Ossicular chain reconstruction in chronic otitis media: hearing results and analysis of prognostic factors / Reconstrução da cadeia ossicular na otite média crônica: resultados auditivos e análise de fatores prognósticos

Abstract Introduction The goal of ossiculoplasty is to improve hearing and the success of this procedure depends on several factors. Objective Analyze the hearing results in patients with chronic otitis media undergoing ossicular chain reconstruction, as well as predictive factors for successful surgery. Methods Charts of patients undergoing ossiculoplasty between 2006 and 2016 were reviewed. Sixty-eight patients were included, totaling 72 ears. The following data was analyzed: gender, age, smoking status, laterality, pathology, audiometric exams, type of surgery, previous surgery, characteristics of the middle ear, otorrhea and ossicular chain status. Patients were also classified according to two indices: middle ear risk index and ossiculoplasty outcome parameter staging. The results were evaluated by comparing the air-bone gap before and after surgery. The success of reconstruction was defined as air-bone gap ≤20 dB and the improvement of speech reception Thresholds, calculated through the mean frequencies 0.5, 1, 2 and 3 kHz. Results Reconstruction success rate was 61%. The mean preoperative air bone gap was 34.63 dB and decreased to 17.26 dB after surgery. There was a correlation between low risk in middle ear risk index and ossiculoplasty outcome parameter staging indices with postoperative success. The most frequently eroded ossicle was the incus and the type of prosthesis most used was tragal cartilage. In the patients without incus, we achieved success in 74.2% of the surgeries. In the absence of the stapes, the success rate decreased to 63.3%. In the absence of the malleus, 85% of the patients had and air bone gap ≤20 dB. Conclusion We achieved good audiometric outcomes in ossiculoplasty and the results are comparable to other centers. Ossicle status influenced postoperative results, especially in the presence of stapes. We also concluded that the indexes analyzed may help to predict the success of the surgery.

Resumo Introdução A ossiculoplastia tem como objetivo a melhoria da audição e o sucesso desse procedimento depende de diversos fatores. Objetivo Analisar os resultados auditivos em pacientes com otite média crônica submetidos a reconstrução da cadeia ossicular, bem como os fatores preditivos de sucesso cirúrgico. Método Prontuários de pacientes submetidos a ossiculoplastia entre 2006 e 2016 foram revistos. Sessenta e oito pacientes foram incluídos, total de 72 orelhas. Os seguintes dados foram analisados: sexo, idade, tabagismo, lateralidade, doença, exames audiométricos, tipo de cirurgia, cirurgia prévia, características da orelha média, otorreia e estado da cadeia ossicular. Os pacientes também foram classificados de acordo com dois índices: índice de risco da orelha média e estadiamento do parâmetro de desfecho da ossiculoplastia. Os resultados foram avaliados comparando o gap aéreo-ósseo antes e após a cirurgia. O sucesso da reconstrução foi definido como gap aéreo-ósseo ≤ 20 dB e a melhoria dos limiares de recepção de fala, calculados pelas frequências médias de 0,5, 1, 2 e 3 kHz. Resultados A taxa de sucesso da reconstrução foi de 61%. O gap aéreo-ósseo pré-operatório médio foi de 34,63 dB e diminuiu para 17,26 dB após a cirurgia. Houve correlação entre baixo risco no índice de risco para orelha média e os índices de estadiamento do parâmetro de desfecho da ossiculoplastia com sucesso pós-operatório. O ossículo com erosão mais frequente foi a bigorna e o tipo de prótese mais utilizada foi a cartilagem tragal. Nos pacientes sem bigorna o sucesso foi alcançado em 74,2% das cirurgias. Na ausência do estribo, a taxa de sucesso diminuiu para 63,3%. Na ausência do martelo, 85% dos pacientes apresentaram gap aéreo-ósseo ≤ 20 dB. Conclusão Melhora significativa da audição foi observada em pacientes submetidos à ossiculoplastia, os resultados foram comparáveis aos de outros centros. O "status" dos ossículos influenciou os resultados pós-operatórios, principalmente a presença do estribo. Também concluímos que os índices analisados podem ajudar a prever o sucesso da cirurgia.

Ossicular chain reconstruction in chronic otitis media: hearing results and analysis of prognostic factors.

INTRODUCTION: The goal of ossiculoplasty is to improve hearing and the success of this procedure depends on several factors. OBJECTIVE: Analyze the hearing results in patients with chronic otitis media undergoing ossicular chain reconstruction, as well as predictive factors for successful surgery. METHODS: Charts of patients undergoing ossiculoplasty between 2006 and 2016 were reviewed. Sixty-eight patients were included, totaling 72 ears. The following data was analyzed: gender, age, smoking status, laterality, pathology, audiometric exams, type of surgery, previous surgery, characteristics of the middle ear, otorrhea and ossicular chain status. Patients were also classified according to two indices: middle ear risk index and ossiculoplasty outcome parameter staging. The results were evaluated by comparing the air-bone gap before and after surgery. The success of reconstruction was defined as air-bone gap ≤20dB and the improvement of speech reception Thresholds, calculated through the mean frequencies 0.5, 1, 2 and 3kHz. RESULTS: Reconstruction success rate was 61%. The mean preoperative air bone gap was 34.63dB and decreased to 17.26dB after surgery. There was a correlation between low risk in middle ear risk index and ossiculoplasty outcome parameter staging indices with postoperative success. The most frequently eroded ossicle was the incus and the type of prosthesis most used was tragal cartilage. In the patients without incus, we achieved success in 74.2% of the surgeries. In the absence of the stapes, the success rate decreased to 63.3%. In the absence of the malleus, 85% of the patients had and air bone gap ≤20dB. CONCLUSION: We achieved good audiometric outcomes in ossiculoplasty and the results are comparable to other centers. Ossicle status influenced postoperative results, especially in the presence of stapes. We also concluded that the indexes analyzed may help to predict the success of the surgery.

Stapes prosthesis length and hearing outcomes.

OBJECTIVES: First, to determine if prosthesis length plays a role in optimizing successful hearing outcomes in stapedotomy surgery; and second, to determine if patient factors such as height are correlated with prosthesis length. STUDY DESIGN: Retrospective chart review. METHODS: Retrospective chart review of patients undergoing stapedotomy surgeries with adequate follow up. Length of prosthesis, pre-/postoperative audiograms, and follow-up data were obtained. RESULTS: The primary group consisted of 227 cases. The prosthesis length ranged from 3.75 mm to 4.75 mm (median 4.25 mm). The greatest improvement in postoperative air-bone gap (ABG) occurred in the 4.25 mm group, and the least in the 3.75 mm group. Patient height showed a positive, although weak, correlation with prosthesis length. No findings reached statistical significance. CONCLUSION: Accurate measurement of prosthesis length is important for successful postoperative hearing outcomes. There is a positive but not significant correlation between patient height and prosthesis length. LEVEL OF EVIDENCE: 4. Laryngoscope, 128:722-726, 2018.

[Tympanoplasty - News And New Perspectives]. / Tympanoplastik ­ Neues und neu Beleuchtetes.

Techniques and biomaterials for reconstructive middle ear surgery are under steady, ongoing development. At the same time, clinical post-surgery results are evaluated to determine success or failure of the therapy. Routine quality assessment and assurance is of growing importance in the medical field, and therefore also in middle ear surgery. The exact definition and acquisition of outcome parameters is essential for both a comprehensive and detailed quality assurance. These parameters are not the audiological results alone, but also additional individual parameters which influence the postoperative outcome after tympanoplasty. Selection of patients and the preoperative clinical situation, the extent of the ossicular chain destruction, the chosen reconstruction technique and material, the audiometric frequency selection and the observational interval are only some of them. If these parameters are not well documented comparative analyses between different studies are of limited value. The present overview aims to describe, compare and evaluate some of the existing assessment and scoring systems for middle ear surgery. Additionally, new methods for an intraoperative quality assessment in ossiculoplasty and the postoperative evaluation of suboptimal hearing results with imaging techniques are available. In the area of implant development functional elements were integrated in prostheses to enable not only good sound transmission but also compensation of occurring atmospheric pressure changes. In combination with other components for ossicular repair they can be used in a modular manner which, so far show experimentally and clinically promising results.

Efficacy of the active middle-ear implant in patients with sensorineural hearing loss.

INTRODUCTION: This systematic review aims to advise on the effectiveness of the active middle-ear implant in patients with sensorineural hearing loss, compared with external hearing aids. METHODS: A systematic search of several electronic databases, including PubMed and Embase, was used to identify relevant studies for inclusion. RESULTS: Fourteen comparative studies were included. Nine studies reported on the primary outcome of functional gain: one found that the middle-ear implant was significantly better than external hearing aids (p < 0.001), while another found that external hearing aids were generally significantly better than middle-ear implants (p < 0.05). Six of the seven remaining studies found that middle-ear implants were better than external hearing aids, although generally no clinically significant difference (i.e. ≥ 10 dB) was seen. CONCLUSION: Generally, the active middle-ear implant appears to be as effective as the external hearing aid in improving hearing outcomes in patients with sensorineural hearing loss.

Good manufacturing practices--grade preformed ossicular prostheses from banked bone via computer numerically controlled micromilling.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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).

Audiological application criteria for implantable hearing aid devices: a clinical experience at the Nijmegen ORL clinic.

OBJECTIVES/HYPOTHESIS: To define audiological application criteria for different implantable hearing aid devices. STUDY DESIGN: Retrospective study. METHODS: Comparisons were made between aided speech recognition scores obtained at conversational level (65 dB) in patients with the Vibrant Soundbridge (VSB) (n = 22), the Otologics middle ear transducer (MET) (n = 10), conventional hearing aids (behind-the-ears) (n = 47), and cochlear implants (CIs) (n = 123). RESULTS: In relation to hearing loss, only for mild hearing loss, speech recognition scores with VSB were comparable to that with conventional hearing aids. In the Otologics MET users, speech recognition scores were comparable with those of the conventional hearing aid users until a mean hearing loss of about 75 dB HL. At a sensorineural hearing loss of about 65 dB HL or more, the Otologics MET users have better speech recognition scores than the VSB users. For comparison with CI users, we followed a more conservative approach. In 90% of the users of a CI, speech recognition scores were better than those in: 1) patients with a conventional hearing aid and a mean hearing loss of about 95 dB HL or worse; 2) patients with an Otologics MET and a mean hearing loss of 85 dB HL or worse. CONCLUSIONS: Patients fitted with a VSB or an Otologics MET middle ear implant do not demonstrate better speech recognition scores than patients fitted with today's conventional hearing aids. Results might even been worse. However, the VSB and Otologics MET are a good option in patients with moderate (VSB) to severe (Otologics MET) sensorineural hearing loss and external otitis.

Cartilage tympanoplasty: literature review.

There has been renewed interest in the use of cartilage for middle-ear reconstructions. The aim of the present review is to examine the indications, techniques and surgical outcomes of cartilage tympanoplasties reported in the literature. There have been concerns regarding weakening of cartilage struts, from histological studies involving explants; as a result, cartilage struts for ossiculoplasty have not gained popularity. On the other hand, cartilage tympanoplasty is now an established procedure for tympanic membrane and attic reconstruction. The commonest techniques involve cartilage palisades and composite cartilage-perichondrial island grafts. There are many variations on the shape, size and thickness of the cartilage grafts. The perceived benefit of cartilage tympanoplasty is to prevent retraction pockets at the grafted site, even though many otologists accept that this technique may not deal with the causal factors involved in the retraction process. Concerns that the stiffness and mass of cartilage grafts may adversely affect hearing have not been substantiated in clinical reports thus far.

Titanium prosthesis with malleus notch: a study of its 'user-friendliness'.

'User-friendliness' is an important factor in the choice of ossicular prosthesis. The current titanium prostheses have a flat, open head plate and are designed to sit under the tympanic membrane. Previously, the author had designed titanium prostheses with a malleus notch extension at the head plate. The present study aimed to assess whether these customized prostheses were user-friendly, compared with conventional prostheses. Fourteen surgeons were recruited to examine the user-friendliness of several ossicular prostheses. They performed ossiculoplasties on temporal bones and rated the user-friendliness of the malleus notch prosthesis against that of some of the more popular conventional ossicular prostheses. For malleus-stapes assembly, eight out of 13 surgeons preferred the malleus notch prosthesis to the Düsseldorf and Goldenberg designs. For malleus-footplate assembly, six out of 10 surgeons preferred the malleus notch prosthesis to the Düsseldorf and Richards designs. Most of the surgeons stated that the reconstruction was more stable using the malleus notch prosthesis.

Human temporal bones versus mechanical model to evaluate three middle ear transducers.

A life-size mechanical middle ear model and human temporal bones were used to evaluate three different middle ear transducers for implantable hearing aids: the driving rod transducer (DRT), the floating mass transducer (FMT) or vibrant sound bridge, and the contactless transducer (CLT). Results of the experiments with the mechanical model were within the range of the results for human temporal bones. However, results with the mechanical model showed better reproducibility. The handling of the mechanical model was considerably simpler and less time-consuming. Systematic variations of mounting parameters showed that the angle of the rod has virtually no effect on the output of the DRT, the mass loading on the cable of the FMT has a larger impact on the output than does the tightness of crimping, and the output level of the CLT can be increased by 10 dB by optimizing the mounting parameters.

Early results of titanium ossiculoplasty using the Kurz titanium prosthesis--a UK perspective.

Titanium has been shown to be a highly biocompatible material and recently interest has been raised by its use as a prosthetic material in the ear. Our objective was to prospectively assess the early results of titanium partial and total ossicular replacement prostheses in chronic ear disease. Thirty-three consecutive patients (20 titanium partials and 13 total ossicular replacement prostheses) were analysed and data from pre and post-operative pure tone audiograms were collected and compared at six months over a four frequency range (0.5-4 kHz) as well as using the American Academy of Otolaryngology-Head and Neck Surgery criteria (0.5-3 kHz). Closure of the air-bone gap and improvement in air conduction at six months was also calculated. 69% of patients obtained an air-bone gap of < or = 20 dB, with titanium partial ossicular replacement prostheses (85 per cent) doing better than total ossicular replacement prostheses (46 per cent). There have been no cases of sensorineural hearing loss or extrusion. In conclusion, titanium prostheses are easy to use, allow good visibility and have shown good short-term results in our hands.

Limitations of titanium dioxide and aluminum oxide as ossicular replacement materials: an evaluation of the effects of porosity on ceramic prostheses.

BACKGROUND: Because the performance of titanium dioxide (TiO2) has not yet been assessed in the unique environment of the middle ear, its role as an ossicular replacement prototype in the form of a total ossicular replacement prosthesis (TORP) was tested and compared with aluminum oxide (Al2O3), once considered to be a suitable implant material. METHODS: Ossiculoplasty was performed by implanting TORPs into the tympanic cavities of rabbits. After an implantation period of 28, 84, or 300 days, the petrous bones were extracted, whereby the biocompatibility of the prostheses was examined using light microscopy and scanning electron microscopy to determine morphologic changes in situ. Proper implant placement and functionality was tested via manual manipulation. RESULTS: Mucosa was seen covering most of the implants by day 84. Inflammatory cells were not observed in any of the specimens examined. The macroporous TiO2 TORPs were subjected to osseous infiltration, material dissolution, and fragmentation, whereas the microporous TiO2 implants were subjected to an increasing frequency of fissure formations. The Al2O3 prostheses demonstrated signs of material dissolution by producing encapsulated aggregates during the experimental trial period. CONCLUSIONS: Neither the macroporous nor microporous oxide ceramics were able to withstand the oscillatory stress to which they were continually subjected. Although porosity allows for the rapid integration of an implant material into a biological environment, its properties are not suited to fulfill the requirements of strength and long-term stability, which are demanded of middle ear prostheses.

Audiometric evaluation of an attempt to optimize the fixation of the transducer of a middle-ear implant to the ossicular chain with bone cement.

Typically, an implantable hearing device consists of a transducer that is coupled to the ossicular chain and electronics. The coupling is of major importance. The Vibrant Soundbridge (VSB) is such an implantable device; normally, the VSB transducer is fixed to the ossicular chain by means of a special clip that is crimped around the long process of the incus. In addition to crimping, bone cement was used to optimize the fixation in six patients. Long-term results were compared to those of five controls with crimp fixation alone. To assess the effect of bone cement (SerenoCem, Corinthian Medical Ltd, Nottingham, UK) on hearing thresholds, long-term post-surgery thresholds were compared to pre-surgery thresholds. Bone cement did not have any negative effect. Next, to test the hypothesis that aided thresholds might be better with the use of bone cement, aided thresholds were studied. After correction for the severity of hearing loss, only a small difference was found between the two groups at one frequency, viz. 2 kHz. It was concluded that there was no negative effect of using bone cement; however, there is also no reason to use bone cement in VSB users on a regular basis.

A comparison of the user-friendliness of hydroxyapatite and titanium ossicular prostheses.

Both hydroxyapatite (Ha) and titanium (Ti) are well-accepted alloplastic materials for ossicular prostheses. Many different designs of Ha and Ti prostheses are presently available. Fourteen surgeons of different seniority and surgical experience were asked to 'test-drive' four different types of ossicular prostheses in cadaveric temporal bones to investigate the user-friendliness of these protheses. The Goldenberg design Ha incus prosthesis and the Dusseldorf design Bell Ti prosthesis were used as partial ossicular replacement prostheses (PORP). The Richards design Ha incus-stapes prosthesis and the Dusseldorf design Aerial Ti prosthesis were used as a total ossicular replacement prostheses (TORP). Nine out of 14 surgeons found the Ha PORP to be more user-friendly because of the notch design in the head. The Ti prosthesis was found to be more difficult to manipulate because it was too light. Half of the surgeons preferred the Ti TORP because of the open design of the top-plate. The Ha TORP was thought to be too top-heavy and to have a tendency to fall over.

Reconstruction of the ossicular chain with titanium implants.

OBJECTIVES: Since 1994 more than 1300 titanium implants have been used to reconstruct the ossicular chain of the middle ear for chronic otitis media. Two different types of implants were used. First, a total and a partial implant of fixed length, available in numerous different lengths. And second, a total and partial implant that has an adjustable length. The implants are commercially available from 2 different companies. Patients were followed for a postoperative term from 6 to 72 months. METHODS: A wide variety of patients aged 5 to 82 years received a tympanoplasty type III. Those patients whose ossicular chain had been reconstructed with titanium implants since 1994 were evaluated. As implants from one company are fixed in length; implants of a second company are trimmable in length. All prostheses are lightweight and made of pure titanium, fitting most anatomical situations. RESULTS: Earlier results already showed a very low complication rate. Extrusions occurred only in cases of middle ear atalectasis with resorption of interposed cartilage (<1%). No adverse reaction to the prostheses could be seen, even in histologic reviews. An average air-bone gap less than 20 dB(A) for all calculated frequencies of 0.5, 1, 2, and 4 kHz was achieved for 76% of cases; 43% of cases showed a calculated air-bone gap of less than 10 dB(A), only 10% higher than 30 dB(A). CONCLUSION: All implants used offer the proven benefits of titanium, namely high biocompatibility and high stability at a very low complication rate with excellent hearing results for the patients. Titanium implants can highly be recommended to reconstruct the ossicular chain of the middle ear.

Magnetic resonance imaging of stapes prostheses.

OBJECTIVE: To assess the magnetic resonance imaging (MRI) compatibility of stapes prostheses. DATA SOURCES: A comprehensive review of the English literature evaluating MRI compatibility of stapes prostheses. Multiple series of stapes prostheses from different manufactures placed in a 1.5-tesla MRI field to determine ferromagnetic properties. RESULTS: When MRI was first introduced, reports demonstrated the MRI compatibility of stapes prostheses. The testing was performed on single copies of various prostheses from several manufacturers. Although implant manufacturers have indicated MRI compatibility, several reports of variable ferromagnetic properties of aneurysm clips have been reported. This variability has led to rotation of the clips and hemorrhage in patients with supposed MRI-compatible clips. These findings suggest that testing single stapes prostheses from a manufacturer might not completely assess the safety of MRI on patients with stapes prostheses. We performed MRI compatibility testing on several series of stapes prostheses from Xomed Surgical Products and Smith & Nephew Richards. Two series of Xomed stapes prostheses were found to have ferromagnetic properties. CONCLUSION: Manufacturing variability could lead to stapes prostheses being MRI incompatible. Each prosthesis should be tested before implantation for ferromagnetic properties.

Comparison of stapes prostheses: a retrospective analysis of individual audiometric results obtained after stapedotomy by implantation of a gold and a teflon piston.

PURPOSE: Evaluation of hearing results after implantation of a Teflon piston (type Causse; Xomed Surgical Products, Jacksonville, FL) and of a pure gold piston (K-piston; Heinz Kurz GmbH Medizintechnik, Dusslingen, Germany), both with a shaft diameter of 0.4 mm in cases of otosclerosis requiring stapedotomy. An important difference between both prostheses is the difference in mass: the gold piston is three times heavier than the Teflon piston. METHODS: Retrospective analyses were carried out of the presurgery and postsurgery audiologic results obtained after primary stapedotomy by implantation of 62 Teflon pistons and 66 gold pistons. The results were compared according to mean values of several audiometric parameters. Furthermore, individual audiometric results have been evaluated with the "Amsterdam Hearing Evaluation Plots" (AHEPs) as a method for visual presentation of hearing results from each operated ear. With this method, "unsuccessfully" and "successfully" inserted prostheses can be recognized easily and a more realistic comparison between prostheses is possible. RESULTS: It was found that in the overall group the heavier gold prosthesis gives a significantly larger gain in air-conductive hearing at 2 kHz (p < 0.05) and in the speech frequency range 0.5 to 2 kHz (p < 0.05). There were no significant intergroup differences with regard to change in bone-conduction and air-bone gaps. Analysis of the hearing results of the subgroup that included only the "successfully" implanted prostheses according to the criteria of the AHEPs had mainly consequences for improvement of air-conduction thresholds: none of the intergroup differences were statistically significant. CONCLUSIONS: For a fair comparison between prostheses, it is necessary to take only the prostheses into account that are inserted properly and that are functioning under normal conditions with regard to transmission of sound vibrations. After analysis of the hearing results of these "successfully" implanted prostheses, a trend was noticed that the heavier gold piston gives more gain in the low- and mid-frequency range and the light-weighted Teflon piston gives more gain in the high-frequency range, although none of the differences were significant.

Surgical results of tympanoplasty with hokudai-shaped partial and total ossicular replacement prostheses.

The surgical results of tympanoplasty using a ceramic partial ossicular replacement prosthesis (PORP) or a ceramic total ossicular replacement prosthesis (TORP) were analyzed. The present study included 25 ears in 22 patients who underwent tympanoplasty between December 1986 and September 1994 and were followed up for more than 6 months postoperatively. Because the ceramic prosthesis was extruded from 2 of the 25 ears, the surgical results in the other 23 ears were analyzed, Surgical results were assessed according to a criterion that permits comparison with data from around the world. The criterion considers a postoperative airbone gap within 20 dB as a success. According to this criterion, the success rate was 90.9% for PORP, 50.0% for TORP, and 69.6% in total. These results are comparable with those found at other centers.