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[Results after rebuilding the ossicular chain using the autogenous incus, ionomer-cement-and titanium implants (tympanoplasty type III)].

BACKGROUND: A defective ossicular chain can reliably be reconstructed with standardized techniques using e. g. modern alloplastic materials. The comparison of clinical and functional results have proved its worth. Prospective clinical trial as well as collecting and evaluating relevant intraoperative and postoperative findings may be helpful to find the appropriate bone substitute in each case when rebuilding middle ear structures. METHOD: In 354 middle ears (332 patients) the defective or destroyed ossicular chain was rebuilt with the carefully trimmed autogenous incus (n = 83), with ionomer-cement implants (n = 100) and with titanium prostheses (n = 171). The follow-up of the earmicroscopic findings and middle ear function extended over a period of 1.5 years postoperatively on an average (min. 3 months, max. 6 years). The modified otologic record form named "Würzburger Ohrbogen" was used for preoperative and operative data, the "Ohrnachsorgebuch" for the postoperative follow-up. RESULTS: Using incus the air bone gap was improved up to 15 dB in the main speech area. Thus the average remaining conduction deficit was less than 10 dB. The "taking" of ionomer based cement prostheses and titanium prostheses was equally good. The cement implants showed a tendency to protrusion (n = 3), 2 titanium implants were extruded. The air bone gap decreased about 10 to 35 dB using titanium total prosthesis and about 15 to 20 dB using ionomer-cement total prosthesis. The remaining air bone gap with titanium implants was slightly less than with the ionomer-cement PORP (10-15 dB). The air bone gap using the titanium TORP was diminished in a reach of 10 to 35 dB, with the ionomer cement prosthesis between 15 to 20 dB. The remaining gap in the main speech area was slightly favorable to titanium (less than 15 dB) compared with the ionomer-cement TORP. Comparing higher frequencies the air bone gap of titanium was recognizable due to its light weight, but less impressive than expected. Revision surgery (n = 50) has to be performed by reason of cholesteatoma (n = 9), adhesive process (n = 8), dislocation of alloplastic prostheses (n = 8) and because of proposed "second look" (n = 14). CONCLUSIONS: Compared with other materials autogenous implants used for reconstruction of the incus have proved their value, however a deterioration of the sound transmission may develop in the long run. The middle ear compatibility of ionomer-cement implants is similar to titanium implants. The functional results of the titanium implants seem to be slightly superior.

Adolescent↗

Patient selection for incus body coupling of a totally implantable middle ear implant.

OBJECTIVE: To evaluate audiologic selection criteria for incus body coupling (IBC) of a totally implantable middle ear implant (TI-MEI) for the treatment of sensorineural hearing loss (SNHL). MATERIAL AND METHODS: The protocol is specified in the Investigational Device Exemption of a Food and Drug Administration-approved multicenter clinical trial. The prospective study compared pre- and postoperative hearing levels using each patient as their own control. In addition, an implant on/off comparison was made. All patients had a follow-up interval of at least 6 months. Audiologic assessment tests included speech discrimination in quiet as the primary efficacy variable and pure-tone audiometry (aided thresholds), gain, speech recognition in noise and subject satisfaction using standardized questionnaires and visual analog scales (VASs) as secondary efficacy variables. The study group of patients (n = 13) was divided into 3 subgroups based on their pure-tone and speech discrimination scores: Group A consisted of 6 patients, Group B 9 patients and Group C of all 13 patients. All patients suffered from long-standing bilateral moderate to severe SNHL. Five patients were dissatisfied hearing aid (HA) users and eight subjects could not wear HAs. All patients were implanted with a TI-MEI which was coupled to the incus body. The amplification level of the device was set postoperatively using inductive digital fitting based on "most comfortable loudness" specifications. RESULTS: The implant produced median improvements from 30% (optimally fit bilateral HAs; n = 5) and 50% (HA non-users; n = 8) to 70% word recognition at 60 dB SPL. Average word recognition scores at 60, 80 and 90 dB SPL in Groups A and B showed increases from 42% (interquartile range +27%, -12%) to 93.5% (+3%, -5%) and 92.5% (+3%, -7%), respectively. In the presence of background noise, the sentence recognition threshold ranged from -2 to 1 dB signal-to-noise ratio. Maximum amplification was 50 dB at 3 kHz and 55 dB at 4 kHz. In Groups A and B, VASs revealed improvements in both natural sound impression and clarity from 62-70% of a natural sound impression to maximum scores of 100%. Using the standardized Gothenburg profile, subjective evaluations of hearing, orientation, social behavior and self-confidence reached 96-98%, 92-96% and 84-92% of the maximum score for Groups A-C, respectively. CONCLUSIONS: In selected cases, IBC of the TI-MEI investigated herein may be indicated for the treatment of SNHL, provided the following four conditions are met. First, the patient does not derive sufficient benefit from conventional HAs. Second, the specific indication for IBC is restricted to situations that do not allow the coupling of the MEI to the long incus process (e.g. due to an anatomical variation of facial nerve location). Third, IBC is restricted to patients with a steeply sloped moderate to severe high frequency SNHL, amounting to 90 dB HL from 3 to 8 kHz. Patients with low frequency SNHL should not be operated on with the IBC technique, as maximum low frequency hearing loss at 0.5 kHz must not exceed 30 dB. Fourth, Schueller's X-ray should reveal normal mastoid pneumatization. Being restricted to a 6-month follow-up period, this paper provides early clinical results and no clinical evidence of long-term efficiency of the implant.

Adult↗

Evaluation of a cement incus replacement prosthesis in a temporal bone model.

In reconstruction of the ossicular chain for a damaged incus, it is important that the incus replacement prosthesis (IRP) length is ideal in order to provide optimal tension between the tympanic membrane or malleus and stapes head to achieve the best post-operative hearing result. Even though the length of commercially available IRPs can be adjusted, it still may be difficult to achieve clinically. We describe experiments in a human temporal bone model using dental cement as an IRP after removal of the incus. This cement IRP (CIRP) hardens in situ and becomes the length of the gap to be spanned so that tension should be ideal. Two different CIRPs were studied; one was a conventional rod-type CIRP connecting either the umbo or mid-malleus handle to the stapes head. The second was a Y-shaped CIRP (Y-CIRP), connecting two sites on the malleus to the stapes head. The wide Y-CIRP connected the malleus head and umbo to the stapes head, while the narrow Y-CIRP connected the malleus neck and mid-handle to the stapes head. The acoustic performance of these experimental CIRPs was studied using a laser Doppler vibrometer system in 12 fresh human temporal bones. The CIRP demonstrated better acoustic performance than conventional IRPs studied previously in the same model. While all the CIRPs showed similar function below 2.0 kHz, the narrow Y-CIRP appeared best above 3.0 kHz. A prosthesis of this type may have an acoustic advantage over conventional IRPs.

Acoustic Stimulation↗

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↗

How we do it: modified Wehrs incus ossiculoplasty.

Keypoints * Ossiculoplasty is commonly performed as part of tympanoplasty. Hydroxyapatite is a favoured material for ossicular protheses. * A modification to the Wehrs incus prosthesis is described. * Twenty-one procedures were performed on 20 patients and the results are reported. * On average there was a 4-5 dB closure of the air-bone gap (ABG), with patients having a hearing gain procedure averaging 11 dB closure. Air-bone gap closure to <or=20 dB was achieved between 78% (0.5, 1, 2 kHz average) and 60% (0.5, 1, 2, 4 kHz average) of patients and this was stable during long-term follow-up of the ABG. * Wehrs incus prosthesis ossiculoplasty provides a reliable result following ossiculoplasty when autograft incus is not available.

Adolescent↗

In vitro evaluation of a malleus head to stapes head 'incus replica' prosthesis.

An ossicular prosthesis produced by making a mould from a cadaveric incus and injecting ionomeric cement into it (incus replica prosthesis, IRP) has been cemented to the malleus head and stapes head and evaluated in fresh human temporal bones using a laser vibrometer. Stapes velocity was recorded under acoustic stimulation and foot plate displacements were derived. Fourteen frequencies between 125 Hz and 8000 Hz have been used. Measurements were made with the ossicular chain intact, following removal of the incus, with the prosthesis cemented to the malleus, but not the stapes, and with the incudo-stapedial joint cemented. In a second series of experiments the performance of the IRP was compared with that of a Causse partial ossicular replacement prosthesis, using the same experimental set-up. The results indicate that the prosthesis performs almost as well as the intact ossicular chain and that cementing the incudo-stapedial joint gives better sound transmission than leaving it uncemented. In addition the IRP outperforms the conventional partial ossicular replacement prosthesis.

Bone Cements↗

Early experience with the Mills sleeve prosthesis for reconstruction of the incus long process.

This paper describes the Mills sleeve technique of ossicular reconstruction for defects of the incus long process and reviews the results of 27 procedures. A retrospective review of operations was performed by eight otologists. The results are compared with those from three other reconstruction techniques (cortical bone graft, cortical bone sleeve and incus autograft). Prostheses were supplied to surgeons who expressed an interest. Pre- and post-operative audiological data forms were analysed for each case along with a questionnaire about use of the prosthesis. The mean post-operative air bone gap (ABG) was compared with results from cortical bone sleeve, incus autograft and simple cortical bone graft reconstruction cases previously performed by the senior author. Twenty-seven procedures were performed. Closure of the ABG to within 10 dB was achieved for 44.4 per cent of Mills sleeve cases compared with 44.7 per cent for the cortical bone sleeve, 52.9 per cent for ossicular and 26.9 per cent for cortical bone grafts. The responses to a questionnaire sent to participating surgeons are discussed. For the current follow-up period (three months to three years) the Mills sleeve prosthesis appears to be safe and easy to use with audiological results at least as good as other reconstructive techniques.

Attitude of Health Personnel↗

Stapedectomy: incus bypass procedures. A report of 203 operations.

The records of 203 stapedectomy operations in which we used a prosthesis from the malleus handle or a columella from the tympanic membrane were reviewed; 63 operations were primary stapedectomies, and 85% had a postoperative conductive deficit of 15 dB or less. The most common single indication for an incus bypass procedure was idiopathic malleus head fixation. Sixty-six operations were revision stapedectomies; 65% had a postoperative deficit of 15 dB or less. In 50% the bypass indication was necrosis of the incus. There were 74 stapedectomies in a previously fenestrated ear; 60% had a postoperative deficit of 15 dB or less. Incus bypass procedures in stapedectomy, when indicated, yield satisfactory hearing results. Otolaryngologists who perform stapedectomy must be familiar with these procedures.

Adipose Tissue↗

Cavernous hemangioma of the incus (an incidental finding).

The incidental discovery of a cavernous hemangioma in an apparently normal incus found during pathological examination is reported. The incus had been removed during the course of a total osseous labyrinthectomy for delayed endolymphatic hydrops (DEH), and this unexpected finding noted. Although rare, hemangiomatous involvement of the temporal bone does occur and its manifestations are discussed. To date there have been no other reports of a hemangioma involving the incus solely.

Adult↗

[Tympanoplasty with incus interposition].

We report on a 5-year experience with 44 patients (1980-1985) with incus interposition using a modelled or sculptured incus, either autograft or homograft, to correct ossicular discontinuity when a functional malleus and stapes are present. After a period of 21 months, 75% of our patients achieved an air-bone gap closure between 1 and 10 dB. The postoperative hearing results of patients with trauma and middle ear atelectases were better than the hearing results of patients with cholesteatomas. These long-term results are dependent upon intact malleus attic ligaments and an intact tensor tympani tendon. It is very important that the modelled incus is repositioned under the malleus handle neck.

Adolescent↗

Ossiculoplasty using a hemi-incus interposition.

A damaged incus is one of the common reconstruction problems encountered by the otologic surgeon. Eighty-five hemi-incus interposition reconstructive procedures performed between 1976 and 1982 were reviewed. Reconstruction consisted of an autogenous or homologous incus bone graft interposed between the tympanic membrane and the mobile stapes superstructure. Air bone gap closure to within 20 dB was obtained in 77% of cases. Reconstruction using bone graft is better tolerated by the middle ear and the extrusion rate less than that of the biocompatible implants.

Audiometry↗

[The virtual image of the incus].

The virtual image of the incus formed by the saline lens is an aid to the safe dissection of the antrum. The saline irrigation fluid indeed may act as a thin negative lens which permits at the antrum the visualization of the image of the incus, around the corner of the bony canal wall overhang. This warning device, predicting the exposure of the incus, prevent in this way inadvertent contact of this ossicle by the power drill and subsequent acoustic trauma.

Dissection↗

[Formation of new bone and bone destruction in preserved incus homografts. Histological examinations of implants from 100 patients (author's transl)].

103 tympanoplastic re-operations were done in 100 patients. 103 Cialit-preserved incus homografts were drawn out for histological examination, which were implanted in the mean two years before. The data of the course of the disease were correlated with the histological finding. All incus homografts showed the well known formation of new bone in a different amount. Moreover 50% showed already macroscopically signs of bone resorption. Distinct indications for defense reactions of the recipient against the devital incus homograft were detected.

Bone Resorption↗

[Diagnosis and therapy of incus luxation].

Diagnosis and treatment of dislocation of the incus are discussed, and three fully described cases are reported. The author emphasizes the need of a multidirectional serial tomography for a correct radiological diagnosis. The reliability of routine impedance measurement for this diagnostical problem is questioned. A systematization of the surgical procedure is proposed. The importance of an optimum and lasting solution is stressed. In this context the author emphasizes the advantages of the anatomical reposition of the incus, the function and adequate application of Histo-Acryl, and the incus remodelling technique following J. Marquet. The success rate in a series of 9 cases is reported regarding the type of ossicular lesion and the used technique.

Acoustic Impedance Tests↗

[A comparison of the results of incus interposition in the Wullstein type III and type IV tympanoplasty (author's transl)].

Incus interposition for reconstruction of the sound conduction mechanism in a deep tympanic cavity can be effectively utilized in both Wullstein Type III and IV tympanoplasties. In the Type III tympanoplasty, in which the incus is interposed between malleus or tympanic membrane and stapes, the average post-operative air-bone gap approximates 16 db, while incus placement on the stapes footplate results in an air-bone gap of 23.5 db. There is no difference in change of bone conduction when all operative mehtods are compared. Improved results in reconstruction of the second conduction mechanism are best obtained by conserving or reconstructing the tympanic membrane and posterior bony external canal wall through improved audio-physiologic dynamics.

Ear Canal↗

Experimental study of the acoustic properties of incus replacement prostheses in a human temporal bone model.

Many middle ear prostheses are available for reconstruction of a missing or damaged incus. Little is known of the relative acoustic performance of these prostheses in vitro and the parameters (mass, shape, tension, angulation, area of head) that modify this performance. This report describes experiments in a human temporal bone model comparing the effect on stapes displacement of six commercially available incus replacement prostheses (IRP). Measurements were performed using a laser Doppler vibrometer before and after incus removal and IRP placement between the tympanic membrane (TM) and stapes head. In addition, experiments were performed on the effect of increasing prosthesis mass, varying the tension between TM and stapes head, changing the surface area in contact with the TM, and comparing different TM contact sites. All prostheses tested showed reasonable acoustic performance compared to the baseline condition. Optimum tension between the TM and stapes head produced the best overall sound transmission. The mid-malleus and umbo locations were the best malleus contact sites; however, the posterior TM contact site also worked well. Increased mass improved low frequency transmission and impaired higher frequency transmission, whereas a larger contact area with the TM contributed to increased gain in the mid frequencies.

Aged↗

An incus replacement prosthesis. The ossicle cup.

To achieve better hearing after incus replacement surgery, the ossicle-cup prosthesis is introduced. This prosthesis incorporates part of a Teflon Robinson's stapes prosthesis into the body of an incus. The ossicle-cup prosthesis has a dynamic joint with the stapes capitulum, as well as a variable height above the stapes. Preliminary hearing results of 45 cases show air-bone gap closure of 67% within 10 dB and 98% within 20 dB.

Ear Ossicles↗