[Discussion of Application Status and Key Attentions on Registration for Ossicular Replacement Prosthesis].

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.

Which is Better for Ossiculoplasty Following Tympanomastoidectomy: Polycel® or Titanium?

OBJECTIVES: The purpose of this study was to compare the surgical outcomes of Polycel® and titanium in ossiculoplasty following tympanomastoidectomy (TM). METHODS: A total of 221 patients underwent ossiculoplasty following TM by a single surgeon using either Polycel® or titanium as prosthesis. Hearing was tested preoperatively and postoperatively at 6 months by pure-tone audiometry. Successful surgery was defined if postoperative air-bone gap (ABG) was <20 dB, the gain in air conduction (AC) hearing was >15 dB HL, or postoperative AC was <30 dB HL. Multiple linear regression was conducted to identify the factors associated with the surgical outcomes. RESULTS: In canal wall up mastoidectomy (CWUM), both Polycel® and titanium showed favorable successful rates if partial ossicular replacement prosthesis (PORP) was used (64.3% of Polycel® and 67.6% in titanium). If total ossicular replacement prosthesis (TORP) was used, both represented similar outcomes (54.5% of Polycel® and 75.0% in titanium). In canal wall down mastoidectomy (CWDM), significant ABG reductions were observed only in the titanium group (5.2 ± 14.7 dB of Polycel® [P = .083] and 7.0 ± 14.2 dB of titanium [P = .002] in PORP; 4.6 ± 13.5 dB of Polycel® [P = .097] and 9.5 ± 11.2 dB of titanium [P < .001] in TORP). In multivariate analysis, titanium had a positive effect on the reduction of postoperative AC thresholds (B: -4.772; 95% CI: -8.706--0.838). CONCLUSIONS: Both Polycel® and titanium showed favorable surgical outcomes for ossiculoplasty following CWUM. Titanium prosthesis is recommended for surgery after CWDM.

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.

Imaging of the Postoperative Temporal Bone.

Evaluation of the postoperative temporal bone can be difficult given the complex anatomy of this region and the myriad surgical approaches for management of a variety of conditions. This article provides an understanding of common postsurgical changes of the temporal bone and their typical imaging appearances. Ultimately, greater radiologist knowledge of postoperative temporal bone imaging findings will help to serve patients and referring clinicians with prompt diagnosis and recognition of expected postintervention changes compared with postoperative complications and/or disease recurrence.

Monograph on Tympanosclerosis-Clinico-Pathological Corelation and Surgical Outcome: A Retrospective Study.

A retrospective study was conducted at a tertiary ENT care hospital with following aims, methodology and results: (1) To know the incidence of tympanosclerosis. (2) To classify tympanosclerosis surgically as well as histologically. (3) To know the long term hearing outcome of Tympanosclerosis surgery. It is a retrospective study at an ENT Hospital Centre in eastern India. Hospital ethical board clearance was duly obtained. All cases of tympanosclerosis were documented with special reference to surgical procedure, areas of involvement and postoperative hearing outcome. In this study, 90 cases of tympanosclerosis was found in 1880 cases of tympanomastoidectomies in 8 years and had been divided into (1) Myringosclerosis (60 cases, 66.6%), (2) Ossicular Tympanosclerosis without involvement of footplate (23 cases, 25.6%), (3) Ossicular Tympanosclerosis with involvement of footplate (7 cases, 7.8%). Treatment options included osssicular mobilization keeping ossicular integrity and mobility, Total or partial ossicular prosthesis after removal of incus & stapes suprastructure, stapedectomy with Long malleus-footplate piston. Overall good hearing outcome (i.e., postoperative air-bone gap less than 20 dB) was noticed in 85.5% of cases of Tympanosclerosis. Removal of tympanosclerosis with keeping the osssicular chain intact is the key to success; results are not favourable if footplate is totally fixed with disease.

[Clinical application of transcanal endoscopic ear surgery in the diagnosis and treatment of conductive hearing loss with intact tympanic membrane].

Objective:To explore the clinical efficacy of transcanal endoscopic ear surgery in the diagnosis and treatment of conductive hearing loss with intact tympanic membrane. Method:The clinical data of 16 patients with conductive hearing loss with intact tympanic membrane were retrospectively analyzed. They were diagnosed and treated by transcanal endoscopic ear surgery. Result:All patients were diagnosed by exploratory tympanotomy, including 6 cases of congenital middle ear anomalies, 5 cases of congenital cholesteatoma, 2 cases of congenital middle ear anomalies with congenital cholesteatoma, 2 cases of otosclerosis, and 1 case of traumatic ossicular chain disruption. During the tympanic exploration by transcanal endoscopic ear surgery, different methods of hearing reconstruction were applied according to the intraoperative lesions. Among 14 cases（14 ears）, 7 patients underwent reconstruction with partial ossicular replacement prosthesis （PORP）, 5 patients had total ossicular replacement prosthesis （TORP）, and 2 patients had piston. The remaining 2 patients did not undergot ossicular reconstruction. After the operation, the mean air-conductive threshold of 14 patients decreased from （61.7±6.5） dB HL to （29.8±10.7） dB HL （P<0.01） and the mean ABG decreased from（36.8±3.2） dB HL to （10.7±6.9） dB HL （P<0.01）. 1 case of congenital middle ear anomalies with congenital cholesteatoma underwent the lesion resection without ossicular reconstruction. Due to lack of suitable Piston, 1 case of congenital middle ear anomalies with fixed stapes did not perform hearing reconstruction. No serious complications occured after operations. Conclusion:Transcanal endoscopic ear surgery was suitable for the diagnosis and treatment of conductive hearing loss with intact tympanic membrane. It was minimally invasive with low complications, and the patients had a good hearing recovery after ossicular reconstruction.

Comparison of total and partial ossicular replacement prostheses in patients with an intact stapes suprastructure.

OBJECTIVES: To compare the results of ossiculoplasty with two different partial ossicular replacement prostheses (PORP) to ossiculoplasty with a total ossicular replacement prosthesis (TORP) in patients with an intact stapes suprastructure. METHODS: All patients required primary or revision surgery for chronic middle ear disease and ossicular reconstruction with either a PORP or a TORP, as well as a with an intact stapes suprastructure. In total, 141 patients receiving classic tympanoplasty with PORP (N = 92), ossiculoplasty with PORP with ball joint (N = 22), or TORP (N = 27) between January 2011 and March 2017 were included in this study. The inclusion criterion was an intact stapes suprastructure. The underlying indication for surgery was either middle ear disease, such as cholesteatoma, or revision surgery for audiological improvement. The main outcome measures were four-frequency pure tone average (0.5, 1, 2, 3 kHz) at early and late follow-up after ossiculoplasty, the effects of clinical factors including the underlying middle ear disease, and primary or revision surgery. RESULTS: All patients showed a significantly reduced air-bone gap (ABG 0.5, 1, 2, 3 kHz) at late follow-up (mean: 18 dB) compared to preoperative measurements (mean: 25.5 dB). A significantly better outcome in ABG closure was shown among patients with a preoperatively intact tympanic membrane, with an intact stapes suprastructure or without preexisting cholesteatoma. Outcome was not significantly influenced by the prosthesis-type, the creation of an open mastoid cavity, the status of the mucosa, or the indication for surgery. CONCLUSION: TORP with an intact stapes suprastructure is a safe procedure and provides audiological outcomes similar to PORP. LEVEL OF EVIDENCE: 2C Laryngoscope, 130:768-775, 2020.

A Study of Use of Autologous Cartilage in Ossicular Reconstruction.

Ossiculoplasty is one of the commonly done and challenging surgery in otology and has been done using various graft materials. Materials such as autologous cartilage (tragal or conchal) or allograft (homograft) of the same tissue and synthetic materials like polyethylene TORP, ceramic and hydroxyapatite PORP or Titanium prosthesis have been used. But the latter synthetic materials are expensive and have high extrusion rates. Autologous cartilage grafts are selected for Ossiculoplasty as they are easy to harvest at the same site of operation, non-toxic, has less extrusion rate, minimum shrinkage and lateralization. The aim of this study is to know the efficacy of cartilage in ossicular reconstruction and to evaluate hearing outcome. It is a prospective study done on patients attending ENT outpatient department at hospitals attached to J.J.M Medical College, Davanagere. 50 patients were included in the study who underwent ossicular reconstruction either with canal wall up or down mastoidectomy with tympanoplasty. Pre-operative mean ABG was 39.3 db whereas 6 months post-operative mean ABG was 31.6 db with mean ABG improvement of 7.7 db which was statistically significant. Hearing improvement is better in cases where stapes suprastructure was present and also in canal wall up mastoidectomy procedures. This study suggests that cartilage graft (tragal and conchal) is effective in cases of ossicular reconstruction in patients of chronic otitis media and gives good hearing gain. It is also a economical option in developing countries.

Utilization of incus with bone cement for total ossicular reconstruction.

Background: Total ossicular chain reconstructions are performed to connect mobile stapes footplate and tympanic membrane. Data on the use of incus for total ossicular reconstruction is quite limited in the literature. Objective: The main objective of this study is to describe a novel surgical method that utilizes incus with bone cement to stabilize the ossicular chain for total ossicular reconstruction. Materials and methods: 16 patients who underwent total ossicular reconstruction using our method were included in this study. We evaluated hearing by comparing preoperative and postoperative air-bone gap (ABG), air conduction (AC) and bone conduction (BC). The percentage of patients achieving ABG ≤20 dB was determined. Results: The mean preoperative ABG was 35.3 ± 8.2 and postoperative ABG decreased significantly to 23.7 ± 7.6 (p < .001). The mean preoperative AC (57.5 ± 10) decreased significantly postoperatively to (46.5 ± 13.3)(p = .014). There was not any difference between pre- and post-operative BC. We achieved successful hearing results (ABG ≤ 20dB) in 44% of patients. Conclusion: The use of incus with bone cement stabilization for total ossicular reconstruction seems a feasible option. Good hearing outcomes, and low cost, complication, and extrusion rate may be the main reasons to prefer this method.

From the laboratory concept to clinical trials: the journey of Otoimplant so far.

INTRODUCTION: Nowadays, the role of alloplastic prostheses has become more important in ossicular chain reconstruction. Especially, bioactive medical devices may be an alternative for those currently used on the market. Areas covered: Medical devices which are implanted for over 30 days in the body are required to fulfill strict requirements. It is crucial to ensure the proper level of biocompatibility, biological stability and lack of cytotoxicity of the implanted material. If a medical device is expected to play an additional role, e.g. act as a bioactive or bactericidal agent, supplementary tests should be conducted to assess the relevant qualities. The aim of this article is to present the sequence of procedures leading to the success of a middle ear prosthesis called Otoimplant - from a theoretical concept to the clinical trial. Expert commentary: However, to introduce a new prosthesis into the market, research such as, in vitro, in vivo and clinical trials are required to keep medical devices approved. This article describes a research path that medical device ought to negotiate before the clinical trials may start.

Hearing Outcomes after Ossicular Reconstruction with Removal of the Malleus.

Objectives (1) Evaluate hearing outcomes of patients after planned malleus removal during ossicular chain reconstruction. (2) Analyze hearing results for titanium (Ti) and hydroxyapatite (HA) total ossicular prostheses (TOPs) and partial ossicular prostheses (POPs). (3) Compare Ti and HA partial prostheses. Study Design Retrospective case series with chart review. Setting Tertiary health care organization. Subjects and Methods A chart review was conducted of 139 consecutive patients who presented with chronic otitis media with perforation (with or without cholesteatoma) and were treated with initial-stage tympanoplasty (with or without mastoidectomy) and managed with TOP (n = 22) or POP (n = 117) between July 2010 and July 2015. The malleus was completely removed in all cases. Hearing was assessed via bone and air conduction pretone averages (0.5, 1, 2 kHz) pre- and postoperatively. Air-bone gap (ABG) and change in ABG (ΔABG) were analyzed. Pre- and postoperative values were compared. Results The overall mean ABG decreased from 29.4 ± 12.3 dB to 18.2 ± 11.4 dB postoperatively ( P < .001) with a mean ΔABG of 14.5 dB (95% CI, 12.793-16.203). Overall success was achieved by 69.1%. The POP group achieved higher success (70.9%) than the TOP group (59.1%; P = .0001). Mean ABG decreased significantly within surgical groups (TOP and POP) and prosthesis material groups (Ti and HA; all P < .001). Ti had statistically higher success than HA in both techniques: POP ( P = .0478) and TOP ( P = .0251). There was a 98% graft take rate. Conclusion Planned malleus removal during ossicular chain reconstruction, regardless of disease extent, allows for simpler reconstruction and comparable favorable results to preservation of the malleus and should be considered during surgical planning.

Middle Ear Prosthesis with Bactericidal Efficacy-In Vitro Investigation.

Materials used in ossicular replacement prostheses must possess appropriate biological properties, such as biocompatibility, stability, no cytotoxicity. Due to the risk of infection (otitis media and chronic otitis media), it is desirable to use an antibacterial agent for illness prevention during the ossicular reconstruction. The goal of this work was to observe biological properties of a new composite prosthesis made of ABS containing silver nanoparticles (AgNPs 45T). Samples for biological tests and then a prototype of middle ear prosthesis were prepared using injection moulding and extrusion techniques. In vitro experiments were carried out to assess bactericidal efficacy against Staphylococcus aureus and Pseudomona aeruginosa standard strains, cell proliferation, viability and cytotoxicity, using Hs680.Tr. fibroblast cells. Surface parameters of the samples were evaluated, including roughness and wettability. The silver ions were continually released from the polymer in aqueous solution. The silver ions release was measured as increasing with time and concentration of the silver nanoparticles in the polymer matrix. No cytotoxicity effect was observed, while bactericidal efficacy was noticed for silver nanoparticles. The roughness studies showed an increase in roughness for the samples with silver nanoparticles. All polymer and composite materials containing silver nanoparticles showed hydrophilic properties. The composites were found to release silver ions at a concentration level capable of rendering the antimicrobial efficacy even with the lowest concentration of silver nanoparticles in the material. Our results demonstrate that middle ear prosthesis made of polymer and silver nanoparticles may eliminate bacteria during inflammation in the middle ear.

Role of Autologous Versus Homologous Cartilage in Ossicular Reconstruction: A Comparative Study.

Ossicular discontinuity is the most common cause of conductive hearing loss. The use of ossicular graft material in ossicular chain reconstruction significantly improves the result in hearing. This study was conducted to compare and analyze the outcome of ossicular reconstruction using autologous conchal cartilage and homologous septal cartilage in terms of hearing results and graft uptake rates. Study design Randomized clinical trial. Study included 100 patients visiting the ENT department of government medical college. Patients between 16 and 50 years of age with history of chronic ear discharge and minimum air bone gap of 20 dB were included in the study. The patients underwent detailed ENT examination, audiological and radiological assessment of temporal bone and those patients with evidence of ossicular erosion were subjected to ossiculoplasty with autologous conchal cartilage (group I) and homologous septal cartilage (group II) randomly. The patients were followed up after 3 and 6 months to analyze functional and anatomical results. Out of 50 patients from group I who underwent autologous cartilage ossicular reconstruction 35 patients (70 %) showed significant improvement in hearing as assessed by pure tone audiogram after 6 months as compared to 34 patients (68 %) with homologous cartilage reconstruction. Complications and extrusion rates were almost similar in both the groups. Hearing results in both the groups are almost comparable but the homologous preserved cartilage being readily available is an equally good option for ossicular reconstruction.

Comparison of Titanium vs. Polycel Total Ossicular Replacement Prosthesis.

INTRODUCTION: Even though modern technology progresses so rapidly, annals of otology are replete with so many challenging article, which often compare various types of prosthesis. Since there has not been a prospective randomized clinical trial study which compares the hearing result of total ossicular replacement prosthesis made of Titanium with omega connector and Polycel in the literature, we decided to perform a study encompassing this issue. MATERIALS AND METHODS: 105 patients, who were in the 2nd stage of their operation and who needed total ossicular replacement prosthesis, were included in this prospective single blind randomized clinical trial study. Patients were classified in two groups: titanium Kurz (TTP™ -Vario system, Kurz GmbH, Dusslingen, Germany) with omega connector and Polycel (Sheehy Plastipore Polycel, Medtronic Xomed Inc). The duration of the follow up was 6-12 months. In order to evaluate hearing results, pure tone audiometric in 0.5, 1, 2, and 4 kHz were checked. In addition, speech reception threshold was recorded. A successful surgery was defined as having a postoperative air-bone gap within 20 dB. RESULTS: We accomplished successful hearing in 64.4% of patients with titanium and 65% of patients with a Polycel prosthesis.Improvement in speech reception threshold was 11.5 dB in the titanium group and 13 dB in the Polycel group. In other words, there was no significant difference between the two groups. In addition, air-bone gap improvement after ossiculoplasty was 11.2 dB in the patients with a titanium prosthesis and 12.4 dB in the Polycel group. In fact, the difference was not significant. CONCLUSION: We found that both the titanium and the Polycel prosthesis improve speech reception threshold and air-bone gap closure in a similar manner.

First results of a novel adjustable-length ossicular reconstruction prosthesis in temporal bones.

OBJECTIVES/HYPOTHESIS: The performance of an ossicular replacement prosthesis (ORP) is influenced by its alignment and appropriate tension between the tympanic membrane and the stapes footplate. A novel ORP with a flexible element that potentially allows for length adjustment in situ is presented and tested for acoustic performance. STUDY DESIGN: Laser Doppler vibrometry in fresh human cadaveric temporal bones was used to test the acoustic performance of the adjustable ORP relative to standard prostheses used for ossiculoplasty. METHODS: The three-dimensional (3D) velocity of the stapes posterior crus was measured in the 0.2- to 20-kHz range using a Polytec CLV-3D laser Doppler vibrometer. The middle ear cavity was accessed through a facial recess approach. After measuring the normal response, the incus was removed and stapes velocity was measured in the disarticulated case, then after insertion of the new prosthesis, a conventional prosthesis (Kurz BELL Dusseldorf type), and a sculpted autologous incus prosthesis in each temporal bone. The 3D stapes velocity transfer function (SVTF) was calculated for each case and compared. RESULTS: The novel ORP design restored stapes velocity to within 6 dB (on average) of the intact response. No significant differences in 3D-SVTF were found between the new, conventional, or autologous ORPs. CONCLUSIONS: The inclusion of an in situ adjustable element into the ORP design did not adversely affect its acoustic performance. The adjustable element may increase the ease of achieving optimal ORP placement, especially through a facial recess approach. LEVEL OF EVIDENCE: NA Laryngoscope, 126:2559-2564, 2016.

Congenital oval or round window malformations in children: Surgical findings and results in 17 cases.

OBJECTIVES/HYPOTHESIS: To prospectively evaluate surgical findings and hearing results in children undergoing surgery for congenital oval or round window malformations (class IV malformations). STUDY DESIGN: A nonrandomized, nonblinded, case series of prospectively collected data. METHODS: Fourteen consecutive pediatric patients who underwent 17 surgical procedures for congenital oval or round window malformations in a tertiary referral center were included. Postoperative pure-tone audiometry was available in 15 cases. The surgical technique for repair of the ossicular chain was dictated by the surgical findings at the time of surgery. The majority of the cases underwent ossiculoplasty using a Teflon piston, bucket-handle prosthesis, or total ossicular replacement prosthesis. Associated surgical techniques included malleus relocation and oval window drill-out procedure. The main outcome measures were preoperative and postoperative hearing status using four-frequency (0.5, 1, 2, and 4 kHz) audiometry. Air-conduction thresholds, bone-conduction thresholds, and air-bone gap were measured. Postoperative audiometry was performed at 3, 6, 9, 12, 18, and 24 months after surgery and at a yearly interval thereafter. RESULTS: Postoperative air-bone gap closure to 10 dB or less was achieved in 47%. A postoperative air-bone gap closure to within 20 dB or less was achieved in 60%. Postoperative sensorineural hearing loss did not occur in this series. CONCLUSIONS: Middle ear surgery for class IV abnormalities is feasible, but success percentages are much lower compared to other types of congenital ossicular malformations. Surgeons should be particularly careful in case of facial nerve abnormalities on computed tomography or during middle ear exploration. LEVEL OF EVIDENCE: 4 Laryngoscope, 126:2552-2558, 2016.

Hearing outcome after sequential cholesteatoma surgery.

The objective of this study was to assess hearing outcome after sequential cholesteatoma surgery stratified for exclusively transcanal technique (ETC), combined transcanal and transmastoidal technique (TCM) and canal wall down surgery (CWD) and to analyze the impact of ossicular reconstruction technique (partial ossicular replacement prostheses/PORP and total ossicular replacement prostheses/TORP) on hearing outcome. This study is a retrospective case review and clinical case study conducted in a tertiary referral center. Patients who underwent 376 cholesteatoma surgeries (2007-2009) and 92 ears in clinical re-examination at least 12 months postoperatively were included. Sequential cholesteatoma surgery with ETC, TCM, or CWD; ossiculoplasty with PORP or TORP were the interventions administered. Pre- and postoperative air-bone gap (ABG) and air conduction threshold (AC) for 0.5-3 kHz were the main outcome measures. Overall, the mean preoperative ABG decreased from 25.3 ± 1.3 to 19.8 ± 0.9 dB with a mean ABG closure of 5.4 ± 1.3 dB (p ≤ 0.001). According to surgical technique, the postoperative ABG after CWD 23.5 ± 2.1 was significantly worse compared to ETC (17.3 ± 1.0 dB, p < 0.05) and TCM (19.4 ± 1.3 dB). A significant ABG closure was observed after ETC (6.8 ± 2.0 dB, p < 0.01) and TCM (6.5 ± 2.0 dB, p < 0.01) contrary to CWD (2.1 ± 2.9 dB, p > 0.05). Patients receiving PORP showed a significantly less ABG postoperatively (19.0 ± 0.9 dB, p ≤ 0.05) compared to the TORP group (24.1 ± 2.5 dB). However, a significant hearing gain was assessed after PORP- (4.7 ± 1.6 dB, p ≤ 0.01) and TORP- implantation (10.4 ± 3.7 dB, p ≤ 0.01). Sequential cholesteatoma surgery allowed for an excellent hearing outcome postoperatively. An intact posterior canal wall and a present stapes suprastructure were identified to predict a significantly superior hearing result. In addition to the technical and prosthetic considerations, the audiological outcome was confounded by the attending middle ear pathology.

Congenital ossicular chain malformations with mobile stapes in children: Results in 17 cases.

OBJECTIVES/HYPOTHESIS: To prospectively evaluate surgical findings and hearing results in children undergoing surgery for congenital malformations of the ossicular chain with a mobile stapes footplate (Teunissen and Cremers class III malformations). STUDY DESIGN: A nonrandomized, nonblinded, prospective case series. METHODS: Fifteen consecutive pediatric patients who underwent 17 surgical procedures for congenital ossicular malformations with a mobile stapes at a tertiary referral center were included. In 16 cases, postoperative pure-tone audiometry was available. The surgical technique for repair of the ossicular chain was dictated by the surgical findings at the time of surgery. The majority of the cases underwent ossiculoplasty. A Teflon piston, partial ossicular replacement prosthesis, or total ossicular replacement prosthesis was used in these cases. Associated surgical techniques included malleus relocation, Silastic banding, drilling out of a bony bridge, and a combination of these techniques. Hearing loss was evaluated using preoperative and postoperative four-frequency (0.5, 1, 2, and 4 kHz) audiometry. Air-conduction thresholds, bone-conduction thresholds, and air-bone gaps were measured. Postoperative audiometry was performed at 3, 6, 9, 12, 18, and 24 months after surgery and at a yearly interval thereafter. RESULTS: Overall, a postoperative air-bone gap closure to 10 dB or less was achieved in 63% of the included cases. A postoperative air-bone gap closure to 20 dB or less was achieved in 75%. Postoperative sensorineural hearing loss did not occur in any of the cases. CONCLUSIONS: Ossicular reconstruction is a feasible treatment option in children with congenital malformations of the ossicular chain with a mobile stapes footplate. LEVEL OF EVIDENCE: 4. Laryngoscope, 126:682-688, 2016.

Pediatric ossiculoplasty with titanium total ossicular replacement prosthesis.

OBJECTIVES/HYPOTHESIS: To assess the medium-term efficacy of total ossicular reconstruction with a titanium total ossicular replacement prosthesis (TORP) in children. STUDY DESIGN: Case series. METHODS: A consecutive series of children receiving an adjustable-length titanium TORP was identified from a prospective surgical and audiological database. Audiometric testing was obtained preoperatively, 2 months postoperatively, and subsequently at 6- to 12-month intervals. Four-frequency pure-tone averages (PTA) were determined for air conduction (AC) and bone conduction thresholds, as well as air-bone gap (ABG). Pre- and postoperative measures were compared to determine degree of improvement. The proportion with successful outcome (defined as ≤ 30 dB hearing level [HL] AC) was determined over time with Kaplan-Meier analysis. RESULTS: Seventy-five TORPs were inserted in 71 children aged 7 to 18 years, with a median follow-up of 2.7 years (0.6-5.5 years). The mean postoperative PTA AC threshold and ABG at 1 year were 35 dB HL and 29 dB, respectively, with ABG closure of 14 dB. The maximum gain in AC was 40 dB, achieved in eight (11%) cases. Successful outcome was seen in 50% of children at first follow-up. Over the following 1 to 3 years, hearing levels deteriorated to AC > 30 dB HL in an additional 10% of patients. Four patients had revision surgery, one for prosthesis extrusion and three for a lack of improvement in hearing. CONCLUSIONS: Titanium TORPs offer children an effective method of ossicular reconstruction, with infrequent extrusion at least in the short term. The hearing improvement achieved in the early postoperative period appears to be maintained over the first year but may not be sustained over longer time periods.

Audiological results after total ossicular reconstruction for stapes fixation.

The objective was to assess audiological results after total ossicular reconstruction for stapes fixation. The study is a retrospective evaluation conducted in a tertiary referral centre. The patients were 16 adults with conductive or mixed hearing loss and stapes fixation due to tympanosclerosis or otosclerosis. A total or partial stapedectomy with perichondrium interposition on the oval window and ossicular reconstruction with titanium total prosthesis were done. To assess pre- and post-operative (1 and 4 years) air and bone-conduction thresholds (frequencies 0.5, 1, 2, 3 kHz), pure-tone average air and bone conduction, and air-bone gaps were measured and the number of decibels of closure of the air-bone gap at 1 year and at 4 years were compared. One year after surgery, air conduction thresholds and pure-tone average air conduction were improved for all frequencies, and there were no significant differences in bone conduction thresholds or in pure-tone average bone conduction. There were no differences in air and bone conduction thresholds, pure-tone average air or bone conduction between 1 and 4 years. The air-bone gap was significantly reduced 1 year after surgery and remained so at 4 years. (Preoperative air-bone gap, 34.04 dB; at 1 year, 16.40 dB; at 4 years, 17.3 dB. Decibels of closure of the air-bone gap at 1 year, 17.64 dB; at 4 years, 16.74 dB.) No differences were found between otosclerosis subjects and all other cases combined. Total ossicular reconstruction in stapes fixation due to tympanosclerosis or otosclerosis produces satisfactory short- and long-term auditory results.