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Active middle ear implants

Theodore R McRackan, Jayne B Ahlstrom, William B Clinkscales, Ted A Meyer, Judy R Dubno
OBJECTIVE: To compare word recognition scores for adults with hearing loss measured using earphones and in the sound field without and with hearing aids (HA). STUDY DESIGN: Independent review of presurgical audiological data from an active middle ear implant (MEI) FDA clinical trial. SETTING: Multicenter prospective FDA clinical trial. PATIENTS: Ninety-four adult HA users. INTERVENTIONS/MAIN OUTCOMES MEASURED: Preoperative earphone, aided word recognition scores, and speech intelligibility index...
September 14, 2016: Otology & Neurotology
Jeon Mi Lee, Jinsei Jung, In Seok Moon, Sung Huhn Kim, Jae Young Choi
OBJECTIVES/HYPOTHESIS: We compared the audiologic benefits of active middle ear implants with those of passive middle ear implants with hearing aids in mixed hearing loss, and also compared the outcomes of stapes vibroplasty with those of round window vibroplasty. STUDY DESIGN: Retrospective chart review. METHODS: Thirty-four patients with mixed hearing loss due to chronic otitis media were treated with a middle ear implant. Of these, 15 were treated with a passive middle ear implant (conventional ossiculoplasty with a partial ossicular replacement prosthesis), nine with an active middle ear implant coupling to the stapes, and 10 with an active middle ear implant coupling to the round window...
August 25, 2016: Laryngoscope
Tina L Samuels, Justin Yan, Pawjai Khampang, Alexander MacKinnon, Wenzhou Hong, Nikki Johnston, Joseph E Kerschner
OBJECTIVE: Toll-like receptor signaling activated by bacterial otitis media pathogens in the middle ear has been shown to play a key role in OM susceptibility, pathogenesis and recovery. Recent studies implicate microRNA 146 (miR-146) in regulation of inflammation via negative feedback of toll-like receptor signaling (TLR) in a wide variety of tissues, however its involvement in otitis media is unknown. METHODS: Human middle ear epithelial cells were stimulated with proinflammatory cytokines, interleukin 1 beta or tumor necrosis factor alpha, for two to twenty-four hours...
September 2016: International Journal of Pediatric Otorhinolaryngology
Thomas Zahnert, Hubert Löwenheim, Dirk Beutner, Rudolf Hagen, Arneborg Ernst, Hans-Wilhelm Pau, Thorsten Zehlicke, Hilke Kühne, Natascha Friese, Anke Tropitzsch, Jan-Christoffer Lüers, Robert Mlynski, Ingo Todt, Karl-Bernd Hüttenbrink
OBJECTIVE: To evaluate the safety and effectiveness of round window (RW), oval window (OW), CliP and Bell couplers for use with an active middle ear implant. METHODS: This is a multicenter, long-term, prospective trial with consecutive enrollment, involving 6 university hospitals in Germany. Bone conduction, air conduction, implant-aided warble-tone thresholds and Freiburger monosyllable word recognition scores were compared with unaided preimplantation results in 28 moderate-to-profound hearing-impaired patients after 12 months of follow-up...
June 29, 2016: Audiology & Neuro-otology
Annekatrin Coordes, Linda Jahreiss, Uwe Schönfeld, Minoo Lenarz
After stapes surgery, patients with mixed or moderate hearing loss have limited possibilities for hearing improvement. We are reporting on a patient who underwent stapedotomy bilaterally 20 years ago and had sensorineural and mixed hearing loss. Recurrent otitis externa prevented the use of hearing aids. This patient was treated bilaterally with the Vibrant Soundbridge (Med-El, Innsbruck, Austria) successively. The Schuknecht piston stapes prostheses remained in situ. The Floating Mass Transducer (FMT; Med-El) was coupled to the round window (RW) and provided good acoustic reinforcement bilaterally...
June 27, 2016: Laryngoscope
Johannes Schnabl, Astrid Wolf-Magele, Stefan Marcel Pok, Lena Hirtler, Gertraud Heinz, Georg M Sprinzl
OBJECTIVE: Magnetic resonance imaging (MRI) has become an essential tool of modern medical imaging and disease diagnosis. In November 2014, a new MRI-conditional (up to 1.5 T) generation of an active middle ear implant (AMEI) was released to the market.The aim of the study was to test the MRI compatibility of the new implant system in a clinical-anatomical study. DESIGN: Experimental cadaver head model. SETTING: Temporal bone laboratory...
August 2016: Otology & Neurotology
Viktor Koci, Josef Seebacher, Viktor Weichbold, Patrick Zorowka, Astrid Wolf-Magele, Georg Sprinzl, Kurt Stephan
CONCLUSIONS: Patients, who are bilaterally supplied with active middle ear implants, perform slightly better in sound localization tasks than when unilaterally aided or unaided. OBJECTIVES: To investigate the impact of bilateral use of active middle ear implants on sound source localization in the horizontal plane in patients with a sloping moderate-to-severe hearing loss. METHODS: Ten adults supplied with Med-EL Vibrant Soundbridge systems (VSB) in both ears participated in the study...
July 2016: Acta Oto-laryngologica
Danni Wang, Shouqin Zhao, Qingguo Zhang, Yi Li, Xiaobo Ma, Ran Ren
OBJECTIVES: To report an integrating surgical method of Vibrant SoundBridge (VSB) implant and auricle reconstruction. METHODS: 4 cases of congenital bilateral external/middle ear malformation were enrolled. All of them were diagnosed as bilateral bony atresia and grade III microtia. Stapes vibroplasty was performed for all subjects in one operation with auricle reconstruction stage 3. The clinical information and hearing outcomes were analyzed. RESULTS: Satisfied aesthetic outcomes were confirmed by sculptured outline and symmetric shape on both sides...
July 2016: International Journal of Pediatric Otorhinolaryngology
Kh M Diab, N A Daikhes, Yu B Suleimanov, D S Kondratchikov, K D Yusifov, A R Siraeva
The objective of the present study was to improve the effectiveness of cochlear implantation (CI) in the patients presenting with cochlear-vestibular abnormalities based on the development and practical application of the algorithm for the insertion of an electrode arrayinto the spiral (Rosenthal's) canal of the cochlea taking into consideration the specific anatomical features of the middle and inner ears. The study included 25 patients with congenital malformations of the inner ear and bilateral grade IV sensorineural loss of hearing or deafness selected for CI...
2016: Vestnik Otorinolaringologii
S Volkenstein, J P Thomas, S Dazert
The majority of patients with moderate to severe hearing loss can be supplied with conventional hearing aids depending on severity and cause for hearing loss in a satisfying way. However, some patients either do not benefit enough from conventional hearing aids or cannot wear them due to inflammatory reactions and chronic infections of the external auditory canal or due to anatomical reasons. For these patients there are fully- and semi-implantable middle ear and bone conduction implants available. These devices either directly stimulate the skull (bone conduction devices), middle ear structures (active middle ear implants) or the cochlea itself (direct acoustic stimulation)...
May 2016: Laryngo- Rhino- Otologie
Antoniu Oreste Gostian, David Pazen, Magdalene Ortmann, Andreas Anagiotos, David Schwarz, Karl Bernd Hüttenbrink, Dirk Beutner
HYPOTHESIS: High loads forcing the floating mass transducer (FMT) of a single active middle ear implant toward the round window membrane (RWM) affect the backward stimulation of the cochlea. BACKGROUND: Various factors influence the backward stimulation of the cochlea. We investigated the effects of various loads applied to the FMT together with different coupling techniques at the fully exposed RWM on the vibration transmission. METHODS: Experimental study on temporal bones with the FMT linked to a load cell mounted on a translation stage moving it against the fully exposed RWM with increasing loads up to 200 mN by itself, with interposed perichondrium, cartilage or connected to the round window coupler...
June 2016: Otology & Neurotology
Maurizio Barbara, Luigi Volpini, Edoardo Covelli, Chiara Filippi, Simonetta Monini
OBJECTIVE: To verify the efficacy of a powerful active hearing device in a patient different from far-advanced otosclerosis, specifically when the stapes footplate is mobile. PATIENT: A patient with severe-to-profound mixed hearing loss, who was not benefiting from the use of a conventional hearing aid, was selected for an inner ear active implant. This was justified by a bone conductive threshold above 60 dB, which had discouraged any other rehabilitative solutions such as a bone conductive implant, or an active middle ear implant (AMEI)...
June 2016: Otology & Neurotology
Martin Koch, Till Moritz Eßinger, Thomas Stoppe, Nikoloz Lasurashvili, Matthias Bornitz, Thomas Zahnert
A fully implantable hearing aid is introduced which is a combined sensor-actuator-transducer designed for insertion into the incudostapedial joint gap (ISJ). The active elements each consist of a thin titanium membrane with an applied piezoelectric single crystal. The effectiveness of the operating principle is verified in a temporal bone study. We also take a closer look at the influence of an implantation-induced increase in middle ear stiffness on the transducer's output. An assembly of the transducer with 1 mm thickness is built and inserted into six temporal bones...
March 31, 2016: Hearing Research
Sebastian P Schraven, Robert Mlynski, Ernst Dalhoff, Andreas Heyd, Daniela Wildenstein, Kristen Rak, Andreas Radeloff, Rudolf Hagen, Anthony W Gummer
The active middle-ear implant Vibrant Soundbridge(©) (VSB) is used to treat mild-to-severe sensorineural hearing losses. The standard surgical approach for incus vibroplasty is a mastoidectomy and a posterior tympanotomy, crimping the Floating Mass Transducer (FMT) to the long process of the incus (LPI) (standard crimped application). However, tight crimping increases the risk of necrosis of the LPI, resulting in reduction of energy transfer and loss of amplification. The aim of this study was to develop a new coupling device for the LPI, that does not require crimping, and to test its vibrational transfer properties in temporal-bone preparations...
March 29, 2016: Hearing Research
Kristin Uhler, Melinda C Anderson, Herman A Jenkins
This study examined the safety and efficacy of a fully implantable active middle ear (AMEI) system. Outcome measures assessed AMEI performance compared with an optimally fitted conventional hearing aid (CHA). Fifty adults with stable, symmetric moderate-to-severe sensorineural hearing loss were implanted at 9 ambulatory settings. Consonant-Nucleus-Consonant (CNC) words, Bamford-Kowel-Bench Speech in Noise test (BKB-SIN), Abbreviated Profile of Hearing Aid Benefit (APHAB), and unaided hearing thresholds in the implanted ear were compared to baseline measures obtained using a personal CHA...
2016: Audiology & Neuro-otology
Joost W Zwartenkot, Jef J S Mulder, Ad F M Snik, Cor W R J Cremers, Emmanuel A M Mylanus
OBJECTIVE: To evaluate the long-term medical and technical results, implant survival, and complications of the semi-implantable vibrant soundbridge (VSB), otologics middle ear transducer (MET), and the otologics fully implantable ossicular stimulator (FIMOS). STUDY DESIGN: Retrospective cohort study. PATIENTS: Patients with chronic external otitis and either moderate to severe sensorineural or conductive/mixed hearing loss. SETTING: Tertiary referral center...
June 2016: Otology & Neurotology
Luca Bruschini, Stefano Berrettini, Francesca Forli, Alessandra Murri, Domenico Cuda
The Carina© system (Cochlear Ltd, Sydney, Australia) is a totally implantable prosthesis designed to meet the needs of acoustic amplification in adults with moderate-to-severe sensorineural or mixed hearing loss. It mechanically stimulates the ossicles or labyrinthine windows. The object of this study was to update surgical and functional results obtained in a consistent sample of Carina© recipients. The data sheets of 26 patients who underwent Carina© surgery at two ENT units [i.e., ENT Audiology and Phoniatrics Unit of the University Hospital of Pisa (Pisa, Italy) and ENT Unit of "Guglielmo da Saliceto" Hospital of Piacenza (Piacenza, Italy)] were evaluated for the surgical and audiological outcomes...
March 23, 2016: European Archives of Oto-rhino-laryngology
J F Polanski, A D Soares, Z M Dos Santos, O L Mendonça Cruz
OBJECTIVE: The Vibrant Soundbridge is an active middle-ear implant for hearing rehabilitation that is usually placed in the long process of the incus or round window. This study reports on the unusual implant attachment to the short process of the incus in a patient with ear malformation, and describes their audiological and clinical outcomes. METHODS: Case report and literature review. RESULTS: Audiological evaluation with the Vibrant Soundbridge implant showed a pure tone average of 31 dB...
April 2016: Journal of Laryngology and Otology
V A Savaş, B Gündüz, R Karamert, R Cevizci, M Düzlü, H Tutar, Y A Bayazit
OBJECTIVE: To compare the auditory outcomes of Carina middle-ear implants with those of conventional hearing aids in patients with moderate-to-severe mixed hearing loss. METHODS: The study comprised nine patients (six males, three females) who underwent middle-ear implantation with Carina fully implantable active middle-ear implants to treat bilateral moderate-to-severe mixed hearing loss. The patients initially used conventional hearing aids and subsequently received the Carina implants...
April 2016: Journal of Laryngology and Otology
Luis Lassaletta, Miryam Calvino, Mario Zernotti, Javier Gavilán
The objective of the study was to evaluate postoperative pain following a transcutaneous active conductive hearing implant. 27 patients undergoing Bonebridge (BB) bone conduction implantation were evaluated with two pain-related questionnaires. The Headache Impact Test (HIT-6) was used to measure the degree of disability including none or little impact (≤49), mild (50-55), moderate (56-59), and severe (≥60). The Brief Pain Inventory (BPI) was used to assess pain severity score and function interference (0 = no pain to 10 = worst pain); meaningful pain was considered to be ≥3...
March 11, 2016: European Archives of Oto-rhino-laryngology
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