Literature DB >> 20111617

Fully implantable Otologics MET Carina device for the treatment of sensorineural hearing loss. Preliminary surgical and clinical results.

L Bruschini1, F Forli, A Santoro, P Bruschini, S Berrettini.   

Abstract

Middle ear implants overcome some of the common problems of conventional hearing aid technology, such as feedback, signal distortion, ear canal occlusion and associated issues. The Otologics MET Carina, Boulder, CO, USA, is a fully implantable hearing prosthesis designed to address the amplification needs of adults (> 18 years of age), with moderate to severe sensorineural hearing loss and normal middle ears, providing a mechanical direct stimulation of middle ear ossicles. Recently, it has been successfully used also in patients with conductive hearing loss. In the present report, personal surgical and clinical experience with the fully implantable Carina is described in 5 adults with moderate to severe sensorineural hearing loss, operated upon between November 2007 and May 2008 in the ENT Unit, University of Pisa. Mean follow-up was 10.2 months of device use (range 7-13). Surgery was performed under general anaesthesia, in approximately 3 hours, with no surgical complications in any of the patients. In these 5 cases, no significant post-operative variation was observed in hearing thresholds, either for air or bone conduction, indicating absence of surgical damage to the cochlea. All patients showed improvements in hearing thresholds, in free field and in speech perception abilities, with the device functioning, moreover, they reported subjective benefits. With regard to post-operative adverse effects, no cases of extrusion of the device, device failure, loss of external communication or increased charging times were observed. Problems of feedback noise occurred, which were resolved with minor fitting adjustments in 4 cases, while a second operation was required to change the microphone position in the other patient. The present results, in agreement with those reported in the literature, confirm that the Otologics MET Carina is viable treatment for moderate to severe sensorineural hearing loss and, in selected cases, may represent an alternative to conventional hearing aids.

Entities:  

Keywords:  Middle ear implants; Sensorineural hearing loss

Mesh:

Year:  2009        PMID: 20111617      PMCID: PMC2808684     

Source DB:  PubMed          Journal:  Acta Otorhinolaryngol Ital        ISSN: 0392-100X            Impact factor:   2.124


  15 in total

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Authors:  J F Kasic; J M Fredrickson
Journal:  Otolaryngol Clin North Am       Date:  2001-04       Impact factor: 3.346

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Journal:  Laryngoscope       Date:  2007-02       Impact factor: 3.325

3.  Committee on Hearing and Equilibrium guidelines for the evaluation of results of treatment of conductive hearing loss. AmericanAcademy of Otolaryngology-Head and Neck Surgery Ffoundation, Inc.

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Journal:  Otolaryngol Head Neck Surg       Date:  1995-09       Impact factor: 3.497

4.  Treatment of mixed hearing losses via implantation of a vibratory transducer on the round window.

Authors:  Vittorio Colletti; Sigfrid D Soli; Marco Carner; L Colletti
Journal:  Int J Audiol       Date:  2006-10       Impact factor: 2.117

5.  Clinical experience with the Vibrant Soundbridge implant device.

Authors:  U Fisch; C W Cremers; T Lenarz; B Weber; G Babighian; A S Uziel; D W Proops; A F O'Connor; R Charachon; J Helms; B Fraysse
Journal:  Otol Neurotol       Date:  2001-11       Impact factor: 2.311

6.  Phase 1 clinical trial results of the Envoy System: a totally implantable middle ear device for sensorineural hearing loss.

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Journal:  Otolaryngol Head Neck Surg       Date:  2004-12       Impact factor: 3.497

7.  Intraoperative ossicular loading with the Otologics fully implantable hearing device.

Authors:  Herman A Jenkins; Nicholas Pergola; James Kasic
Journal:  Acta Otolaryngol       Date:  2007-04       Impact factor: 1.494

8.  Otologics Middle Ear Transducer Ossicular Stimulator: performance results with varying degrees of sensorineural hearing loss.

Authors:  Herman A Jenkins; John K Niparko; William H Slattery; J Gail Neely; John M Fredrickson
Journal:  Acta Otolaryngol       Date:  2004-05       Impact factor: 1.494

9.  Exclusive transcanal surgical approach for Vibrant Soundbridge implantation: surgical and functional results.

Authors:  Luca Bruschini; Francesca Forli; Michela Giannarelli; Paolo Bruschini; Stefano Berrettini
Journal:  Otol Neurotol       Date:  2009-10       Impact factor: 2.311

10.  A middle ear implant, the Symphonix Vibrant Soundbridge: retrospective study of the first 125 patients implanted in France.

Authors:  Olivier Sterkers; Didier Boucarra; Samia Labassi; Jean-Pierre Bebear; Christian Dubreuil; Bruno Frachet; Bernard Fraysse; Jean-Pierre Lavieille; Jacques Magnan; Christian Martin; Eric Truy; Alain Uziel; François Michel Vaneecloo
Journal:  Otol Neurotol       Date:  2003-05       Impact factor: 2.311

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  11 in total

1.  Controlling the position and the dislocation of the middle ear transducer with high-resolution computed tomography and digital volume tomography: implications for the transducers' design.

Authors:  Georgios Kontorinis; Anja M Giesemann; Thomas Witt; Friedrich Goetz; Burkard Schwab
Journal:  Eur Arch Otorhinolaryngol       Date:  2011-09-22       Impact factor: 2.503

Review 2.  [Implantable hearing aids].

Authors:  J C Luers; D Beutner; K-B Hüttenbrink
Journal:  HNO       Date:  2011-10       Impact factor: 1.284

3.  Air- and Bone-Conducted Sources of Feedback With an Active Middle Ear Implant.

Authors:  Renee M Banakis Hartl; James R Easter; Mohamed A Alhussaini; Daniel J Tollin; Herman A Jenkins
Journal:  Ear Hear       Date:  2019 May/Jun       Impact factor: 3.570

4.  The first results of a totally implanted active middle ear device.

Authors:  Maria da Conceição Peixoto; Cristina Miranda; Mafalda Bento; Susana Oliveira; Rui Pratas; Victor Correia da Silva
Journal:  Eur Arch Otorhinolaryngol       Date:  2019-07-24       Impact factor: 2.503

5.  Feasible pickup from intact ossicular chain with floating piezoelectric microphone.

Authors:  Hou-Yong Kang; Gao Na; Fang-Lu Chi; Kai Jin; Tie-Zheng Pan; Zhen Gao
Journal:  Biomed Eng Online       Date:  2012-02-22       Impact factor: 2.819

6.  The Carina© middle ear implant: surgical and functional outcomes.

Authors:  Luca Bruschini; Stefano Berrettini; Francesca Forli; Alessandra Murri; Domenico Cuda
Journal:  Eur Arch Otorhinolaryngol       Date:  2016-03-23       Impact factor: 2.503

7.  First bilateral simultaneous implantation with fully implantable middle ear hearing device.

Authors:  Magdalena Lachowska; Kazimierz Niemczyk; Alain Yazbeck; Krzysztof Morawski; Antoni Bruzgielewicz
Journal:  Arch Med Sci       Date:  2012-09-08       Impact factor: 3.318

8.  A New Trans-Tympanic Microphone Approach for Fully Implantable Hearing Devices.

Authors:  Seong Tak Woo; Dong Ho Shin; Hyung-Gyu Lim; Ki-Woong Seong; Peter Gottlieb; Sunil Puria; Kyu-Yup Lee; Jin-Ho Cho
Journal:  Sensors (Basel)       Date:  2015-09-09       Impact factor: 3.576

9.  Carina® and Esteem®: a systematic review of fully implantable hearing devices.

Authors:  Janaina Oliveira Bentivi Pulcherio; Aline Gomes Bittencourt; Patrick Rademaker Burke; Rafael da Costa Monsanto; Rubens de Brito; Robinson Koji Tsuji; Ricardo Ferreira Bento
Journal:  PLoS One       Date:  2014-10-17       Impact factor: 3.240

Review 10.  Implantable hearing devices.

Authors:  Matthias Tisch
Journal:  GMS Curr Top Otorhinolaryngol Head Neck Surg       Date:  2017-12-18
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