Titanium Partial Ossicular Replacement Prosthesis Research Articles

Feasibility of 3D-printed middle ear prostheses in partial ossicular chain reconstruction.

Despite advances in prosthesis materials, operating microscopes and surgical techniques during the last 50 years, long-lasting hearing improvement remains a challenge in ossicular chain reconstruction. Failures in the reconstruction are mainly due to inadequate length or shape of the prosthesis, or defects in the surgical procedure. 3D-printed middle ear prosthesis might offer a solution to individualize treatment and obtain better results. The aim of the study was to study the possibilities and limitations of 3D-printed middle ear prostheses. Design of the 3D-printed prosthesis was inspired by a commercial titanium partial ossicular replacement prosthesis. 3D models of different lengths (1.5-3.0 mm) were created with Solidworks 2019-2021 software. The prostheses were 3D-printed with vat photopolymerization using liquid photopolymer Clear V4. Accuracy and reproducibility of 3D printing were evaluated with micro-CT imaging. The acoustical performance of the prostheses was determined in cadaver temporal bones with laser Doppler vibrometry. In this paper, we present an outline of individualized middle ear prosthesis manufacturing. 3D printing accuracy was excellent when comparing dimensions of the 3D-printed prostheses and their 3D models. Reproducibility of 3D printing was good if the diameter of the prosthesis shaft was 0.6 mm. 3D-printed partial ossicular replacement prostheses were easy to manipulate during surgery even though they were a bit stiffer and less flexible than conventional titanium prostheses. Their acoustical performance was similar to that of a commercial titanium partial ossicular replacement prosthesis. It is possible to 3D print functional individualized middle ear prostheses made of liquid photopolymer with good accuracy and reproducibility. These prostheses are currently suitable for otosurgical training. Further research is needed to explore their usability in a clinical setting. In the future, 3D printing of individualized middle ear prostheses may provide better audiological outcomes for patients.

Comparative Analysis of the Hearing Effects of Partial Ossicular Replacement Prosthesis Versus Conchal Cartilage in Canal Wall Down Mastoidectomy with Type II Tympanoplasty: A Retrospective Case Review Study.

To investigate the effects of titanium partial ossicular replacement prosthesis (PORP) and conchal cartilage for ossiculoplasty on hearing results in single-stage canal wall down (CWD) mastoidectomy surgery with type II tympanoplasty in patients with cholesteatoma. The patients were performed surgeries for the first time by a senior otosurgeon from 2009 to 2022 and were performed CWD mastoidectomy with type II tympanoplasty in one stage were enrolled. Patients who could not be followed up were excluded. Titanium PORP or conchal cartilage was used for ossiculoplasty. When the stapes head was intact, a cartilage 1.2-1.5mm thick was attached directly to the stapes; when the head of the stapes was eroded, a 1mm high PORP and cartilage of .2-.5mm thick were placed on the stapes simultaneously. 148 patients were included in the study in total. The titanium PORP and conchal cartilage groups showed no statistically significant differences at 500, 1000, 2000, and 4000Hz considering the number of decibels of closure of the air-bone gap (ABG) (P > .05) and pure-tone average ABG (PTA-ABG) (P > .05). Meanwhile, the closure of PTA-ABG between the 2 groups showed no statistically significant differences in the overall distribution (P > .05). For patients with cholesteatoma and mobile stapes who underwent CWD mastoidectomy with type II tympanoplasty in one stage, either PORP or conchal cartilage is a satisfactory material for ossiculoplasty.

Comparison of partial vs. total ossicular chain reconstruction using titanium prosthesis: a retrospective cohort study.

Comparison of the hearing outcomes of titanium partial ossicular replacement prosthesis (PORP) vs. titanium total ossicular replacement prosthesis (TORP) with footplate shoe (Omega Connector) in second stage ossicular chain reconstruction surgeries. In this retrospective cohort study in a tertiary hospital, we compared the hearing outcomes in 248 patients who had undergone ossicular chain reconstruction with titanium prostheses PORP (n = 115) vs. TORP (n = 133) from August 2017 to June 2021. Pre-and post-operative audiometric data were assessed. In general, we found that there were no significant differences between PORP and TORP groups in gains of BC (P = 0.080), AC (P = 0.454), ABG (P = 0.928), SRT (P = 0.065), and SDS (P = 0.363). There were no significant differences in terms of ABG gain between the two groups. Regarding ABG gains frequency-specific analysis in the ears with pre-operative conductive hearing loss, there were no significant differences between low-frequencies (P = 0.260) and high-frequencies (P = 0.973) between the two groups. To sum up, this research provided additional evidence with respect to hearing outcomes after staged ossicular chain reconstruction with PORP and TORP. The practical application of our study is that TORP with footplate shoe (Omega Connector) is comparable with PORP in staged ossiculoplasty.

Functional Outcomes of Single-Stage Ossiculoplasty in Chronic Otitis Media With or Without Cholesteatoma.

Background:Two-stage ossiculoplasty has been widely used for hearing improvement in chronic otitis media with or without cholesteatoma. However, the outcomes of single-stage ossiculoplasty have not been fully clarified.The aim of this study is to determine whether the outcomes of single-stage ossiculoplasty are comparable with those of 2-stage ossiculoplasty in chronic otitis media with or without cholesteatoma.Methods:Medical records of 191 cases (187 patients) who underwent single-stage ossiculoplasty from January 2011 to May 2018 at our hospital were retrospectively reviewed.Results:Polycel and titanium were used in 56 and 135 cases, respectively. In chronic otitis media without cholesteatoma, the success rate of polycel and titanium partial ossicular replacement prosthesis was 80.7% and 81.6%, respectively. In chronic otitis media with cholesteatoma, the success rate of polycel and titanium partial ossicular replacement prosthesis was 63.6% and 64.6%, respectively, while that of polycel and titanium total ossicular replacement prosthesis was 45.9% and 47.8%, respectively.Conclusion:These results suggest that single-stage ossiculoplasty is a suitable option for recovering postoperative hearing in chronic otitis media with or without cholesteatoma. Thus, if middle ear inflammation can be sufficiently treated in the first stage, single-stage ossiculoplasty is a suitable option for chronic otitis media with or without cholesteatoma.

Endoscopic Transcanal Autologous Cartilage Ossiculoplasty.

This was a randomized clinical trial, of thirty-two patients undergoing endoscopic ossiculoplasty, as a second look surgery, at 6months after primary endoscopic cholesteatoma surgery, in a duration of 9years. All patients underwent trans-canal endoscopic ossiculoplasty under local anesthesia. Prosthesis used were (1) Titanium partial ossicular replacement prosthesis (PORP) in fourteen, (2) Titanium total ossicular replacement prosthesis (TORP) in six and (3) Autologous cartilage in twelve cases. Puretone audiometry (PTA) were done preoperatively and postoperatively at 2months and 3years. Out of twenty-four cases, which presented only with stapes superstructure; fourteen underwent PORP ossiculoplasty and twelve had cartilage short columella ossiculoplasty (SCC). Out of eight cases, which had only mobile stapes footplate, six underwent TORP ossiculoplasty and only two underwent long columella cartilage ossiculoplasty (LCC). Pre-operative average air conduction threshold (AC) of pure tone audiometry were 45.47dB (PORP), 66.10dB (TORP), 49.15dB (SCC) and 59.15dB (LCC) groups. The post-operative AC at 2months were respectively 27.37dB (PORP), 45.83dB (TORP), 29.99dB (SCC) and 39.15dB (LCC) groups. The gap of air and bone conduction (ABG) at 2months post-operative stage were 19.05dB (PORP), 20dB (TORP), 20.32dB (SCC) and 39.15dB (LCC) groups and not much changed after 3years. Extrusion occurred in three PORPs and four TORPs at 4-8years after surgery. Four cases were lost to follow up. No extrusion occurred in cartilage ossiculoplasty. Trans-canal endoscopic autologous cartilage ossiculoplasty shows encouraging results comparable to titanium prosthesis in repairing ossicles in cholesteatoma disease.

The outcomes comparison between autologous incus and titanium PORP in Austin A and C type ossicle defect cases

Objective: A series of otitis media patients with Austin A and C type ossicles defects received ossicular chain reconstruction surgery using either autologous incus or titanium partial ossicular replacement prosthesis (PORP).The hearing outcomes and exclusion rate of prosthesis were compared between these two groups. Method: One hundred and seventy-six patients with chronic otitis media underwent ossiculoplasty in our hospital during 2016-2017. These patients were divided into 2 groups: group A consisted of those receiving autologous incus replacement (n=85), and group B consisted of those receiving titanium PORP (n=91). All the patients received CWD mastoidectomy and ossiculoplasty in one stage and were followedup in postoperative 3, 6 and 12 months. Result: The postoperative hearing improvement rates in group A and B were 85.88% and 92.31%, respectively, and there was no statistical difference. No statistical difference of the postoperative hearing improvement rates was observed between Austin A and C type in 2 groups. Three cases (3.29%) had ossicle exclusion in B group, and 0 case in A group, which was not statistical different (P>0.05). Conclusion: Patients receiving ossicular chain reconstruction surgery using autologous incus show similar hearing outcomes as those using titanium PORP. The risk of prosthesis exclusion is lower for autologous incus than titanium PORP. The residual handle of malleus has no obvious influence on the postoperative hearing improvement.

A Self-Adjusting Ossicular Prosthesis Containing Polyurethane Sponge

Middle ear ossicular replacement prostheses whose length can adjust in vivo to changes in middle ear dimensions following insertion may have acoustic advantages. Optimal tension is an important factor in the acoustic performance of incus-stapes replacement prostheses. Length is the primary determinant of postinsertion tension with conventional prostheses. Postoperative changes in prosthesis tension may occur leading to a worsening of postoperative hearing. Testing of a self-adjusting prosthesis (SAP) containing a polyurethane sponge attached to the head of a titanium partial ossicular replacement prosthesis (PORP) was performed in 5 fresh temporal bones. This SAP was compared with optimal length PORPs at different tensions. Sound input was 80 dB sound pressure level at 0.1 to 10 kHz. Stapes footplate displacement was measured using a laser Doppler vibrometer before and after incus removal and after PORP and SAP insertion between the malleus and stapes. One to 3 glass shims were then inserted between the malleus and optimal length PORP and SAP to change prosthesis tension. Measurement of stapes displacement was repeated with increased prosthesis lengths of 0.15, 0.30, and 0.45 mm. There was a clear tendency in the optimal length PORPs for a decrease in footplate displacement below 1.0 kHz, in general proportional to the increasing length. The SAP provided equivalent transmission as the optimal length PORP below 4.0 kHz and better transmission below 1.0 kHz at the varying increased lengths. An SAP seems to decrease the effect of changes in prosthesis length between the malleus and stapes at lower frequencies.

Kurz titanium prosthesis ossiculoplasty—Follow-up statistical analysis of factors affecting one year hearing results

Objective Analysis of the one year results of Kurz titanium ossicular prosthesis and the factors affecting the outcome from this prosthesis. The hearing results of titanium partial ossicular replacement prosthesis (PORP) and total ossicular replacement prosthesis (TORP) were compared. Methods This is prospective study of 97 Kurz prosthesis ossiculoplasties, performed by the same senior author (VVR) between 2004 and 2006. All patients undergoing ossiculoplasty using Kurz prosthesis between 2004 and 2006 were included. All patients had minimum follow-up period of one year. There were 97 patients in total. 65 patients had PORP's and 32 had TORP's. The mean preoperative and postoperative air-bone gaps for the frequencies (500, 1000, 2000, and 3000 Hz) were calculated. The improvement of the mean air-bone gap (ABG) and air conduction over the same frequencies were measured. A postoperative ABG less than or equal to 20 dB was considered a successful result. Statistical analysis was used to identify the factors which affect the postoperative results. Results The mean preoperative ABG was 27.89 dB (SD = 11.71). The mean postoperative ABG for the entire series was 11.39 dB (SD = 10.47). The mean improvement in ABG was 16.50 dB (SD = 14.00). 81.4% (79 patients) had postoperative ABG ≤ 20 dB. 56.7% (55 patients) of the patients had postoperative ABG ≤ 10 dB. The mean postoperative ABG for all PORP patients was 10.6 dB (SD = 9.7). The mean postoperative ABG of TORP was higher in this study (14.84 dB, SD = 12.86) but it was not statistically significant ( p = 0.10, 2-tailed t-test, 95% CI −9.35 to 0.924). There was no significant effect of age, presence or absence of cholesteatoma or retraction pocket, type of mastoid surgery and thickness of the cartilage graft used on the results. The effect of the preoperative ossicular condition on the postoperative hearing results was also analysed. Conclusion Titanium ossicular reconstruction gives stable short-term results. There was no statistically significant difference between the total and partial replacement prostheses. The preoperative status of the stapes superstructure did influence the mean postoperative ABG.

Ossicular reconstruction: Incus versus universal titanium prosthesis

Objectives The main purpose of this study is to compare audiological outcomes of incus reconstruction, Xomed Medtronic universal titanium partial ossicular replacement prosthesis (PORP) and total ossicular replacement prosthesis (TORP). We also compared results based on surgical technique, history of previous surgery, form of the prosthesis head, pathology and frequency. Methods A chart review was performed and included reconstructions performed between June 2003 and December 2006. Results were based on air–bone gap and pure tone average. Results Postoperative mean air–bone gap and mean pure tone average are significantly lower using incus reconstruction compared with the titanium prosthesis groups. PORP and TORP groups yielded similar outcomes. Closure of ABG is similar in all three groups. Postoperative results were better using an intact canal wall mastoidectomy compared with a canal wall down technique, but ABG closure was similar in both groups. Primary surgeries gave better results than revisions of reconstructions performed by the senior author or elsewhere. Conclusion Though Xomed Medtronic titanium prostheses are effective in ossicular reconstruction, incus reconstruction is at least as effective when feasible. Canal wall down mastoidectomy should be reserved for cases where preservation of the canal wall is contraindicated. Previous same ear surgery is a poor prognostic factor for successful outcome. Preliminary results indicate that round head PORPs may be superior to their oval head counterparts.

A New Implantable Middle Ear Hearing Device for Mixed Hearing Loss

To assess the feasibility of a new, active middle ear device in temporal bones (TB). This device is designed for patients with mixed hearing loss subsequent to chronic middle ear infection, surgery, or trauma. This Bell-Vibroplasty is built from a VIBRANT MED-EL Vibrant Soundbridge and a Kurz Bell titanium partial ossicular replacement prosthesis. In three fresh TBs, healthy and reconstructed middle ears were analyzed by means of laser Doppler interferometry. The sound transmission properties of a partial ossicular replacement prosthesis and a passive and an active Bell-Vibroplasty were compared with healthy middle ear function. The measurements provided reliable results with small standard deviations and good signal-to-noise ratios. The performance levels of the partial ossicular replacement prosthesis and of the passive Bell-Vibroplasty were comparable with that of healthy middle ear function. The activated Bell-Vibroplasty provided linear function and a flat frequency response within the measured frequency range (500 Hz-8 kHz), with peak deviations of less than 10 dB. The maximum output of the Bell-Vibroplasty was equivalent to 125-dB sound pressure level. Bell-Vibroplasty is feasible in TBs. Bell-Vibroplasty performance in TBs is sufficient to allow for a clinical trial as a next step.

Hearing results with the titanium ossicular replacement prostheses

The purpose was to study the hearing results in patients receiving a Kurz titanium Bell partial ossicular replacement prosthesis (PORP) or an Aerial total ossicular replacement prosthesis (TORP). The study was a retrospective chart review in a tertiary otologic referral center. A computerized otologic database was used to identify 111 patients implanted with either a PORP or TORP prosthesis. Audiograms were reviewed and air-bone gaps were calculated for each patient. The improvement of the average air-bone gap (ABG) was 10.2 and 12.7 dB at 3 and 20 months after ossiculoplasty, respectively. Sixty-six percent of patients (73/111) had a postoperative air-bone gap of 20 dB or less. The ABG for the titanium PORP prosthesis was 14.3+/-9.7 dB, compared with 25.2+/-13.7 dB for the TORP prosthesis (P <0.05). The ABG to within 20 dB or less was obtained in the PORP group in 77% of the cases, versus 52% of the cases in the TORP group (P <0.05). Two extrusions of the prostheses were observed at 17 and 20 months after surgery (1.8%). Revision procedures for functional failure were carried out in 20 patients (18%). The rate of sensorineural hearing loss was 3.6%. The major factors influencing good audiometric results were the surgical procedure preserving the external auditory canal and the presence of the stapes. The best hearing results were achieved when a PORP was used in an intact canal wall (ICW) procedure, and the worst hearing results were achieved when a TORP was used in a canal wall down (CWD) procedure. The titanium Kurz prosthesis has been an effective implant at our institution for ossicular reconstruction.