The ossicular replacement prosthesis should have good biocompatibility, stability, easy to install, and excellent sound transmission capacity. In this study, the characteristics of ideal materials for the ossicular replacement prosthesis were analyzed by searching the types of materials used in clinical practice and comparing the advantages and disadvantages of various materials and structures. At the same time, in combination with the current evaluation requirements and evaluation experience, the focus of the performance research project of ossicular replacement prosthesis in the process of registration is discussed to clarify the performance evaluation requirements of these products, so as to provide reference for the future work of manufacturers and regulators. The performance evaluation of ossicular replacement prosthesis focuses on its mechanical properties, fixation stability, sound transmission characteristics, biological characteristics, and magnetic resonance compatibility.
Ossicular Prosthesis ; Ossicular Replacement ; Sound ; Prosthesis Design ; Treatment Outcome

OBJECTIVE: To evaluate the efficiency of autologous conchal cartlage in ossicular chain reconstruction in patients with chronic suppurative otitis media. METHOD: Seventy-three cases of chronic suppurative otitis media (COM) with or without cholesteatoma who had undergone mastoidectomy with tympanoplasty and ossicular chain reconstruction(OCR) using autologous conchal cartilage as prosthesis were studied retrospectively. Sixty-six cases of COM who had undergone mastoidectomy with tympanoplasty and without OCR were studied as control. The examination of pure tone hearing level of air conduction(AC) and bone conduction(BC) was done before operation, 2 months and 6 months after operation respectively. The pure tone average (PTA) of 0.5, 1.0, 2.0 kHz was observed. RESULT: The average air conduction gain was more than 15dB or the PTA (AC) was less than 25 dB 2 months after operation in 35 out of 73 cases who had undergone OCR. Nevertheless, the data became 56 out of 73 cases 6 months after operation. In the control group, The average air conduction gain was more than 15dB or the PTA(AC) was less than 25 dB 2 months after operation in 10 out of 66 cases who had not undergone OCR. The data became 14 out of 66 cases 6 months after operation. In OCR group, air bone gap(ABG) was less than 20 dB in 39 cases 2 months after operation and in 57 cases 6 months after operation. In the control group without OCR, ABG was less than 20 dB only in 11 cases 2 months after operation and in 16 cases 6 months after operation. By statistically analysis, there was significant difference of postoperative hearing improvement between the two groups. CONCLUSION The autologous conchal cartilage can be used as the material of prosthesis for ossicular chain reconstruction in the operation of chronic otitis media. It has many advantages, such as easily--obtained, good histocompatibility, easy to shape and so on.
Audiometry, Pure-Tone ; Bone Conduction ; Cartilage ; transplantation ; Cholesteatoma ; surgery ; Chronic Disease ; Ear Auricle ; Hearing ; Humans ; Mastoid ; surgery ; Ossicular Prosthesis ; Ossicular Replacement ; Otitis Media, Suppurative ; surgery ; Postoperative Period ; Reconstructive Surgical Procedures ; Retrospective Studies ; Treatment Outcome ; Tympanoplasty

OBJECTIVE: To assess hearing effect of ossicular chain reconstruction with titanium ossicular replacement prosthesis during mastoidectomy with synchronous ossiculoplasty in chronic middle ear disease. METHOD: Retrospective reviews were performed for 139 patients who had underwent mastoidectomy and tympanoplasty with titanium ossicular replacement prostheses at the same time between 2008 and 2011. The partial ossicular replacement prostheses (PORP) were used in 91 patients and the total ossicular replacement prostheses (TORP) were used in 48 patients respectively. All patients had follow-up for 2 to 5 years. The preoperative and postoperative mean air conduction and air-bone gaps(ABG) for the four frequencies (0.5, 1.0, 2.0 and 4.0 kHz) were evaluated. The improvement of mean air conduction and ABG over the same frequencies were measured. A postoperative ABG less than or equal to 20 dB was considered a successful operation. The hearing results of titanium PORP and TORP were compared. RESULT: The mean air conductions were (53.97 +/- 11.32)dB and (36.80 +/- 11.68) dB preoperatively and postoperatively in PORP group. The mean improvement in air conduction was (17.17 +/- 5.79)dB. The mean ABG was (31.84 +/- 6.17)dB and (15.13 +/- 7.22)dB preoperatively and postoperatively in PORP group. The mean improvement in ABG was (17.71 +/- 5.5)dB. The difference of hearing threshold between preoperative and postoperative had statistical significance (P < 0.01). The mean air conduction were (58.05 +/- 11.35)dB and (44.53 +/- 13.15)dB preoperatively and postoperatively in TORP group. The mean improvement in air conduction was (13.52 +/- 7.81)dB. The mean ABG; were (35.67 +/- 5.73)dB and (21.48 +/- 7.01)dB preoperatively and postoperatively for TORP group. The mean improvement of hearing threshold in ABG was (14.18 +/- 7.53)dB. The difference of hearing threshold between preoperative and postoperative had statistical significance (P < 0.01). ABG less than 20 dB after operationwas happened in 68.63% of the patients (74.73% for PORP and 54.17% for TORP). There was statistically significant difference between PORP and TORP (P < 0.05). CONCLUSION We conclude that titanium ossicular reconstruction during mastoidectomy with synchronous ossiculoplasty give stable and excellent hearing results. We obtained better results with PORP than with TORP.
Adolescent ; Adult ; Aged ; Child ; Female ; Follow-Up Studies ; Humans ; Male ; Mastoid ; surgery ; Middle Aged ; Ossicular Prosthesis ; Ossicular Replacement ; methods ; Retrospective Studies ; Titanium ; Treatment Outcome ; Tympanoplasty ; methods ; Young Adult

OBJECTIVE: To study the effects of different types of prosthesis used in ossiculoplasty on mastoidectomy of treating chronic otitis media. METHOD: One hundred and forty three patients with chronic otitis media were treated by canal wall-down tympanoplasty with ossiculoplasty in a single stage. According to material of prosthesis, they were classified as titanium group (group A, 52 cases), hydroxypatite group (group B, 47 cases) and autogenous bone group(group C, 44 cases). The postoperative complication and hearing thresholds were analyzed in the 24 months follow-up. Average postoperative air-conduction gain and air-bone gap were measured at four frequencies: 0.5, 1.0.2, and 4.0 kHz. RESULT: 12-month after operation, the average air threshold and air-bone gaps of the three groups were reduced (P < 0.05). The reconstruction successful rate (78.7%) of group A was slightly better than that of B, C (68.1%, 70.4%), there was no statistically significant difference. The difference of the average air threshold and air-bone gaps of group B, C after 24-month of operation and 12-month after operation was statistically significant (P < 0.05). The reconstruction successful rate (48.9%, 45.5%) of group B, C was lower than that of A (76.9%), the difference was also statistically significant (P < 0.05). CONCLUSION Prostheses using titanium type could give good functional results and strong stability with low complication.
Adult ; Chronic Disease ; Female ; Humans ; Male ; Middle Aged ; Ossicular Prosthesis ; classification ; Ossicular Replacement ; instrumentation ; methods ; Otitis Media ; surgery ; Titanium ; Treatment Outcome

OBJECTIVE: To investigate the effect of different malleus treatments on the postoperative efficacy in the tympanosclerosis patients receiving ossicular chain reconstruction. METHOD: Fifty-nine patients (62 ears) with tympanosclerosis were treated by ossicular chain reconstruction. All the patients were divided into three groups, including malleus removal group (A, 24 ears), retaining only the malleus handle group (B, 18 ears) and the intact malleus group (C, 20 ears). All the patients were followed up 3 months pre-operation, 3 months and 1 year post-operation by audiometric measurement (the average hearing threshold at 0.5, 1.0, 2.0 kHz HI). Tympanic membrane was examined by ear endoscope. RESULT: The pre-operation mean air bone gap (ABG) in these groups were 40.07 +/- 77.56 dB, 37.31 +/- 76.45 dB, and 36.75 +/- 76.72 dB, among which the difference had no statistical significance (P > 0.05). At 3 months after operation, the ABG in all cases was improved at 0.5, 1 and 2 kHz. The difference of ABG improvement among these three groups had no statistical significance (P > 0.05). One year after surgery, the ABG of the three groups were decreased by 17.92 +/- 9.28 dB, 16.76 +/- 5.19 dB and 10.58 +/- 7.38 dB respectively. The hearing improvement in group C is less than the other two groups (P = 0.03, P = 0.016). The difference of hearing improvement between group A and group B had no statistical significance(P > 0.05). Group A and group B each have one case of tympanic membrane perforation and artificial ossicle falling off. CONCLUSION The operating processes of malleus in ossicular chain reconstruction of patients with tympanosclerosis were introduced. In terms of short-term efficacy, the three groups showed no significant difference. However, the long-term efficacy of the patients in the group A and group B were better compared with the group C.
Adolescent ; Adult ; Female ; Humans ; Male ; Malleus ; surgery ; Middle Aged ; Myringosclerosis ; surgery ; Ossicular Replacement ; methods ; Retrospective Studies ; Treatment Outcome ; Young Adult

OBJECTIVE: To investigate the diagnose therapy and the postoperative curative effect of traumatic ossicular chain disruption and dislocation. METHOD: Eight cases (8 ears) with traumatic ossicular chain disruption. Six cases of unilateral conductivity deafness, 2 of mixed deafness still with conductive primarily. Eight ears all were performed tympanic exploration and ossicular replacement prosthesis, 1 ear with TORP (total ossicular replacement prosthesis). 4 ears with PORP (partial ossicular replacement prosthesis), 2 with ossicular chain reset, 1 with artificial incus reconstruction. The treatment effect was compared by the preoperative and postoperative ABG (air bone gap). RESULT: Preoperative average ABG was 42. 9 dB, the average ABG 3 weeks after operation was 22.3 dB, which reduced 20.6 dB compared to the preoperative, having a statistically significant difference (t = 22.10, P < 0.01). The average ABG was 18.6 dB 6-8 months after operation, which reduced 24.3 dB compared to the preoperative, having a statistically significant difference (t = 12.813, P < 0.01). CONCLUSION The conductivity hearing loss after traumatic ossicular chain disruption or dislocation is preferred operation treatment, and replacement should use different ways according to the operation in case, and the hearing improvement was obvious.
Adolescent ; Adult ; Bone Conduction ; Ear Ossicles ; injuries ; Female ; Hearing Loss, Mixed Conductive-Sensorineural ; diagnosis ; etiology ; surgery ; Humans ; Male ; Middle Aged ; Ossicular Prosthesis ; Ossicular Replacement ; Young Adult

BACKGROUND AND OBJECTIVES: Tympanosclerosis is a nonspecific and irreversible result of chronic inflammation or infection of the middle ear. However, there remains disagreement about how best to surgically treat tympanosclerotic ossicular fixation, with the controversy over its management when stapes is involved. The aim of this study was to evaluate operative findings and hearing results of tympanosclerosis involving the ossicular chain, which in turn would establish better surgical treatment of tympanosclerotic ossicular fixation. SUBJECTS AND METHODS: In this prospective study conducted from Mar 2000 to Dec 2007, 38 patients with tympanosclerosis who had undergone surgical treatment were evaluated. The clinical and operational records and pre- and postoperative pure tone audiograms were reviewed. RESULTS: Operative findings showed stapes fixation is the most common. In 8 patients (21.1%), stapes was mobile, while, in the remaining 30 patients (78.9%), stapes fixation was found. In all cases with stapes fixation, stapes mobilization was possible. Following hearing result reporting guideline by the Korean Otological Society, the success rate of middle ear surgery was 68.4% (26 of 38 patients). In cases with stapes fixation, the success rate was 66.6% (20 of 30 patients), while, in cases with no stapes fixation, the success rate was 75.0% (6 of 8 patients). However, there was no statistical significance between the two groups. CONCLUSION: Stapes fixation was found in 78.9% of tympanosclerotic ossicular fixation. In management of tympanosclerotic stapes fixation, meticulous excision of tympanosclerotic plaques and removal of new bone formation around stapes footplate after adequate exposure could achieve a relatively good hearing result without stapes surgery.
Ear, Middle ; Hearing ; Humans ; Inflammation ; Myringosclerosis ; Ossicular Replacement ; Osteogenesis ; Prospective Studies ; Stapes ; Stapes Mobilization ; Stapes Surgery

OBJECTIVETo evaluate the effect of ossicular reconstruction with partial ossicular replacement prosthesis (PORP) in patients with tympanosclerosis.

METHODSThe data of 31 cases of tympanosclerosis treated between 1992 and 2009 were reviewed. Of the 31 patients, 17 (17 ears) underwent ossicular reconstruction with porous macromolecular polyethylene PORP, and 14 (14 ears) with bioceramic PORP. All the patients were followed up for 3-24 months.

RESULTSSignificant improvement was found in postoperative speech frequency (500, 1000, 2000 Hz) pure tone average (PTA) and air-bone gap (ABG) (P < 0.05) after the treatments without statistically significant differences between the two groups (P > 0.05).

CONCLUSIONPorous macromolecular polyethylene and bioceramic are valuable ossicular prosthesis for tympanosclerosis.

Adult ; Biocompatible Materials ; Ceramics ; chemistry ; Female ; Humans ; Macromolecular Substances ; chemistry ; Male ; Middle Aged ; Ossicular Prosthesis ; Ossicular Replacement ; methods ; Otosclerosis ; surgery ; Polyethylene ; chemistry ; Porosity ; Prosthesis Implantation ; methods ; Treatment Outcome

OBJECTIVES: A non-progressive and conductive hearing loss with normal eardrum, but no history of trauma and infection, is highly suggestive of a congenital ossicular malformation. Among ossicular anomalies, stapes anomaly is the most common. The purpose of this study is to describe patterns of stapes anomaly and to analyze its surgical outcome with special reference to its patterns. METHODS: We conducted a retrospective case review. The subjects comprised 66 patients (76 ears) who were decisively confirmed by the exploratory tympanotomy as congenital stapes anomalies without any anomalies of the tympanic membrane and external auditory canal. The preoperative and postoperative audiological findings, temporal bone computed tomography scan, and operative findings were analyzed. RESULTS: There were 16 anomalous patterns of stapes among which footplate fixation was the most common anomaly. These 16 patterns were classified into 4 types according to the status of stapes footplate. Successful hearing gain was achieved in 51 out of 76 ears (67.1%) after surgical treatment. CONCLUSION: Footplate fixation was usually bilateral, whereas stapes anomalies associated with other ossicular anomaly were usually unilateral. The success of the surgical treatment of stapes anomaly might depend on its developmental status of the footplate. Stapes anomalies were detected without any fixed patterns, therefore, it is quite possible to detect a large variety of patterns in future.
Ear ; Ear Canal ; Hearing ; Hearing Loss, Conductive ; Humans ; Ossicular Replacement ; Retrospective Studies ; Stapes ; Temporal Bone ; Tympanic Membrane

BACKGROUD AND OBJECTIVES: Incus erosion with intact stapes head was most common ossicular impairment in chronic otitis media. Here, we aimed to investigate hearing and clinical results of the ossiculoplasties when the stapes head was intact. SUBJECTS AND METHOD: We analyzed 281 patients of ossiculoplasties over stapes head performed from 1990 to 2005. Patients were divided into 3 groups: Si group (n=121) included patients with interposition of prosthesis between malleus and stapes; Sc-PORP group (n=99) included patients with columellarization between tympanic membrane and stapes head with PORP; Sc-SC group (n=61) included patients with columellarization with the autologous materials between tympanic membrane and stapes head. Hearing improvement and extrusion rates of three groups were analyzed. RESULTS: At 6 months after the surgery, the postoperative air-bone gap (ABG) level within 20 dB was 45%, 44%, 25% in Si, Sc-PORP, Sc-Sc, respectively. The closure of ABG was statistically better in Si and Sc-PORP compared with Sc-SC. In canal wall-up mastoidectomy, Sc-PORP showed better hearing results than Si, while Si was better than Sc-PORP in canal wall-down mastoidectomy. At 36 months after the surgery, extrusion-free survival according to the type of ossiculoplasty were 100%, 89.6%, 100% in Si, Sc-PORP, Sc-SC, respectively. CONCLUSION: Si and Sc-PORP provide good hearing results. However, Si has lower extrusion rates than Sc-PORP and remains stable over time.
Head ; Hearing ; Humans ; Incus ; Malleus ; Ossicular Prosthesis ; Ossicular Replacement ; Otitis Media ; Prostheses and Implants ; Stapes ; Tympanic Membrane