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

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

BACKGROUND AND OBJECTIVES: Multiple techniques of ossicular replacement have been advocated for hearing gain in the setting of chronic otitis media. The purpose of this study is to investigate hearing gain in the middle ear surgery according to the surgical technique and the materials. MATERIALS AND METHOD: Ninety-nine cases with ossicular replacement with mastoidectomy in the Konkuk University Hospital from 1995 to 2001 were reviewed retrospectively. Postoperative hearing gains were compared with the two methods of mastoidectomy and the two materials of ossicular replacement separately. RESULTS: A successful hearing gain was defined as a postoperative air-bone gap less than 30dB. According to this criterion, 47% of intact canal wall mastoidectomy cases and 43% of open cavity mastoidectomy cases were successful. Thirty-one percent of ossicular replacement case using cartilage-perichondrium and 62% using hydroxyapatite-PORP were successful. The extrusion rate was zero % in ossicular replacement using cartilage-perichondrium, and 57% in ossicular replacement using PORP. CONCLUSION: There was a significant differences in hearing gain and extrusion rate by using two different materials for ossicular replacement such as cartilage and hydroxyapatite-PORP (p<0.05). There was no statistically significant differences in hearing gain between the two methods of mastoidectomy (p>0.05).
Cartilage ; Ear, Middle ; Hearing* ; Incus* ; Malleus* ; Ossicular Prosthesis ; Ossicular Replacement ; Otitis Media ; Retrospective Studies

OBJECTIVE: To evaluate the results in patients who had ossicular chain reconstruction with a new type ossicular prostheses mixed bone morphogenetic protein and hydroxyapatite. METHOD: Analyze The effect of ossiculoplasty were analyzed in 59 cases. Ossiculoplasty using HA-BMP prostheses was performed in 26 ears,PORP was performed in 19 ears, TORP was performed in 7 ears. RESULT: The hearing success rate was 92.3% of 26 ears and no extrusion were found in HA-BMP group. There was a significant difference in mean postoperative air-bone gap between HA-BMP prostheses and autograft bone. CONCLUSION The new type HA-BMP prostheses can provide stable hearing results with high success rate over time.
Adult ; Bone Morphogenetic Proteins ; Bone Substitutes ; Female ; Humans ; Male ; Ossicular Prosthesis ; Ossicular Replacement ; Tympanoplasty

BACKGROUND AND OBJECTIVES: During the last decade, the surgical use of alloplasts has become more and more widespread among otologists. In this study, we evaluated the hearing results of ossiculoplasty using Polycel(R) prosthesis. SUBJECTS AND METHOD: One hundred eighty eight cases who underwent ossicular chain reconstruction using Polycel(R) prosthesis and had been followed up postoperatively for more than 12 months at Severance Eye-ENT Hospital from 1998 to 2002 were reviewed retrospectively. Postoperative hearing results were assessed by measuring the postoperative air-bone gap (ABG) and closure in air-bone gap. Successful postoperative ABG criteria were defined as the following three groups ; ABG of < or =10 dB, ABG of < or =20 dB, and ABG of < or =30 dB. Several prognostic factors such as the condition of middle ear mucosa and ossicles, presence or absence of cholesteatoma, surgical method, staging and revision surgery were analyzed. RESULTS: Of the total of 188 cases, 22 cases (11.7%) were < or =10 dB ABG, 96 (51.1%) cases were < or =20 dB ABG, and 158 (84.0%) cases were < or =30 dB ABG. The hearing results were good for healthy middle ear mucosa and cases which contained stapes superstructure, the hearing results were Good. CONCLUSION: Polycel(R) is a good material to be used in ossiculoplasty as a hydroxyapatite and autologous bone. In ossiculoplasty, good prognostic factors of the middle ear condition were healthy middle ear mucosa and the presence of stapes superstructure.
Audiometry ; Cholesteatoma ; Durapatite ; Ear, Middle ; Hearing* ; Mucous Membrane ; Ossicular Prosthesis ; Ossicular Replacement ; Polyethylene ; Prostheses and Implants* ; Retrospective Studies ; Stapes

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

BACKGROUND AND OBJECTIVES: Various materials have been used for ossicular reconstruction, but there have been no reports for titanium prosthesis in South Korea. The purpose of this study was to assess the hearing results of Kurz titanium prosthesis in chronic ear diseases. SUBJECTS AND METHOD: A retrospective review was made of 62 cases who underwent ossicular reconstruction using either titanium (TTP(R)-VARIO System) or plastipore (Polycel(R)) prosthesis from January 2003 to July 2005. Postoperative hearing results were analyzed taking in several prognostic factors such as the condition of middle ear mucosa and ossicle, or surgical method. RESULTS: A postoperative air-bone gap of E20 dB was obtained in 75.6% of the titanium and 56% of plastipore ossiculoplasty. The Postoperative ABG (air bone gap) show better results in healthy middle ear mucosa and in those cases which contain stapes superstructure. CONCLUSION: Titanium have a good biocompatibility and low extrusion rates with excellent hearing results. Besides, good visualization and accurate placement were easy to achieve.
Ear Diseases ; Ear, Middle ; Hearing ; Korea ; Mucous Membrane ; Ossicular Replacement ; Prostheses and Implants* ; Retrospective Studies ; Stapes ; Titanium*

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

BACKGROUND AND OBJECTIVES: Primary goals of surgery for chronic ear disease are infection control and hearing restoration. When performing ossiculoplasty with total ossicular replacement prosthesis (TORP), it is difficult to keep the prosthesis stable. We intended to establish a method for stabilizing TORP in ossiculoplasty and to evaluate the results of the procedure. SUBJECTS AND METHOD: Thirty nine cases of ossiculoplasty performed between January 2000 and February 2003 were analyzed. The follow-up period was from 6 to 31 months (mean 13.1). The pure tone average threshold of the frequencies of 0.5, 1, 2, 3 kHz was used to evaluate results. The degree of hearing improvement, previous mastoid operation method, disease, and extrusion rate of prosthesis were analyzed. To stabilize the TORP, we made a hole in the tragal cartilage and put the shaft of the prosthesis into the hole. RESULTS: A successful hearing gain was defined as a postoperative air-bone gap of < or = 20 dB. According to this criteria, the success rate was 43.6%. Averages of pre and postoperative air conduction were 57.6 dB and 47.1 dB, respectively. The degree of hearing improvement according to the types of mastoid surgery were 48.1% and 33.3% for intact canal wall mastoidectomy and open cavity mastoidectomy, respectively. Four patients underwent reoperation. The findings were 2 cases of short TORP and 2 cases of empty middle ear space, but prostheses were stable in each case. There was one case of extruded prosthesis (2.6%). CONCLUSION: With our method, TORP was kept stable in the oval window niche. However, for hearing improvement, other factors such as middle ear mucosa status or Eustachian tube function are important and further investigation is needed.
Cartilage ; Ear Diseases ; Ear, Middle ; Eustachian Tube ; Follow-Up Studies ; Hearing ; Humans ; Infection Control ; Mastoid ; Mucous Membrane ; Ossicular Prosthesis* ; Ossicular Replacement ; Prostheses and Implants ; Reoperation

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