[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.

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.

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.

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.

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.

[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.

Round window stimulation for conductive and mixed hearing loss.

OBJECTIVE: Assess surgical complications, postoperative residual hearing, and speech perception outcomes of placement of a middle ear implant on the round window in conductive and mixed hearing loss cases. STUDY DESIGN: Single-subject, repeated-measures design where each subject served as his or her own control. SETTING: Tertiary referral medical systems. SUBJECTS: Eighteen subjects with either conductive or mixed hearing loss who could not benefit from conventional amplification were enrolled in a clinical trial investigating vibratory stimulation of the round window. INTERVENTION: The floating mass transducer (FMT) was positioned in the round window niche. MAIN OUTCOME MEASURES: Unaided residual hearing, and aided sound field thresholds and speech perception abilities were evaluated preoperatively, and at 1, 3, 6, and 10 months post-activation of the external speech processor. RESULTS: Six subjects experienced complications that either required further medical management or resolved on their own. There was no difference in residual bone conduction thresholds or unaided word discrimination over time. All subjects experienced a significant improvement in aided speech perception abilities as compared to preoperative performance. CONCLUSION: Subjects with conductive and mixed hearing loss with placement of the FMT in the round window niche experienced improved sound field thresholds and speech perception, without compromising residual hearing thresholds. Vibratory stimulation of the round window via a middle ear implant may be an appropriate treatment option for patients with conductive and mixed hearing loss. Additional research is needed on the preferred placement of the FMT, improvement of functional gain, and methods to limit postoperative complications and need for revision surgery.

Delayed facial nerve palsy after surgery for the Esteem(®) fully implantable middle ear hearing device.

CONCLUSION: Delayed facial nerve (FN) impairment was shown to occur after Esteem(®) surgery, and taste disturbances were found in a limited number of subjects. Thus, when this type of active middle ear implant (AMEI) is to be implanted, these specific complications need to be shared with the candidate. OBJECTIVES: To report on FN involvement in Esteem(®) AMEI surgery. METHODS: A total of 23 males and 11 females, who presented with sensorineural hearing loss of varying severity, underwent surgical implantation of the Esteem(®) AMEI. FN function was assessed according to the House-Brackmann (HB) grading system. A specific question regarding taste impairment was administered to each patient on the first day and 3 months after surgery. RESULTS: None of the patients presented with a FN deficit in the first postoperative days. In three patients (8.8%), FN palsy developed after 7 days (two patients) and 10 days (one patient), and the severities were HB 4 (two cases) and HB 5 (one case). All patients fully recovered (HB 1) after 6-8 weeks. In 10 of the 34 implanted subjects (29.4%), taste disturbances were found on postoperative day 1, and these impairments remained in only 6 (17.6%) patients at the 3-month postoperative follow-up.

Clinical investigation of flat panel CT following middle ear reconstruction: a study of 107 patients.

OBJECTIVES: After middle ear reconstruction using partial or total ossicular replacement prostheses (PORP/TORP), an air-bone gap (ABG) may persist because of prosthesis displacement or malposition. So far, CT of the temporal bone has played the main role in the diagnosis of reasons for postoperative insufficient ABG improvement. Recent experimental and clinical studies have evaluated flat panel CT (fpCT) as an alternative imaging technique that provides images with high isovolumetric resolution, fewer metal-induced artefacts and lower irradiation doses. METHODS: One hundred and seven consecutive patients with chronic otitis media with or without cholesteatoma underwent reconstruction by PORP (n = 52) or TORP (n = 55). All subjects underwent preoperative and postoperative audiometric testing and postoperative fpCT. RESULTS: Statistical evaluation of all 107 patients as well as the sole sub-assembly groups (PORP or TORP) showed a highly significant correlation between hearing improvement and fpCT-determined prosthesis position. FpCT enables detailed postoperative information on patients with middle ear reconstruction. CONCLUSIONS: FpCT is a new imaging technique that provides immediate feedback on surgical results after reconstructive middle ear surgery. Specific parameters evaluated by fpCT may serve as a predictive tool for estimated postoperative hearing improvement. Therefore this imaging technique is suitable for postoperative quality control in reconstructive middle ear surgery. KEY POINTS: • Flat panel CT offers advantages with regard to artefacts and radiation dose. • FpCT provides higher isovolumetric resolution of temporal bone and middle ear implants. • FpCT allows prediction of the postoperative hearing outcome in patients. • FpCT is an important tool for immediate postoperative quality control. • FpCT improves postoperative management of patients with complications following ossicular replacement.