Ossicular Replacement Research Articles

Ossiculoplasty With Total Ossicular Replacement Prosthesis and Omega Connector

Among other difficulties, achieving a stable position of a total ossicular replacement prosthesis (TORP) is demanding because of a limited view on the TORP-footplate interface and individual angles between the footplate and tympanic membrane. The Kurz Omega Connector aims at a simplified insertion of the TORP. The performance of total ossicular reconstruction using the Omega Connector was evaluated. Prospective cohort study and experimental measurements with a fresh human temporal bone. Tertiary referral center. Seventeen consecutive patients receiving total ossicular reconstruction were included. Historical control group composed of 36 patients. Total ossicular reconstruction using the Omega Connector. (a) Handling of the TORP and Omega Connector intraoperatively, (b) functional short-term results compared with a historical control group, (c) sound transmission properties with 3 different connective positions between the TORP and the Omega Connector. Placing the Omega Connector on the footplate and coupling the Omega Connector to the TORP was straightforward in 65% of cases. A stable final position of the TORP was obtained in 88% of cases. Mean (SD) preoperative and postoperative air-bone gaps were 36.00 (11.05) and 25.29 (12.25) dB and were almost identical with those in the historical control group (p = 0.9). In the experimental measurements, functional outcomes with "partial connection" showed almost the same results as those with "full connection." The Omega Connector provides easy handling of the TORP. The short-term functional results were comparable to those achieved previously without the Omega Connector. The temporal bone measurement supports tolerance in connective position between the TORP and the Omega Connector.

The sandwich cartilage shoe technique for ossicular reconstruction in a case of an unsecure stapes footplate

This article describes a new surgical method for total ossicular reconstruction in a case of a broken stapes footplate. We developed the technique of the "cartilage shoe sandwich," which consists of two surgical steps. First, the closure of the oval window is achieved by a cartilage shoe without a central perforation. During this surgical intervention, the prearrangement of a secure placement of a total ossicular replacement prosthesis is provided by a second cartilage with a central hole that is plugged with silicone. In a staged procedure, the silicone plug is removed and the ossicular reconstruction can be performed. The audiological results of the first patients show a stable inner ear function with an air-conduction gain of 9 dB. The technique described herein has proven to be safe and reliable in total ossicular reconstruction in the event of an unsecure stapes footplate.

Ossiculoplasty in Intact Stapes and Malleus Patients

To compare hearing results in patients undergoing ossiculoplasty using either partial ossicular replacement prosthesis (PORP) or total ossicular replacement prosthesis (TORP) with Silastic banding and malleus relocation techniques in cases with malleus and stapes both present and mobile. Prospective nonrandomized clinical study. Tertiary referral center. Five hundred eighty-five patients undergoing ossiculoplasty were enrolled in this study from April 1991 to May 2010. Comparative analyses were made between a group of 304 patients who underwent ossiculoplasty with partial prosthesis positioned from the malleus to the stapes head and 281 patients who underwent ossiculoplasty with total prosthesis positioned from the malleus to the stapes footplate. Preoperative and postoperative audiometric evaluation using conventional audiometry, that is, air-bone gap (ABG), bone-conduction thresholds, and air-conduction thresholds were assessed. In the PORP group, the mean postoperative ABG was 13.1 dB compared with 8.9 dB in the TORP group, (95% confidence interval [CI], 2.2-6.2 dB; p ≤ 0.001). Fifty-four percent of patients from the PORP group had a postoperative ABG of 10 dB or less, compared with 68.9% in the TORP group (mean difference, 14.6%; 95% CI, 6%-23%; p < 0.001). The postoperative ABG was closed to within 20 dB in 70.4% of cases in the PORP group compared with 86.9% in the TORP group (mean difference, 14.5%; 95% CI, 10%-23%; p < 0.001). In patients with an absent incus and intact stapes and malleus, ossicular reconstruction with TORP combined with our malleus relocation and Silastic banding technique results in significantly better hearing outcomes compared with reconstructions with PORP.

Numerical Simulation and Study about Partial Ossicular Replacement Prostheses with Several Various Materials on Hearing Restoration

Conclusion:A good short-term hearing improvement is gained by partial ossicular replacement prostheses with several common various materials.A better sound transmission in lower frequencies is obtained by partial ossicular replacement prostheses with hydroxyapatite ceramics, stainless steel and alumina ceramics.However,A better sound transmission in higher frequencies is gained by partial ossicular replacement prostheses with porous polyethylene and polytetrafluoroethylene.Considering a long-term effect on hearing improvement,they are better materials on hearing restoration because titanium, polytetrafluoroethylene and hydroxyapatite ceramics have a good biocompatibility for the patients.And these conclusions can provide certain reference values for human ear clinical studies.Objectives:This paper qualitatively and quantitatively studied the effect of partial ossicular replacement prostheses (PORPs) with several various materials on hearing restoration.Methods:The CT data of the right ear from a normal human body was digitalized and imported into PATRAN to establish a three dimension finite element mode1by self-compiling program,and then a frequency response analysis was made for the model using NASTRAN to study the effect of partial ossicular replacement prostheses with several various materials on hearing restoration.Results:the model was carried through a harmonic response analysis of normal ear structure and confirmed by the consistency in the calculated and experimental data after comparision.

Passive and active middle ear implants.

Besides eradication of chronic middle ear disease, the reconstruction of the sound conduction apparatus is a major goal of modern ear microsurgery. The material of choice in cases of partial ossicular replacement prosthesis is the autogenous ossicle. In the event of more extensive destruction of the ossicular chain diverse alloplastic materials, e.g. metals, ceramics, plastics or composits are used for total reconstruction. Their specialised role in conducting sound energy within a half-open implant bed sets high demands on the biocompatibility as well as the acoustic-mechanic properties of the prosthesis. Recently, sophisticated titanium middle ear implants allowing individual adaptation to anatomical variations are widely used for this procedure. However, despite modern developments, hearing restoration with passive implants often faces its limitations due to tubal-middle-ear dysfunction. Here, implantable hearing aids, successfully used in cases of sensorineural hearing loss, offer a promising alternative. This article reviews the actual state of affairs of passive and active middle ear implants.

Isolated otosclerosis of the incus in a Korean woman

We report an isolated otosclerosis of the incus that was removed using a transcanal approach and the ossicular chain was reconstructed using a total ossicular replacement prosthesis due to a tilted stapes.

Incus Replacement Malleostapedotomy in Quiescent Chronic Otitis Media With a Mobile Stapes Footplate

To review the results of malleostapedotomy for incus replacement in the setting of quiescent chronic otitis media and a mobile stapes footplate and to discuss the potential application for this technique in select cases. Seven individuals having undergone malleostapedotomy in the setting of quiescent chronic otitis media and a mobile stapes footplate between 2004 and 2009. Review of surgical results and hearing outcomes as measured by preoperative and postoperative pure-tone audiometry. Closure of preoperative air-bone gap and change in preoperative versus postoperative pure-tone bone conduction thresholds. Improvement in air-bone gap was noted in 6 of 7 subjects with an average closure of 17 dB. In 5 of 7 subjects, the air-bone gap was closed to 20 dB or less, and in 3 of 7 subjects, the air-bone gap was closed to 10 dB or less. No significant changes in postoperative bone conduction pure-tone average thresholds were noted. No immediate or delayed complications were encountered over an average follow-up time of 23.6 months (range, 5-42 mo). Although the data are limited by the small sample size, malleostapedotomy seems to be a potentially safe and effective alternative to placement of a total ossicular replacement prosthesis in properly selected specialized instances of quiescent chronic otitis media. Further study is recommended to more definitively establish the safety and efficacy of this technique.

Cartilage Shield Tympanoplasty in Children

To assess the efficacy of partial ossicular chain reconstruction using autologous cartilage. Prospective study (April 1, 1997, through January 1, 2008). Tertiary academic children's hospital. Two hundred forty-eight children (268 ears) underwent partial ossicular chain reconstruction using a shaped block of tragal cartilage interposed between the head of the stapes and an underlay tympanic membrane reconstruction along with tragal cartilage and its perichondrium. Anatomical and audiologic results were evaluated according to the American Academy of Otolaryngology-Head and Neck Surgery guidelines. χ² Tests and multivariate analysis were used for statistical evaluation. Mean age at surgery was 10.9 years. Single-stage surgery was performed in 124 ears (46.3%) (62.9% for cholesteatomas and 32.3% for retraction pockets). Second-look patients (53.7%) included 93.8% of staged surgery. Audiometric results were available for 222 ears at 1 year and for 78 ears at 5 years. Closure of the average air-bone gap (ABG) to within 20 dB was achieved in 62.2% of ears at 1 year. The mean (SD) preoperative and 1-year postoperative ABGs were 25 (11.8) dB and 18.9 (10.3) dB, respectively. Anatomical results were satisfactory in 87.3%. No cases of extrusion, resorption, or displacement of the cartilage were encountered. No statistically significant difference was found between audiometric results at 1 and 5 years. Multivariate analysis showed a significant negative correlation between preoperative and postoperative ABGs and between postoperative otitis media with effusion and postoperative ABG (P < .05). Cartilage ossiculoplasty is a reliable technique for partial ossicular replacement. Long-term hearing outcomes remain stable and satisfactory. Preoperative ABG and postoperative otitis media are the predictive factors of the hearing outcome.

Titanium ossicular chain replacement prostheses: Prognostic factors and preliminary functional results

To assess the efficiency of ossiculoplasty procedures with the Kurz titanium ossicular prosthesis and evaluate prognostic factors for the functional results. Retrospective chart reviews were performed for ossiculoplasty involving Kurz titanium prostheses between 2006 and 2009 in the ENT Head and Neck Department of the hôpital Nord, Marseille, France. The population studied was 70 patients, with 37 procedures using the partial (PORP) and 33 the total ossicular replacement prosthesis (TORP). Mean follow-up was 9 months. Pre- and postoperative audiological parameters on four frequency averages (0.5, 1, 2, and 3kHz) were compared according to AAO-HNS guidelines. A postoperative air-bone gap (ABG)≤20dB was obtained in 71.43% of the patients (86.49% for PORP, and 54.55% for TORP). The mean change in ABG was 12.45dB in cholesteatomatous otitis versus 13.41dB in non-cholesteatomatous otitis. Increasing the length of the ossicular prosthesis, especially TORP, may improve postoperative functional results.

Good Manufacturing Practices—Grade Preformed Ossicular Prostheses from Banked Bone via Computer Numerically Controlled Micromilling

The aim of this study was the fabrication of ossicular replacement prostheses (ORPs) from decellularized banked cortical bone via computer numerically controlled (CNC) ultraprecision micromilling, in order to obtain preformed clinical-grade tissue products, reproducing shape, size, and details perfectly comparable to those of synthetic devices. Banked femoral compact bone was used to fabricate partial and total ORPs via CNC micromilling according to Good Manufacturing Practices procedures. Drawings of ORPs with different shapes and sizes were uploaded to the computer interface, and different surface-finish parameters were tested. The obtained products underwent dimensional, weight, and surface characterizations. A histologic analysis was pursued to compare the bone matrix compactness of the produced ORPs to that of the ear ossicles. Banked-bone ORPs were produced with high dimensional accuracy. Partial ORP weights averaged (+/- SD) 31.2 +/- 0.6 mg, and total ORP weights averaged 69.3 +/- 0.7 mg. The best-finish mode allowed microscale or nanoscale roughness free from machinery textures to be obtained. Finally, the histologic analysis confirmed that the extracellular matrix compactness of the produced ORPs was suitable for ossicular chain replacement. This study assesses the fabrication feasibility of novel banked-bone ORPs of extremely high dimensional accuracy. Such devices are aimed at combining the most favorable aspects of both synthetic (reproducibility, convenience, and biosafety) and biological replacements (total biocompatibility).

The Floating Mass Transducer on the Round Window Versus Attachment to an Ossicular Replacement Prosthesis

The Vibrant Soundbridge floating mass transducer (FMT) is part of a commercially available implantable hearing device in which the FMT can be placed in the round window (RW) niche or attached to a partial (V-PORP) or total ossicular replacement prosthesis (V-TORP) contacting the stapes head or footplate. The goal is to provide efficient transfer of sound vibration into the cochlea. The hypothesis is that the FMT location on the prosthesis is superior to the RW location. No direct comparisons of the 3 FMT sites have been performed using the same measurement location. A new measurement method called the third window method was used in eleven fresh human temporal bones to compare the sites. A small hole was made into the scala tympani of the temporal bones preserving the endosteum. A reflective target was placed on the third window endosteum and displacement of the cochlear fluid was measured using a Polytec HLV-1000 laser Doppler vibrometer. The input to the FMT at all locations was a constant 316 millivolts (mV); the frequency range was 0.5 to 8.0 kHz. The V-PORP and V-TORP FMT locations both provided statistically significant better performance above 1.0 kHz than the RW site but not below that frequency. The V-PORP and V-TORP responses were similar at all test frequencies. In this temporal bone model, the FMT provided better higher frequency performance when attached to a PORP or TORP than in the RW niche.

Bioceramics in Ossicular Replacement Prostheses: A Review

For many decades, bioceramic materials have been used in a variety of biomedical applications due to their biocompatibility, hardness, wear resistance and compressive strength properties. Bioceramic materials, including Bioglass, glass ceramic materials, and hydroxyapatite, have used to create total ossicular replacement prostheses and partial ossicular replacement prostheses. This review describes design factors associated with middle ear implants as well as clinical use of bioceramic materials in middle ear implants.

A Self-Adjusting Ossicular Prosthesis Containing Polyurethane Sponge

Middle ear ossicular replacement prostheses whose length can adjust in vivo to changes in middle ear dimensions following insertion may have acoustic advantages. Optimal tension is an important factor in the acoustic performance of incus-stapes replacement prostheses. Length is the primary determinant of postinsertion tension with conventional prostheses. Postoperative changes in prosthesis tension may occur leading to a worsening of postoperative hearing. Testing of a self-adjusting prosthesis (SAP) containing a polyurethane sponge attached to the head of a titanium partial ossicular replacement prosthesis (PORP) was performed in 5 fresh temporal bones. This SAP was compared with optimal length PORPs at different tensions. Sound input was 80 dB sound pressure level at 0.1 to 10 kHz. Stapes footplate displacement was measured using a laser Doppler vibrometer before and after incus removal and after PORP and SAP insertion between the malleus and stapes. One to 3 glass shims were then inserted between the malleus and optimal length PORP and SAP to change prosthesis tension. Measurement of stapes displacement was repeated with increased prosthesis lengths of 0.15, 0.30, and 0.45 mm. There was a clear tendency in the optimal length PORPs for a decrease in footplate displacement below 1.0 kHz, in general proportional to the increasing length. The SAP provided equivalent transmission as the optimal length PORP below 4.0 kHz and better transmission below 1.0 kHz at the varying increased lengths. An SAP seems to decrease the effect of changes in prosthesis length between the malleus and stapes at lower frequencies.

Hearing results using titanium ossicular replacement prosthesis in intact canal wall tympanoplasty for cholesteatoma

Conclusions: Titanium proved to be a valuable alternative to ossicles in ossiculoplasty procedures. Complication rates are comparable to those obtained by other authors with titanium and nontitanium prostheses. Hearing results were worse compared with other reports; however, no conclusion can be drawn on the basis of the literature because of the heterogeneity of the populations studied. Objectives: To evaluate the results and complications of total (TORP) and partial (PORP) titanium ossicular replacement prostheses in middle ear cholesteatoma. Methods: Fifty-seven patients affected by acquired cholesteatoma of the middle ear undergoing titanium ossiculoplasty during second stage intact canal wall tympanoplasty were evaluated. Postoperative hearing gain, complication rate, and revision rate were analyzed. Results: Average postoperative gain was 13.6 dB HL for PORP and 17.9 dB HL for TORP. After ossicular reconstruction the mean postoperative ABG was 24.1 dB HL in PORPs and 27.2 dB HL in TORPs. The difference in air-bone gap (ABG) between the two groups after ossiculoplasty was not significant. The number of patients with an ABG > 30 dB was higher in the TORP group compared with the PORP group (p = 0.024) after ossicular reconstruction. The total extrusion rate was 5.2% and the total revision rate was 10.5%.

Long-Term Results of Palisade Cartilage Tympanoplasty

Evaluation of morphologic and functional long-term results of palisade cartilage tympanoplasty (PCT) combined with titanium ossicular replacement prostheses. Retrospective review of tympanoplasties. Tertiary referral center. Twenty-nine patients (12 women and 17 men; mean age, 39 yr; range, 17-72 yr) operated on more than 9 years ago (mean follow up, 9.1 yr) because of cholesteatoma, adhesive otitis, chronic otitis media, subtotal tympanic membrane defects, and tympanic fibrosis requiring tympanoplasty. Tympanoplasty, applying the PCT. For ossiculoplasty, total or partial titanium ossicular replacement prostheses were used. Questionnaire on postoperative course, otoscopic findings, and hearing results using a 4-frequency pure-tone average air-bone gap. A recurrent defect was not observed. The graft take rate was 100%. There was one case of prosthesis protrusion which required revision surgery and insertion of a shorter prosthesis. A pure-tone average air-bone gap of 0 to 10 dB was seen preoperatively in 1 ear, 11 to 30 dB in 16 ears, and 31 to 59 dB in 12 ears. Postoperatively, the corresponding numbers were 10, 15, and 4 ears. The PCT is a reliable surgical method to manage difficult middle ear pathology on a long-term (>9 yr) basis. It offers satisfactory morphologic and functional results in combination with titanium prosthesis ossiculoplasty.

Early results with semisynthetic total ossicular replacement prosthesis

Early results with semisynthetic total ossicular replacement prosthesis

Titanium Versus Nontitanium Ossicular Prostheses-A Randomized Controlled Study of the Medium-Term Outcome

The study compares the medium-term outcome of ossiculoplasty using titanium and nontitanium prostheses. Randomized controlled, prospective clinical trial. District general hospital. Patients with chronic otitis media with partial and total ossicular reconstructions were included. Trauma and congenital malformation cases were excluded. Partial and total ossicular reconstructions using either titanium (Ti) or hydroxyapatite (HA) prostheses. Cartilage plate was used to cover the Ti head plate but not the HA head plate. The principal outcome was hearing gain and postoperative air-bone gaps. The secondary outcome was extrusion of the prosthesis. The mean hearing gain in the HA partial ossicular replacement prosthesis (PORP) and the Ti PORP cohorts were 14.30 and 15.10 dB, respectively. The mean hearing gain in the HA total ossicular replacement prosthesis (TORP) and Ti TORP cohorts were 13.52 and 13.48 dB, respectively. There was no significant difference between HA and Ti for both PORPs and TORPs. There also was no significant difference in the extrusion rate between both prostheses. The lack of statistical difference in the clinical outcome of the 2 prostheses may be due to the limitation of randomized controlled trial with the small sample size and limited statistical power in the comparison of surgical techniques.

Infection associated with hydroxyapatite prosthesis and related factors

Background The purpose of otomicrosurgery in modern times is to achieve complete removal of disease, which is the basis for hearing rehabilitation. Artificial ossicles are important for hearing rehabilitation. One of the materials is hydroxyapatite that acts as ossicular replacement prosthesis (HA prosthesis, PORP & TORP) and is commonly used as substitute bone in clinics. Although HA prostheses feature good biocompatibility, stability and certain resistance to infection, the structure of the material can be decomposed and absorbed. Based upon animal experiments and clinical application, this article explores the infectivity of HA prostheses and influencing factors. Materials and Methods HA prostheses were implanted in the bulla in guinea pigs. Infected HA prostheses were examined under a scanning electron microscope. Ninety patients implanted with HA prostheses were followed for more than 3 months. Five cases that had undergone revision operations were reported. Results Scanning electronic microscopy showed that the normal compact structures had disappeared and become loose in infected HA prostheses, with their micropores infiltrated with effusion, fibrous tissue and inflammatory cells. As a result, the normal ceramic structure was decomposed and the micropores structure disappeared. The infected mesotympanum in the reported cases also led to HA infection. The shape and structure of bone were destroyed, which was visible by visual examination and light microscopy. The process of cholesteatoma recurrence was always associated with infection, although the HA prosthesis was sometimes spared. Conclusion While HA prosthesis is anti–infective to some extent, long–term infection and cholesteatoma recurrence can lead to destruction and decomposition of HA prostheses. Long–term infected middle ear cavity, dysfunctional Eustachian tube, residual and recurrent cholesteatoma and other factors can cause decomposition of HA prosthesis and result in hearing loss.

A Modified Prosthesis Head for Middle Ear Titanium Implants-Experimental and First Clinical Results

An ossicular chain defect represents a challenging situation for otosurgeons. Despite modern reconstruction techniques, unsatisfying postoperative hearing results regularly occur. These are commonly caused by prosthesis dislocation. Whereas the reasons for prosthesis dysfunction occurring months or years after implantation are related to independent chronic conditions, early events of dislocations are more related to the technical fixation of the prosthesis inside the middle ear cavity. Consequently, a safe coupling between prosthesis head and tympanic membrane is essential for a successful type III tympanoplasty. Our study evaluated the use of a new prosthesis design with the aim to reduce short-term postoperative prosthesis dislocation in mind. Prospective experimental and clinical study. A modified titanium total ossicular replacement prosthesis (TORP), whose head had spikes that extend into the cartilaginous neotympanic membrane, was designed and tested experimentally and then clinically. The lateral holding force of the new prosthesis head against lateral shift was measured and compared with common prosthesis heads without spikes. After proving this design experimentally, the prostheses were used intraoperatively in 35 tympanoplasty type III operations. Results were analyzed prospectively and compared with 35 retrospectively analyzed controls with conventional TORP prostheses. The lateral holding forces for the spike prosthesis heads were significantly higher (134 mN) than those for common prosthesis heads (92 mN) at a contact pressure of 100 mN. Postoperatively, pure-tone audiometry revealed satisfying hearing results. Spiked and conventional titanium TORPs yielded postoperative air-bone gaps (ABGs) of 20.9 and 18.6 dB with 54% and 57% ABG closure, within 20 dB, respectively. The air-bone gap was reduced by an average of 14 and 15 dB, respectively. However, these differences were not statistically significant. Both in the study and in the control group, no signs of prosthesis dislocation were discovered. The experimental data show that the new modified prosthesis head has an increased lateral holding force and thus reduces the risk of dislocation at the coupling side of the tympanic membrane. The postoperative hearing results are comparable to those of conventional prostheses. To confirm the advantage of the modified prosthesis plates over conventional prostheses, future studies with larger study populations are necessary.

A constant tension middle ear ossicular replacement prosthesis: Why don’t we have one?

A constant tension middle ear ossicular replacement prosthesis: Why don’t we have one?