Longitudinal economic analysis of Bonebridge 601 versus percutaneous bone-anchored hearing devices over a 5-year follow-up period.

OBJECTIVES: Percutaneous bone-anchored hearing devices (pBAHDs) are the most commonly used bone conduction implants (BCI). Concerns surround the long-term complications, notably skin-related, in patients with percutaneous abutments. The active transcutaneous BCI Bonebridge system can help avoid some of these pitfalls but is often considered a second-line option due to various factors including perceived increased overall costs. DESIGN: Longitudinal economic analysis of Bonebridge BCI 601 versus pBAHD over a 5-year follow-up period. SETTING: A specialist hearing implant centre. PARTICIPANTS: Adult patients (≥16 years) with conductive hearing loss, mixed hearing loss or single-sided deafness, who received a Bonebridge or pBAHD implant between 1/7/2013 and 1/12/2018 with a minimum 12-month follow-up. MAIN OUTCOME MEASURES: We compared the mean costs per implanted patient for both implants at 1, 3 and 5 years postoperative time points. Clinical effectiveness was evaluated using objective and patient-reported outcome measures. RESULTS: The mean total cost per patient of Bonebridge was significantly higher than pBAHD at 1-year post-implantation (£8512 standard deviation [SD] £715 vs £5590 SD £1394, P < .001); however, by 5-years post-implantation this difference was no longer statistically significant (£12 453 SD £2159 vs £12 575 SD £3854, P > .05). The overall cost convergence was mainly accounted for by the increased long-term complications, revision surgery rates and higher cost of the pBAHD external processor compared to Bonebridge. CONCLUSIONS: Long-term costs of Bonebridge to healthcare providers are comparable to pBAHDs, whilst offering lower complication rates, comparable audiological benefit and patient satisfaction. Bonebridge should be considered as a first-line BCI option in appropriate cases.

ACTIVE MIDDLE EAR VIBRANT SOUNDBRIDGE SOUND IMPLANT.

The 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.

Audiological and clinical outcomes of a transcutaneous bone conduction hearing implant: Six-month results from a multicentre study.

OBJECTIVES: To compare the hearing performance of patients with conductive and mild mixed hearing loss and single-sided sensorineural deafness provided with a new transcutaneous bone conduction hearing implant (the Baha Attract System) with unaided hearing as well as aided with a sound processor on a softband. Furthermore, to evaluate safety and subjective benefit before and after implantation of the test device. PARTICIPANTS: Fifty-four adult patients in five participating centres were enrolled in this prospective study. Baseline data were collected during a pre-operative visit, and after a softband trial, all patients were implanted unilaterally. Follow-up visits were scheduled at 10 days, 4, 6, 12 weeks and 6 months. MAIN OUTCOME MEASURES: Free-field hearing thresholds pure-tone average (PTA4 in dB HL; mean threshold at 500, 1000, 2000, 4000 Hz; primary outcome measure). Individual free-field hearing thresholds, speech recognition in quiet and in noise, soft tissue status during follow-up and subjective benefit as measured with the Abbreviated Profile of Hearing Aid Benefit (APHAB), Speech, Spatial and Qualities of Hearing Scale (SSQ) and Health Utilities Index (HUI) questionnaires. RESULTS: Implantation of the Baha Attract System resulted in favourable audiological outcomes compared to unaided conditions. On the primary outcome parameter, a statistically significant improvement was observed compared to unaided hearing for the patients with conductive/mixed hearing loss (mean PTA4 difference -20.8 dB HL, SD 9.8; P < 0.0001) and for the patients with single-sided sensorineural deafness (SSD) (mean PTA4 difference -21.6 dB HL, SD 12.2; P < 0.0001). During all audiology tests, the non-test ear was blocked. Statistically significant improvements were also recorded in speech tests in quiet and noise compared to unaided hearing for the conductive/mixed hearing loss group and for speech in quiet in the SSD group. Compared to the pre-operative measurement with softband, no significant differences were recorded in the PTA4 free-field hearing threshold or the other audiological outcomes in either of the groups (P > 0.05). Soft tissue-related issues observed during follow-up included numbness, pain/discomfort at the implant site and to a lesser extent pressure-related skin complications. A declining trend was noted in the rate of these complications during follow-up. Approximately 20% of patients reported some degree of numbness and 38% (slight) pain/discomfort at final follow-up of 6 months. Good results on the subjective benefit questionnaires were observed, with statistically significant improvements on APHAB and SSQ questionnaires, and on the hearing attribute of HUI3. CONCLUSIONS: The Baha Attract System provided a significant improvement in hearing performance and subjective benefit compared to the pre-operative unaided condition (with the non-test ear blocked). Hearing performance of the Baha Attract was similar to a test situation with the same sound processor on a softband. A proportion of the patients reported numbness and pain/discomfort at the implant site during follow-up, especially during the first post-operative weeks. Based on the results of the current multicentre study, the Baha Attract can be considered as a treatment option for patients with the aforementioned hearing losses. Especially in the SSD patients, a careful selection procedure is warranted. Therefore, a pre-operative trial should be part of the decision-making process before fitting a patient with the Baha Attract System.

Physical outcome measures for conductive and mixed hearing loss treatment: A systematic review.

BACKGROUND: The number of potential options for rehabilitation of patients with conductive or mixed hearing loss is continually expanding. To be able to inform patients and other stakeholders, there is a need to identify and develop patient-centred outcomes for treatment of hearing loss. OBJECTIVE OF REVIEW: To identify outcome measures in the physical core area used when reporting the outcome after treatment of conductive and mixed hearing loss in adult patients. TYPE OF REVIEW: Systematic review. SEARCH STRATEGY: Systematic review of the literature related to reported physical outcome measures after treatment of mixed or conductive hearing loss without restrictions regarding type of intervention, treatment or device. EVALUATION METHOD: Any measure reporting the physical outcome after treatment or intervention of mixed or conductive hearing loss was sought and categorised. The physical outcome measures that had been extracted were then grouped into domains. RESULTS: The literature search resulted in the identification of 1434 studies, of which 153 were selected for inclusion in the review. The majority (57%) of papers reported results from middle ear surgery, with the remainder reporting results from either bone conduction hearing devices or middle ear implants. Outcomes related to complications were categorised into 17 domains, whereas outcomes related to treatment success was categorised into 22 domains. CONCLUSIONS: The importance of these domains to patients and other stakeholders needs to be further explored in order to establish which of these domains are most relevant to interventions for conductive or mixed hearing loss. This will allow us to then assess which outcome measures are most suitable for inclusion in the core set.

Advanced Otosclerosis: Stapes Surgery or Cochlear Implantation?

Diagnosis and treatment of advanced otosclerosis can be controversial. In 1961, House and Sheehy defined advanced otosclerosis as hearing loss in air conduction threshold by 85 dB with nonmeasurable bone conduction. Recently, the definition of advanced otosclerosis is mostly based on the decrease of speech recognition. There are some treatment modalities: stapes surgery and hearing aids, cochlear implantation, or direct acoustic cochlear implant. The authors propose a new algorithm for treatment. If the patient is treated with cochlear implantation, the surgeon should be cautious for facial nerve stimulation after surgery because it is the most prevalent complication.

On the evaluation of a superpower sound processor for bone-anchored hearing.

OBJECTIVES: Performance of a superpower bone-anchored hearing aid (Baha), the Baha Cordelle from Cochlear Bone-Anchored Solutions (BCD1), was compared to its successor, the Baha 5 SuperPower (BCD2). DESIGN: A comparative study in which each patient served as its own control. SETTING: Tertiary clinic. PARTICIPANTS: Ten experienced BCD1 users with profound mixed hearing loss. For comparison, data from another study with 10 experienced users with a severe mixed hearing loss using a Cochlear Baha 5 power sound processor (BCD-P) were included. MAIN OUTCOME MEASURES: Speech reception thresholds in noise and APHAB and SSQ questionnaires. RESULTS: Speech reception thresholds for the digits-in-noise (DIN) test were significantly lower (P < 5%), that is more favourable, for BCD2 in the speech and noise frontal condition and in the speech frontal and noise contralateral condition than for BCD1. For the group with severe mixed loss fitted with BCD-P, the SRTs were not significantly different (P > 5%) from the BCD2 values. With the APHAB questionnaire scores were significantly lower, that is more favourable, for the ease of communication (P < 5%) and the background noise (P < 1%) domains for BCD2 than for BCD1. APHAB scores for the aversiveness of loud sounds domain were not significantly different for both devices (P > 5%). Scores for the speech and quality domains of the SSQ questionnaire were significantly higher, that is more favourable, for BCD2 than for BCD1. APHAB and SSQ scores for BCD-P were not significantly different from those for BCD2 (P > 5%). CONCLUSIONS: Data for BCD2 in profound mixed loss are similar to those for BCD-P and a severe mixed loss. Of 10 patients, 2 expressed a strong preference for BCD2 over BCD1, and 7 patients had a preference for BCD2 over BCD1. One patient preferred BCD1 because of its built-in telecoil facility.

A multicenter study on objective and subjective benefits with a transcutaneous bone-anchored hearing aid device: first Nordic results.

Examination of objective as well as subjective outcomes with a new transcutaneous bone-anchored hearing aid device. The study was designed as a prospective multicenter consecutive case-series study involving tertiary referral centers at two Danish University Hospitals. A total of 23 patients were implanted. Three were lost to follow-up. Patients had single-sided deafness, conductive or mixed hearing loss. INTERVENTION: Rehabilitative. Aided and unaided sound field hearing was evaluated objectively using (1) pure warble tone thresholds, (2) pure-tone average (PTA4), (3) speech discrimination score (SDS) in quiet, and (4) speech reception threshold 50% at 70 dB SPL noise level (SRT50%). Subjective benefit was evaluated by three validated questionnaires: (1) the IOI-HA, (2) the SSQ-12, and (3) a questionnaire evaluating both the frequency and the duration of hearing aid usage. The mean aided PTA4 was lowered by 14.7 dB. SDS was increased by 37.5% at 50 dB SPL, SRT50% in noise improved 1.4 dB. Aided thresholds improved insignificantly at frequencies above 2 kHz. 52.9% of the patients used their device every day, and 76.5% used the device at least 5 days a week. Mean IOI-HA score was 3.4, corresponding to a good benefit. In SSQ-12, "quality of hearing" scored especially high. Patients with a conductive and/or mixed hearing loss benefitted the most. This device demonstrates a significant subjective hearing benefit 8 month post surgery. In patients with conductive and/or mixed hearing losses, patient satisfaction and frequency of use were high. Objective gain measures showed less promising results especially in patients with single-sided deafness (SSD) compared to other bone conduction devices.

Cone beam computed tomography after round window vibroplasty: do the radiological findings match the auditory outcome?

CONCLUSION: The cone beam computed tomography (CBCT) imaging technique has proved to be reliable for assessing the appropriate positioning of the floating mass transducer (FMT) in the round window (RW) niche, although some parameters do not seem to be essential for achieving a satisfactory functional outcome. OBJECTIVES: To evaluate the role that specific imaging parameters derived from CBCT of the temporal bone have for predicting the functional outcome after RW vibroplasty (RW-VP). METHODS: CBCT imaging was carried out in a homogeneous group of patients who presented with a mixed type of hearing loss after open tympanoplasty. Three arbitrary radiological parameters were taken into account: the FMT/RW membrane contact, bony contacts of the FMT margins, and the inferior FMT tissue support. The audiological assessment took into consideration the PTA4 (500-4000 Hz), the PTA2 (125-250 Hz), and the word recognition score (WRS) in quiet and in noise. RESULTS: One subject presented with all positive CBCT parameters and showed a good, but not the best auditory performance among the study group. In the majority of the subjects, with a satisfactory postoperative hearing improvement, at least two of the three radiological parameters were present. In comparison with the unaided condition, an improvement in both the PTA4 and PTA2 was found in all the subjects.

Active bone conduction system: outcomes with the Bonebridge transcutaneous device.

OBJECTIVE: To describe our experience with positioning the Bonebridge (BB) device, a semi-implantable transcutaneous bone conduction implant for patients with conductive and mixed hearing loss as well as for those suffering from single-sided deafness. METHODS: The following is a retrospective case review of 4 adults suffering from conductive or mixed hearing loss and single-sided deafness. The BB device was implanted unilaterally via 2 different approaches selected case by case: the presigmoid transmastoid and the retrosigmoid approach. An audiological evaluation in the free field was conducted to observe the functional benefit with this device. The Glasgow Health Status Inventory (GHSI) and the Glasgow Benefit Inventory (GBI) questionnaires were filled out to evaluate patients' quality of life in relationship to the intervention. RESULTS: No intra- or postoperative complications were observed. The performance in the speech test in all 4 cases reached 100% in the aided condition at 65 dB, while in the unaided condition at 65 dB, it was less than 10%. The GHSI and GBI questionnaires showed an improvement in quality of life after implantation. CONCLUSIONS: The BB device is a safe and effective solution for individuals with pathologies such as chronic otitis media, atresia auris and otosclerosis with inadequate benefit from conventional surgery or bone conduction hearing aids.

Clinical performance of a new magnetic bone conduction hearing implant system: results from a prospective, multicenter, clinical investigation.

OBJECTIVE: The aim of the investigation was to prospectively evaluate, in a multicenter setting, the clinical performance of a new magnetic bone conduction hearing implant system. METHODS: The test device was the Cochlear Baha Attract System (Cochlear Bone Anchored Solutions AB, Mölnlycke, Sweden). Instead of the skin-penetrating abutment of traditional bone conduction hearing implants, the test device uses an implantable and an external magnet to transmit sound from the sound processor (SP) through intact skin to the skull bone. Twenty-seven adult patients with a conductive or mild mixed hearing loss or single-sided sensorineural deafness were included in the clinical investigation across four investigational sites. The patients were followed for 9 months after implantation. The study evaluated efficacy in terms of hearing performance compared with unaided hearing and with hearing with the SP on a softband. Patient benefit, soft tissue status, device retention, and safety parameters were monitored continuously throughout the investigation. RESULTS: Surgery and healing was uneventful. Statistically significant improvements in audibility and speech understanding in noise and quiet were recorded for the test device compared with preoperative unaided hearing. Speech recognition was similar or better than tests performed with the same SP on a softband. Good soft tissue outcomes were reported, without major pressure-related complications. At the end of the investigation, all patients continued to use and benefit from the device. CONCLUSION: The test device provides good hearing performance in patients with a conductive hearing loss or single-sided sensorineural deafness, with good wearing comfort and minimal soft tissue complications.

Sophono Alpha System and subtotal petrosectomy with external auditory canal blind sac closure.

Recently, a new acoustic device, the so-called Sophono Alpha System, has been introduced into clinical practice. The aim of this study was to assess Sophono Alpha System hearing aids in ten patients suffering from recurrent chronic middle ear disease who underwent subtotal petrosectomy. Presence of mixed hearing loss with bone conduction thresholds better than or equal to 45 dB was present in each patient. Audiometric tests were performed before and after Sophono implantation and using a conventional bone conduction hearing aid (hearing glasses). Speech audiometry data (speech recognition threshold and word recognition score) were also collected. Speech recognition threshold in dB and percentage of word recognition score at 65 dB were subsequently calculated. After implantation and activation of the Sophono Alpha System, audiological data showed an average air conduction value of 42.1 dB. By comparing this data with the values of air conduction following subtotal petrosectomy, an average acoustic improvement of 29.7 dB could be calculated. The hearing results showed significantly better outcomes of Sophono Alpha System vs. conventional bone conduction aid. Indications to MRI use in patients undergoing Sophono Alpha System implantation are also provided.

The bone conduction implant--first implantation, surgical and audiologic aspects.

OBJECTIVE: To report on preoperative assessment, surgery, and audiologic outcome of the first patient implanted with the bone conduction implant (BCI). BACKGROUND: The BCI is a bone conduction hearing device with an intact skin solution where the transducer is implanted close to the ear canal opening. By avoiding a percutaneous screw attachment to the skull, the BCI is anticipated to reduce complications associated with the Bone-Anchored Hearing Aid (BAHA) solution. METHODS: The first patient to receive a BCI was a 42-year-old woman with a unilateral mixed hearing loss due to tympanosclerosis. Preoperative and postoperative cone beam computed tomography and a virtual planning tool for 3D reconstruction were used to optimize and control the position of the BCI in the mastoid. The transducer was placed in a 5-mm deep seating in the mastoid and secured with a titanium bar. Free field tone and speech audiometry were conducted to evaluate the audiologic outcome at baseline (1 month postoperatively) and 1 month after baseline. RESULTS: The BCI was placed in the position according to the preoperative 3D planning. On average, the tone thresholds improved by 30 dB, speech reception thresholds by 25.5 dB and speech signal-to-noise ratio by 9.7 dB. The surgical procedure was considered simple and safe. CONCLUSION: The BCI can be implanted by a safe and easy surgical procedure. 3D preoperative planning can be helpful to optimize the BCI position. The BCI is a realistic alternative to the BAHA.

Vibroplasty for mixed and conductive hearing loss.

OBJECTIVE: To summarize new application methods of an active middle ear implant (Vibrant Soundbridge) in patients with conductive or mixed hearing loss. DATA SOURCES: Publications listed in the Medline/PubMed database. STUDY SELECTION: All publications published in English language; search term Vibrant Soundbridge AND floating mass transducer in all fields. DATA EXTRACTION: Structured analysis of all publications. DATA SYNTHESIS: Extraction of significant findings and conclusions and audiometric data. CONCLUSION: Modern application methods of an active middle ear implant (VSB) open new therapeutic options for patients with various outer and middle ear diseases resulting in conductive or mixed hearing loss. Titanium couplers can help to couple the active middle ear implant in a standardized way to remnants of the ossicular chain or to the round window. Thus, the active middle ear implant has been established as an alternative treatment option for patients with mixed and conductive hearing. However, the heterogeneity of the studies published so far complicates the analysis of the audiometric results, and thus, the functional hearing gain after VSB implantation varies a lot.

Long-term outcome of round window Vibrant SoundBridge implantation in extensive ossicular chain defects.

OBJECTIVE: To evaluate retrospectively the long-term safety and efficacy of the first 50 patients, all suffering from severe ossicular chain defects and with moderate to severe mixed hearing loss, who received the Vibrant SoundBridge with the floating mass transducer located on the round window membrane. To evaluate differences in outcome versus etiology and age of the patient population. STUDY DESIGN: Case series with planned data collection. SETTING: Tertiary referral medical center. SUBJECTS AND METHODS: Patients eligible for implantation of the floating mass transducer on the round window membrane ranged in age from 2 months to 74 years with a moderate to severe conductive or mixed hearing loss from different etiologies. For each adult patient, preoperative versus postoperative bone and air conduction thresholds, air-bone gaps, and speech understanding scores were evaluated at 24-month follow-up. At 60-month follow-up, data were available from 33 patients. Preoperative and postoperative free-field auditory brainstem responses were studied in infants and children. Intraoperative and short- and long-term postoperative complications are presented. RESULTS: There were significant improvements in speech perception and pure-tone audiometry in adults and auditory brainstem response thresholds in infants immediately after surgery and at follow-up examinations (12 to 71 months). No significant complications or device extrusions were observed in the present series. CONCLUSIONS: Infants, children, and adults with moderate to severe conductive or mixed hearing loss obtained substantial benefit from implantation of the floating mass transducer on the round window membrane regardless of the etiology of hearing loss and previous surgery.

Bilateral duplicated internal carotid arteries presenting as middle ear masses: a case report and review of the literature.

OBJECTIVES: We seek to describe an individual with bilateral duplicated internal carotid arteries (ICAs) presenting as middle ear masses, to discuss the anatomy and characteristic imaging findings associated with this condition, and to familiarize clinicians with effective methods to prevent and manage complications related to this entity. METHODS: The clinical presentation of an individual with this unusual vascular anomaly was reviewed. A literature search was then performed to identify previously reported studies describing aberrant ICAs in order to characterize the presentation, anatomy, imaging findings, and management of this condition. RESULTS: An aberrant ICA presenting as a middle ear mass is uncommon; there are only approximately 45 reported cases to date. The majority of these cases presented as a unilateral anomaly without a duplication, were associated with pulsatile tinnitus and hearing loss, and were diagnosed during middle ear procedures. Bilateral aberrant ICAs are exceedingly rare, with only 14 existing reports. Only 1 of these cases presented with duplicated ICAs. Our report demonstrates an unusual presentation of aberrant ICAs, as pulsatile tinnitus was absent and previous middle ear surgery had been performed without establishing this diagnosis and without any resulting complications. Furthermore, this case represents the first known instance of a bilateral duplicated ICA system without persistent stapedial arteries. Although vascular middle ear anomalies are unusual, complications of surgical manipulation have been documented. CONCLUSIONS: The clinician must have a high index of suspicion for vascular lesions in patients presenting with a retrotympanic mass. Appropriate diagnostic imaging studies should be performed to exclude this diagnosis before middle ear exploration. Should injury to the carotid artery occur, surgeons should follow specific guidelines to avoid potentially serious complications.

[Epidemiological and demographic analysis of indications for Baha® surgery in Poland--multicenter study]. / Analiza epidemiologiczna i demograficzna wskazan do implantacji systemu Baha® w Polsce--badanie wieloosrodkowe.

AIM OF THE STUDY: To collect and analyze epidemiological and demographical data of patients qualified for and implanted with the Baha® system in Poland. MATERIAL AND METHOD: 17 out of 28 otolaryngology departments performing Baha® implantation in Poland participated in the study. Up to date there were 286 patients registered in database. Data were obtained from the preoperative questionnaires including information such as age and gender, indications for the implantation, previous hearing aid use as well as data regarding the surgical technique. RESULTS: The most frequent indication for the Baha® system was bilateral mixed hearing loss (51%), followed by SSD (18%), bilateral conductive hearing loss (17%), unilateral mixed (8%) and conductive (6%) hearing loss. In 11% of subjects hearing impairment was congenital versus 89% cases of acquired. The mean age was 44 years with the slight prevalence of women (52%). 63% of patients did not have previous experience with hearing aids. The most frequent surgical technique was classic dermatome single stage procedure performed under general anesthesia (65%). CONCLUSIONS: Data gather in this multicentre research serve as a valuable source of information on qualifications for the Baha®, shows demographic spectrum of adult recipients in Poland. It also presents the preferences of surgical procedures. Outcomes of the study may constitute a reference for each centre participating in this research as well as for new centers starting the Baha® procedure.

[Treatment of severe to profound mixed hearing loss with the BAHA Cordelle II]. / Tratamiento de las hipoacusias mixtas severas a profundas con el BAHA Cordelle II.

GOALS: Evaluation of the audiological outcome and subjective satisfaction of BAHA Cordelle II in the treatment of patients with severe to profound bilateral mixed hearing loss. MATERIAL AND METHOD: Retrospective study of 12 patients suffering a severe to profound bilateral sensorineural hearing loss, using pure tone audiometry (PTA), speech audiometry and subjective evaluation before and after the implantation of a BAHA Cordelle II (Cochlear(®)). RESULTS: The average gain in conversational frequencies (0.5 to 4kHz) with BAHA in free field was 43, 51, 47 and 44dB, respectively. We observed a GAP over closure in 10 of the 12 patients. Speech audiometry improved from 85% at 83dB of maximum discrimination to 96% at 62dB. The subjective evaluation questionnaires showed great satisfaction with a slight decrease in noisy or windy environments. The great majority of our patients used the BAHA device throughout the entire day. CONCLUSIONS: The BAHA Cordelle II (Cochlear(®)) is a good option in the treatment of severe to profound bilateral mixed hearing loss. Its best advantages are a low risk of labyrinthization, high result predictability, easy and step-by-step surgery, no need for general anaesthesia, and the GAP over closure in all frequencies. Active middle ear devices represent another alternative, but specific indications have not been defined yet because of low universal experience. When the intelligibility of the patient is poor, cochlear implantation should be considered.

Impact of floating mass transducer coupling and positioning in round window vibroplasty.

OBJECTIVE: The round window application of the Vibrant Sound bridge, the so-called round window vibroplasty, is gaining increasing popularity for hearing rehabilitation of patients with mixed hearing loss or conductive hearing loss. In these patients, conventional hearing amplification and/or surgical restoration is either not possible or has failed because of chronic ear disease, extensive otosclerosis, or malformations. The exact mechanisms of direct cochlear stimulation via the round window membrane are not yet completely understood. It is unclear what kind and what degree of contact is required between the floating mass transducer (FMT) and the round window membrane (RWM) to elicit a functional hearing perception with the implant. We investigated the coupling efficiency between the FMT and the RWM and how the efficiency is altered by the FMT position, the degree of FMT-RWM contact, and the use of a soft tissue coupler. STUDY DESIGN: Prospective cohort study. SETTING: Tertiary referral center in Western Australia. PATIENTS: Patients undergoing round window vibroplasty for a mixed or conductive hearing loss otherwise not aidable. INTERVENTION: Patients underwent round window vibroplasty and received audiological and coupling analysis in the follow-up. These data were then correlated with FMT positioning and the extent of FMT-RWM interface as determined by postoperative high-resolution temporal bone computed tomography. MAIN OUTCOME MEASURES: Coupling and hearing levels in relation to FMT positioning and degree of FMT-RWM contact. RESULTS: Of 10 patients, 8 were available for vibroplasty behavioral threshold testing. In 2 patients, testing could not be done because of wound breakdown requiring device explantation in 1 case, and in the other case, the bone conduction thresholds dropped 2 months after implantation, thus falling out of the performance range of the device. Postoperative FMT migration occurred in 50% of the patients (3/6) with recurrent chronic ear disease and status after multiple previous ear operations. All patients, including the 3 patients requiring surgical repositioning of the FMT, attained significantly improved speech in quiet and speech in noise when compared with the preoperatively best aided performance. All patients showed significantly improved average Abbreviated Profile of Hearing Benefit scores with the use of the FMT. Direct (partial or complete) contact with the RWM resulted in good coupling efficiency; soft tissue coupling resulted in a reduced coupling efficiency.

Long-term results with the Rion E-type semi-implantable hearing aid.

OBJECTIVE: The Rion implantable hearing aid (IHA) Ehime (E)-type was developed for ears with middle ear diseases. This study focused on the current status of the patients, device problems, postoperative difficulties, and preventive measures against them. STUDY DESIGN: Case series with chart review. SETTING: Tertiary referral hospital. SUBJECTS AND METHODS: Subjects were 30 patients who were implanted with the IHA E-type between 1984 and 1997 and followed up for more than 10 years. Current status of IHA implantees, incidents of device problems, and postoperative troubles and hearing outcomes were reviewed. RESULTS: Eleven patients (36.7%) still use the original device. The average period of use was 16.6 +/- 3.3 years (21 years at most). The incidence of problems was lower with the second version of the device compared to the first version. Frequencies of the troubles were related to the types of original ear diseases: seven of 17 cases with chronic otitis media (41.2%), two of seven cases with cholesteatoma (28.6%), and two of six cases with tympanosclerosis (33.3%). No cholesteatoma occurred after surgical procedures (i.e., external ear canal closure and tympanic membrane lateralized) (P = 0.06). The device was exposed through a retroauricular skin fistula where the internal coil had been implanted. Significantly fewer infections were observed when the two-stage operation was used (P < 0.01). CONCLUSION: For long-term success in implantation of the IHA, careful control of middle ear inflammation and measures against eustachian tube dysfunction are required in addition to technological advancements.