[Differential indication of active middle ear implants]. / Differenzialindikation aktiver Mittelohrimplantate.

INTRODUCTION: Hearing aids (HA) provide adequate support for many patients with hearing loss, but not all. Around one third of 10.000 patients provided with hearing aids in the Abbreviated Profile of Hearing Aid Benefit felt no actual benefit when using the hearing aid, although they demonstrated the necessary hearing improvement on speech audiometry. Epidemiological data show bad compliance, especially in older people. Only one in three hearing aid owners wears their device regularly. For this subpopulation of patients active middle ear implants (AMEIs) have been used since 1998. In the present review, the current indications for AMEIs are presented. MATERIAL AND METHODS: A selective literature search in PubMed, as well as a guideline search at the Arbeitsgemeinschaft der Wissenschaftlichen Fachgesellschaften e. V. (German Association of Scientific Societies), was carried out. RESULTS: The present review shows that when there is an adequate indication the hearing capacity of patients can be thoroughly rehabilitated and thus their quality of life improved with the help of AMEIs. Although most commercially available systems have a satisfactory risk profile, increased extrusion rates, malfunctioning and facial paresis have been reported in older implant series. The advantages of AMEIs include increased hearing gain, reduced feedback, increased hearing quality, increased speech discrimination in the presence of background noise, and an absence of occlusion. CONCLUSIONS: The audiological indication for AMEIs in primary care is usually controversial, since the functional hearing gain and increase in speech discrimination may be small compared with modern conventional hearing aids. AMEIs thus play a main role in the secondary care of patients who do not have sufficient benefit or who have side effects after having a conventional hearing aid fitted.

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.

Grading system for the selection of patients with congenital aural atresia for active middle ear implants.

INTRODUCTION: Active middle ear implants (aMEI) are being increasingly used for hearing restoration in congenital aural atresia. The existing gradings used for CT findings do not meet the requirements for these implants. Some items are expendable, whereas other important imaging factors are missing. We aimed to create a new grading system that could describe the extent of the malformation and predict the viability and challenges of implanting an aMEI. METHODS: One hundred three malformed ears were evaluated using HRCT of the temporal bone. The qualitative items middle ear and mastoid pneumatization, oval window, stapes, round window, tegmen mastoideum displacement and facial nerve displacement were included. An anterior- and posterior round window corridor, oval window and stapes corridor were quantified and novelly included. They describe the size of the surgical field and the sight towards the windows. RESULTS: The ears were graded on a 16-point scale (16-13 easy, 12-9 moderate, 8-5 difficult, 4-0 high risk). The strength of agreement between the calculated score and the performed implantations was good. The comparison of the new 16-point scale with the Jahrsdoerfer score showed that both were able to conclusively detect the high-risk group; however, the new 16-point scale was able to further determine which malformed ears were favorable for aMEI, which the Jahrsdoerfer score could not do. CONCLUSION: The Active Middle Ear Implant Score for aural atresia (aMEI score) allows more precise risk stratification and decision making regarding the implantation. The use of operative corridors seems to have significantly better prognostic accuracy than the Jahrsdoerfer score.

Long-Term Outcome of Hearing Rehabilitation With An Active Middle Ear Implant.

OBJECTIVE: To assess the audiological and long-term medical and technical follow-up outcomes of an active middle ear implant. METHODS: This was a retrospective medical chart analysis of all patients provided with an active middle ear implant in a tertiary academic medical referral center between September 1, 1998, and July 31, 2015. Main outcome measures were medical and technical complications, revisions, reimplantations, explantations, coupling approaches, mean time of use, pre- and postoperative hearing thresholds, functional hearing gain across frequencies (250-4,000 Hz), and Freiburg monosyllablic word test at 65 dB. RESULTS: One hundred and three patients were identified. Fifteen were implanted bilaterally (n = 118 Vibrant Soundbridge devices [MED-EL, Innsbruck, Austria]). Seventy-seven devices were implanted for sensorineural and 41 for mixed and conductive hearing loss. Patients used the implant for 6.7 years (range 0.7 months-17.9 years) on average. Ninety-one patients (77.12%) were using the device at the end of the observation period. An overall complication rate of 16.1% was observed. The revision and explantation rates were higher for devices implanted between 2004 and 2006. The device failure rate was 3.4%. Audiological evaluation showed significant hearing gains for both hearing loss patient groups. CONCLUSION: This long-term follow-up reveals the reliability of the active middle ear implant in a single center. Overall complication rate and device failure rate are acceptable. The complication rate was higher during implementation of alternative coupling approaches. The audiological benefit was satisfactory in patients with all hearing loss types. The majority of implanted patients used the implant at the end of the observation period. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:477-481, 2019.

Evaluating speech perception of the MAXUM middle ear implant versus speech perception under inserts.

OBJECTIVES/HYPOTHESIS: To evaluate the speech perception of the Ototronix MAXUM middle ear implant relative to the cochlear potential for speech perception of patients. STUDY DESIGN: Clinical study chart review. METHODS: We performed an evaluation of data from a prospective clinical study of 10 MAXUM patients. Primary outcome measures included comparison of word recognition (WR) scores with MAXUM (WRMAXUM ) versus word recognition under inserts (WRinserts ), and the functional gain improvement for pure-tone average (PTA) (0.5, 1, and 2 kHz) and high-frequency pure-tone average (2, 3, and 4 kHz). RESULTS: Ten ears in 10 adult patients (six female; average age 68.7 years) were included. The average speech perception gap (difference between WRinserts and WRMAXUM ) with MAXUM was -9.2% (range, -26% to 4%). A negative number indicates that WRMAXUM was higher than the WRinserts . The average PTA with MAXUM was 23.1 dB (range, 18.7-30 dB), a 38.0-dB gain over the preoperative unaided condition (range, 20-53.3 dB). The average high-frequency pure-tone average with MAXUM was 34.4 dB (range, 26-43.3 dB), a 42.8-dB gain over the preoperative unaided condition (range, 32.3-58.7 dB). CONCLUSIONS: These data demonstrate that a significant, very strong correlation was observed between WRinserts and WRMAXUM scores (r = 0.86, P = .001), and a patient's WRinserts score may be used to reasonably predict the word recognition outcomes with MAXUM. LEVEL OF EVIDENCE: 4. Laryngoscope, 128:456-460, 2018.

Factors associated with benefit of active middle ear implants compared to conventional hearing aids.

OBJECTIVE: Identify factors associated with benefit of middle ear implants (MEIs) as compared to conventional hearing aids (HAs). STUDY DESIGN: Independent review of audiological data from a multicenter prospective U.S. Food and Drug Administration (FDA) clinical trial. Preoperative and postoperative earphone, unaided/aided/implanted pure-tone thresholds, and word recognition scores were evaluated. RESULTS: Ninety-one subjects were included in this study. Mean word recognition was better with MEIs than with HAs (81.8% ± 12.0% vs. 77.6% ± 14.6%, P = 0.035). Word recognition with MEIs showed a low positive correlation with word recognition measured with earphones (r = 0.25, P = 0.016) and a moderate positive correlation with aided word recognition (r = 0.42, P < 0.001). Earphone word recognition alone was not predictive of MEI benefit over HA benefit (r = 0.09, P = 0.41), unlike differences between scores with earphone and HAs (earphone-aided differences [EAD]) (r = 0.62, P < 0.011). As compared to those with -EADs, subjects with +EADs showed greater improvement in word recognition from unaided to implanted and from HAs to implanted (P < 0.0001). Using the 95% CI for word recognition scores, 16 subjects showed significantly higher scores with the MEI than with HAs. Of those, 14 had +EAD. CONCLUSION: Word recognition benefit derived from conventional HAs and MEIs from this large, multi-center FDA trial provides further evidence of the importance of aided word recognition in clinical decision making, such as determining candidacy for and success with MEIs. LEVEL OF EVIDENCE: 2b. Laryngoscope, 128:2133-2138, 2018.

Review of a single surgeon's stapedotomy cases performed with a nickel titanium prosthesis over a 14-year period.

CONCLUSION: Stapes surgery with a nickel titanium prosthesis is a safe and well-tolerated procedure that leads to a significant improvement in hearing outcomes. OBJECTIVE: To identify the efficacy and safety of stapedotomy procedures performed with a nickel titanium prosthesis for patients with otosclerosis. METHODS: A review of 431 unique stapedotomies performed over 14 years by a single surgeon at an academic tertiary care center yielded 312 cases with nickel titanium prosthesis that met inclusion criteria of otosclerosis diagnosis, initial surgery in operative ear, and presence of pre-operative and post-operative audiograms. Pure-tone averages (PTA) at baseline and 8 weeks after surgery were calculated over four frequencies; 0.5, 1, 2, and 4 kHz. Average air-bone gaps (ABG) were calculated from pre-operative and post-operative audiograms. RESULTS: Average pre-operative baseline PTA was 56.7 dB in the affected ear. Post-operative PTA was 30.1 dB, a 26.6 dB improvement. Initial average ABG was 29.7 dB, while post-operative ABG averaged 5.4 dB, a 24.2 dB improvement. Surgical success (closure of ABG within 10 dB) was achieved in 263 (84%) patients. Rate of surgical success was not correlated with age, gender, race, or affected ear. Complications included recurrent conductive hearing loss (14), progressive SNHL (4), and post-operative BPPV (3).

Patient satisfaction after auditory implant surgery: ten-year experience from a single implanting unit center.

CONCLUSIONS: The satisfaction rate of the subjects with an auditory implant appears strictly related to the resulting auditory improvement, and the surgical variables would play a prevailing role in respect to the esthetic factors. OBJECTIVES: To assess the rate of satisfaction in subjects who underwent the surgical application of an auditory device at a single Implanting Center Unit. METHOD: A series of validated questionnaires has been administered to subjects who underwent the surgical application of different auditory devices. The Glasgow Benefit Inventory (GBI), the Visual Analog Scale (VAS), and the Abbreviated Profile of Hearing Aid Benefit (APHAB) have been used to compare the implanted situation with the hearing-aided one; a percutaneous bone conductive implant (pBCI) with an active middle ear implant (AMEI) on the round window in mixed hearing loss; and an invisible, fully-implantable device with a frankly and bulky semi-implantable device. RESULTS: The mean GBI scores were higher in Vibrant Soundbridge (VSB)® and Bonebridge® subjects, without significant differences among the various devices. The mean VAS score increased for all the devices in comparison with the conventional hearing aid. The mean APHAB score was similarly better in the implanted condition as total and partial scores.

Improvement of sound source localization abilities in patients bilaterally supplied with active middle ear implants.

CONCLUSIONS: Patients, who are bilaterally supplied with active middle ear implants, perform slightly better in sound localization tasks than when unilaterally aided or unaided. OBJECTIVES: To investigate the impact of bilateral use of active middle ear implants on sound source localization in the horizontal plane in patients with a sloping moderate-to-severe hearing loss. METHODS: Ten adults supplied with Med-EL Vibrant Soundbridge systems (VSB) in both ears participated in the study. Four listening conditions were tested: unaided, aided with VSB on left or right ear and on both sides. In each condition the subjects had to judge the direction of broadband noises delivered randomly across a semicircular array of 11 loudspeakers arranged in an anechoic chamber. RESULTS: When unaided or bilaterally aided, the subjects localized on average 40% of the stimuli correct; when unilaterally aided (left or right), this rate dropped to 20-30% in either condition. Precision of sound localization was highest when bilaterally aided, i.e. the mean RMS angular error was 10°, and lowest when unilaterally aided, i.e. 15°. This is in line with bilateral hearing aid users, who show similar performance in sound localization tasks.

Comparison of Carina active middle-ear implant with conventional hearing aids for mixed hearing loss.

OBJECTIVE: To compare the auditory outcomes of Carina middle-ear implants with those of conventional hearing aids in patients with moderate-to-severe mixed hearing loss. METHODS: The study comprised nine patients (six males, three females) who underwent middle-ear implantation with Carina fully implantable active middle-ear implants to treat bilateral moderate-to-severe mixed hearing loss. The patients initially used conventional hearing aids and subsequently received the Carina implants. The hearing thresholds with implants and hearing aids were compared. RESULTS: There were no significant differences between: the pre-operative and post-operative air and bone conduction thresholds (p > 0.05), the thresholds with hearing aids and Carina implants (p > 0.05), or the pre-operative (mean, 72.8 ± 19 per cent) and post-operative (mean, 69.9 ± 24 per cent) speech discrimination scores (p > 0.05). One of the patients suffered total sensorineural hearing loss three months following implantation despite an initial 38 dB functional gain. All except one patient showed clinical improvements after implantation according to quality of life questionnaire (Glasgow Benefit Inventory) scores. CONCLUSION: Acceptance of Carina implants is better than with conventional hearing aids in patients with mixed hearing loss, although both yield similar hearing amplification. Cosmetic reasons appear to be critical for patient acceptance.

Gold and titanium in the oval window: a comparison of two metal stapes prostheses.

OBJECTIVE: The objective of this study was to evaluate the hearing results of stapes surgery with 2 different full metal stapes prostheses. STUDY DESIGN: Retrospective analyses were carried out on the pre- and postoperative hearing results obtained after primary stapedotomy with 2 different prostheses. PATIENTS: We studied 106 patients with otosclerosis treated by stapes surgery. INTERVENTION: Fifty-three patients had a stapedotomy with a gold piston and 53 patients received a titanium piston after stapedotomy. MAIN OUTCOME MEASURES: The results were compared according to mean audiometric parameters. Furthermore, the individual audiologic results were demonstrated with the Amsterdam Hearing Evaluations Plot (AHEP). This method is a visual presentation of the hearing result for each operated ear. RESULTS: These AHEPs showed that the heavier gold piston (shaft Ø 0.4 mm and weight 10192.0 microg) gives more overclosure gain (28.3%) than the lightweight (shaft Ø 0.4 mm and weight 2541.0 microg) titanium piston (9.4% cases of overclosure). CONCLUSIONS: Because of the different properties of the 2 pistons (gold very malleable, titanium rather stiff), a choice can be made for different anatomic or pathologic situations in the operated middle ear. The "overclosure effect" of the gold piston is higher compared with the titanium piston.

A new approach for malleus/incus fixation: no prosthesis necessary.

OBJECTIVE: To describe a novel approach to manage malleus/incus fixation. STUDY DESIGN: Retrospective review of 363 patients with conductive hearing loss operated on since 1996. SETTING: Academic tertiary referral center. PATIENTS: Three hundred sixty-three patients with conductive hearing loss, an intact tympanic membrane, and without history for chronic infection underwent middle ear exploration. Three hundred forty-three had otosclerosis and underwent laser stapedotomy; the remaining 20 patients had laser release of their malleus/incus fixation. INTERVENTION: Twenty patients are presented in this paper. Nineteen patients were diagnosed with malleus fixation before surgery. One patient had a total perforation and mobility of the ossicular chain was not verified preoperatively. This patient was, intraoperatively, noted to have complete ossicular fixation. Conductive hearing loss was identified using audiometry and tuning forks. Nineteen of the 20 patients had the diagnosis confirmed using micropneumotoscopy and noting immobility of the malleus. A transcanal approach was used, and the malleus/incus fixation was released using a laser. This space was expanded upon using a drill. A 1.5-2.0 mm space was created where the ossicular fixation existed, thereby reducing the likelihood of refixation. MAIN OUTCOME MEASURE: Audiometric studies before and after intervention were compared. One to seven years of follow up are provided. RESULTS: Preoperative air-bone gaps ranged from 18 dB to 51 dB and averaged 33 dB. Postoperative air-bone gaps ranged from 1-36 dB and averaged 13 dB. No patients have experienced refixation. There were two complications: one perforation requiring a tympanoplasty and one patient sustaining a 20 dB high-frequency sensorineural loss, most likely secondary to inadvertent drill contact to the ossicular chain. CONCLUSION: When fixation of the malleus and/or incus is found, treatment options exist. A common technique involves removal of the incus and head of the malleus and reconstruction with an incus interposition or a partial ossicular prosthesis. Another technique proposed by the senior author (M.D.S.) is maintenance of the normal anatomy and use of the potassium-titanyl-phosphate laser and drill to free the ossicles and widen the epitympanum. This series shows successful closure of the air-bone gap with this technique.

Statistical analysis of otosclerosis surgery performed by Jean Marquet.

The early and long-term hearing results of 1,681 primary otosclerosis operations performed by the same surgeon, Jean Marquet, were reviewed retrospectively and analyzed with very strict statistical standards. Significantly better short- and long-term results were achieved with the stapedotomy technique compared to total stapedectomy, mainly at the higher frequencies (4 and 8 kHz) important for speech discrimination. Whatever technique was used to open the footplate (micropick, microdrill, or laser), no statistical audiometric difference could be found. The results were equal whether or not the stapedial tendon was preserved. Perioperative problems like pronounced oozing, difficult anatomic relationships, and accidental perilymph aspiration could affect hearing at higher frequencies. The calibrated hole technique was equally as good as conventional oval window sealing in sealing of the fenestra to prevent fistula. The stapedotomy technique was found the safest, having fewer complications.

Incidence and characteristics of otosclerosis in the Japanese population.

OBJECTIVE: Otosclerosis is thought to be quite an uncommon disease in Japan. However, in recent years the incidence of this disease seems to have increased. Here we report about the characteristics and incidence of this disease in the Japanese population who underwent stapes surgery in our department. METHODS: A total of 80 patients (115 ears), who underwent stapes surgery by a single surgeon in 21 years and 8 months were included in this study. RESULTS: The incidence of clinical otosclerosis was found to be 0.22% among the outpatients with ear disease. During the first half of the period, the ratio of stapes surgery/tympanoplasty was less than 0.05. While, during the second half of this period, this ratio had increased to 0.08. The average number of stapes surgery performed in the first half period was 3.7 ears/year, and that in the second half was 6.8 ears/year. In contrast to otosclerosis in Caucasians, pure tone threshold in lower frequencies was much higher than that of higher frequencies (except for 8000 Hz). However, the improvement of the threshold after surgery was not so different from that reported in Caucasians. CONCLUSIONS: Taken together, the present results clearly demonstrate that the incidence of otosclerosis in Japan has been increasing. Moreover the rise in the slope of the conduction curve at higher frequencies may be a reflection of the pathological characteristics of otosclerosis in Japanese population, which is less invasive and has limited otosclerotic foci in the temporal bone.

TORP-vibroplasty: a new alternative for the chronically disabled middle ear.

OBJECTIVE: Surgery can often eradicate chronic middle ear disease in patients with recurrent cholesteatoma, tubal dysfunction, and others; however, in many cases, social hearing cannot be restored even after multiple revision tympanoplasties. A hearing aid is then recommended. Placement of an implantable hearing aid with its advantage of an unoccluded ear canal, irrespective of middle ear function, seems to be a promising alternative. STUDY DESIGN: After establishing the biomechanics of the ear in our temporal bone laboratory, various locations and attachments of a Vibrant transducer were investigated. These experiments resulted in the development of a new titanium clip holder for a Vibrant integrated total ossicular replacement prosthesis assembly with placement on the footplate. Four patients with permanent severe combined hearing loss were implanted with this device after multiple revision tympanoplasties. The first case is described in detail. RESULTS: Placing a transducer directly on the footplate via a rod transmission gave a better gain for the high frequencies than in the round window location. The acoustic results of the patients showed an improved gain in speech understanding, unobtainable by a conventional hearing aid. CONCLUSION: The concept of a total ossicular replacement prosthesis-vibroplasty establishes a straightforward procedure in the tympanic cavity similar to a normal tympanoplasty. The open ear canal and its superior acoustic performance offer a promising perspective for revision operations in cases of incurable middle ear dysfunction.

Ossiculoplasty: a UK survey.

The aim of this study was to assess and quantify the current surgical practice of ossiculoplasty among British otolaryngology consultants, using a postal questionnaire. Ossiculoplasty is not a very common procedure. It is only performed by otologists with a special interest in ossiculoplasty. Among the 280 respondents (response rate 51.9 per cent), only 179 (63.9 per cent) performed ossiculoplasty. The majority of the consultants (86.5 per cent) used artificial prostheses, and 63.7 per cent used patients' own ossicles (autografts). Most of the consultants (77.6 per cent) performed ossiculoplasty with primary tympanoplasty surgery rather than with primary cholesteatoma surgery (46.3 per cent). The majority of the consultants (50.8 per cent) performed less than 10 ossiculoplasties per year. This is the first survey on ossiculoplasty surgery in the United Kingdom.