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PubMed2003

Type III tympanoplasty applying the palisade cartilage technique: a study of 61 cases.

OBJECTIVE: To determine the morphologic and hearing results of the combined application of the palisade cartilage technique and titanium ossicular replacement prostheses in Type III tympanoplasty. STUDY DESIGN: Retrospective review of 61 tympanoplasties. SETTING: Tertiary referral center. PATIENTS: 59 patients (39 women and 20 men, mean age 36 years, range 7-81 years) consecutively operated on because of cholesteatoma, adhesive otitis, chronic otitis media, subtotal tympanic membrane defects, and tympanofibrosis requiring tympanoplasty with ossiculoplasty. INTERVENTIONS: Tympanoplasty Type III, with application of the palisade cartilage technique and total or partial titanium ossicular replacement prosthesis. MAIN OUTCOME MEASURES: Otoscopic findings and hearing results using a four-frequency pure tone average air-bone gap. RESULTS: A recurrent defect was seen in 1 ear (1.6%). The graft take rate was 100%. There were no extrusions of prostheses. Preoperatively, a pure tone average air-bone gap of 0 to 10 dB was seen in 1 ear, 11 to 30 dB in 30, and 31 to 50 dB in another 30 ears. Postoperatively, the corresponding numbers were 11, 41, and 9 ears, respectively. Hearing results were better in the total ossicular replacement prosthesis group. CONCLUSIONS: The palisade cartilage technique is suitable to manage difficult pathologic conditions in middle ear surgery. It was demonstrated that the palisade cartilage technique can be combined safely with titanium ossicular replacement prostheses. Regarding postoperative hearing results, the negative preselection of pathologic conditions must be considered.

Adolescent↗

PubMed2003

Early results with titanium ossicular implants.

OBJECTIVE: To report the efficacy of titanium middle ear prosthesis for ossicular reconstruction. STUDY DESIGN: Retrospective chart reviews were performed for 25 patients who had undergone titanium ossicular implants between January 1, 1999, and June 1, 20001. SETTING: Tertiary otology referral center. PATIENTS: All patients had a minimum of 6 months of postoperative follow-up and no evidence of recurrent otologic disease. INTERVENTION: All patients had undergone ossiculoplasty using titanium middle ear implants. MAIN OUTCOME MEASURES: Comparisons of preoperative and postoperative pure tone averages were performed. Air-bone gap closures and implant extrusion rates were measured. RESULTS Overall mean pure tone averages improved 22.2 dB with air-bone gap improvement at 20.9 dB. Fifty-six percent of patients achieved air-bone gap less than 20 dB postoperatively. The overall extrusion rate was 4%. However, with the placement of cartilage graft interposed between the prosthesis and the tympanic membrane, no extrusion was observed. CONCLUSION: Titanium implants provide comparable hearing improvement compared with other materials. The extrusion rate seems quite low if cartilage interposition graft is inserted. Its ease of handling, biocompatible properties, and sound conducting properties improve its efficacy as an ossicular implant.

Adolescent↗

PubMed1996

Laser Doppler vibrometer (LDV)--a new clinical tool for the otologist.

We describe a laser Doppler system (LDS) that can be used clinically for the measurement of tympanic membrane (TM), malleus and prosthesis head displacement in response to sound inputs of 80-to 100-dB sound-pressure level (SPL). It also has the potential for use in the operating room to perform measurements of prosthesis and stapes displacement. The information provided by such testing gives the otologist knowledge of TM and ossicular function that is unique in evaluating middle ear function; it should help select the best type of reconstruction in a given case and direct us toward new and better methods of TM and ossicular reconstruction. The results of umbo displacement measurements in 95 human ears are reported. Examples are provided of LDS measurements in representative ears and how they can be of help to the clinician. The potential of multisite TM-displacement testing is demonstrated in two temporal bones, including before and after partial ossicular replacement prosthesis (PORP) insertion.

Audiometry, Pure-Tone↗

PubMed2006

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.

Adolescent↗

PubMed2000

Hearing results in the second stage of open mastoidectomy: A comparison of the different techniques.

OBJECTIVE: The goal of this study was to compare the hearing results obtained through different hearing-restoration techniques in open-cavity mastoidectomy. METHODS AND MATERIAL: A total of 116 ears operated on during the second stage of open mastoidectomy were studied. The hearing gain was registered as the difference between preoperative and 1-year postoperative conversational frequency means (500, 1000, 2000 Hz). High-pitched frequencies (4000 Hz) were used equally. Two groups of studies were carried out: in one study the stapes was intact, and in the other the stapes arch was absent. The columella techniques we examined, from a hearing point of view, are total and partial ossicular replacement prostheses, ossiculoplasty, cartilage with or without perichondrium, and the myringostapediopexy. RESULTS AND CONCLUSIONS: In the group of patients in whom the stapes was intact, the differences in high-pitched frequencies found between the different techniques were negligible, but the differences were quite significant in conversational frequencies, where the partial ossicular replacement prosthesis turned out to be the technique with the worst results. In ears in which only the footplate was present, the total ossicular replacement prosthesis gave better results than any other technique, both in conversational frequencies and in 4000-Hz frequency.

Adult↗

PubMed2005

In vivo performance of the Nitinol shape-memory stapes prosthesis during hearing restoration surgery in otosclerosis: a first report.

The limitations of manual prosthesis crimping in hearing restoration surgery for otosclerosis are thought to have a key role in the occurrence of incomplete postoperative elimination of conductive hearing loss and postoperative recurrences of conductive hearing loss. To eliminate manual crimping, the self-crimping, shape-memory alloy Nitinol stapes piston was introduced in nine otosclerosis patients. The results were compared with those in a database of surgeries performed with conventional titanium pistons. The effects of the self-crimping Nitinol prosthesis on the postoperative elimination of conductive hearing loss and its postoperative variations were investigated. The variations of postoperative residual conductive hearing loss were significantly smaller and the extent of conductive hearing-loss elimination greater in the Nitinol group. The mean postoperative residual conductive hearing loss was smaller in the Nitinol group. The postoperative stability of conductive hearing loss elimination was similar in both patient groups. Preliminary results suggest that the self-crimping shape-memory alloy Nitinol stapes piston overcomes the drawbacks of manual crimping in hearing restoration surgery for otosclerosis.

Adult↗

PubMed2001

Prognostic factors in ossiculoplasty: a statistical staging system.

OBJECTIVE: To determine factors that predict hearing results using a standard prosthesis system. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary referral center. PATIENTS: All patients undergoing ossiculoplasty with the Dornhoffer HAPEX partial and total ossicular replacement prostheses (PORP and TORP) from February 1995 to May 1999 who had documented postoperative follow-up and no congenital atresia or stapes fixation. A total of 185 patients (200 ears), 105 men and 80 women, were evaluated. INTERVENTIONS: Ossiculoplasty with the Dornhoffer prostheses. MAIN OUTCOME MEASURES: Hearing results using a four-frequency pure-tone average air-bone gap (PTA-ABG). Multivariate statistical analysis determined the effect of mucosal status, ossicular chain status, and type of reconstruction techniques on hearing. RESULTS: The PTA-ABGs were 13.4+/-8.1 dB and 14.0+/-8.4 dB for the PORPs (n = 114) and TORPs (n = 86), respectively, which was not statistically different. When the malleus handle was present (n = 126), the PTA-ABG was 11.6+/-6.2 dB, compared with 16.9+/-10.1 dB when it was absent (n = 74), which was statistically significant (p < 0.05). Mucosal fibrosis, drainage, revision ear surgery, and type of surgical procedure had a significant detrimental impact on hearing. The type of pathologic process (perforation vs. cholesteatoma) had no significant impact on hearing results. CONCLUSIONS: The revised staging system, the Ossiculoplasty Outcome Parameter Staging Index, more adequately predicts hearing outcome in this series of 200 cases.

Adolescent↗

PubMedDate not supplied

A new stapedotomy prosthesis: preliminary report.

Our study describes a newly designed stapedotomy prosthesis which consists of two components: (1) a platinum ribbon, and (2) a Teflon shaft. The first innovation is a flattened 'tab' on the posterior aspect of the platinum ribbon. The second innovation concerns the dual diameter cylinder-like shaft. Our prosthesis was implanted into 25 individuals, who underwent stapedotomy for stapes fixation, and the results are shown and discussed. Our innovations offer a proper and safe insertion of the prosthesis into the oval window associated with excellent manipulation and handling. At the same time, maximum visualization of the surgical field is achieved, while the stepped-down design of the shaft prevents the prosthesis protruding into the vestibule.

Adult↗

PubMed2004

How do cartilage and other material overlay over a prosthesis affect its vibration transmission properties in ossiculoplasty?

OBJECTIVE: The prosthesis/eardrum interface is often deliberately modified by cartilage overlay, or by soft tissue in-growth. We examined the effects of vibration transmission to the footplate of inserting cartilage of varying sizes, and materials of varying rigidities. STUDY DESIGN AND SETTING: Using fresh human cadaveric temporal bones, stapes vibrations were measured. A partial ossicular reconstruction prosthesis was covered with differing materials and cartilage sizes. Materials used included glass (rigid), cartilage (intermediate), and Merocel (soft). Cartilage sizes varied in size relative to the prosthesis head. RESULTS: Rigidity of material had little impact. Cartilage size had an impact, with smaller cartilage covers performing best. CONCLUSION: Larger cartilage sizes performed worse. This could be a result of increased tension on the eardrum from larger cartilage size. There is little impact stiffness of interposed material stiffness. SIGNIFICANCE: Cartilage of the size used clinically has little impact on vibration transmission to the footplate. A wide range of materials could clinically be interposed over the prosthesis.

Cartilage↗

PubMed2005

Surgical-handling properties of the titanium prosthesis in ossiculoplasty.

Despite the wide variety of ossiculoplasty techniques that are available, success rates are limited. Current use indicates that surgeons prefer ceramic, autograft bone, and plastic pore prostheses. During the past decade, titanium prostheses have been used with great promise. Although their use is not widespread, satisfaction rates are high. An earlier study of ossiculoplasty showed that titanium prostheses were effective in reducing conductive hearing loss. To date, the surgical-handling attributes of titanium middle ear prostheses have not been assessed. We report the results of our survey of 32 otologic surgeons who used the open Tübingen titanium prosthesis for primary and revision ossiculoplasty during tympanoplasty in 400 patients at 12 academic and nonacademic otolaryngology clinics, most of them in Germany. Because the audiometric efficacy of titanium prostheses has been previously reported, our primary outcomes measures included ease of use with respect to the amount of time required to prepare the implants for placement and the surgeons' overall impression of the intraoperative handling characteristics of the implants, taking into consideration factors such as positioning, length adjustment, visibility, and the stability of the coupling. Surgeons also compared the properties of the titanium implant with those of gold, ceramic, and autograft implants that they had used in the past. Based on the results of 383 of the 400 ossiculoplasties, our survey revealed that the titanium implant was significantly superior to the others in all measured respects.

Adult↗

PubMed1999

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.

Adolescent↗

PubMed1978

Biocompatible ossicular implants.

Proplast and Plastipore, two new biocompatible implant materials that encourage tissue ingrowth, were used in 225 tympanoplasties. A 12 to 28-month follow-up shows that in 133 tympanoplasties using a drum-to-footplate or total ossicular replacement prosthesis (TORP), there was an average air conduction gain of 19 dB and 65% closure of the air-bone gap to within 20 dB. In 17 tympanoplasties using a drum-to-stapes or partial ossicular replacement prosthesis (PORP), there was an average air conduction gain of 20 dB and 100% closure of the air-bone gap. In 53 tympanoplasties/mastoidectomies using a TORP, there was an average air conduction gain of 19 dB and 87% closure of the air-bone gap. In 22 tympanoplasties mastoidectomies using a PORP, there was an average air conduction gain of 25 dB and 100% closure of the air-bone gap. Five (2.2%) of the 225 Plastipore prostheses have extruded.

Animals↗

PubMedDate not supplied

Dynamics of middle ear prostheses - simulations and measurements.

The efficient and systematic development of a middle ear prosthesis necessitates the use of computer models for the prosthesis itself and the reconstructed middle ear. The structure and parameters of the computer model have to be verified by specific measurements of the implant and the reconstructed ear. To obtain a realistic model of a reconstructed ear, three steps of modeling and measurements have been carried out. To get a first approach of the coupling elements a mechanical test rig representing a simplified reconstructed middle ear was built. The velocity of the stapedial footplate was measured with a laser Doppler vibrometer. The corresponding computer model was formulated, and the respective parameters were determined using the measured dynamical transfer functions. In the second step, a prosthesis was implanted into a human temporal bone without inner ear. Exciting this system with noise, the velocity of the stapes footplate was measured with the laser Doppler vibrometer. Based on the multibody system approach, a mechanical computer model was generated to describe the spatial motions of the reconstructed ossicular chain. Varying some significant parameters, simulations have been carried out. To describe the dynamical behavior of the system consisting of middle and inner ear, the computer model used in the second step has been enlarged by adding a simplified structure of the inner ear. The results were compared with in situ measurements taken from living humans.

Acoustic Stimulation↗

PubMed1992

A dynamic and natural frequency analysis of the Fisch II spandrel using the finite element method.

The recent introduction of the Fisch II spandrel total ossicular replacement prosthesis (TORP), has provided impressive initial hearing benefits in patients. The design, based on a combination of soft plastic and a highly flexible metal shaft, has been analysed in terms of its sound collecting and conducting behaviour using the finite element method. The analysis has examined the mode shapes, displacements and natural frequencies of the prosthesis for a variety of material properties and geometries. The results indicate the optimum vibration characteristics are obtained with a Polycell elastic modulus of 100 N/mm2, with the natural frequency independent of modulus above this value. Furthermore, the diameter of the spandrel shaft is crucially important, with an increase in magnitude of the first natural frequency of 54% for a 25% increase in shaft diameter. At a Polycell membrane thickness of 0.07 mm and a shaft diameter of 0.12 mm, the tympanic membrane and Fisch II prosthesis have almost identical frequencies over the 1st to 6th frequency range. This fact, together with the flexibility of clinical procedures involved in its use, may be the reason for its success.

Animals↗

PubMed1995

Three-dimensional investigation of the postoperative condition after ossiculoplasty with hydroxylapatite corp. (Running title; 3-D investigation of Corp).

From January 1985 to December 1993, at Oita Medical University, we have employed hydroxylapatite ceramic ossicular replacement prosthesis (Corp) for 42 ossiculoplasties for chronic otitis media with and without cholesteatoma and investigated the relationship between 3-dimensional condition of the prosthesis and hearing improvement after surgery according to the method of 3-D reconstruction technique as previously reported. The images of the middle ear and inner ear structures were traced on 4 or 6 tomograms of 2 mm thick slices from frontal view and input into the Nexus 6800 image processor. The 3-D images were reconstructed by using a 3-D reconstruction microsoft, TRI. The postoperative hearing improvement in ossiculoplasty with Corp was achieved in 23 (55%) of 42 ears. In 28 (67%) of 42 ears, Corp was found to be in the proper position on tomograms and to tilt upwards in 10 years (24%) and downwards in 3 ears (7%). In one case, the prosthesis was rejected through the tympanic membrane 23 days after surgery because the head of Corp was not covered with cartilage plate. In 19 (67%) of 28 ears, satisfactory hearing improvement was achieved, and Corp was well fitted to the tympanic membrane out of touch with other surrounding structures and vertical to the tympanic membrane, 3-dimensionally. In contrast, in 9 ears (33%) without improved hearing, the prosthesis was fixed in the proper position on the frontal plain, but it sifted backwards or forwards in 3-D reconstructed images.(ABSTRACT TRUNCATED AT 250 WORDS)

Ceramics↗

PubMed2002

Cartilage interposition in ossiculoplasty with hydroxylapatite prostheses: a histopathologic study in the guinea pig.

In this experimental animal study, a cartilage disk was interposed between a synthetic middle ear prosthesis and the tympanic membrane in guinea pigs to investigate its effect on the extrusion process of the implant. Two groups of guinea pigs were studied. One group consisted of animals in which the prosthesis was directly in contact with the tympanic membrane, and the other group consisted of animals in which a cartilage disk had been inserted between the head of the prosthesis and the tympanic membrane. Before histologic processing, in situ inspection was performed with an operating microscope. After fixation and embedding, light microscopic and transmission electron microscopic examination were performed. We studied the histopathologic aspects of the tympanic membrane with regard to the protrusion and extrusion processes of the middle ear implant. In this experimental model, protrusion and extrusion of a hydroxylapatite middle ear prosthesis was greatly reduced by interposition of a cartilage disk. Further clinical evaluation of these experimental results is needed in the human middle ear.

Animals↗

PubMed2006

Effect of adhesion on the acoustic functioning of partial ossicular replacement prostheses in the cadaveric human ear.

BACKGROUND: Adhesion formation following ossiculoplasty surgery has been implicated as a cause of the progressive deterioration of an initially good postoperative hearing result. Scar tissue between the partial ossicular reconstruction prosthesis (PORP) and adjacent middle ear structures is a common finding at revision surgery. OBJECTIVES: This study aims to investigate the effects of simulated scarring on the microacoustic transmission characteristics of a PORP in the fresh cadaveric human temporal bone. METHODS: Cortical mastoidectomy and extended posterior tympanotomy permitted access to reflective markers placed on the stapes footplate. A sound stimulus at 80 to 95 dB was presented to the closed external ear canal and displacements were measured with the laser Doppler vibrometer. PORPs were placed in cadaveric specimens, and the shaft of the prosthesis was cemented to the adjacent promontory using dental cement. Serial measurements were made from the stapes footplate as the adhesive was allowed to harden, a process that we have taken to simulate the gradual fixation of the prosthesis by scarring in the live patient. RESULTS: There was a consistent reduction in stapes footplate displacement as the cement hardened. CONCLUSION: The gradual adhesion of a PORP to the promontory produces a consistent reduction in microacoustic transfer to the stapes footplate in the fresh human cadaveric model.

Acoustics↗

PubMed1999

Results of tympanoplasty with titanium prostheses.

To improve the hearing results associated with tympanoplasty, we performed the operation in 113 cases (124 ears) using ossicular replacement prostheses made of titanium. The results demonstrated that among all the operated ears, 115 of 124 (92.7%) had a hearing gain of more than 10 dB. The average improvement of pure-tone hearing was 24.6 dB, and the average reduction of the air-bone gap was 23.2 dB. No rejection reaction or recurrent cholesteatoma was found. This operative technique, based on animal experiments and applied anatomic study of the suprastapedial structure in human beings, has had a good rate of success and has resulted in remarkable hearing improvement of a relatively large magnitude. The application of a new material-titanium-which has high biocompatibility with human body tissues, is in large measure the reason for this success. The ossicular replacement prosthesis was appropriately designed and manufactured. It fit well, could be tightly joined to the suprastapedial structure, and was difficult to displace. We also adopted the method of enlarging the tympanic isthmus, which led to good aeration of the mastoid and attic, resulting in the best state of mobility of the tympanic membrane. All these factors contributed to the effective hearing gain.

Adolescent↗