due to their availability, versatility, and durability. A survey conducted by Goldenberg et al revealed that 70% of otologists prefer synthetic materials over bone (25.15%) or cartilage (4.4%). No statistically significant difference has been found in hearing improvement between autograft and synthetic prostheses.[39]

The 3 synthetic ossicular prosthesis categories are the following:

  • PORP: This type links an intact stapes suprastructure to the malleus or tympanic membrane.
  • TORP: This type links the stapes footplate to the malleus or tympanic membrane.
  • Incus-interposition or incus-replacement prosthesis:
    • Incus interposition is used when the long process is compromised. This type connects the stapes superstructure to the remnant incus long process.
    • An incus replacement prosthesis is used when the incus is missing. The prosthesis is placed between the manubrium and the stapes capitulum.  

Artificial ossicular prostheses were first used in 1952, and they were composed of vinyl-acryl plastic. Over the last few decades, prostheses have been manufactured from plastics (polyethylene, polytetrafluorethylene, Teflon™, plastipore, proplast, silicone), metals (stainless steel, titanium, platinum, gold, tantalum), and biomaterials (aluminum oxide ceramic, bioglass, Ceravital™, hydroxyapatite, carbon). Prostheses must remain inert in the middle cavity to prevent foreign body reactions and chronic inflammation, as such conditions can result in an osteolytic process and subsequent ossicular remnant necrosis.[40] Disadvantages of allograft materials such as polyethylene, plastipore, Teflon, and Ceravital include inflammatory middle ear reactions, biodegradation, prosthesis extrusion, displacement, and migration into the inner ear.[41][42]

The best biomaterial is hydroxyapatite, the mineral matrix of bone, since it has many advantages, including safety, cost-effectiveness, and ease of use.[43] Hydroxyapatite is composed of calcium phosphate ceramic, similar to bone mineral, and has good biocompatibility.[44] Grote first used hydroxyapatite in the 1980s. Extrusion rates are 4% to 16%, which are reduced to less than 2% when a cartilage graft is interposed between the implant and the tympanic membrane.[45][46] However, hydroxyapatite is brittle, challenging to sculpt, and difficult to place due to its bulk.[47][48][49]

Titanium is lightweight, rigid, and biocompatible, recently gaining popularity.[50] This material more easily conforms to different shapes and may be more precisely fitted than hydroxyapatite, facilitating its placement. The extrusion rate is 1% to 2%, and hearing results are similar to hydroxyapatite or autografts.[51][52][53] 

Bone cement serves as a good adjunct for ossiculoplasty. This material is easy to prepare and apply with fast setting times and good biocompatibility. Bone cement can be molded to augment the ossicular remnant, allowing ossicle preservation. Around 90% of patients who underwent bone cement reconstruction have reported an air-bone gap closure of 20dB or better.[54][55] 

Material selection for ossiculoplasty depends on factors such as surgeon preference, patient-specific needs, and material availability. Surgeons choose the materials that yield the best results for them or what is readily available.[56]

Personnel

The healthcare professionals involved in the performance of an ossiculoplasty include the following:

  • Otologic surgeon
  • Anesthesiologist
  • Surgical technician or operating room nurse
  • Circulating or operating room nurse

The combined expertise of these professionals contributes to the safety and success of the procedure.

Preparation

Patient selection and evaluation for ossiculoplasty primarily rely on clinical assessment, taking into consideration the patient's history, physical examination, and audiometry and imaging results. Laboratory tests, biopsies, and cultures are usually not required. Conducting a thorough risk assessment is crucial, especially if the patient has only 1 hearing ear, is at risk for vestibular, intracranial, or facial nerve complications, or has significant comorbidities.

Preoperative pure-tone audiometry should be performed in every patient. Audiometric evaluations should include:

  • Air and bone conduction
  • Speech reception thresholds
  • Speech discrimination
  • Tympanometry
  • Acoustic reflexes

Imaging has become increasingly common for otologic surgeons, particularly thin-cut, high-resolution temporal bone computed tomography (CT) that does not require contrast. This imaging technique can detect bony defects in the temporal bone and offer valuable insights into the integrity of the ossicular chain, as well as any accompanying tympanomastoid disease, which can influence surgical planning. The disadvantage of these images is that they may lack specificity in distinguishing between granulation tissue, scarring, fluid, and keratinizing squamous debris.

Magnetic resonance imaging (MRI) of the temporal bone, including a T2-weighted series in both coronal and axial planes, can provide important information about the middle ear space, particularly the ossicular chain and Eustachian tube. Combining CT scans of the temporal bone with diffusion-weighted MRI may also be advantageous.[57][58]

Informed consent must be obtained before surgery. The risks associated with the procedure include bleeding, infection, immediate or delayed displacement or extrusion of the ossicular prosthesis, hearing loss, dizziness, altered taste, facial nerve injuries resulting in facial paralysis, stapes subluxation leading to deafness, perilymphatic fistula, and the possibility of requiring additional surgery in the future. Alternatives for improving hearing include conventional hearing aids and bone conduction devices.

Technique or Treatment

Ossiculoplasty may be performed under general anesthesia or intravenous sedation with local anesthesia, depending on whether additional otologic procedures are necessary. If a surgical procedure to eliminate middle ear or mastoid disease, such as a tympanomastoidectomy, is planned, general anesthesia is typically used along with intraoperative facial nerve monitoring. However, if the goal is to restore ossicular continuity in an ear without active disease, such as in a planned staged ear surgery, the tympanomeatal flap may be raised, and ossiculoplasty may be performed under intravenous sedation with local anesthesia.

The ear is prepared and draped in a sterile manner. Access to the middle ear cavity may be obtained through either the transcanal or postauricular approach. In both methods, a tympanomeatal flap is raised to expose the middle ear and access the ossicular chain. The postauricular approach is preferable for patients with a narrow external auditory canal or pronounced bony prominences, which can make a transcanal approach difficult. This technique is also suitable if a concurrent mastoidectomy is planned.

In both approaches, a local anesthetic that contains a vasoconstricting agent (eg, 1% lidocaine with 1:100,000 epinephrine) is injected into the ear canal to promote local anesthesia and control bleeding. This injection is performed under direct observation through an operating microscope to ensure precise delivery at the bony-cartilaginous junction in the subperiosteal plane, resulting in diffuse blanching of the area.

Transcanal Approach

The tympanomeatal flap is elevated using a transcanal approach. This technique involves making a pair of 8-mm radial longitudinal incisions: one superiorly, located lateral to the annulus at the tympanosquamous suture line, and another inferiorly. A transverse incision connects the 2 radial incisions laterally to create a medially-based U-shaped flap. The canal skin and periosteum are then elevated in continuity with the fibrous annulus, which is lifted out of its bony groove. Finally, the tympanomeatal flap is reflected forward to access the posterior mesotympanum and the ossicles.

Postauricular Approach

Ossiculoplasty in chronic ear surgery typically takes place as the final step following a tympanomastoidectomy and the removal of cholesteatoma or other pathology. The middle ear should be well exposed at this point, allowing for ossiculoplasty and tympanoplasty.

If a tympanomastoidectomy is not performed and a posterior auricular approach is selected, incisions similar to those in the transcanal approach are made to enable the elevation of a tympanomeatal flap. A posterior auricular incision is created that extends down to a plane just lateral to the temporalis fascia. An additional incision through the musculoperiosteum is made along the temporal line, along with a perpendicular musculoperiosteal incision behind the cartilaginous ear canal and directed toward the mastoid tip. 

The anterior-based musculoperiosteal flap formed by these incisions is elevated toward the membranous ear canal, allowing access to the bony ear canal. The posterior canal skin of the bony canal is then elevated medially until the tympanomeatal flap incisions are reached. A Perkins retractor is used to pull the auricle and the posterior canal skin forward. The tympanomeatal flap can be raised at this point to provide access to the middle ear.

If the patency of the ear canal is compromised due to an anterior canal wall bulge or an enlarged tympanic ring, the canal skin covering the bony prominence is elevated and thinned using an otologic drill until sufficient access to the middle ear is achieved.

Prosthesis Placement

Once the middle ear cavity is accessed and exposed, the ossicles are carefully inspected for defects and gently palpated to assess for mobility and continuity. The choice of the most suitable ossicular reconstruction solution depends on the otologic surgeon's preference, who must decide between autologous and synthetic (artificial) options. 

The mobility of the stapes footplate should be evaluated, along with approximate measurements, to determine the appropriate ossicular chain replacements. A PORP may be utilized if the stapes capitulum is intact. Conversely, a TORP may be the sole option if the stapes footplate alone is intact and mobile. The platform of the TORP or PORP may be positioned either beneath the manubrium or on the undersurface of the native or grafted tympanic membrane. 

Autologous cartilage may be harvested from the tragus or the conchal bowl to serve as a shield or cap over the prosthesis platform to prevent the prosthesis from extruding. The tensor tympani tendon should be transected if the manubrium is intact but medialized or foreshortened. The manubrium should be laterally repositioned to accommodate the ossicular reconstruction better. 

The prosthesis may be trimmed to a length that spans the distance from the mobile stapes superstructure or footplate medially to the tympanic membrane or manubrium laterally. This length must account for the thickness of the cartilage shield or cap on the prosthesis platform. Proper placement of the prosthesis is crucial for achieving stability, ensuring that it is not prone to dislocation or displacement.

A gelatin sponge soaked in topical antibiotic drops may be used to pack around the reconstruction to enhance stability further. Some metallic prostheses are equipped with a crimpable metallic cage that may be securely attached to the capitulum for added stabilization. 

After completing the ossicular reconstruction, the tympanomeatal flap or the grafted tympanic membrane is placed over the cartilage-prosthetic complex. Another antibiotic-soaked gelatin sponge is then positioned laterally to the tympanic membrane or graft to help secure it. Some otologic surgeons may use various packing materials in the ear canal for hemostasis and ear canal expansion, which may require removal following the procedure.

All patients have a mastoid dressing applied for compression for 24 to 48 hours. Most otologic surgeons prescribe otologic drops containing antibiotics, steroids, or both for several weeks postoperatively. Patients are also instructed regarding dry ear precautions. Follow-up visits usually involve meticulous debridement under otomicroscopy. This procedure is performed only after sufficient healing has occurred to prevent suctioning from dislodging the tympanic membrane graft or ossiculoplasty. Pure-tone audiometry is typically delayed for 3 to 6 months, depending on the patient’s healing process. CT and MRI imaging are usually not performed unless a clinical concern arises, such as cholesteatoma recurrence.

Complications

Ossiculoplasty is a complex surgical procedure that may be modified according to individual patient characteristics. A standard for what constitutes a normal postoperative course is often absent. Both clinicians and patients may interpret a lack of hearing improvement as a complication, but this perception can be subjective. Despite significant advancements in biomedical technology, overall outcomes have not dramatically improved. Traditionally, the closure of the air-bone gap to below 20 dB on pure tone audiometry has served as an arbitrary marker of surgical success.[59] 

The surgical risks of ossiculoplasty include:

  • Sensorineural or worsening conductive hearing loss
  • Ipsilateral taste disturbance
  • Facial nerve paralysis
  • Dizziness
  • Tympanic membrane perforation
  • Infection
  • Tinnitus
  • No hearing improvement 

Defining a complication post-ossiculoplasty can be challenging when conductive hearing loss does not improve, as the degree of hearing improvement may vary due to potential prosthesis failure. In some cases, patients may initially experience favorable results, only to later notice a decline in hearing due to various factors, including:

  • Necrosis of an autologous osseous graft or remnant native ossicles
  • Prosthesis extrusion or migration
  • Fracture of the stapes superstructure
  • Displacement of the stapes
  • Annular ligament disruption at the oval window, potentially leading to a perilymphatic fistula and, subsequently, severe or complete sensorineural hearing loss and vertigo

Factors that influence surgical failure include middle ear pathology, the type of prosthesis, the condition of the ossicular chain at the time of ossiculoplasty, the surgical technique used, the status of the external auditory canal wall in cases of canal wall down mastoid surgery, various patient comorbidities, and the ossiculoplasty staging. Middle ear pathology (eg, drainage, acute and chronic otitis media, or cholesteatoma) accounts for up to 56% of all surgical failures, mostly due to atelectasis.[60][61] Prosthesis displacement or migration may result in maximum conductive hearing loss.

Middle ear effusion or ongoing middle ear disease, graft failure, or displaced prosthesis occurs most often in the immediate postoperative period. Delayed hearing loss after an initial period of improvement is more likely due to cholesteatoma recurrence or recidivistic disease, delayed graft failure, prosthesis displacement, or the formation of scarring around the prosthesis.[62] 

The Ossiculoplasty Outcome Parameter Staging (OOPS) index was created in 2001 to predict hearing outcomes in patients undergoing ossiculoplasty. This index takes into account preoperative patient characteristics and intraoperative findings, such as the presence of middle ear drainage, the condition of the middle ear mucosa (normal or fibrotic), the presence of the malleus, the type of surgery performed (canal wall up or canal wall down mastoidectomy), and whether the surgery is a revision.[63]

The OOPS index has helped providers predict surgical success, identify patients at risk for complications, compare various surgical techniques and prostheses, and evaluate progress in surgical skills. The OOPS is important for predicting both short-term and long-term hearing success. Subsequent authors have identified additional factors causing an increased risk of complications after ossiculoplasty, including poor hearing results on the first postoperative audiometry, absence of the malleus, middle ear disease, Eustachian tube dysfunction, recurrent otitis media, tobacco smoking, and an inability to perform the Valsalva maneuver.[64][65][66][67][68] 

To enhance the success rates of ossiculoplasty, a delayed reconstruction of the ossicular chain may be recommended for patients with significant diseases that require extensive middle ear and mastoid surgery, canal wall down mastoidectomy, residual cholesteatoma, and excessive resection of middle ear mucosa.[69] After surgery, patients undergo annual audiometric tests to assess the long-term stability of their hearing. Additionally, an office otomicroscopic examination is performed to check for any recurrence of middle ear disease.

If patients have unsatisfactory audiometric results, the reasons for these outcomes, especially potentially rectifiable factors, must be identified. In certain cases, CT and MRI scans can help surgeons evaluate the position of the prosthesis and investigate whether ongoing tympanomastoid disease may be influencing the results. Revision surgery may be considered, depending on the clinical situation.

Clinical Significance

Since the 1950s, ossiculoplasty has been performed on patients with conductive hearing loss resulting from disruptions in the ossicular chain. This procedure has led to significant improvements in speech, social development, and overall quality of life for many individuals. However, the rates of air-bone gap closure observed on audiometric tests, the long-term stability of postoperative hearing improvement, and the overall success of the surgery have shown considerable variability. Many prosthetics and surgical techniques have been developed over the past 50 years, yet no consensus has been established regarding the ideal treatment method.

The theory underlying ossiculoplasty presents challenges, as prostheses typically replace 2 joints with one. Numerous confounding variables exist, particularly when managing patients with extensive cholesteatoma disease. These complexities underscore the necessity for additional research aimed at identifying better strategies for middle ear reconstruction.

To provide optimal care, otologic surgeons, referring physicians, radiologists, audiologists, nurses, and other healthcare professionals must have a thorough understanding of the anatomy and physiology of the ear, as well as the causes, evaluation methods, and treatment options for middle ear diseases, neoplasia, and trauma.

Enhancing Healthcare Team Outcomes

Managing conductive hearing loss requires a collaborative and interprofessional healthcare team to provide patient-centered care, improve outcomes, ensure safety, and optimize team performance. Key members of this team include otolaryngologists, primary care physicians, emergency room doctors, pediatricians, audiologists, anesthesiologists, speech therapists, nurses, and medical device specialists. Patients with acute and chronic ear diseases, ear trauma, or hearing loss resulting from neoplasia should be referred to otologic surgeons and audiologists for evaluation, which may include microotoscopy, pure-tone audiometry with acoustic reflexes, speech reception thresholds, and imaging studies such as CT or MRI.

Patient care and outcomes improve when an interprofessional approach is employed in managing middle ear disease, trauma, or neoplasia that leads to ossicular chain disruption and conductive hearing loss. Physicians, advanced practitioners, nurses, audiologists, speech therapists, medical device specialists, and other allied healthcare professionals can work together seamlessly to ensure a coordinated response. Early diagnosis and treatment of conductive hearing loss are essential for long-term speech fluency and social function. Otologic surgeons provide clinical expertise to diagnose and treat adverse events promptly, tailoring interventions to meet the patient's needs. Audiologists closely monitor hearing results while otologic surgeons watch for early warning signs of adverse reactions.

Otolaryngology surgical nurses and medical device specialists play a crucial role by providing necessary tools and valuable insights regarding prosthesis selection and availability during ossiculoplasty preparation and surgery. Speech therapists may contribute to enhancing hearing outcomes and improving speech fluency, particularly in pediatric patients. Effective communication and collaboration within the team are vital, allowing for an efficient and comprehensive response that maximizes hearing outcomes and minimizes patient risks. In managing patients with conductive hearing loss, an interprofessional healthcare team ensures a thorough approach, reduces complications, and prioritizes patient safety and quality of care.

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