Discussion of Application Status and Key Attentions on Registration for Ossicular Replacement Prosthesis / 中国医疗器械杂志

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.

The Diagnosis and SurgicaI Treatment of Trauma Induced Stapes Fracture / 听力学及言语疾病杂志

Objective To analyze the medical and audiological features of trauma induced stapes fracture ,and to summarize the key diagnostic points and to observe the effects of surgical treatment .Methods Five patients with trauma induced stapes fracture confirmed by the surgical exploration from January 1995 to October 2013 were retro_spectively reviewed .Ossicular chain reconstruction was performed on each patient .The preoperative and postopera_tive pure-tone thresholds were compared to judge the effects of surgical treatment .ResuIts The surgical explora_tion revealed 4 cases of stapes feet fracture ,1 case of stapes neck fracture with temporal bone fracture and peripheral paralysis of the facial nerve .Different types of ossicular reconstruction were performed according to the exploration results:2 cases with autogenous stapes remodeling ,1 case with allogenous stapes remodeling ,1 case with bone piece of external acoustic meatus ,and 1 case with artificial auditory ossicle(TORP) implanting .Additionally ,the case of peripheral paralysis of the facial nerve received facial nerve decompression .After the operation ,5 patients felt that their hearing was improved .The mean postoperative pure-tone threshold was 30 .7 dB HL ,and the mean ABG(air-bone-gap) was 18 dB HL while the mean preoperative pure-tone threshold was 61 dB HL(t=6 .725 ,P<0 .05) and the mean ABG was 38 .7 dB HL(t=3 .616 ,P<0 .05) .The facial nerve functions of the case with facial paralysis recovered to House-Brackmann Grade I three months after receiving facial nerve decompression .ConcIu_sion Stapes fractures are rare .Being different from the general conductive hearing loss ,patients with stapes fracture usu_ally have the acoustic stapedius reflex .Through ossicular reconstruction ,we can yield a satisfying hearing recovery .

A comparative study of ossiculoplasty by using various graft materials.

Introduction: The use of ossicular graft material in the ossicular chain reconstruction has significantly improved the results in the hearing after the tympanoplasty and tympanomastoid surgery for the chronic otitis media. The ossicular chain transmits the vibration of tympanic membrane to the inner ear with impedance matching function failure to which results in > 50dB hearing loss of conductive variety. Material and Method: A Prospective study of 76 patients who underwent ossiculoplasty was done in the department of ENT & Head and Neck Surgery , Sir T. Hospital ,Bhavnagar, Gujarat between May 2007 to June 2009.Only patients with conductive hearing loss were included in study and underwent ossiculoplasty with using various graft material and assessment done by post operative closure of air bone gap. Most available graft material used are auto graft, cartilage and bone, and various biosynthetic materials like gold,Teflon,plastipore,titanium etc. Results: Majority of patients are middle age group with moderate conductive hearing loss. The comparison of hearing improvement between various graft materials at 2 month and 5 months post operatively were studied in the relation to the postoperative air bone gap closure shows that auto graft and gold prosthesis are cost effective with comparable results obtained as by expensive titanium and plastipore prosthesis. Discussion & Conclusion: The ossiculoplasty materials produce varying results. The titanium and plastipore are rather expensive for the Indian patients , particularly for the government hospital poor class patients. We have tried to evaluate the results using the economical and readily available graft materials like cartilage, bone and gold prosthesis for ossiculoplasty and compared its results with costly plastipore and titanium prosthesis. prosthesis

Hearing Results of Tympanoplasties in 175 Patients with Chronic Otitis Media / 대한이비인후과학회지

BACKGROUND AND OBJECTIVES: To report the hearing results of tympanoplasty for chronic otitis media with or without cholesteatoma. SUBJECTS AND METHOD: One hundred and seventy-five patients presenting chronic otitis media with or without cholesteatoma were involved in a retrospective study. Tympanoplasties were performed by the same surgeon over a 30-month period. Audiometric results were reviewed. Audiometric results according to the following techniques were measured: tympanoplasty type 1 (T1), interposition (Si) and/or columella (Sc) over stapedial head, and interposition or columella (Fic) over footplate. The follow-up period ranged from 6 to 32 months. Audiological parameters using the average of four frequencies were assessed pre- and post-operatively. RESULTS: Overall hearing results showed postoperative air-bone gaps (ABG) < or =20 dB in 69% of cases. ABG was closed to within 20 dB in 89% for T1, 67% for Sc, 58% for Si, and 30% for Fic. ABG was closed to within 30 dB in 95% for T1, 67% for Sc, 83% for Si, and 70% for Fic. There was a significant improvement between preoperative and postoperative ABGs. The overall improvement of the air-bone gap was 8+/-13 dB. There was no significant functional difference between different surgical techniques. CONCLUSION: Our hearing results after tympanoplasties were similar to those from other studies. The hearing results observed in this study confirmed that successful results can be obtained by applying the current principles and approach to ossicular reconstruction.

Assessment on the results of hearing improvement achieved through surgery, with partial ossicular reconstruction prothesis using bioceramic and autograft bone in patients with chronic otitis media

Background: In Viet Nam, chronic otitis media is a relatively common disease, accounting for 2-4% of the population. The most common sequalae of chronic otitis media is hearing deficiency. One of the most severe hearing deficiency causes of chronic otitis media is ossicular damages. In developed countries, the partial ossicular reconstruction prosthesis by various materials is relatively common.The partial ossicular reconstruction prosthesis is still limited in Viet Nam.Objectives: To assess the results of hearing improvement after the surgery of partial ossicular reconstruction prothesis and compare the effects of bioceramic and autograft bone. Subjects and method: A study was performed on 135 patients with chronic otitis media who were submitted to partial ossicular reconstruction prostheses with bioceramic and autograft bone at the National Ear Nose Throat Hospital. This was a prospective study. Results: PTA was 54.5 +/- 12.6 dB for four frequencies (0.5, 1, 2, and 3 kHz) in pre-operation, compared to 33.8 +/- 12.8 dB at 6 months after the operation. The ABG improvements for four frequencies and PTA with bioceramic and autograft bone were 18.28 +/- 11.85 dB, 17.99 +/- 10.42 dB, and 18.46 +/- 12.26 dB, 18.81 +/- 11.56 dB, respectively. Conclusions: The hearing levels and ABG were better in post-operation than those in pre-operation. The improvements of hearing levels after the ossiculoplasty using bioceramics was similar to those using autograft bone.

Postoperative Results of Tympanoplasty Type III and IV / 대한이비인후과학회지

BACKGROUND AND OBJECTIVES: The treatment goal of both chronic and cholesteatomatous otitis media is to irradicate inflammation and to improve hearing. Recently, it has become more important to improve hearing acuity, and thus ossicular reconstruction has become essential in middle ear surgery. To find out the effective method of ossiculoplasty, we analysed tympanoplasty cases, especially type III and IV by Wullstein, performed in our hospital. MATERIALS AND METHOD: 120 cases of type III and IV tympanoplasty performed from January 1995 to December 2000 were analysed. Age and sex distribution, success rate of hearing improvement, recurrence rate of infection, and extrusion rate were analysed according to implanted material and type of surgery. RESULTS: 1) Success rate of hearing improvement according to the implanted material were 35.7%, 33.3%, 43.5%, and 29.2% in fascia, TORP, PORP, and autologous ossicle, respectively. The success rate was highest for the PORP group and with the average of 37.5%. 2) Recurrence rate of infection according to implanted material were 4.8%, 4.2%, 4.3% with fascia, TORP, and PORP, respectively. Infection was the highest in the autologous ossicle (12.3%), and the average recurrence rate was 6.7%. 3) Extrusion rates according to implanted material were 12.5% (TORP), 4.3% (PORP), and 0%(autologous ossicle). The average was 5.1%. 4) Success rate of hearing improvement according to type of surgery were 51%, 46.7%, and 33.3% in atticotomy, intact canal wall mastoidectomy and open cavity mastoidectomy, respectively. The surgery which conserves the middle ear structure tended to have high success rate. 5) Recurrence rate of infection according to type of surgery were 8%, 6.7%, 6.1% in atticotomy, intact canal wall mastoidectomy, and open cavity mastoidectomy, respectively. CONCLUSION: To obtain better results by operating, we should consider the kind of implantation material and proper type of operation. For better hearing improvement, it is preferable to use TORP or PORP instead of autologous ossicles. Although TORP and PORP tend to extrude more frequently than ossicles, they are still better than autologous ossicles if recurrence of infection is considered. Therefore, it is more preferable to use biocompatible materials such as TORP and PORP with adequate type of operation for tympanoplasty III and IV cases.