A longitudinal study on postoperative hearing thresholds with the Vibrant Soundbridge device

The Vibrant Soundbridge is a semi-implantable middle ear hearing device used in the rehabilitation of adults with sensorineural hearing loss. In order to evaluate the long-term effects of the implanted part of the device, audiological data from 39 patients implanted over several implant sites across France were collected and analyzed retrospectively. The mean follow-up time was 16 months; 25 patients had a follow-up period of over 1 year. Surgery was uneventful in all cases. The present study of the 39 implanted patients with a mid- to long-term follow-up found a statistically significant modification of hearing thresholds (pre- versus postoperative) for frequencies of 0.5 and 4 kHz. However, the shift of threshold was rather limited (2.79 and 3.34 dB, respectively), and this variation was not statistically different from the evolution of the opposite non-operated ear.     

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.     

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.     

振动声桥在先天性中外耳畸形患者的应用

目的报道振动声桥在先天性中外耳畸形患者(尤其有特殊情况者)的应用,探索其在该类患者的适应症。方法对4例先天性中外耳畸形患者行振动声桥植入术,均为男性,年龄3-18岁(平均13.5岁),3例双耳畸形,1例单耳畸形,均为左侧植入,对具有特殊情况者根据具体情况采用相应措施完成手术。手术径路分为经面神经隐窝径路(3例)和面神经后径路(1例)。振动声桥植入方式分为镫骨振动型(2例)和圆窗振动型(2例)。对比开机前后听力与言语测听结果,及日常交流情况进行评估。结果 4例患者均顺利完成手术,无并发症。开机后,听力改善明显,0.25k-4kHz平均纯音或条件反射测听气导听阈改善35dB(开机前69dB/后34dB),助听后安静环境下65dBSPL语句识别率,双耳畸形者平均为86%(术前0%),单耳畸形者100%(术前100%),但噪声环境(-8dBSNR)下为20%(裸耳0%)。结论振动声桥植入是先天性中外耳畸形患者一种良好的听力解决方案,即便有些特殊情况者,亦可以完成手术取得良好效果     

The Vibrant Soundbridge® middle ear implant: A historical overview

Objective: To present a historical overview of the Vibrant Soundbridge^® (VSB) middle ear implant (MEI), since its beginning in the 1990s to date and to describe its course and contemplate what it might become in the future.

History: MEIs started to take form in researchers’ mind in the 1930s with the first experiment of Wilska. In the 1970s, several devices, such as the Goode and Perkins’, the Maniglia’s, or the Hough and Dormer’s were created but remained prototypes. It is only in the 1990s the devices that emerged remained on the market. In 1994, Symphonix, Inc. was created and aimed to manufacture and commercialize its semi-implantable MEI, the VSB. The principle of the VSB lies on a direct drive of the sound to a vibratory structure of the middle ear through an electromagnetic transducer, the floating mass transducer (FMT). The particularity of the system VSB is the simplicity of the transducer which is made of both the magnet and the coil; thus, the FMT, fixed on a vibrating middle ear structure, mimics the natural movement of the ossicular chain by moving in the same direction. The goal of the VSB was to give an alternative to patients with mild-to-severe sensorineural hearing loss who could not wear hearing aids (HAs) or who were unsatisfied conventional HA users. Subsequent to Tjellström’s experiment in 1997, implantations started to include etiologies such as otosclerosis, radical mastoidectomy, failed ossiculoplasty/tympanoplasty, and atresia.

Nowadays, the VSB, with more than 20 years of experience, is the oldest and most used middle ear implant worldwide. It is well acknowledged that the straightforward design and reliability of the transducer have certainly contributed to the success of the device.     

面神经后入路振动声桥圆窗植入术治疗小耳畸形

目的探讨双侧小耳畸形合并耳道骨性闭锁患者,面神经垂直段后进路振动声桥植入的可行性和术后效果.方法1例双耳先天小耳畸形合并耳道骨性闭锁患者,左耳传导性耳聋,右耳混合性聋,语频区平均骨气导差为55 dB.Jahrsdoerfer评分患者左侧为5分,右侧为4分.双侧面神经后进路开放骨性隧道,一期双耳振动声桥圆窗植入.结果双耳面神经后进路振动声桥圆窗植入,术后2.5个月开机使用,声场测听语频区左耳听阈平均40 dB HL,右耳平均听阈39 dB HL,双耳气导听阈降低15~16 dB HL.开放式汉语单声母、韵母言语识别率为98%.结论面神经后进路开放骨性隧道暴露圆窗行振动声桥圆窗植入术治疗小耳畸形,听力改善较为理想.     

先天性内耳畸形并中耳畸形患者多通道人工耳蜗植入术3例报告

目的：探讨先天性内耳畸形并中耳畸形患者行多通道人工耳蜗植入术的方法及效果。方法：1995年5月-2002年5月我院为3例罕见的先天性内耳畸形并中耳畸形患者经乳突进路行人工耳蜗植入术,分别植入27、28、32个电极,植入后3个月行声场测听。结果：3例患者均成功地行人工耳蜗植入,术中、术后无严重并发症发生,术后声场测听听阈达35-40dBHL。结论：罕见的先天性内耳畸形并中耳畸形患者也可行人工耳蜗植入术,术后效果满意。     

Round window application of an active middle ear implant (AMEI) system in congenital oval window atresia

Conclusion: Application of the Vibrant Soundbridge to the round window (RW) membrane can be utilized as an efficient therapy for congenital oval window (OW) atresia. Objective: To report the surgical technique and auditory outcome of an active middle ear implant (AMEI) system used in patients with congenital OW atresia. Methods: Nine subjects with congenital OW atresia (six males and three females, ranging in age from 5.5 to 25 years, average 12.5 years) were implanted with an AMEI (Vibrant Soundbridge) at the round window (RW-Vibroplasty). Five cases were diagnosed as having isolated congenital OW atresia while four patients presented with combined external/middle ear malformation. Results: An improvement of 30 dB in average pure-tone air conduction thresholds (0.5–4 kHz) was achieved, with the high frequencies showing greater results. The subjects achieved postoperative speech recognition scores of 80–100% on the Computerized Mandarin Speech Test System (CMSTS) sentence test. Bone conduction thresholds were confirmed as stable in all subjects postoperatively. Decline in auditory benefit was noticed in two subjects, who then underwent revision surgery. One of these revision surgery patients then experienced stable hearing recovery, while the other patient’s hearing declined.     

Our auditory results using the Vibrant Soundbridge on the long process of the incus: 20 years of data

Objective

After 20 years of experience with different types of middle ear implants, we analyzed our database about the Vibrant Soundbridge (VSB) to know the rate of complications, the effect on the residual hearing and the audiometric gain in our center.

Re-implantation of the Rion E-type semi-implantable hearing aid: status of long-term use and hearing outcomes in eight patients

Objectives

The Rion Ehime (E)-type implantable hearing aid (IHA) is the first middle ear implant. We implanted 39 IHAs into 39 patients, and found that the IHA functioned well for >15 years. So far, 28 IHAs have been removed because they stopped functioning. An IHA was re-implanted in 8 of the 28 cases. This study assessed the status of long-term use and hearing outcomes in the eight patients to confirm the safety and advantages of repeated implant operation.

Methods

Current status and operational findings of the eight re-implantees and hearing outcomes were investigated by reviewing the patients’ records.

Results

Four of the eight cases still use their devices; all four originally suffered from cholesteatoma. In the remaining four cases, the devices stopped functioning 2.4–9.4 years after re-implantation; they suffered from chronic otitis media. Preoperative air and bone conduction hearing and IHA hearing 3 months after the first implantation were 61.1 ± 13.1 dB, 40.6 ± 11.3 dB, and 26.9 ± 10.5 dB, respectively (n = 8). At the time of removal, they were 59.4 ± 12.4 dB, 40.2 ± 14.2 dB, and 42.9 ± 14.9 dB, respectively. Three months after re-implantation, they were 60.4 ± 14.6 dB, 37.3 ± 14.7 dB, and 29.4 ± 13.4 dB, respectively.

Conclusions

Re-implantation of an IHA is beneficial and safe for patients. As the absence of active inflammation has a crucial effect on the period of use, re-implantation should be judged carefully after deterioration of the initial implant.     

Management of acquired cholesteatoma in children: A 15 year review in ENT service of CHNU de FANN Dakar

Objectives

To analyze the epidemiology, diagnosis, management and the prognosis of cholesteatoma of the middle ear in children.

Methods

This was a retrospective study of 15 years (from 01 January 1995 to 31 December 2009) for patients aged 0–15 years admitted in ENT ward of FANN hospital for chronic otitis media complicated with cholesteatoma The parameters studied were epidemiology, clinical presentation, disease progression and management.

Results

Sixty-six participants were included. We noted a slight male predominance with a sex ratio of 1.44. The average mean age was 10 years. Most patients presented with signs of complications (69.7%) and mastoiditis was the most common complication (63.6%). The otorrhea was noted in almost all patients: n = 64 (97%) and deafness in 49 patients (74, 2%). There was a slight predominance of cholesteatoma on the right side (51.5%). Schuller's view of the mastoid cells was done in 21.2% of patients (n = 14) and showed sclerotic mastoid air cells for all them. Eighty-two percent (82%) of patients presented with conductive hearing loss. A radical mastoidectomy was performed in 66.7% and modified radical mastoidectomy in 33.3% of cases. Mean follow-up was 6 months. Recurrence of cholesteatoma was noted in 13% of cases.

Conclusions

ENT ward of Hospital Fann is one of the two centers in Senegal where cholesteatoma of the middle ear are treated. This low number of cholesteatoma in children in a developing country is in relation to the fact that patients only present when complications develop: 70% of cases. The reason for this in our setting include insufficient human and manpower resources necessary for prompt management of the disease and also lack of awareness among the populace. In these settings we advocate canal wall down mastoidectomy (radical or modified radical) as the treatment of choice.     

Vibrant Soundbridge implantation via a retrofacial approach in a patient with congenital aural atresia

Objective

A method of Vibrant Soundbridge (VSB) placement to the round window (RW) via the retrofacial approach with preoperative evaluation of the relationship between the facial nerve (FN) and RW by 3D-CT reconstruction was proposed for the treatment of congenital aural atresia (CAA) patient.

Age at implantation and auditory memory in cochlear implanted children

Abstract

Early cochlear implantation, before the age of 3 years, provides the best outcome regarding listening, speech, cognition an memory due to maximal central nervous system plasticity. Intensive postoperative training improves not only auditory performance and language, but affects auditory memory as well. The aim of this study was to discover if the age at implantation affects auditory memory function in cochlear implanted children. A total of 50 cochlear implanted children aged 4 to 8 years were enrolled in this study: early implanted (1-3y) n = 27 and late implanted (4-6y) n = 23. Two types of memory tests were used: Immediate Verbal Memory Test and Forward and Backward Digit Span Test. Early implanted children performed better on both verbal and numeric tasks of auditory memory. The difference was statistically significant, especially on the complex tasks. Early cochlear implantation, before the age of 3 years, significantly improve auditory memory and contribute to better cognitive and education outcomes.