Literature DB >> 12072610

Results from a European clinical investigation of the Nucleus multichannel auditory brainstem implant.

Barry Nevison1, Roland Laszig, Wolf-Peter Sollmann, Thomas Lenarz, Olivier Sterkers, Richard Ramsden, Bernard Fraysse, Manuel Manrique, Helge Rask-Andersen, Emilio Garcia-Ibanez, Vittorio Colletti, Ernst von Wallenberg.   

Abstract

OBJECTIVE: This study was designed to investigate the perceptual benefits and potential risks of implanting the Nucleus(R) multichannel auditory brainstem implant.
DESIGN: Between September 1992 and October 1997 a total of 27 subjects received a Nucleus 20- or 21-channel Auditory Brainstem Implant (ABI). All subjects involved in the trial had bilateral acoustic tumour as a result of neurofibromatosis type 2 (NF2) resulting in complete dysfunction of the VIIIth nerve. The study used each subject as their own control without a preoperative baseline because residual hearing, if existing, was destroyed at surgery by tumour removal. A battery of speech tests was conducted to evaluate each patient's performance and communication abilities. Tests were conducted, where possible, in the auditory-only, visual-only, and auditory-visual conditions at 3 days postoperatively (baseline), at 3-mo intervals for the first year and every 12 mo thereafter. A subjective performance questionnaire was administered together with an extensive neurological examination at each test interval.
RESULTS: 27 subjects involved in this trial were successfully implanted with a Nucleus ABI. One subject died 2 days postoperatively due to a lung embolism unrelated to the device. Twenty-six subjects underwent device activation and all but one patient received auditory sensation at initial stimulation (96.2%). On average 8.6 (+/-4.2) of the available 21 electrodes were used in the patients' MAPs. Performance evaluation measures showed that the majority of users had access to auditory information such as environmental sound awareness together with stress and rhythm cues in speech that assist with lipreading. Although most subjects did not achieve any functional auditory-alone, open-set speech understanding, two subjects from this series (7.4%) did receive sufficient benefit to be able to use the ABI in conversation without lipreading.
CONCLUSIONS: Although the medical risks and surgical complexity associated with ABI device implantation are far greater than those for a cochlear implant, the clinical results from this trial show that the Nucleus multichannel ABI is capable of providing a significant patient benefit over risk ratio for subjects suffering loss of hearing due to bilateral retrocochlear lesions.

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Mesh:

Year:  2002        PMID: 12072610     DOI: 10.1097/00003446-200206000-00002

Source DB:  PubMed          Journal:  Ear Hear        ISSN: 0196-0202            Impact factor:   3.570


  28 in total

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3.  Internal auditory canal hypoplasia associated with bilateral vestibulocochlear nerve aplasia and deviant facial nerve course: A case report and MRI findings.

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4.  [Vestibular schwannoma. Part 2: therapy, prognosis, and rehabilitation].

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5.  Longitudinal Changes in Electrically Evoked Auditory Event-Related Potentials in Children With Auditory Brainstem Implants: Preliminary Results Recorded Over 3 Years.

Authors:  Shuman He; Holly F B Teagle; Tyler C McFayden; Matthew Ewend; Lillian Henderson; Nancy He; Craig A Buchman
Journal:  Ear Hear       Date:  2018 Mar/Apr       Impact factor: 3.570

6.  Auditory and audio-visual processing in patients with cochlear, auditory brainstem, and auditory midbrain implants: An EEG study.

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Review 7.  Advances in auditory prostheses.

Authors:  Robert V Shannon
Journal:  Curr Opin Neurol       Date:  2012-02       Impact factor: 5.710

8.  The High Rate CIS Auditory Brainstem Implant for Restoration of Hearing in NF-2 Patients.

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9.  Electrically Evoked Auditory Event-Related Responses in Patients with Auditory Brainstem Implants: Morphological Characteristics, Test-Retest Reliability, Effects of Stimulation Level, and Association with Auditory Detection.

Authors:  Shuman He; Tyler C McFayden; Holly F B Teagle; Matthew Ewend; Lillian Henderson; Craig A Buchman
Journal:  Ear Hear       Date:  2016 Nov/Dec       Impact factor: 3.570

10.  Regulatory and funding strategies to develop a safety study of an auditory brainstem implant in young children who are deaf.

Authors:  Laurel M Fisher; Laurie S Eisenberg; Mark Krieger; Eric P Wilkinson; Robert V Shannon
Journal:  Ther Innov Regul Sci       Date:  2015-09       Impact factor: 1.778

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