Vibrant Soundbridge Research Articles

Clinical Experience of Vibroplasty With Direct Coupling to the Oval Window Without Use of a Coupler.

To investigate the efficacy of direct implantation of a Vibrant Soundbridge (VSB) implant in the oval window (OW) without the use of an OW coupler in patients with severe mixed hearing loss. Retrospective chart review METHODS: A total of 62 patients underwent VSB implantation between July 2016 and December 2018 at Severance Hospital in Seoul, South Korea. Among them, eight patients (nine ears) with moderate-to-severe mixed hearing loss were implanted with a VSB directly in the OW. A floating mass transducer (FMT) was attached to the stapes footplate and covered with tragal cartilage. The outcomes were evaluated using pure-tone audiogram and speech audiogram preoperatively and postoperatively. Word recognition score (WRS; % correct) were measured at the most comfortable loudness (MCL) level to evaluate speech perception. All cases posed difficulty with round window vibroplasty during surgery, and eventually, an FMT was appropriately placed in the OW without a coupler. Preoperative and postoperative bone conduction thresholds were not different. VSB-aided threshold improved in terms of functional and effective gains. Interestingly, four cases showed improved air conduction thresholds without the use of a VSB. In addition, MCL level with a VSB was significantly lower than that with a hearing aid, and VSB-aided WRS improved over time. Direct implantation of a VSB in the OW without the use of a coupler showed favorable hearing outcomes, and the OW vibroplasty was safe. Direct OW vibroplasty without a coupler is a reliable procedure and can be a good option for hearing rehabilitation in patients with severe mixed hearing loss. 4 Laryngoscope, 2020.

Intraoperative Estimation of the Coupling Efficiency and Clinical Outcomes of the Vibrant Soundbridge Active Middle Ear Implant Using Auditory Brainstem Response Measurements.

Purpose This study intraoperatively measured the coupling efficiency of the Vibrant Soundbridge (VSB), with the aim of avoiding revision surgery due to insufficient outcome. This method can also be used to test the integrity of the implant at the end of the implantation surgery and to evaluate aided thresholds. In addition, this method makes it possible to objectively test how well the VSB has been fitted, provide assistance in fitting handicapped patients or children, evaluate hearing degradation, or test for a drop in coupling efficiency before revision surgeries. In order to analyze the feasibility of these new VSB-aided auditory brainstem response (ABR) thresholds, they were compared to behavioral thresholds from the Vibrogram and the preoperative bone conduction thresholds. Method The study included 30 patients with mild-to-severe hearing loss implanted with a VSB (VORP503). Intraoperative ABR thresholds during the VSB implantation were recorded using a VSB-optimized chirp stimulus. The new method is compared to the bone conduction threshold of the study sample and the aided Vibrogram thresholds. Speech intelligibility results up to 24 months after surgery are also presented. Results A reliable correlation between the bone conduction thresholds and the intraoperative ABRs was found and was higher in comparison to the Vibrogram. Furthermore, speech intelligibility outcomes were stable over time. Conclusion ABR measurements can be used intraoperatively to estimate the coupling efficiency of the VSB and test the integrity of the implant at the end of surgery.

Stapedotomy with incus vibroplasty – A novel surgical solution of advanced otosclerosis and its place among existing therapeutic modalities – Hungarian single institutional experiences

ObjectiveTo delineate the advantages and steps of stapedotomy with incus vibroplasty, to assess the safety and efficacy of this method via the authors’ experiences, and to overview the literature regarding other surgical options in advanced otosclerosis determining the place of stapedotomy with incus vibroplasty in the therapeutic range. MethodsFour patients were enrolled in the study presenting severe mixed hearing loss of at least one side on pure tone audiometry. Based on complementary audiological examinations including stapedial reflex test and multifrequency tympanometry, all cases were suspected as advanced otosclerosis. Stapedotomy with incus vibroplasty – the combination of laser stapedotomy and simultaneous Vibrant Soundbridge implantation – was performed in each patient. Preoperative pure tone average, speech recognition thresholds and word recognition scores were compared to one-year postoperative free-field values with the implant switched on focusing on functional gain. ResultsAmong 4 participants (3 females, 1 male) the mean age (SD) was 66 years (35). In three cases Nitinol, in one case NitiBond piston was inserted. One-year postoperative free-field functional gains were 30 dB, 34 dB, 42 dB and 51 dB, respectively. One-year postoperative free-field speech recognition thresholds were 45 dB, 45 dB, 49 dB and 50 dB, respectively, while word recognition scores were 70%, 70%, 70% and 75%, respectively. ConclusionPostoperative results in our serie regarding pure tone average and word recognition score proved to be better than those found in the literature. Stapedotomy with incus vibroplasty – through sufficient air-bone gap closure and simultaneous sensorineural component management – seems to be a promising surgical solution in advanced otosclerosis, requiring further investigation.

Complications after round window vibroplasty.

To evaluate the complication rate in adult subjects with open cavities that were implanted with the Vibrant Soundbridge implant, using the round window (RW) vibroplasty procedure. From2009 to 2014, 21 adult subjects with mixed hearing loss, all with sequel from open tympanoplasty surgery, underwent RW vibroplasty (RW-VPL). Surgical complications were recorded and a standard minimal approach was used as a basis for all the cases that needed revision. The mean follow-up was 42months (range 12-76). Complications occurred in nearly half of the cases and included: cable extrusion (23.8%), hardware failure (14.3%), profound hearing loss (9.5%), and inadequate RW coupling (9.5%). A minimal endaural approach (MEA) was used in the majority of the cases (86.7%), while the extended endaural approach was adopted for those patients requiring explantation with or without replacement (14.3%). RW-VPL can be considered a possible option for the rehabilitation of auditory impairment derived from an open tympanoplasty procedure due to cholesteatoma. The procedure may lead to minor/major complications that may require a surgical revision. By adopting an MEA, it has been possible to manage all the situations in which functionality of the device is worth being preserved.

Vibroplasty combined with tympanic membrane reconstruction in middle ear ventilation disorders

Although the Vibrant Soundbridge is one of the most frequently used active middle ear implants, data regarding how middle ear ventilation disorders may affect the transmission behavior of its floating mass transducer are still insufficient. Studies involving coupling the floating mass transducer to the stapes head are particularly lacking.This temporal bone study evaluated the influence of simulated middle ear ventilation disorders on the middle ear transfer function in the reconstructed middle ear. The middle ear transfer function was measured using Laser Doppler Vibrometry after vibroplasty onto the stapes head, with or without tympanic membrane reconstruction. Middle ear ventilation disorders were simulated through changes in static pressure via the external ear channel with a maximum pressure of +3 kPa. Slice thickness of tympanic membrane reconstruction material was measured using micro-CT.When the reconstructed ossicular chain and the reconstructed tympanic membrane were mechanically excited by the floating mass transducer under conditions of ambient static pressure, the transmission behavior was found to be independent of the type of tissue used. Increase in static pressure up to +3 kPa caused maximum low frequency transmission loss of 15 dB when elastic grafts were used and 5 dB when stiff tissue was inserted. At high frequencies, measured loss of up to 5 dB was relatively independent of the tissue stiffness.Increase in static pressure led to displacement of the tissues towards the vestibulum and caused stiffening, especially of the annular ligament. Stiffening-induced transmission losses were mainly found at low frequencies and could not be compensated by the floating mass transducer in this range. Above 1300 Hz, the continuous force spectrum of the actuator sufficiently protected against loss of amplitude. To minimize postoperative transmission loss due to persisting ventilation disorders, choosing a very stiff tympanic membrane reconstruction material seems to be appropriate.

Feasibility of direct promontory stimulation by bone conduction: A preliminary study of frequency-response characteristics in cats

BackgroundAs an alternative pathway to air conduction, bone conduction is a multipathway process that transmits sound energy to the inner ear through the skull in general. Based on this mechanism, bone conduction devices (BCDs) have been used widely in the rehabilitation of hearing loss. Although great efforts have been devoted to improving BCDs, drawbacks still exist in most categories of BCDs due to the complicated process of bone conduction. We hypothesized that if a bone conduction transducer was placed on the cochlea to stimulate it directly, the attenuation would be minimized, and the frequency dependency would be different from that of the vibratory response induced by traditional BCDs. This study aimed to explore the feasibility of direct promontory stimulation and to investigate its frequency-response characteristics. MethodsMeasurements were conducted in twelve cat ears. To stimulate the promontory directly, the floating mass transducer (FMT) of the Vibrant Soundbridge© (VSB) implant was glued to the promontory coupled with an oval window (OW) coupler. Auditory brainstem response (ABR) and laser Doppler vibrometry (LDV) measurements were used to evaluate the auditory response induced by the FMT. In both measurements, the FMT was driven by direct voltage stimuli. ResultsABR waves could be induced under direct promontory stimulation by the FMT. In the frequency range of 1–12 kHz, the variation in the voltage threshold level were limited to 16 dB SPL with a maximum of 0.2 V at 1 kHz and a minimum of 0.04 V at 10 kHz. In the LDV measurements and the relative motion of the round window membrane (RWM) and the promontory were used to evaluate the cochlear response. The LDV results indicated a weak frequency dependency from 1 to 12 kHz. ConclusionDifferent from traditional stimulation via transcranial bone conduction, direct promontory stimulation is a new method in which a small bone conduction transducer stimulates the cochlear shell directly. The current experimental data demonstrate that it is feasible to generate sensations through bone conduction by stimulating the cochlea directly. Furthermore, the cochlear response induced by this type of stimulus in cats was weakly frequency dependent at frequencies ranging from 1 to 12 kHz. This study may provide a basis for the design of new transducers that can perform well over a wide range of frequencies.

ACTIVE MIDDLE EAR VIBRANT SOUNDBRIDGE SOUND IMPLANT.

SUMMARYThe Vibrant Soundbridge represents a new approach to hearing improvement in the form of active implantable middle ear hearing device. Unlike conventional acoustic hearing aids, which increase the volume of sound that goes to the eardrum, the Vibrant Soundbridge bypasses the ear canal and eardrum by directly vibrating the small bones in the middle ear. Because of its design, no portion of the device is placed in the ear canal itself. The Vibrant Soundbridge has been approved by the FDA as a safe and effective treatment option for adults with moderate to severe sensorineural, conductive or mixed hearing losses who desire an alternative to the acoustic hearing aids, for better hearing. The paper presents a review of the active middle ear implant Vibrant Soundbridge, which has been also implanted at the Department of Otorhinolaryngology and Head and Neck Surgery, Sestre milosrdnice University Hospital Center, which is the Referral Center for Cochlear Implantation and Surgery of Hearing Impairment and Deafness of the Ministry of Health, Republic of Croatia.

Treatment of moderate-to-severe otosclerosis with simultaneous piston surgery and incus vibroplasty.

Objective:Whereas the nature of otosclerosis has been extensively investigated, treatment modalities in advanced otosclerosis with the sensorineural hearing loss (SNHL) are relatively unexplored.Materials and Methods:This article presents a retrospective case series study of nine patients who received a one-stage piston coupled with Vibrant Soundbridge® vibroplasty in treating otosclerosis with moderate-to-severe SNHL.Results:The findings suggest that hearing loss could be restored across frequencies and no significant change in the bone-conduction threshold were measured.Conclusion:One-stage piston surgery coupled with incus vibroplasty is a safe procedure and has sufficient efficacy to restore hearing loss in patients with otosclerosis with moderate-to-severe SNHL.

A Case of Middle Ear Implantation Using the Vibrant Soundbridge in a Patient with Bilateral Mixed Hearing Loss

A Case of Middle Ear Implantation Using the Vibrant Soundbridge in a Patient with Bilateral Mixed Hearing Loss

The application of cartilage in middle ear surgery

Summary The aim of this study is to review the application, techniques and procedures of cartilage in the middle ear surgery. Cartilage offers the advantage of higher mechanical stability in tympanoplasty, which is the most common procedure in the middle ear surgery, thus apply to much complicated situation especially for tubal dysfunction and adhesive processes. There are many variations on the shape, size, thickness and technical matters of the cartilage grafts. The past decades and literature have observed excellent graft take rates and good postoperative hearing outcomes for cartilage tympanoplasty and the reservation of perichondrium seems to show better long-term survival. There have been concerns regarding malacia of cartilage struts, as a result, cartilage struts for ossiculoplasty have not gained popularity except for combined application with synthetic materials. Meanwhile, the benefits of cartilage in the reconstruction of posterior canal wall and attic, mastoid obliteration and adhesive otitis media have been demonstrated in the previously published studies. It is well to be reminded that cartilage could be applied in some unusual cases such as vibrant soundbridge, meningoencephalocele.

The development of active middle ear implants: A historical perspective and clinical outcomes.

Objective (s)Energy emitting, active middle ear implants (aMEI) have taken more than two decades of research to reach technological sophistication, medical safety, and regulatory approval to become a powerful tool in treating sensorineural, conductive, and mixed hearing loss. The present review covers this era.Data SourceLiterature found from searching Pubmed (MEDLINE); EMBASE, SciSearch, German Medical Science Journals and Meetings, and The Cochrane Library; and published as of February 2017. Study bibliographies were hand‐searched to find further materials.MethodsA systematic literature review was conducted to identify studies evaluating the safety, efficacy, effectiveness, and subjective outcomes of partially implantable aMEIs. Data were extracted on systems with regulatory approval and summarized narratively. Meta‐analyses were conducted for aMEIs with more than 25 publications. Study selection, data extraction, and quality appraisal for quantitative data synthesis was carried out by two reviewers.ResultsFour hundred thirty‐one studies included in narrative synthesis describe that albeit good audiological outcomes, clinical safety and (dis)investment are major barriers to continued market access. The synthesised risk of adverse events was three fold with the MET than with the VIBRANT SOUNDBRIDGE. With the latter system, audiological outcomes were stable and similar for all indications and age groups.ConclusionTo date, the majority of the literature covers the clinical application of the VIBRANT SOUNDBRIDGE system as it is applicable to a wide range of otologic and audiological conditions, particularly with the introduction of couplers to extend its clinical reach. The MAXUM and MET still have to find their way into surgical routine.Level of Evidence:

Classification of facial nerve aberration in congenital malformation of middle ear: Implications for surgery of hearing restoration

ObjectivesFacial nerve aberration is the most troublesome situation in congenital malformations of middle ear. The aim of our study is to investigate its imaging and clinical features as well as relevant choice of surgical techniques for hearing improvement. MethodsA retrospective study involving review of clinical data of 227 patients (256 ears) with congenital middle ear anomaly was undertaken, including preoperative computed tomography (CT) data, surgical records and videos. ResultsAberration involving intratemporal facial nerve was found in 82/256 ears (32.03%) with congenital middle ear anomaly. The most common forms of aberration included overhanging over the oval window (50/82 ears, 60.98%), bifurcation (3/82 ears, 3.66%) and transverse over the promontory (3/82 ears, 3.66%), counting for 68.29% (56/82) of the cases with facial nerve aberration. Concomitant stapes malformation was found in 76/82 ears (92.68%) and atresia or stenosis of the oval window in 27/82 ears (32.93%). In 9/82 ears (10.98%) both stapes and oval window was absent. Elective surgeries for the purpose of hearing improvement included stapodotomy + piston implantation, labyrinthotomy, labyrinthotomy + total ossicular replacement prosthesis (TORP) implantation and Vibrant Soundbridge (VSB) implantation. ConclusionThe majority of facial nerve aberration in congenital malformation of middle ear involves displacement of facial nerve, in addition to concomitant malformations of the stapes and/or oval window, which may influence the choice of surgery for hearing improvement. VSB implantation may be considered as a useful option.

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

ObjectiveA 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. MethodsA fenestration to the mesotympanum was made mastoid portion of the FN. During the approach, part of the stapedial muscle was encountered and removed. The RW niche was identified, and the floating mass transducer was placed from an inferior approach into the RW niche. ResultsThere were no intra-operative or post-operative surgical complications. ConclusionThe VSB placement to the RW via the retrofacial approach with partial removal of the stapedial muscle can be feasible alternative in CAA cases associated with an anteriorly and laterally positioned aberrant FN. Preoperative assessment using 3D CT may facilitate in assessing the feasibility of the approach and implantation of VSB.

KORZYŚCI Z AKTUALIZACJI PROCESORA AUDIO U DOŚWIADCZONYCH UŻYTKOWNIKÓW AKTYWNEGO IMPLANTU UCHA ŚRODKOWEGO: ROZUMIENIE MOWY W HAŁASIE I SUBIEKTYWNA OCENA

BackgroundMicrophone directionality plays an important role in speech understanding in challenging acoustic environments. A new audio processor (AP) from Med-El, known as Samba, automatically detects and selects optimal settings depending on the listening situation. This clinical investigation evaluated speech understanding in noise and subjective benefit of an AP upgrade from the prior Amadé to the new Samba.Material and MethodsFourteen Vibrant Soundbridge users with at least 3 months experience with the Amadé AP received the new Samba AP. Speech recognition in quiet was measured using the Freiburger monosyllable test. Speech understanding in noise was assessed using the Oldenburger sentence test. Subjective benefit was determined with the Hearing Device Satisfaction Scale and the Abbreviated Profile of Hearing Aid Benefit.ResultsNo differences were detected in pure tone audiometry or speech recognition in quiet between the two audio processors. However, the new Samba AP performed significantly better in challenging noise situations: when speech came from the front and noise from the back, the signal-to-noise ratio (SNR) improved by 3.4 dB with the automatic mode of the Samba AP compared to the Amadé AP. When the sources of speech and noise were switched, a significant improvement of 1.8 dB SNR was observed. Based on the two questionnaires, subjective benefit in daily life and device satisfaction were comparable for the two APs.ConclusionsDue to its new features, the Samba AP gave significantly better results in challenging acoustical test situations. Even when the direction of background noise changed, the Samba AP performed better due to the new built-in adaptive directional microphones.

Improved directional hearing of children with congenital unilateral conductive hearing loss implanted with an active bone-conduction implant or an active middle ear implant

Different amplification options are available for listeners with congenital unilateral conductive hearing loss (UCHL). For example, bone-conduction devices (BCDs) and middle ear implants. The present study investigated whether intervention with an active BCD, the Bonebridge, or a middle ear implant, the Vibrant Soundbridge (VSB), affected sound-localization performance of listeners with congenital UCHL. Listening with a Bonebridge or VSB might provide access to binaural cues. However, when fitted with the Bonebridge, but not with a VSB, binaural processing might be affected through cross stimulation of the contralateral normal hearing ear, and could interfere with processing of binaural cues. In the present study twenty-three listeners with congenital UCHL were included. To assess processing of binaural cues, we investigated localization abilities of broadband (BB, 0.5–20 kHz) filtered noise presented at varying sound levels. Sound localization abilities were analyzed separately for stimuli presented at the side of the normal-hearing ear, and for stimuli presented at the side of the hearing-impaired ear. Twenty-six normal hearing children and young adults were tested as control listeners. Sound localization abilities were measured under open-loop conditions by recording head-movement responses. We demonstrate improved sound localization abilities of children with congenital UCHL, when listening with a Bonebridge or VSB, predominantly for stimuli presented at the impaired (aided) side. Our results suggest that the improvement is not related to accurate processing of binaural cues. When listening with the Bonebridge, despite cross stimulation of the contralateral cochlea, localization performance was not deteriorated compared to listening with a VSB.

Surgical Impact of Coupling an Active Middle Ear Implant to Short Incus Process.

Since 1996 the active middle-ear implant Vibrant Soundbridge (VSB) is used to treat mild-to-severe sensorineural hearing losses. The former standard surgical approach for incus vibroplasty included a mastoidectomy and a posterior tympanotomy, crimping the Floating-Mass Transducer (FMT) to the long incus process. The introduction of the short process (SP) coupler allows the attachment of the FMT to the incus body making the procedure of a posterior tympanotomy unnecessary. The aim of this study was to evaluate the duration of surgery (surgical case length) and to compare the audiological results of SP coupling with the former standard surgical approach to the long incus process. Patients undergoing an incus vibroplasty between October 2009 and February 2016 were included in this cohort study. The patients received an incus vibroplasty with crimping the FMT to the long incus process (former standard application) (n = 25) and with the SP coupler (n = 17) respectively. The surgical case length as well as the functional audiological outcome was assessed 12 months postoperatively using pure-tone audiometry and speech audiometry. The surgical case length was significantly shorter in the SP coupler group compared to the standard application incus vibroplasty (85 ± 29 min vs. 114 ± 50 min). Additionally, patients receiving the SP coupler had an increased speech perception if compared to the standard application (Freiburger monosyllables at 65 dB SPL: 76.1 ± 16.1% vs. 66.2 ± 23.5%). The SP coupler leads to a shortened time of surgery and by the less invasive surgery to reduced risks for facial nerve and chorda tympani. Speech perception is significantly improved by SP coupling compared to classic long incus coupling.

The Impact of Two-Stage Subtotal Petrosectomy and Round Window Vibroplasty on Bone Conduction Thresholds

Objective: To evaluate possible increases in bone conduction (BC) hearing thresholds in patients undergoing subtotal petrosectomy (SP) with fat obliteration and blind sac closure of the outer ear canal and subsequent round window vibroplasty. Patients and Interventions: Between 1997 and 2013, 43 patients (45 ears) with combined hearing loss and recurrent chronic otitis or status post formation of a radical cavity underwent SP around 6 months prior to implantation of a Vibrant Soundbridge^TM. Pure tone audiograms (0.5, 1, 1.5, 2, 3, 4, and 6 kHz) prior to SP, after SP, prior to implantation, after implantation, and at first fitting around 5 weeks after implantation were collected and statistically analyzed. Results: The comparison between BC thresholds before SP and at first fitting showed an overall decline during the two-step procedure between 2.8 and 6 dB that was significant (p < 0.05, Student t test) at 2, 3, 4, and 6 kHz. Conclusion: In some cases, SP is the only way to eradicate chronic otitis and to achieve a suitable environment for the implantation of active middle ear implants. The present data demonstrate a relatively small but significant decline in BC thresholds throughout the whole procedure. Knowledge of its extent is mandatory for a correct indication for later implantation of a Vibrant Soundbridge^TM.

ZASTOSOWANIE ZACZEPU NA ODNOGĘ KRÓTKĄ KOWADEŁKA IMPLANTU UCHA ŚRODKOWEGO VIBRANT SOUNDBRIDGE W PRZEWLEKŁYM ZAROSTOWYM ZAPALENIU PRZEWODU SŁUCHOWEGO ZEWNĘTRZNEGO – OPIS PRZYPADKU

ObjectiveChronic obstructive inflammation of the external ear canal after different kinds of surgeries often leads to restenosis. There are different approaches to treatment of such cases, and one solution is a middle ear implant. Here we analyze the efficacy of using the Vibrant Soundbridge middle ear implant with a new incus short process (SP) coupler in this type of case.Material and MethodsWe present a case study of a 29-year old patient with bilateral mixed hearing loss caused by bilateral obstructive inflammation of the external ear canals. He had undergone meatoplasty with very short-lived improvement. Afterwards he qualified for middle ear implantation to restore hearing, and the Vibrant Soundbridge was implanted with a new SP coupler to which the floating mass transducer (FMT) is attached. Postoperative hearing tests included pure tone audiometry, free field audiometry, speech recognition, and APHAB questionnaire.ResultsSpeech recognition after implantation improved to 100%. Pre- and postoperative bone conduction thresholds were unchanged. Vibrometry thresholds 10 months after surgery did not deteriorate. There was a decrease in global APHAB score by 61% from 2 to 10 months after implantation.ConclusionsApplication of the Vibrant Soundbridge middle ear implant can be an effective treatment in cases of hearing loss caused by obstructive inflammation of the external ear canals. The new incus SP coupler seems to be an effective method of stimulating the middle ear in mixed hearing loss.

Evaluating the effectiveness and reliability of the Vibrant Soundbridge and Bonebridge auditory implants in clinical practice: Study design and methods for a multi-centre longitudinal observational study.

BackgroundThe Vibrant Soundbridge middle ear implant and the Bonebridge bone conducting hearing device are hearing implants that use radio frequency transmission to send information from the sound processor to the internal transducer. This reduces the risk of skin problems and infection but requires a more involved surgical procedure than competitor skin penetrating devices. It is not known whether more complex surgery will lead to additional complications. There is little information available on the reliability of these systems and adverse medical or surgical events. The primary research question is to determine the reliability and complication rate for the Vibrant Soundbridge and Bonebridge. The secondary research question explores changes in quality of life following implantation of the devices. The tertiary research question looks at effectiveness via changes in auditory performance.MethodThe study was designed based on a combination of a literature search, two clinician focus groups and expert review.A multi-centre longitudinal observational study was designed. There are three study groups, two will have been implanted prior to the start of the study and one group, the prospective group, will be implanted after initiation of the study. Outcomes are surgical questionnaires, measures of quality of life, user satisfaction and speech perception tests in quiet and in noise.ConclusionThis is the first multi-centre study to look at these interventions and includes follow up over time to understand effectiveness, reliability, quality of life and complications.

Comparison of the Effects of Middle Ear Implants and Conventional Hearing Aids on Cognitive Function

Background and Objectives The association between hearing impairment and cognitive function has been established in previous studies. The aim of this study was to compare the effects of conventional hearing aids and middle ear implants on cognitive function. Subjects and Method This study included 22 participants who underwent middle ear implantation between October 2013 and September 2016. Their mean age at surgery was 70 years. Using Pure tone audiometry (PTA), the Speech discrimination test (SDT), and the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire, we compared audiologic benefits of three conditions [without hearing aids, with conventional hearing aids, or with Vibrant Sound bridge (VSB)]. Cognitive ability was evaluated using neuropsychological testings (Seoul Neuropsychological Screening Battery) at intervals of approximately eight weeks. Results The results of PTA showed a 7.96 dB HL gain with conventional hearing aids and a 10.00 dB HL gain with the use of VSB. SDT results showed a 4.10% gain with conventional hearing aids and a 10% gain with the use of VSB. Results of the APHAB questionnaire showed a significant increase with the use of VSB compared to conventional hearing aids. In the Korean Mini-Mental State Examination, a slight improvement was observed after middle ear implantation. In the Digit Span Test and Korean-Boston Naming Test, a significant improvement was seen with the use of VSB compared to conventional hearing aids. Conclusion The use of middle ear implants in rehabilitation of hearing communication in patients showed improvements in cognitive abilities, compared to the use of conventional hearing aids. Key words: Hearing loss ㆍ Cognition ㆍ Middle ear implant ㆍ Hearing aids