Literature DB >> 19005251

A pilot study of the safety and performance of the Otologics fully implantable hearing device: transducing sounds via the round window membrane to the inner ear.

P P Lefebvre1, C Martin, C Dubreuil, M Decat, A Yazbeck, J Kasic, S Tringali.   

Abstract

OBJECTIVES: The safety and performance of the Otologics fully implantable hearing device were assessed in adult patients with mixed conductive and sensorineural hearing loss.
METHODS: The subcutaneous microphone of this fully implantable device picks up ambient sounds, converts them into an electrical signal, amplifies the signal according to the user's needs, and sends it to an electromechanical transducer. The transducer tip is customized with a prosthesis in order to be in contact with the round window membrane and is protected by fascia; this translates the electrical signal into a mechanical motion that directly stimulates the round window membrane and enables the user to perceive sound. The implanted battery is recharged daily via an external charger and the user can turn the implant on and off as well as adjust the volume with a hand-held remote control. In this pilot study, 6 patients with mixed conductive and sensorineural hearing loss were implanted with the Otologics fully implantable hearing device. Pre- and postoperative air conduction, bone conduction, as well as aided and unaided thresholds and speech scores were measured.
RESULTS: No significant differences between preoperative and postoperative pure-tone averages were noted. Average improvement ranged from 19.16 to 35.8 dB of functional gain across audiometric frequencies with a mean of 26.17 +/- 5.15 dB. Long-term average functional gain at 12 months was 20.83 +/- 6.22 dB. Word recognition scores demonstrated significant differences between unaided and implant-aided conditions.
CONCLUSIONS: Preliminary results of this trial of the Otologics fully implantable hearing device provide evidence that this fully implantable device is capable of efficiently transferring the sound to the inner ear via the round window membrane in patients with mixed hearing loss. Copyright 2008 S. Karger AG, Basel.

Entities:  

Mesh:

Year:  2008        PMID: 19005251     DOI: 10.1159/000171479

Source DB:  PubMed          Journal:  Audiol Neurootol        ISSN: 1420-3030            Impact factor:   1.854


  10 in total

1.  An Intracochlear Pressure Sensor as a Microphone for a Fully Implantable Cochlear Implant.

Authors:  Francis Pete X Creighton; Xiying Guan; Steve Park; Ioannis John Kymissis; Hideko Heidi Nakajima; Elizabeth S Olson
Journal:  Otol Neurotol       Date:  2016-12       Impact factor: 2.311

2.  Round window membrane implantation with an active middle ear implant: a study of the effects on the performance of round window exposure and transducer tip diameter in human cadaveric temporal bones.

Authors:  Stéphane Tringali; Kanthaiah Koka; Arnaud Deveze; N Julian Holland; Herman A Jenkins; Daniel J Tollin
Journal:  Audiol Neurootol       Date:  2010-02-11       Impact factor: 1.854

3.  A tri-coil bellows-type round window transducer with improved frequency characteristics for middle-ear implants.

Authors:  Dong Ho Shin; Ki Woong Seong; Sunil Puria; Kyu-Yup Lee; Jin-Ho Cho
Journal:  Hear Res       Date:  2016-09-02       Impact factor: 3.208

4.  A Retrospective Multicentre Cohort Review of Patient Characteristics and Surgical Aspects versus the Long-Term Outcomes for Recipients of a Fully Implantable Active Middle Ear Implant.

Authors:  Philippe P Lefebvre; Javier Gisbert; Domenico Cuda; Stéphane Tringali; Arnaud Deveze
Journal:  Audiol Neurootol       Date:  2017-01-05       Impact factor: 1.854

Review 5.  Middle ear implantable hearing devices: an overview.

Authors:  David S Haynes; Jadrien A Young; George B Wanna; Michael E Glasscock
Journal:  Trends Amplif       Date:  2009-09

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.  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 9.  Implantable hearing devices.

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

10.  Design Study of a Round Window Piezoelectric Transducer for Active Middle Ear Implants.

Authors:  Dong Ho Shin
Journal:  Sensors (Basel)       Date:  2021-01-31       Impact factor: 3.576

  10 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.