[Allergic reactions to bioimplants]. / Allergische Reaktionen auf Bioimplantate.

BACKGROUND: Bioimplants are used in a variety of ways in otorhinolaryngology, most commonly in facial reconstructive surgery, cochlear implants (CI), bone-anchored hearing aids, and partial/total ossicular replacement prostheses (PORP/TORP), but also for tympanic drainage, laryngeal cannula, voice prostheses after laryngectomy, etc., and in otorhinolaryngology-related procedures as dental implants in dentistry. METHODS: A literature search was performed to analyze the immunology of allergic reactions to bioimplants and to determine the available evidence by searching Medline, PubMed, and national and international study and guideline registries and the Cochrane Library. Human studies published in the period up to and including 12/2021 were considered. RESULTS: Based on the international literature and previous experience, a review of allergies to bioimplants in otolaryngology is presented. CONCLUSION: Otorhinolaryngologists should always consider the possibility of allergic reactions when inserting allogeneic materials, particularly, but not only, when using bioimplants.

Device failure caused by the dissociation of floating mass transducer in Vibrant SoundBridge®.

BACKGROUND: Vibrant SoundBridge® (VSB), a semi-implantable middle ear device, is one of the treatment options for patients with mild-to-severe sensorineural hearing loss or mixed hearing loss. Herein, we report delayed device failure after VSB surgery in two patients. CASE PRESENTATION: In both cases, a revision surgery was performed for the removal of the device; dissociation of the floating mass transducer (FMT) and coupler was noticed in one patient, and dissociation of the FMT-coupler complex from the short process of the incus in the other. In Case 1, the vibration-like sounds disappeared after the surgery. In Case 2, wearing bilateral hearing aids improved hearing after removal surgery, but complaints regarding speech discrimination persisted. Both cases show the importance of not loosening the connectivity between the FMT, coupler, and short process of the incus during VSB surgery. CONCLUSIONS: To our knowledge, there has been no report of dissociation from the short process of the incus or the dissociation between an FMT and the coupler.

Adverse Events Associated With Ossicular Prostheses: Utility of a Federal Database.

OBJECTIVES: Ossicular prostheses have demonstrated utility in ossicular chain reconstruction, but their use also is associated with complications. This study aims to explore the utility of the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database for the systematic analysis of complications associated with ossicular prostheses. It also summarizes adverse events to patients (AEPs) and device malfunctions (DMs) reported in the MAUDE database, and attempts to examine the consequences brought about by these events and to identify likely root causes. STUDY DESIGN: Retrospective analysis of the MAUDE database. METHODS: The MAUDE database was queried for reports from January 2010 to May 2020. Data were extracted from reports involving the use of ossicular prostheses. RESULTS: Seventy-three medical device reports, reports submitted to the Food and Drug Administration detailing suspected device-associated malfunctions, injuries, and deaths, involved ossicular prostheses and were included for analysis, from which 126 adverse events were extracted. Of these, 50 (39.7%) were AEPs, while 76 (60.3%) were DMs. The most common AEPs were foreign body and hearing loss, while the DMs reported most commonly were broken prosthesis and displaced prosthesis. Of the 76 DMs, 19 (25%) were attributed to mishandling by the operator, while 6 (7.9%) were due to a defective device. Broken prosthesis was the DM most commonly attributed to mishandling by the operator in 16 (32.7%) cases. CONCLUSION: Ossicular prostheses are used extensively for ossicular chain reconstruction, but also are associated with adverse events. The MAUDE database in its current form does not appear sufficient for the systematic review of adverse events associated with ossicular prostheses. A more standardized reporting format with clearly defined categories and inclusion of relevant variables might improve the quality of information provided by the MAUDE database.

Audiologic outcomes and complications of active middle ear implantation in older adults.

BACKGROUND: A few studies have reported the use of middle ear implants (MEIs) in older adults. OBJECTIVES: To evaluate the audiologic outcomes and postoperative complications of MEIs in older adults. METHODS: This retrospective study reviewed audiologic data and medical records from a single referral centre. We identified 34 patients aged ≥65 years who underwent middle ear implantation using the Vibrant SoundbridgeTM device. Preoperative audiometric testing and postoperative aided audiometric testing were performed to evaluate the functional hearing gain at 1 year postoperatively. Patients were divided into 2 groups depending on whether they underwent explantation because of poor hearing benefit. RESULTS: Follow-up duration ranged from <1 to 5.3 years. The functional gain with MEIs significantly improved relative to the preoperative air conduction thresholds at 0.5, 1, 2, and 4 kHz. Eight patients underwent explantation and 7 lost their external audio processor devices. Those who removed their implants because of the poor hearing (group 1) showed significantly worse hearing thresholds at 1 kHz and speech discrimination scores than the others (group 2). CONCLUSIONS AND SIGNIFICANCE: MEIs for auditory rehabilitation can provide improved speech recognition and significant functional gains in older adults. Patients must be given appropriate preoperative explanations regarding the expected outcomes.

Displacement of a Total Ossicular Replacement Prosthesis Following Ossicular Chain Reconstruction.

OBJECTIVE: Herein we describe the diagnosis and management of total ossicular replacement prosthesis (TORP) displacement following tympanoplasty with ossicular chain reconstruction (OCR). METHODS: Case report with literature review. RESULTS/CASE: A 40-year-old male with otorrhea and tympanic membrane perforation underwent a right revision tympanoplasty with OCR using a TORP with a tragal chondroperichondrial graft. On postoperative day (POD) 4, he developed vertigo and profound right-sided hearing loss. Temporal bone computed tomography showed the prosthesis in the vestibule. After a steroid taper with mild improvement in symptoms, the TORP was removed two weeks later and the patient continued to improve. CONCLUSION: TORP displacement into the vestibule is a very rare complication following OCR. Conservative management with high dose steroids may improve symptoms, however further middle ear exploration and surgical management may be warranted depending on the depth of displacement into the inner ear as well as symptom severity.

Navigational guidelines and positional relationships of the human auditory ossicles from three-dimensional topography for ensuring safe and effective malleostapedotomy : Stereotactic topography of the auditory ossicles and its clinical implication.

PURPOSE: The aims of the present study were to identify detailed positional relationship between the auditory ossicles and to provide theoretic navigational guidelines for optimal prosthesis adaptation and effective malleostapedotomy. METHODS: Fifty sides of the temporal bone from donated cadavers were scanned by MicroCT and the malleus, incus, stapes and tympanic membrane were materialized three dimensionally using computer software. Dimensions between the auditory ossicles closely related to malleostapedotomy were measured twice. RESULTS: The grip site of malleus handle was mean 1.8 mm superior and mean 1.3 mm anterior, and linear distance between the grip site of malleus handle and the footplate of the stapes was mean 6.5 mm. The stapes was not parallel to the tympanic membrane and rotated mean 10.7° posteriorly relative to the tympanic membrane. CONCLUSION: Surgeons should start with at least 8.75 mm prosthesis to cover the upper limits of potential anatomy and then trim down to the individualization to the case. The ideal loop morphology has to be oval shape more than 1.4 mm in the long diameter and 1.0 mm in the short diameter. The wire of the prosthesis has to be bended at the two points: about 10° anteriorly at the most proximal point of the wire and about 50° superiorly at the stapes head point.

Long-Term Stability and Safety of the Soundbridge Coupled to the Round Window.

OBJECTIVE: The objective of the study was to demonstrate the long-term outcomes of patients implanted with the active middle ear implant (AMEI) Vibrant Soundbridge (VSB) through coupling the floating mass transducer (FMT) to the round window (RW). METHODS: This retrospective study evaluated the short- and long-term clinical performance (audiological outcomes) and safety (revisions/explantations) of the VSB coupled to the RW between 2013 and 2019 at the St. Pölten University Hospital, Austria. For the outcome analysis, the sample was divided into a short-term examination group followed up for less than 12 months (<12 months) and a long-term examination group followed up for more than 12 months (>12 months). Cumulative survival outcomes were separately analyzed for subjects with and without cholesteatoma. RESULTS: 46 patients with an average long-term follow-up period of 31.43 months (13-75 months) were investigated. Complications requiring revision surgery were reported in total in seven patients with cholesteatoma (15.2%) and none in subjects without cholesteatoma (0%). Residual hearing was not affected by VSB surgery. Word understanding on the Freiburger monosyllabic speech test improved significantly at 65 dB (P < .0001) and 80 dB (P < .0001), and these outcomes were stable for long-term follow up. CONCLUSION: The VSB coupled to the RW is a safe implantation method for patients with conductive or mixed hearing loss. Hearing improvement was stable for the long-term follow-up up to 74 months. The revision rates are directly related to the underlying pathology of cholesteatoma (with radical cavity); thus, this special cohort requires additional counseling on potential complications. LEVEL OF EVIDENCE: 4 (Case-series) Laryngoscope, 131:E1434-E1442, 2021.

Adverse events associated with bone-conduction and middle-ear implants: a systematic review.

PURPOSE: To review types and frequencies of adverse events (AE) associated with bone-conduction hearing implants (BCHIs) and active middle-ear implants (aMEIs) as reported in the literature. METHODS: Cochrane, PubMed, and EMBASE libraries were searched for primary articles in English or German language that reported on adverse events following BCHI or aMEI implantation, included at least five patients and were published between 1996 and 2016. Study characteristics, demographics, and counts of adverse events were tabulated and analyzed within the R statistical programming environment. RESULTS: Following assessment of the reporting quality of adverse events, we present a brief guideline that potentially improves AE reporting in this field of research. For the full dataset, we summarize study-level adverse event frequencies in terms of ratio of events to ears (REE) by AE groups and by device. For a subset of studies, we also report cumulative incidence (risk) for minor- and major adverse-events by device and by device groups. CONCLUSIONS: Data analyzed in this review show that: (1) the reporting quality of adverse events associated with BCHI and aMEIs is often very low; (2) adverse events associated with BCHI and aMEIs are qualitatively different and not equally frequent among devices; (3) state-of-the-art implantable BCHIs and aMEIs are a safe treatment option for hearing loss.

Short-Term Hearing Prognosis of Ossiculoplasty in Pars Flaccida Cholesteatoma Using the EAONO/JOS Staging System.

OBJECTIVES: The aim of the present study was to investigate the prognostic factors for short-term hearing outcomes of ossiculoplasty for primary pars flaccida cholesteatoma according to the European Academy of Otology and Neurotology/Japanese Otological Society (EAONO/JOS) and 2015 JOS staging systems. MATERIALS AND METHODS: A total of 34 patients with primary pars flaccida cholesteatoma who underwent one-stage tympanomastoidectomy with partial ossicular reconstruction using double cartilage block were included in the study. The postoperative pure-tone average air-bone gap (PTA-ABG) was calculated, and two criteria of successful hearing outcomes were defined as ≤10 and ≤20 dB. Patients were classified according to the EAONO/JOS and 2015 JOS staging systems. Cochran-Armitage test was used to statistically analyze staging, and Fisher's exact test was used to analyze other factors. RESULTS: Successful hearing outcome with postoperative PTA-ABG ≤10 and ≤20 dB occurred in 23.5% and 55.9% of cases, respectively. When postoperative PTA-ABG ≤20 dB was defined as successful, the success rate significantly decreased with increase in EAONO/JOS stage, and S0 pathological status of the stapes (no involvement) was a significantly favorable predictive factor. When postoperative PTA-ABG ≤10 dB was regarded as successful, the significantly favorable predictive factors were S0 pathological status of the stapes and development of mastoid cells with MC2-3 (better developed cells). CONCLUSION: Favorable prognostic factors for hearing outcomes of tympanomastoidectomy with partial ossicular reconstruction for primary pars flaccida cholesteatoma were low stage following the EAONO/JOS staging system and no stapes involvement and better development of mastoid cells following the 2015 JOS staging system.

A Rare Cause of Stapedotomy Failure: When the Depth Marker Becomes a Locking Device: A Report on 2 Cases.

We report 2 cases of stapes surgery failure due to the depth marker groove of the piston of a Big Easy titanium prosthesis getting caught at the edge of the stapedotomy hole. In the first case, the stapedotomy failure, detected peroperatively, was corrected by modifying the angulation of the shaft of the prosthesis. In the second case, the failure occurred after a delay during which scar tissue developed around the depth marker groove, hampering the movement of the prosthesis. The usual postoperative imaging did not detect this complication. The diagnosis was made during revision surgery and the condition was treated by enlarging the hole in the footplate. Alternatively, the use of a piston without a depth marker groove would have resolved the problem. Although a rare event, the possibility of stapes surgery failure due to the depth marker groove should not be overlooked.

Two cases of Tullio phenomenon in which oval and round window reinforcement surgery was effective.

AIM: To report the effect of oval and round window reinforcement surgery performed in two patients with the Tullio phenomenon. Case 1: A male with bilateral superior canal dehiscence syndrome. Downbeat nystagmus with leftward horizontal eye movement was recorded in an electronystagmogram using a pure-tone sound of 110dB at 2000 or 4000Hz in the right ear. Case 2: A female who had undergone stapes surgery. Computed tomography revealed an ossicular prosthesis in the vestibule. An audiogram indicated mild to moderate hearing impairment in the right ear. Leftward horizontal nystagmus was recorded in an electronystagmogram using a pure-tone sound of 110dB at 500 or 1000Hz in the right ear. Surgical findings indicated that the prosthesis was inserted deep into the oval window, which was closed with thin connective tissue. OUTCOMES: After oval and round window reinforcement surgery was performed in the right ear, and loud, pure-tone sounds elicited neither nystagmus nor dizziness in either patient.

Revision stapes surgery after stapedotomy: A retrospective evaluation of 75 cases.

We retrospectively evaluated a series of 75 surgical revisions after stapedotomy for the treatment of otosclerosis, carried out between 2001 and 2015. Intraoperative findings, causes of failure, and surgical solutions using an angular prosthesis, Causse prosthesis, and glass-ionomer cement were reviewed. Audiometric results performed the day before revision surgery and 1 to 2 months postoperatively were also examined. An incus necrosis was discovered in 65 patients; 55 of whom had partial necrosis of the long process of the incus and 10 with total necrosis. In 5 patients, a dislocation of the foot of the piston alone was recognized, and in 5 patients, a prolapsed facial nerve associated with dislocation of the prosthesis was observed. In this series, the air-bone gap was closed to <10 dB in 89.3%. This percentage differs from that reported in the literature (50 to 60%). No significant postoperative sensorineural hearing loss (>15 dB) was observed in this series. Revision stapes surgery is more difficult and demanding than the first stapes surgery. Revision is a consequence of a delayed erosion of the long process of the incus or a consequence of a poorly performed surgery. Operating in a standardized way, despite the change in basic anatomic conditions, can lead to functional results similar to those of primary surgery.

Autosomal dominant stapes fixation, syndactyly, and symphalangism in a family with NOG mutation: Long term follow-up on surgical treatment.

OBJECTIVE: Evaluation of clinical findings and audiological outcome after surgery in a Danish family with autosomal dominant facio-audio-symphalangism syndrome with stapes fixation, syndactyly and symphalangism. METHODS: Retrospective report on eight affected family members in a Danish family. Clinical investigation included X-ray, audiology and in one case video-recorded surgery. Main outcome measure was audiologic results after stapedectomy. Sanger DNA sequencing of NOG was performed on peripheral blood. RESULTS: Audiologic analysis showed that seven of eight affected family members had bilateral conductive hearing loss. Three patients were treated with stapedectomy, on one or both ears, due to fixation of stapes. All the affected members had syndactyly and symphalangism. A not previously reported mutation in the NOG gene (c.688_699del, p.Cys230_Cys232delins11) was found to segregate with the stapes fixation, syndactyly, and symphalangism. p.Cys230_Cysdelins11 was classified as likely pathogenic according to guidelines from the American College of Medical Genetics and Genomics. CONCLUSION: The clinical presentation of the reported mutation corresponds with previous case reports of families with NOG mutation. In this family, surgery with stapedectomy had lasting effect without renewed fixation of the stapes in a follow up period of 18 months-38 years.

Revision Surgery for Otosclerosis.

This article is an overview of the care of patients requiring revision surgery for otosclerosis. Preoperative evaluation of the patient including surgical history, audiologic results, and physical findings is discussed, and the causes of failure of primary surgery are reviewed. A discussion of evidence-based surgical technique and postoperative care then follows.

Factors influencing hearing outcomes in pediatric patients undergoing ossicular chain reconstruction.

OBJECTIVE: Ossicular chain disruption in children leads to conductive hearing loss. Few studies have focused on factors influencing successful results in pediatric ossicular chain reconstruction (OCR). We aim to determine whether demographic or surgical factors affect hearing outcomes in pediatric OCR. METHODS: We conducted a retrospective chart review of 120 patients undergoing OCR at our institution, a tertiary care hospital, between 2003 and 2014, with median length of follow-up of 2.2 years (range 0.1-9.3 years). Pediatric patients (<18 years old at time of surgical procedure) who had current procedural terminology (CPT) codes of OCR, and available pre- and post-operative audiograms were included in the study. Demographic information, surgical details, and pre- and post-operative pure-tone averages (PTA), speech reception thresholds (SRT), and air-bone gaps (ABG) were recorded from clinic notes, audiograms and operative reports. Differences between PTA, SRT and ABG pre- and post-operatively, as well as demographic and surgical factors, were evaluated using Wilcoxon rank-sum tests. Factors influencing revision were evaluated using Log-rank tests. RESULTS: A total of 120 patients (123 ears) were included. 35.8% of cases were revised, most commonly due to displaced prostheses. 28.5% of surgeries resulted in normal hearing (PTA ≤25 dB) post-operatively. Post-operative SRT and ABG were significantly better in patients with partial ossicular replacement prosthesis (PORP) compared with those with total ossicular replacement prosthesis (TORP) (p = 0.016, 0.027). Titanium prostheses resulted in better post-operative PTA and larger changes in PTA compared with all other materials (p = 0.034, p = 0.038). CONCLUSIONS: In our experience, children with titanium prostheses had better hearing outcomes than those with other materials, and children with PORP had better hearing outcomes than those with TORP.

Autologous incus versus titanium partial ossicular replacement prosthesis in reconstruction of Austin type A ossicular defects: a prospective randomised clinical trial.

OBJECTIVE: This study aimed to compare the functional and anatomical outcomes of ossiculoplasty using an autograft incus or a titanium partial ossicular replacement prosthesis for reconstructing Austin type A ossicular defects. METHODS: Patients with Austin A ossicular defects were randomly divided into two groups: one group underwent ossiculoplasty with an autologous incus (the autologous incus group) and the other underwent ossiculoplasty with a titanium partial ossicular replacement prosthesis (the titanium prosthesis group). Otoscopic examination and audiological assessment was done pre-operatively and at 3, 6 and 12 months post-operatively. RESULTS: A post-operative average air-bone gap closure of less than 20 dB was seen in 13 patients (65 per cent) in the autologous incus group and 7 (35 per cent) in the titanium prosthesis group. There were fewer post-operative complications in the autologous incus group (20 per cent) than in the titanium prosthesis group (45 per cent). CONCLUSION: Hearing outcomes and graft take up after ossiculoplasty were significantly better when an autologous incus rather than a titanium partial ossicular replacement prosthesis was used to reconstruct Austin type A ossicular defects. The major disadvantages of the titanium prosthesis were unpredictable results and more post-operative complications.

Systematic review to evaluate the safety, efficacy and economical outcomes of the Vibrant Soundbridge for the treatment of sensorineural hearing loss.

Introduced in the late 90s, the active middle ear implant Vibrant Soundbridge (VSB) is nowadays used for hearing rehabilitation in patients with mild to severe sensorineural hearing loss (SNHL) unable to tolerate conventional hearing aids. In experienced hands, the surgical implantation is fast done, safe and highly standardized. Here, we present a systematic review, after more than 15 years of application, to determine the efficacy/effectiveness and cost-effectiveness, as well as patient satisfaction with the VSB active middle ear implant in the treatment of mild to severe SNHL. A systematic search of electronic databases, investigating the safety and effectiveness of the VSB in SNHL plus medical condition resulted in a total of 1640 papers. After removing duplicates, unrelated articles, screening against inclusion criteria and after in-depth screening, the number decreased to 37 articles. 13 articles were further excluded due to insufficient outcome data. 24 studies remained to be systematically reviewed. Data was searched on safety, efficacy and economical outcomes with the VSB. Safety-oriented outcomes included complication/adverse event rates, damage to the middle/inner ear, revision surgery/explant rate/device failure and mortality. Efficacy outcomes were divided into audiological outcomes, including hearing thresholds, functional gain, speech perception in quiet and noise, speech recognition thresholds, real ear insertion gain and subjective outcomes determined by questionnaires and patient-oriented scales. Data related to quality of life (QALY, ICER) were considered under economical outcomes. The VSB turns out to be a highly reliable and a safe device which significantly improves perception of speech in noisy situations with a high sound quality. In addition, the subjective benefit of the VSB was found to be mostly significant in all studies. Finally, implantation with the VSB proved to be a cost-effective and justified health care intervention.

Bony ankylosis of hydroxyapatite prostheses in the middle ear.

BACKGROUND: Ossiculoplasty is a commonly performed middle ear procedure. Ossicular chain reconstruction (OCR) prostheses should be made of a biocompatible material; one such common material is hydroxyapatite (HA). METHODS: 2 patients were identified who had HA OCR prostheses which had fused to the middle ear bony structures. One HA OCR had fused to the fallopian canal in the tympanic segment and represented a management dilemma. The other fused to the scutum. CONCLUSION: Bony ankylosis of a HA containing OCR prosthesis should be considered in the differential diagnosis of a failed ossiculoplasty. Depending on the location of the fusion, special measures may be needed to free the prosthesis from the underlying middle ear structures.

MRI scanning in patients implanted with a round window or stapes coupled floating mass transducer of the Vibrant Soundbridge.

Conclusion MRI examinations in patients with an alternatively coupled VSB can lead to unpleasant side-effects. However, the residual hearing was not impaired, whereas the hearing performance with the VSB was decreased in one patient which could be fixed by a surgical revision. Different experiences for the VSB 503 can be expected. Objective To investigate the in vivo effects of MRI scanning on the Vibrant Soundbridge system (VSB) with an alternatively coupled Floating Mass Transducer (FMT). Method Sixty-five VSB (502) implantees were included in this study. Of them, 42 questionnaires could be evaluated with the patients' statements about their medical, otological, and general condition before, during, and after an MRI scan which was indicated for different medical reasons, despite the previous implantation of an alternatively coupled Vibrant Soundbridge System. Results In four patients (9.5%), five MRI examinations were performed. These were done for different indications (e.g. knee and shoulder joint diagnostics). During the scanning, noise and subjectively perceived distortion of the implant were described. A deterioration of the hearing gain with the VSB in place was found in one patient. A decrease of the hearing threshold was not observed.

[The possibilities for the application of the fluoroplast-based prostheses with a diamond-like carbon nanocoating in ear surgery (an experimental study)].

The objective of the present study was to elucidate general and local characteristics of the tissue reactions to the implantation of radiation-modified polytetrafluoroethylene (PTFE)-based fluoroplast F-4PM20 with a diamond-like carbon (DLC) nanocoating or with the diamond-like carbon coating containing the dispersed nano-sized silver particles to the experimental animals (rats). A total of 150 inbred white rats were included into the experiment; they were divided into 3 groups comprised of 50 animals each. The rats in group 1 were implanted with the 5 nm thick strips of fluoroplast F-4PM20 having the diamond-like carbon nanocoating. The animals of group 2 were implanted with the same material containing nanoparticles of chemically pure silver dispersed in the coating, those in group 3 (controls) were implanted with the fluoroplast F-4PM20 without a coating. The animals were sacrificed on days 7, 21, 30, and 60 days after the onset of the experiment. The tissues surrounding the implant as well as heart, lung, spleen, liver, and kidney tissues were taken for the histological study. The local reactions of different tissues were found to be uniform even though there was an apparent tendency toward the less pronounced granulation and scarification processes in the animals implanted with the diamond-like carbon coating containing the dispersed nano-sized silver particles. In none of the groups, the animals exhibited statistically significant lymphoid tissue hyperplasia in the spleen which suggested the activation of the immune system in response to implantation. It is concluded that the PTFE-based fluoroplast F-4PM20 implants with the 5 nm thick DLC coating and a similar coating containing the dispersed nano-sized silver particles can be applied for middle ear reconstructive surgery, being a histologically compatible material that does not cause an inflammatory degenerative response of the tissues.