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Ossicular reconstruction--a new prosthesis.

We have used human teeth for ossicular reconstruction in 20 tympanoplasties, the longest follow-up being over 2 years. The take of the graft and the hearing improvement have been very satisfactory and long-lasting. This preliminary report discusses the merits of the tooth as a prosthetic material for ossicular reconstruction. Our experience to-date indicates that the material satisfies all the criteria of an ideal prosthesis.

Bioprosthesis↗

Closed tympanoplasty in cholesteatoma surgery: long-term (10 years) hearing results using cartilage ossiculoplasty.

The aim of this retrospective study was to evaluate the long-term hearing results of using costal cartilage prostheses in ossicular chain reconstruction procedures in subjects operated on for a middle ear cholesteatoma with an intact canal wall tympanoplasty. Thirty-six patients (four with bilateral disease) followed up for 10 years who underwent an ossiculoplasty with a cartilage prostheses between January 1987 and December 1989 constituted the population studied. All the subjects underwent a staged intact canal wall tympanoplasty with mastoidectomy. Ossiculoplasty with total or partial chondroprosthesis was performed during the second stage. The long-term outcome was evaluated in terms of hearing according to the guidelines of the Committee on Hearing and Equilibrium (1995), and in terms of complications (anatomical and functional). In 18 patients a partial cartilage ossicular replacement prosthesis (PORP) was used, while in 22 a total cartilage ossicular replacement prosthesis (TORP) was used. In the PORP group the mean preoperative air-bone gap (ABG) was 22.4 dB hearing level (HL); before the second stage the ABG was 37.9 dB HL, at 2 years it was 12.1 dB HL, at 5 years 15.3 dB HL and at 10 years 15.8 dB HL. In the TORP group the mean preoperative ABG was 31.6 dB HL; before the second stage the ABG was 41.1 dB HL, at 2 years it was 14.4 dB HL, at 5 years 17 dB HL and at 10 years 18.5 dB HL. In both groups the number of cases with a postoperative ABG of < 20 dB HL remained stable (P > 0.05) over time. The failure rate was 17.5%, but only in 5% of cases was a functional revision needed. No cases of extrusion of the prostheses were encountered. The use of a chondroprosthesis is associated with functional results similar to those obtained by other authors. The efficacy of the prostheses remains stable over time and is associated with a very low rate of complications and failures. In this series no extrusion occurred and in no case did an infectious disease develop after cartilage transplantation.

Adolescent↗

Exploratory tympanotomy revealing incus discontinuity and stapedial otosclerosis as a cause of conductive hearing loss.

OBJECTIVE: To describe a unilateral progressive conductive hearing loss caused by incus discontinuity (without erosion of the long process of the incus), and otosclerosis with fixation of the stapedial footplate. STUDY DESIGN: Case report. SETTING: Department of Otolaryngology, Head and Neck Surgery of the University of Rochester Medical Center, which is a regional tertiary referral center. PATIENT: A 54-year-old woman with multiple otologic complaints including tympanic membrane perforations, otalgia, tinnitus, and hearing loss. Audiography demonstrated 100% speech discrimination bilaterally and a significant conductive right-sided hearing loss. INTERVENTION: The patient underwent a stapedectomy, during which a discontinuity between the long process of the incus and the stapes with no bony erosion was identified. The stapedectomy was completed and an ossicular piston prosthesis was inserted to reestablish ossicular continuity with the tympanic membrane. MAIN OUTCOME MEASURE: Improved subjective hearing confirmed objectively by audiography. CONCLUSION: This is the third reported case of an unusual combination of otosclerosis and ossicular discontinuity, and the first such case report in a patient without head trauma. In addition, it adds a unique item to the differential diagnosis of the pathologic features implicated in an ear with a conductive deficit and normal tympanogram.

Ear, Middle↗

Surgical treatment of tympanosclerosis.

During the 5-year period (1971--1976), 45 patients at the Shea Clinic underwent reconstructive surgery for tympanosclerosis. The most common ossicular chain problem was found to be malleus and incus fixation (33%); malleus, incus, and stapes fixation (22%); and stapes fixation (13%). The most successful reconstrucitve approaches included removal of tympanosclerosis from tympanic membrane or isolated plaque from ossicular chain, the use of the Partial Ossicular Replacement Prosthesis (PORP), and the Total Ossicular Replacement Prosthesis (TORP).

Ear Ossicles↗

Extrusion rates and hearing results in ossicular reconstruction.

OBJECTIVES: To examine hearing results, extrusion rates, and factors likely to affect outcome in patients who underwent ossicular chain reconstruction with Plasti-Pore and hydroxylapatite total ossicular replacement prostheses (TORPs) and partial ossicular replacement prosthesis (PORPs). STUDY DESIGN AND SETTING: Retrospective chart review was used. Subjects were 1210 consecutive tympanoplasties with or without mastoidectomy that involved ossicular reconstruction with TORPs (n = 560) or PORPs (n = 650) performed in a tertiary referral neurotologic private practice. Only 20% of the cases were primary surgeries, with the majority planned second stage or revision procedures. RESULTS: Average last postoperative air-bone gap (ABG) was 19.2 dB with closure of the ABG to within 20 dB in 62.9%. Hearing results were better for cases who had not had previous surgery, in those with a diagnosis other than chronic otitis media, when a cartilage graft was used, and for Plasti-Pore rather than hydroxylapatite. Extrusion was known to occur in 4%. CONCLUSION: After more than 25 years of use in our clinic, Plasti-Pore ossicular replacement prostheses continue to provide reliable hearing results with a low rate of extrusion.

Adult↗

Is hydroxyapatite ceramic an adequate biomaterial in ossicular chain reconstruction?

The suitability of high-density hydroxyapatite ceramic without macropores for ossicular chain reconstruction was examined in animal experiments. The material was implanted both mobilely and immobilely, in compact cylinders and as granules at different locations. Biocompatibility was studied by the sawing and grinding technique without decalcification. If high-density hydroxyapatite was not in direct and stable contact with living bone, resorption and osteoneogenesis could not be observed. In cases of mobile contact with living bone there was a jointlike connection. Osteoneogenesis was seen only if the hydroxyapatite was in primary stable contact with living bone. We concluded that high-density hydroxyapatite ceramic, positioned as an ossicular replacement prosthesis, is an adequate biomaterial in ossicular chain reconstruction.

Animals↗

Disintegration of porous polyethylene prostheses.

A Plastipore (porous polyethylene) Total Ossicular Replacement Prosthesis gave an excellent initial hearing result which was maintained for 14 years. Hearing then began to deteriorate and revision surgery showed disintegration of the prosthesis and a defect in the stapes footplate. Histological examination confirmed previous findings in porous polyethylene with multinucleated foreign body giant cells and breakdown of the material.

Adult↗

Reconstruction of the ossicular chain using a multistrand wire spring prosthesis.

A multistrand wire spring prosthesis is presented for ossicular reconstruction. This device offers a workable solution not only to the ossiculoplasty problems associated with lateralization of the tympanic graft and displacement of the prosthesis, but also to other problems such as fixation to middle ear wall, tissue reaction, resorption, degeneration, biodegradation, or poor sound conduction, which are obviated using a stainless steel wire for the ossicular prosthesis. The spring also protects the inner ear from external trauma. Long-term reconstruction results of 14 cases using first generation coil spring prosthesis are presented. A freely mobile prosthesis head composed of cartilage with perichondrium on a wire-mesh platform distributes pressure evenly to the undersurface of the tympanic membrane and further ensures the prevention of pressure necrosis and extrusion. When the handle of the malleus is present, the head-loop assembly of the spring prosthesis is designed to securely capture the handle. There is no practical loss of sound energy passing through the spring. Over a period of 14 years none of the wire prosthesis was found to have eroded through the stapedial footplate.

Bone Conduction↗

Revision ossicular reconstruction with the titanium Kurz prosthesis.

OBJECTIVE/HYPOTHESIS: One European multicenter study has reported favorable outcomes after ossicular reconstruction with the titanium Kurz prosthesis. At the time of this study, however, no study has analyzed its outcomes when used for reconstruction after prior failure with another implant (revision reconstruction). The study reports our experience with the titanium Kurz prosthesis for revision ossicular reconstruction. STUDY DESIGN: A retrospective review was made of all revision ossicular reconstructions at our institution from October 1998 to September 2001. METHODS: Seventeen cases were reviewed. Patients were divided into two groups: patients who underwent revision ossicular reconstruction with the Kurz prosthesis and patients who underwent revision ossicular reconstruction with another prosthesis (the "other" group). Audiograms were reviewed and air-bone gaps were calculated for each patient. RESULTS: The average postoperative air-bone gap after Kurz revision was 15.6 dB, a statistically significant improvement over the average postoperative air-bone gap from the "other" revision group (P =.022). CONCLUSION: The titanium Kurz prosthesis has been an effective implant at our institution for revision ossicular reconstruction. Future research should focus on a prospective, randomized trial comparing the Kurz prosthesis with other prostheses currently in use.

Adolescent↗

Current use of implants in middle ear surgery.

OBJECTIVE: The authors report the results of a survey of members of the American Otological Society (AOS) and the American Neurotology Society (ANS) regarding their use of prostheses currently available for ossiculoplasty and stapedectomy. These findings are compared with a similar study presented by one of the authors in 1989. METHODS: Questionnaires were sent to the entire membership of the AOS and ANS with questions regarding biomaterial and prosthesis usage for stapes and chronic ear surgery, as well as satisfaction with each type of prosthesis used. Of the 575 questionnaires mailed, 274 (47%) were returned. Only 248 of the respondents performed middle ear surgery (43%), and their responses constitute the database for this study. RESULTS: For those respondents performing stapes surgery in both 1989 and 1999, the mean number of cases per year has increased from 32 to 37 (p < or = 0.004). The mean number of chronic ear cases has also increased from 95 in 1989 to 110 in 1999 (p < or = 0.001). As a biomaterial, hydroxyapatite prostheses are used by most surgeons (82%), followed by autograft and homograft bone (72%), autograft and homograft cartilage (62%), and Plastipore (59%). (Although 62% of respondents use cartilage, only 4.4% ranked it first in preference.) In 1989, bone was used most (93%), followed by cartilage (78%) and Plastipore (81%). Hydroxyapatite, which had just been introduced as a biomaterial, was used by only 9% of respondents. For stapes prostheses in 1999, the majority of respondents used stainless steel/platinum (71%), bucket handle (69%), or partial fluoroplastic (56%) prostheses. There was a high overall satisfaction rate in the use of most of these prostheses (> 85%), with several exceptions. The lowest satisfaction rate was 71% for Plastipore partial ossicular replacement prosthesis and total ossicular replacement prosthesis. Usage and satisfaction rates are presented for specific types of implants and compared with the earlier survey findings. CONCLUSION: The current use of implants in middle ear surgery demonstrates a specific pattern with a high degree of user satisfaction. The preference for implants by respondents has remained stable over the past 10 years; there has been a decrease in the percentage of use of bone, cartilage, and Plastipore with a corresponding increase in the use of hydroxyapatite.

Biocompatible Materials↗

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.

Aluminum Oxide↗

Ossiculoplasty with intact stapes and absent malleus: the silastic banding technique.

OBJECTIVE: To report an original method of ossicular reconstruction with intact stapes and absent malleus. Ossiculoplasty is performed with a total ossicular replacement prosthesis positioned from the stapes footplate to the under-surface of the tympanic membrane, using a Silastic banding technique to stabilize the prosthesis. STUDY DESIGN: A prospective study of ossicular reconstruction using the Silastic banding technique. A consecutive series of cases with intact stapes superstructure and missing malleus handle (Austin-Kartush Group C) is presented. SETTING: One tertiary referral center. PATIENTS: Ninety-nine patients who underwent total ossicular reconstruction with Silastic banding technique were enrolled in the study from January 2000 to December 2002. INTERVENTIONS: Ossiculoplasty with total ossicular replacement prostheses with Silastic Rubber Band for chronic otitis media and non-inflammatory disease. MAIN OUTCOME MEASURES: Preoperative and postoperative audiometric evaluation using conventional audiometry. Air-bone gap, bone-conduction threshold, and air-conduction threshold were assessed. Postoperative audiometry was performed at the 6th, 9th, 12th, 18th, 24th, and 36th months. RESULTS: Overall, a postoperative air-bone gap closed to within 10 dB was achieved in 61.5% of cases. An air-bone gap smaller than 20 dB was obtained in 77% of cases. Postoperative improvement of air-conduction thresholds by at least 20 dB was found in 51% of cases. There was no case of postoperative sensorineural hearing loss. One case of extrusion of the prosthesis was seen (1%). CONCLUSION: Stabilizing the total ossicular replacement prosthesis with the Silastic banding technique when performing ossicular reconstruction is a safe, effective method when the stapes supra-structure is present and the malleus absent.

Adolescent↗

Long-term results and experience with the first-generation semi-implantable electromagnetic hearing aid with ossicular replacement device for mixed hearing loss.

OBJECTIVE: To document the long-term surgical and audiologic results of the implantation of a first-generation semi-implantable hearing aid for mixed hearing loss, consisting of a magnetic partial or total ossicular replacement prosthesis and an electromagnetic driver fitted in the ear canal. The short-term results have previously been published as excellent in both surgical and audiologic terms. To analyze and discuss reasons of treatment failure, as well as future perspectives. STUDY DESIGN: Patient file review, follow-up otomicroscopic examination and audiometry, as well as patient interview. SETTING Tertiary referral center at a University hospital. PATIENTS: Of nine patients operated on, six with a mixed hearing loss after chronic otitis media could be evaluated primarily. Two underwent implantation with a partial and four with a total ossicular replacement prosthesis. MAIN OUTCOME MEASURES: Use of and satisfaction with the hearing aid, apparatus function and integrity, hearing without electromagnetic driver, prostheses containment, drum abnormalities, nonaudiologic ear symptoms, e.g., discharge. RESULTS: All patients attended follow-up for a mean of 9.5 years after implantation (range 8.8-10 years). No patients used the semi-implantable hearing aid at follow-up. The mean semi-implantable hearing aid using time was 24 months (range 3-60 months). The main reasons for discontinuation of use were problems fitting the electromagnetic driver correctly in the ear canal and prosthesis extrusion or dislocation. CONCLUSIONS: Despite excellent short-term surgical and audiologic results, it is concluded that these first long-term results of the first-generation electromagnetic semi-implantable hearing aids with ossicular replacement prosthesis for mixed hearing loss are disappointing. However, improvements in the surgical approach and in the reshaping, refinement, and overall improvement of the semi-implantable hearing aid could lead to satisfactory treatment of this group of patients.

Aged↗

A new implantable middle ear hearing device for mixed hearing loss: A feasibility study in human temporal bones.

HYPOTHESIS: To assess the feasibility of a new, active middle ear device in temporal bones (TB). BACKGROUND: This device is designed for patients with mixed hearing loss subsequent to chronic middle ear infection, surgery, or trauma. This Bell-Vibroplasty is built from a VIBRANT MED-EL Vibrant Soundbridge and a Kurz Bell titanium partial ossicular replacement prosthesis. METHODS: In three fresh TBs, healthy and reconstructed middle ears were analyzed by means of laser Doppler interferometry. The sound transmission properties of a partial ossicular replacement prosthesis and a passive and an active Bell-Vibroplasty were compared with healthy middle ear function. RESULTS: The measurements provided reliable results with small standard deviations and good signal-to-noise ratios. The performance levels of the partial ossicular replacement prosthesis and of the passive Bell-Vibroplasty were comparable with that of healthy middle ear function. The activated Bell-Vibroplasty provided linear function and a flat frequency response within the measured frequency range (500 Hz-8 kHz), with peak deviations of less than 10 dB. The maximum output of the Bell-Vibroplasty was equivalent to 125-dB sound pressure level. CONCLUSION: Bell-Vibroplasty is feasible in TBs. Bell-Vibroplasty performance in TBs is sufficient to allow for a clinical trial as a next step.

Acoustic Stimulation↗

Revision chronic ear surgery.

OBJECTIVE: To report results of revision chronic ear surgery following guidelines of the American Academy of Otolaryngology-Head and Neck Surgery and to establish expectations for infection and cholesteatoma control and hearing outcomes. STUDY DESIGN: Retrospective case review of all patients who underwent revision chronic ear surgery from January 1, 1990 to December 31, 2000. Revision chronic ear surgery included canal wall up and canal wall down procedures with ossicular chain reconstruction performed as needed. Cholesteatoma control, hearing improvement, and closure of middle ear space are main outcome measures. SETTING: Tertiary referral center. RESULTS: Cholesteatoma recurrence rate was 57% at 1 year after surgery and 14% in patients with a minimum of a 5-year follow-up. Disease control was achieved in 96% of patients. Hearing was significantly improved in all surgical groups. Closure of the air-bone gap for revision partial ossicular replacement prosthesis cases (PORP) to less than 20 dB occurred in 50% of patients. Closure of the air-bone gap to within 30 dB for revision total ossicular replacement prosthesis (TORP) occurred in 60% of patients. Canal wall down status had a significant impact on hearing results after PORPs and TORPs; patients with intact canal walls had significantly better hearing results. Diagnosis of cholesteatoma significantly impacted hearing results for TORPs but not PORPS. CONCLUSIONS: Cholesteatoma control rates after revision surgery are similar to primary cases. Significant improvement in hearing can be expected after revision chronic ear surgery. Hearing results after a revision surgery that requires a PORP is worse than primary cases and is canal wall status dependent. Closure of the middle ear space and creation of a safe dry ear can be expected after revision chronic ear surgery. SIGNIFICANCE: This is a review of a large series of exclusively revision chronic ear surgery. EBM RATING: C-4.

Adult↗

An analysis of the single-stage tympanoplasty with over-underlay grafting in tympanosclerosis.

OBJECTIVES: Our objective was to analyze the results of tympanosclerosis surgery using over-underlay tympanoplasty and to find out the effect of single-stage surgery on hearing results. MATERIALS AND METHODS: Forty-two patients who were operated on for tympanosclerosis between July 1998 and February 2002 were included in the study. These were one-stage tympanoplasties, because second-stage operations and revisions were not included. Operative records and audiograms of the patients were obtained. Of the patients, 48% had bilateral tympanosclerosis. In three (7.1%) of the patients, tympanosclerosis and cholesteatoma occurred concomitantly. The cog was present in eight (20%) of 40 mastoidectomies. Körner's septum was present in nine (22.5%) patients. The graft take rate was 95.2%. RESULTS: The pre- and postoperative air-bone gap values of the patients were not significantly different (p > 0.05). Thirty-three percent of the patients met the successful hearing criteria (air-bone gap <20 dB). However, 47% had an air-bone gap closure between 20 dB and 30 dB, whereas 20% had a gap of more than 30 dB. CONCLUSION: Single-stage surgery does not result in a satisfactory hearing improvement in most of the patients with tympanosclerosis. Only one third of the patients, most of whom had a mobile stapes, had satisfactory hearing results. Mobilization of a fixed stapes is not an effective option for hearing restoration in tympanosclerosis. Second-stage surgery for stapedectomy and placement of a prosthesis-like piston or total ossicular replacement prosthesis should be considered to obtain better hearing results in tympanosclerosis.

Audiometry, Pure-Tone↗