Speech perception and hearing effort using a new active middle ear implant audio processor

Purpose The Vibrant Soundbridge (VSB) was introduced in 1996, and the fourth generation of the audio processor recently released. This clinical study evaluates the audiological performance and subjective satisfaction of the new SAMBA 2 audio processor compared to its predecessor, SAMBA. Method Fifteen VSB users tested both audio processors for approximately 3 weeks. Air conduction and bone conduction thresholds and unaided and aided sound field thresholds were measured with both devices. Speech performance in quiet (Freiburg monosyllables) and noise (OLSA) was evaluated as well as subjective listening effort (ACALES) and questionnaire outcomes (SSQ12 and APSQ). In addition, data from 16 subjects with normal hearing were gathered on sound field tests and ACALES. Results Both audio processors showed substantial improvement compared to the unaided condition. The SAMBA and SAMBA 2 had comparable performance in sound filed thresholds, while the SAMBA 2 was significantly better in speech in quiet, speech in noise, reduced listening effort, and improved subjective satisfaction compared with the SAMBA. Conclusion The SAMBA 2 audio processor, compared to its predecessor SAMBA, offers improved performance throughout the parameters investigated in this study. Patients with a VSB implant would benefit from an upgrade to SAMBA 2.

New Considerations for a Totally Implantable Active Middle Ear Implant

Totally implantable active middle ear implants (AMEI) provide full-time hearing amplification to those with moderate to severe sensorineural hearing loss. While technology in conventional hearing aids (CHA) has advanced greatly, limitations remain for people with active lifestyles, limited vision or dexterity, and hearing aid fit issues. Furthermore, direct-drive properties of AMEI are thought to provide those with inefficient middle ear transfer functions a distinct advantage in delivering prescribed sound to the cochlea, ultimately improving speech understanding with less distortion. AMEI safety, stability, and efficacy outcomes are well documented and fitting strategies continue to improve. Recent studies show how simple aided speech testing can help predict whether a patient struggling with CHA may instead benefit from an AMEI. Totally implantable AMEI continue to be a viable option for patients who cannot or will not utilize traditional hearing aids.

A Vibrant Soundbridge aktív középfül-implantátum történeti áttekintése és sebészi alkalmazásának lehetőségei

Összefoglaló. A Vibrant Soundbridge aktív középfül-implantátum vezetéses, sensorineuralis és kevert típusú halláscsökkenés esetén is megoldást jelenthet a beteg hallásrehabilitációja során. Sensorineuralis halláscsökkenés esetén akkor indikálható, ha a légvezetéses hallásküszöb nem haladja meg a 80–85 dBHL-t a 3–4 kHz frekvenciákon, vezetéses, illetve kevert típusú halláscsökkenés esetén pedig akkor, ha a csontvezetéses hallásküszöb nem haladja meg a 45–65 dBHL-t a 0,5–4 kHz közti frekvenciatartományban. Az implantátum beültetését eleinte tisztán sensorineuralis halláscsökkenés esetén végezték, és csupán egyféleképpen történhetett: a rezgéskeltő rendszer oldalán lévő rögzítőcsipeszt rá kellett applikálni az incus hosszú nyújtványára. Azokra az esetekre, amikor a rezgéskeltő rögzítése nem kivitelezhető, különböző rögzítőelemeket (coupler) fejlesztettek ki. Az incusra való rögzítés hosszúnyújtvány-couplerrel, illetve rövidnyújtvány-couplerrel lehetséges. Vezetéses és kevert típusú halláscsökkenés esetén a kerek ablak membránjához is illeszthető a rendszer, előrehaladott otosclerosis esetén pedig a Soundbridge-implantáció stapedotomiával kiegészített változata („power stapes”) hozhat kielégítő halláseredményt. Ezek a technikák meglehetősen megnövelték a sebész szabadságát, így széles körben alkalmazott, megbízható megoldássá váltak. A Pécsi Tudományegyetem Fül-Orr-Gégészeti és Fej-Nyaksebészeti Klinikáján az elmúlt évtizedben számos incusvibroplastica történt, de kerekablak-vibroplasticára is több alkalommal sor került. A jelen összefoglaló tanulmányban a Vibrant Soundbridge implantátum technikai fejlődésének történeti áttekintésén felül az alkalmazható műtéti megoldásokat mutatjuk be. Orv Hetil. 2021; 162(40): 1619–1626. Summary. The Vibrant Soundbridge active middle ear implant can provide a reliable solution for hearing rehabilitation of patients with conductive, sensorineural or mixed hearing loss. For sensorineural hearing loss, the air conduction threshold of the patient should not be more increased than 80–85 dBHL at the range of 3–4 kHz, and for conductive and mixed hearing loss, the bone conduction threshold should not be more increased than 45–65 dBHL between 0.5 and 4 kHz. The standard surgical procedure was originally designed for purely sensorineural hearing loss, and the fixation clip of the vibrating transducer needed to be crimped onto the long process of the incus. In many cases, it is impossible to crimp the vibrator onto the incus. In order to solve such circumstances, fixation clips (couplers) have been developed. There are two options to crimp the device on the incus: applying a long process coupler or a short process coupler. For conductive or mixed hearing loss, a round window soft coupler has been introduced. In advanced otosclerotic cases, a special combined technique of Soundbridge implantation with simultaneous stapedotomy can result in sufficient hearing rehabilitation. These techniques significantly broadened the scale of possibilities for the implantation, therefore, it became a widely utilized, reliable procedure. At the Department of Otorhino-laryngology, Clinical Center, University of Pécs, in addition to a noteworthy amount of incus vibroplasty, several cases of round window vibroplasty have also been performed. The aim of the present study is to summarize the history of development of the Vibrant Soundbridge and to present an overview of the applicable surgical techniques. Orv Hetil. 2021; 162(40): 1619–1626.

A Miniature, Fiber-Optic Vibrometer for Measuring Unintended Acoustic Output of Active Hearing Implants during Magnetic Resonance Imaging

Making use of magnetic resonance imaging (MRI) for diagnostics on patients with implanted medical devices requires caution due to mutual interactions between the device and the electromagnetic fields used by the scanner that can cause a number of adverse events. The presented study offers a novel test method to quantify the risk of unintended output of acoustically stimulating hearing implants. The design and operating principle of an all-optical, MRI safe vibrometer is outlined, followed by an experimental verification of a prototype. Results obtained in an MRI environment indicate that the system can detect peak displacements down to 8 pm for audible frequencies. Feasibility testing was performed with an active middle ear implant that was exposed to several pulse sequences in a 1.5 Tesla MRI environment. Magnetic field induced actuator vibrations, measured during scanning, turned out to be equivalent to estimated sound pressure levels between 25 and 85 dB SPL, depending on the signal frequency. These sound pressure levels are situated well below ambient sound pressure levels generated by the MRI scanning process. The presented case study therefore indicates a limited risk of audible unintended output for the examined hearing implant during MRI.

A New Stapes-Head Coupler for the Vibrant Soundbridge System

Introduction: The Vibrant Soundbridge (MED-EL Medical Electronics, Austria) is an active middle ear implant with a floating mass transducer (FMT) for patients with conductive, sensorineural, or mixed hearing loss. While the FMT is vertically aligned above the stapes head (SH) with the current Vibroplasty Clip coupler (MED-EL Medical Electronics), the new SH coupler was developed to mount the FMT on the inferior side of the stapes and to fit in the reduced middle ear space after canal-wall-down mastoidectomy. Methods: Using 11 human cadaveric temporal bones (TBs), placements of the new SH couplers on the stapes were examined, and effective stimuli to the cochlea were evaluated by measuring piston-like motion of the stapes footplate with a current of 1 mA on the FMT. The results were assessed in comparison with the Vibroplasty Clip coupler. Results: The new SH coupler showed perfect coupling on the stapes in 9 out of 11 TBs. A small gap between the SH and the plate of the connection link part was unavoidable in 2 TBs but had negligible effect on vibrational motion of the stapes. Vibrational motion of the stapes with the new SH coupler was reduced at frequencies above 3 kHz compared to the corresponding motion with the current Vibroplasty Clip coupler, but the relative attenuation over all 11 cadaveric temporal bones was <10 dB. Conclusions: The new SH coupler provides an alternative with more stable fixation when placement of the current Vibroplasty Clip coupler is limited due to insufficient space after canal-wall-down mastoidectomy, while still delivering effective stimuli to the cochlea.

Simultane Implantation von Epithesenankern und Bonebridge zur Versorgung großer Ohrmissbildungen

Zusammenfassung Hintergrund Die chirurgische Versorgung mit einem Hörimplantat und Epithesen bei Ohrmissbildungen bietet eine gute Kombination aus Hörrehabilitation und kosmetischer Rekonstruktion. Oft wird die Versorgung in 2-zeitigen Operationsschritten durchgeführt. Ziel der Arbeit war es, Erfahrungswerte mit einem Vorgehen zu gewinnen, bei dem das Hörimplantat und die Epithesenanker simultan eingesetzt werden. Material und Methoden Vier Ohren von 3 Patienten (nw = 1, nm = 2) mit großen Ohrmissbildungen (Typ III nach Weerda) erhielten jeweils in einer Operation eine MedEL Bonebridge und einen Epithesenanker mit 3 Basispfosten. Zuvor war die Indikation mithilfe des Active Middle Ear Implant (aMEI) -Scores nach Frenzel (2013) gestellt worden. Ergebnisse Alle Patienten erzielten jeweils 4 Punkte im aMEI-Score, was auf eine ungünstige Prognose für eine erfolgreiche Implantation eines aktiven Mittelohrimplantats hinwies. Die Versorgung mit der Bonebridge und einem Epithesenanker konnte daraufhin komplikationslos durchgeführt werden. Postoperativ erfolgten nach 4 Wochen die audiologische Erstanpassung und die Bestückung mit Magneten. In der Audiometrie bestand ein funktioneller Gewinn von bis zu 30 dB sowie ein verbessertes Sprachverständnis. Die Epithese wurde dem gesunden Ohr nachgebildet. Nach der Versorgung waren die Patienten mit dem audiologischen und kosmetischen Ergebnis zufrieden. Schlussfolgerungen Das simultane chirurgische Vorgehen mit einem Hörimplantat und Epithesenankern stellt eine gute Option in der Versorgung von Ohrmissbildungen dar. Der aMEI-Score war ein hilfreiches Instrument zur Indikationsstellung. Durch das Vorgehen konnten das Operationsrisiko und der Aufwand der Versorgung reduziert werden.