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The Active Middle Ear Implant Vibrant Soundbridge: Outcomes on Safety, Efficacy, Effectiveness, and Subjective Benefit 1996–2017
Published in Stavros Hatzopoulos, Andrea Ciorba, Mark Krumm, Advances in Audiology and Hearing Science, 2020
Michael Urban, Francesca Scandurra, Anna Truntschnig, Severin Fürhapter, Geoffrey Ball
The VSB is comprised of external and internal units and has seen the evolution of the VORP 503 implant, a new generation of Vibroplasty Couplers and the distinctive SAMBA audio processor. The internal part of the VSB, the VORP 503 (Fig. 4.5), is surgically implanted and consists of the receiver and magnet which is surrounded by an internal coil, a conductor link, electronics (demodulator), fixation wings and the FMT. In SNHL, the conductor link relays the signal from the receiver to the FMT, which is attached to the incus, one of the three small bones in the middle ear. In cases of mixed or CHL, the FMT may be attached to the round window, to remnants of the stapes or onto the stapes footplate. The FMT converts the signal into vibrations that directly drive and move the vibratory structures of the middle ear and amplify their natural movement. These vibrations are conducted to the inner ear and lead to a normal stimulation of the hair cells within the inner ear. The external component is called the audio processor (AP) and implant unit is called the vibrating ossicular prosthesis (VORP). It is the only middle ear implant that is solely attached to a vibratory structure of the middle ear and thus stimulates hearing in the inner ear.
Middle Ear Implants
Published in John C Watkinson, Raymond W Clarke, Christopher P Aldren, Doris-Eva Bamiou, Raymond W Clarke, Richard M Irving, Haytham Kubba, Shakeel R Saeed, Paediatrics, The Ear, Skull Base, 2018
Maarten J.F. de Wolf, Richard M. Irving
Ideal candidates for middle ear implants are patients with high-frequency sensorineural or mixed hearing loss, in which amplification with conventional hearing aids – with or without stapedotomy – or bone-conduction implant (BCI) has failed. In most cases failure is caused by acoustic feedback, occlusion effect, insufficient high-frequency amplification or wearing discomfort. Although the VSB and the MET/Carina is cleared for use in patients under the age of 18,7,23 the majority of these devices have been placed in adults. Candidates should not have any skin conditions that may prevent attachment of any external component of the device and should be medically fit for surgery and the anaesthesia required. In addition, candidates should have been appropriately counselled by a surgeon and be judged to have realistic expectations. Further selection is made based upon audiological and otological conditions.
Middle Ear Implants
Published in James R. Tysome, Rahul G. Kanegaonkar, Hearing, 2015
The term middle ear implant describes a device placed within the middle ear in order to improve hearing. Middle ear implants (MEIs) are divided into active and passive. Passive devices are ossiculoplasty prostheses; their role is to attempt to restore middle ear mechanics. Active MEIs are surgically implanted ‘hearing aids’ that are directly coupled to either the ossicles or inner ear. Sound is converted to electrical energy and then transduced to mechanical energy to vibrate the ossicles or directly drive the cochlea via the round or oval windows.
Implantability of endaurally insertable active vibratory middle-ear implants – an anatomical study
Published in Acta Oto-Laryngologica, 2019
Katrin Reimann, Sebastian Schraven, Erich Dalhoff, Hans-Peter Zenner, Heinz Arnold
In western countries, epidemiological studies show a prevalence for hearing disorders in 19% of the population [1]. In many cases, an acoustic hearing aid is an option to support hearing in these patients. However, distortion of the acoustic signal in the external auditory canal may cause major problems and discomfort, often leading to low acceptance of hearing aids in these patients. Active vibratory middle-ear implants (AMEIs) that are mechanically coupled to the ossicular chain or the round window (RW) contribute to solve this problem by directly transmitting vibrations into the acoustic system and thereby have the potential to provide higher amplification and better sound fidelity. Nevertheless, despite these beneficial aspects, the implantation technique for most AMEIs still requires extended otosurgical approaches including mastoidectomy and a posterior tympanotomy. This carries relevant operative risks for the patient, e.g. facial nerve palsy or injury of the chorda tympany. From an economical point of view, these surgical procedures are time consuming, enhancing the costs of treatment.
Ten years of active middle ear implantation for sensorineural hearing loss
Published in Acta Oto-Laryngologica, 2018
Maurizio Barbara, Chiara Filippi, Edoardo Covelli, Luigi Volpini, Simonetta Monini
The pre-operative audiological assessment has included pure tone and speech audiometry as baseline unaided (BU) values: the former to ascertain that the degree of hearing loss was within the Company’s recommended indication range (Figure 1) and to select the ear (or the first ear) to be implanted; the latter, to exclude individuals with word discrimination lower than 30%, for whom the application would be contraindicated. The same tests have also been performed under the aided condition—baseline aided (BA)—in those subjects who were regularly using a cHA. Throughout baseline and post-operative testing, the non-test ear remained plugged. Impedance audiometry was carried out in order to confirm a normal middle ear function, as shown by a type A tympanogram, an essential prerequisite for the functioning of any type of AMEI in SNHL. A further selection level, represented by a pre-operative computed tomography (CT) scan of the temporal bone, allowed us to measure the least space to accommodate the two transducers, and more specifically: the distance from the incus body to the sino-dural angle for the sensor (16 mm), and from the stapes head to the anterior aspect of the sigmoid sinus for the driver (20 mm) (Figure 2). Other general causes that would contraindicate a middle ear implant surgery (allergy, psychological issues, Eustachian tube dysfunction, diabetes) were also searched.
Intraoperative determination of coupling efficiency of Carina® middle ear implant by means of auditory evoked potentials
Published in International Journal of Audiology, 2020
Mario Cebulla, Rudolf Hagen, Kristen Rak, Ute Geiger
Active middle ear implants are widely used to treat patients with sensorineural, conductive, and mixed hearing loss. The fully implantable Carina® system (Cochlear Ltd, Sydney, Australia) is one of the active middle ear implant systems available which have an integrated microphone and a battery, making the device independent of any external equipment. The implant is characterised by effective performance for patients with moderate-to-severe hearing loss, and it is an alternative to conventional hearing aids (Bruschini et al. 2016; Pulcherio et al. 2014). Since surgery is required for implantation, the Carina® system may be best solution for patients who cannot wear conventional hearing aids and benefit from full implantability with respect to cosmetic concerns.