Consensus Statement on Bone Conduction Devices and Active Middle Ear Implants in Conductive and Mixed Hearing Loss

Nowadays, several options are available to treat patients with conductive or mixed hearing loss. Whenever surgical intervention is not possible or contra-indicated, and amplification by a conventional hearing device (e.g., behind-the-ear device) is not feasible, then implantable hearing devices are an indispensable next option. Implantable bone-conduction devices and middle-ear implants have advantages but also limitations concerning complexity/invasiveness of the surgery, medical complications, and effectiveness. To counsel the patient, the clinician should have a good overview of the options with regard to safety and reliability as well as unequivocal technical performance data. The present consensus document is the outcome of an extensive iterative process including ENT specialists, audiologists, health-policy scientists, and representatives/technicians of the main companies in this field. This document should provide a first framework for procedures and technical characterization to enhance effective communication between these stakeholders, improving health care

Indications and outcome of subtotal petrosectomy for active middle ear implants

The aim of this study was to describe the outcome and possible complications of subtotal petrosectomy (SP) for Vibrant Soundbridge (VSB) device surgery in a tertiary referral center. A secondary objective was the evaluation of hearing results in a subgroup of subjects who received the VSB device. Between 2009 and early 2011, 22 adult subjects with chronic otitis media (COM) underwent a SP, blind sac closure of the external auditory canal and abdominal fat obliteration to facilitate the application of an active middle ear implant (AMEI) in a staged procedure. Indications consisted of mixed hearing loss after previous tympanomastoplasty and failure of hearing rehabilitation with a hearing aid or bone conduction device in COM. Pre- and postoperative pure-tone audiograms were analyzed in respect to deterioration of inner ear function, unaided and aided (hearing aid, bone-anchored hearing aid and VSB) speech audiograms were compared to verify improvements in communications skills and functional gains. Incidence and type of complications were reviewed. No significant change was observed regarding mean bone conduction thresholds after the first stage procedure. Some minor wound healing problems were noted. Speech perception using the VSB (n = 16) showed a mean aided speech discrimination at 65-dB SPL of 75 % [standard deviation (SD) 28.7], at 80-dB SPL of 90 % (SD 25.1). Our results suggest that for selected patients with open mastoid cavities and chronic middle ear disease, SP with abdominal fat obliteration is an effective and safe technique to facilitate safe AMEI placement.status: publishe

Indications and outcome of subtotal petrosectomy for active middle ear implants

status: publishe

Normative data of multifrequency tympanometry in rabbits

In an experimental study, we evaluated acoustic immittance in rabbits in order to use these data as normative values for further experimental investigations. This study is the first experimental evaluation of both conventional 226 Hz and multifrequency tympanometry (MFT) in rabbits. For the investigation, we used 33 female New Zealand rabbits weighing 3.2 - 4.4 kg and aged six months. Bilateral measurements using conventional 226 Hz and MFT were performed under general anaesthetic. A 226 Hz tympanogram was recorded for all animals by conducting an air pressure sweep from +200 to -400 daPa at a rate of 50 daPa/s. Subsequent tympanograms were recorded over a wide frequency range from 250 to 2000 Hz. The acoustic impedance device used in this study provided reproducible and evaluable tympanograms. The applied tone frequency of 226 Hz proved to be especially suitable for determining compliance. Normative data obtained from our study reveal the resonance frequency to be 1368±205 standard deviation (SD) for the right side and 1413±216 SD for the left side. The values for physiological acoustic immittance of the middle ear in the rabbit obtained here can serve as normative data in subsequent experimental animal studies. © Laboratory Animals Ltd

Comparison between incus short process and long process coupling of the vibrant soundbridge in human temporal bones.

OBJECTIVE The Vibrant Soundbridge (VSB) is one of the most widely used implantable hearing devices. It consists of a vibrating floating mass transducer (FMT) that is connected to a middle ear structure. The standard coupling devices for sensorineural hearing loss are short process (SP) or long process (LP) couplers. DESIGN AND STUDY SAMPLE This study directly compared the electro-mechanical performance of the SP- and LP-coupled FMT of the VSB in the same temporal bone specimen (n = 10). We measured velocity magnitudes and total harmonic distortions (THD) of the stapes (ST) and the round window (RW) using laser Doppler Vibrometry (LDV). RESULTS Comparison shows a maximally 10 dB higher magnitude for the LP coupler at ST and RW for frequencies below 600 Hz, whereas the SP coupler shows a maximally 20 dB higher magnitude at the ST and RW for frequencies above 600 Hz. THD show similar behaviour with less distortion at 500 Hz for the LP coupler and less distortions for the SP coupler in higher frequencies. CONCLUSIONS Our experiments showed that the SP coupling may be mechanically favourable, in terms of magnitude and distortion, for the transmission of FMT vibrations at higher frequencies

Multicenter study with a direct acoustic cochlear implant

OBJECTIVE To confirm the clinical efficacy and safety of a direct acoustic cochlear implant. STUDY DESIGN Prospective multicenter study. SETTING The study was performed at 3 university hospitals in Europe (Germany, The Netherlands, and Switzerland). PATIENTS Fifteen patients with severe-to-profound mixed hearing loss because of otosclerosis or previous failed stapes surgery. INTERVENTION Implantation with a Codacs direct acoustic cochlear implant investigational device (ID) combined with a stapedotomy with a conventional stapes prosthesis MAIN OUTCOME MEASURES Preoperative and postoperative (3 months after activation of the investigational direct acoustic cochlear implant) audiometric evaluation measuring conventional pure tone and speech audiometry, tympanometry, aided thresholds in sound field and hearing difficulty by the Abbreviated Profile of Hearing Aid Benefit questionnaire. RESULTS The preoperative and postoperative air and bone conduction thresholds did not change significantly by the implantation with the investigational Direct Acoustic Cochlear Implant. The mean sound field thresholds (0.25-8 kHz) improved significantly by 48 dB. The word recognition scores (WRS) at 50, 65, and 80 dB SPL improved significantly by 30.4%, 75%, and 78.2%, respectively, after implantation with the investigational direct acoustic cochlear implant compared with the preoperative unaided condition. The difficulty in hearing, measured by the Abbreviated Profile of Hearing Aid Benefit, decreased by 27% after implantation with the investigational direct acoustic cochlear implant. CONCLUSION Patients with moderate-to-severe mixed hearing loss because of otosclerosis can benefit substantially using the Codacs investigational device