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1,046 result(s) for "Ear prostheses"
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Improved Fabrication of Implant Retained Auricular Prosthesis with Digital Technologies
A 28-year-old male patient came to the prosthodontics department seeking replacement for his congenital defect left ear. With the use of digital technology, a silicone implant supported bar retained auricular prosthesis that is an exact match in size, shape, and orientation to the existing contralateral ear was made.
Auditory effects of autologous fat graft for TORP stabilization in the middle ear: a cadaveric study
Background Total ossicular replacement prostheses (TORP) are often used to re-establish ossicular coupling of sound in an ear lacking a stapes supra-structure. The use of TORPs, however, is associated with a 2/3 five year failure rate due to their anatomic instability over time in the middle ear. The use of autologous fat to try and stabilize TORPs may improve long-term results with this challenging ossicular reconstruction technique. Methods A cadaveric temporal bone model was developed and laser Doppler vibrometry was used to measure and record round window membrane vibration in response to sound stimulation under the following conditions: normal middle ear, middle ear filled with fat, normal middle ear with TORP prosthesis, TORP prosthesis with fat around its distal end and TORP prosthesis with fat filling the middle ear. Fourteen temporal bones were used. Results There was a significant decrease in round window membrane velocity after filling the middle ear with fat in both the normal middle ear (− 8.6 dB; p  < 0.0001) and prosthesis conditions (− 13.7 dB; p  < 0.0001). However, there was no significant drop in round window membrane velocity associated with using fat around the distal end of the TORP prosthesis as compared to the prosthesis without fat condition ( p  > 0.05). Conclusions Autologous fat around the distal end of a TORP prosthesis may not be associated with any additional hearing loss, as demonstrated in this cadaveric model. The additional hearing loss potentially caused by using fat to completely surround the prosthesis and fill the middle ear is probably not clinically acceptable at this time, especially given the unknown way in which the fat will atrophy over time in this context.
Integration of 3D-printed middle ear models and middle ear prostheses in otosurgical training
Background In otosurgical training, cadaveric temporal bones are primarily used to provide a realistic tactile experience. However, using cadaveric temporal bones is challenging due to their limited availability, high cost, and potential for infection. Utilizing current three-dimensional (3D) technologies could overcome the limitations associated with cadaveric bones. This study focused on how a 3D-printed middle ear model can be used in otosurgical training. Methods A cadaveric temporal bone was imaged using microcomputed tomography (micro-CT) to generate a 3D model of the middle ear. The final model was printed from transparent photopolymers using a laser-based 3D printer (vat photopolymerization), yielding a 3D-printed phantom of the external ear canal and middle ear. The feasibility of this phantom for otosurgical training was evaluated through an ossiculoplasty simulation involving ten otosurgeons and ten otolaryngology–head and neck surgery (ORL-HNS) residents. The participants were tasked with drilling, scooping, and placing a 3D-printed partial ossicular replacement prosthesis (PORP). Following the simulation, a questionnaire was used to collect the participants' opinions and feedback. Results A transparent photopolymer was deemed suitable for both the middle ear phantom and PORP. The printing procedure was precise, and the anatomical landmarks were recognizable. Based on the evaluations, the phantom had realistic maneuverability, although the haptic feedback during drilling and scooping received some criticism from ORL-HNS residents. Both otosurgeons and ORL-HNS residents were optimistic about the application of these 3D-printed models as training tools. Conclusions The 3D-printed middle ear phantom and PORP used in this study can be used for low-threshold training in the future. The integration of 3D-printed models in conventional otosurgical training holds significant promise.
Nitinol Prosthesis in Stapes Surgery: Evolution from Heat-Activated to Superelastic Nitinol: A Systematic Review
Background/Objectives: Stapes surgery is a well-established treatment for conductive hearing loss caused by otosclerosis, with the choice of prosthesis playing a pivotal role in audiological outcomes and safety. Heat-activated and superelastic nitinol prostheses are widely used, but their comparative effectiveness and complication profiles remain debated. This systematic review and meta-analysis aimed to evaluate the audiological outcomes, complication rates, and overall performance of these two prosthesis types. Methods: A systematic review was conducted following PRISMA guidelines. Seven studies involving 273 patients were included. Data on mean air–bone gap (ABG) reduction, complication rates, and follow-up outcomes were extracted. Meta-analyses were performed using a random-effects model, and odds ratios (OR) with 95% confidence intervals (CI) were calculated for comparative analysis. Results: The pooled mean ABG reduction was 20.2 dB (95% CI: 19.47–20.95), indicating substantial and comparable improvements in hearing for both prosthesis types. Heat-activated prostheses achieved slightly higher ABG reduction in individual studies, while superelastic prostheses offered advantages in procedural simplicity. Complication rates were 6.0% for heat-activated and 5.6% for superelastic prostheses. The most common complications included sensorineural hearing loss (2.0–2.4%) and incus-related issues such as necrosis and lateralization. Conclusions: Both prosthesis types provide comparable audiological outcomes and surgical success rates. However, the slightly lower complication rate observed with superelastic prostheses emphasizes their safety and predictability. The choice of prosthesis should be guided by patient anatomy, surgeon expertise, and procedural considerations. Future studies should prioritize long-term outcomes and standardized reporting to further refine prosthesis selection.
Effect of Middle Ear Prosthesis Diameter in Platinotomy and Partial Platinectomy on Hearing Gain: A Finite Element Study
This study investigates, for the first time, using finite element analysis (FEA), the differential impact of middle ear prosthesis diameter on hearing gain in two distinct surgical techniques: stapedotomy and partial stapedectomy. The model represented the cochlea as two fluid-filled straight channels separated by the basilar membrane and considered pistons of 0.4 mm and 0.6 mm diameters. The results demonstrated that in stapedotomy, a 0.6 mm diameter piston yielded a significantly better reduction in ABG (8.31 dB) compared to the 0.4 mm piston (10.67 dB), indicating improved hearing gain. Conversely, in partial stapedectomy, the smaller 0.4 mm piston was more effective, reducing ABG to 11.2 dB versus 12.12 dB with the larger piston. These findings highlight that the optimal prosthesis diameter varies according to surgical technique, emphasizing the need for tailored prosthesis selection.
Effect of Titanium Artifacts on Cholesteatoma in Magnetic Resonance Imaging After Reconstruction of the Middle Ear
Background/Objectives: Surgical removal is the treatment of choice for cholesteatoma control. Depending on the size, the surgery involves partial resection of the ossicular chain and, if necessary, the bony skull base. Titanium foreign materials (prostheses, meshes) can be used to restore sound transmission and to cover larger defects of the skull base. After the operation, recurrence and residual control are necessary. This can be achieved by means of second-look surgery or an MRI examination with a non-EPI DWI sequence. Similarly to other metal implants, artifacts may occur in the image due to the titanium used. In this study, we assessed the magnitude of the MRI hardware differences induced by titanium prostheses and meshes and whether these differences could obscure cholesteatoma detection. Methods: 28 MRI examinations (T1-, T2-, non-EPI DWI sequences) in 14 males and 14 females (5.2–92.4 years) after cholesteatoma surgery and single-staged implantation of a PORP, TORP, or titanium mesh were considered. The size of the respective artifacts was measured, and the mean artifact sizes of the respective prosthesis types were compared. A second look surgery was performed in all cases due to the MRI result or clinical findings. Both were also compared. Results: Artifacts occurred in all titanium foreign bodies depending on the used MRI sequence (PORP, TORP, Mesh). We found a positive association between the size of the prosthesis and the size of the artifact. All subsequent second-look surgeries confirmed the MRI examinations according to a positive control for the presence of cholesteatoma. The detection rate was 82.1%. All false results were false negatives, and there were no positive results. Conclusions: Titanium material-related artifacts might influence the MRI detectability of recurrent cholesteatoma. Small cholesteatoma might be missed by an MRI-based follow-up. This finding supports the reevaluation of single-stage versus staged reconstruction modern approaches.
Safety and efficacy of the mAXIS stapes prosthesis
Purpose Otosclerosis leads to a fixed stapes footplate and thus to hearing loss. The predominant treatment method is surgery, with various types of stapes prostheses available. The aim of this study was to investigate the safety and efficacy of the new mAXIS Stapes Prosthesis. Methods 34 cases of otosclerosis were implanted with the new mAXIS Stapes Prosthesis. Comprehensive clinical assessments, including pre- and postoperative pure tone audiometry was performed at short-term (ST) follow-up at 25 (± 15) days and mid-term (MT) follow-up at 181 (± 107) days. The pure tone average of 0.5, 1, 2 and 3 kHz (PTA4) was calculated. Results In all cases, the application of the prosthesis was successful and straightforward. The postoperative PTA4 air-bone gap was 10.7 ± 5.2 dB at ST follow-up ( n  = 34) and 8.3 ± 4.1 dB at MT follow-up ( n  = 18). In 61% of cases, the ABG-closure was within 10 dB and in 100% of cases within 20 dB at MT follow-up. Conclusion Findings of this study support that the mAXIS Stapes Prosthesis is safe for implantation and shows promising audiological outcome. Future investigations will contribute its long-term efficacy and safety profile.
Systematic and Individualized Preparation of External Ear Canal Implants: Development and Validation of an Efficient and Accurate Automated Segmentation System
External ear canal (EEC) stenosis, often associated with cholesteatoma, carries a high risk of postoperative restenosis despite surgical intervention. While individualized implants offer promise in preventing restenosis, the high morphological variability of EECs and the lack of standardized definitions hinder systematic implant design. This study aimed to characterize individual EEC morphology and to develop a validated automated segmentation system for efficient implant preparation. Reference datasets were first generated by manual segmentation using 3D SlicerTM software version 5.2.2. Based on these, we developed a customized plugin capable of automatically identifying the maximal implantable region within the EEC and measuring its key dimensions. The accuracy of the plugin was assessed by comparing it with manual segmentation results in terms of shape, volume, length, and width. Validation was further performed using three temporal bone implantation experiments with 3D-Bioplotter©-fabricated EEC implants. The automated system demonstrated strong consistency with manual methods and significantly improved segmentation efficiency. The plugin-generated models enabled successful implant fabrication and placement in all validation tests. These results confirm the system’s clinical feasibility and support its use for individualized and systematic EEC implant design. The developed tool holds potential to improve surgical planning and reduce postoperative restenosis in EEC stenosis treatment.
Measurements of the local evoked potential from the cochlear nucleus in patients with an auditory brainstem implant and its implication to auditory perception and audio processor programming
The measurement of the electrically evoked compound action potential (ECAP) in cochlear implant (CI) patients is widely used to provide evidence of a functioning electrode-nerve interface, to confirm proper location of the electrode array and to program the sound processor. In patients with an auditory brainstem implant (ABI), a likewise versatile measurement would be desirable. The ECAP measurement paradigm “Alternating Polarity” was utilized to record responses via the implanted ABI electrode array placed on the cochlear nucleus. Emphasizing on the different location of stimulation and recording, these responses are called local evoked potentials (LEP). LEP measurements were conducted during the clinical routine in 16 ABI patients (12 children and 4 adults), corresponding to 191 electrode contacts. A retrospective analysis of these data revealed, that LEP responses were observed in 64.9% of all measured electrode contacts. LEP responses predicted auditory perception with a sensitivity of 90.5%. False-positive rate was 33.7%. Objective LEP thresholds were highly significantly (p < 0.001) correlated both to behavioral thresholds (Pearson’s r = 0.697) and behavioral most comfortable levels (r = 0.840). Therefore, LEP measurements have the potential to support fitting in ABI patients.
Applications of CAD/CAM Technology for Craniofacial Implants Placement and Manufacturing of Auricular Prostheses—Systematic Review
This systematic review was aimed at gathering the clinical and technical applications of CAD/CAM technology for craniofacial implant placement and processing of auricular prostheses based on clinical cases. According to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, an electronic data search was performed. Human clinical studies utilizing digital planning, designing, and printing systems for craniofacial implant placement and processing of auricular prostheses for prosthetic rehabilitation of auricular defects were included. Following a data search, a total of 36 clinical human studies were included, which were digitally planned and executed through various virtual software to rehabilitate auricular defects. Preoperative data were collected mainly through computed tomography scans (CT scans) (55 cases); meanwhile, the most common laser scanners were the 3dMDface System (3dMD LLC, Atlanta, Georgia, USA) (6 cases) and the 3 Shape scanner (3 Shape, Copenhagen, Denmark) (6 cases). The most common digital design software are Mimics Software (Mimics Innovation Suite, Materialize, Leuven, Belgium) (18 cases), Freeform software (Freeform, NC, USA) (13 cases), and 3 Shape software (3 Shape, Copenhagen, Denmark) (12 cases). Surgical templates were designed and utilized in 35 cases to place 88 craniofacial implants in auricular defect areas. The most common craniofacial implants were Vistafix craniofacial implants (Entific Medical Systems, Goteborg, Sweden) in 22 cases. A surgical navigation system was used to place 20 craniofacial implants in the mastoid bone. Digital applications of CAD/CAM technology include, but are not limited to, study models, mirrored replicas of intact ears, molds, retentive attachments, customized implants, substructures, and silicone prostheses. The included studies demonstrated a predictable clinical outcome, reduced the patient’s visits, and completed the prosthetic rehabilitation in reasonable time and at reasonable cost. However, equipment costs and trained technical staff were highlighted as possible limitations to the use of CAD/CAM systems.