Intraoperative adjustments to optimize active middle ear implant performance

Tringali, S.; Koka, Kanthaiah; Devèze, Arnaud; Ferber, Alexander T.; Jenkins, Herman A.; Tollin, Daniel J.

doi:10.3109/00016489.2010.507779

Cited by 21 publications

(17 citation statements)

References 19 publications

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“…Using the “classic” reference stapes vibration amplitude, the output of a T2 actuator in incus body stimulation had also been determined in earlier cadaver studies by Tringali et al . 25 and Devèze et al . 7 .…”

Section: Discussionmentioning

confidence: 94%

Validation of methods for prediction of clinical output levels of active middle ear implants from measurements in human cadaveric ears

Großöhmichen

Waldmann²,

Salcher

et al. 2017

Sci Rep

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Today, the standard method to predict output levels of active middle ear implants (AMEIs) before clinical data are available is stapes vibration measurement in human cadaveric ears, according to ASTM standard F2504-05. Although this procedure is well established, the validity of the predicted output levels has never been demonstrated clinically. Furthermore, this procedure requires a mobile and visually accessible stapes and an AMEI stimulating the ossicular chain. Thus, an alternative method is needed to quantify the output level of AMEIs in all other stimulation modes, e.g. reverse stimulation of the round window. Intracochlear pressure difference (ICPD) is a good candidate for such a method as it correlates with evoked potentials in animals and it is measurable in cadaveric ears. To validate this method we correlated AMEI output levels calculated from ICPD and from stapes vibration in cadaveric ears with outputs levels determined from clinical data. Output levels calculated from ICPD were similar to output levels calculated from stapes vibration and almost identical to clinical data. Our results demonstrate that both ICPD and stapes vibration can be used as a measure to predict AMEI clinical output levels in cadaveric ears and that ICPD as reference provided even more accurate results.

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Section: Discussionmentioning

confidence: 94%

Validation of methods for prediction of clinical output levels of active middle ear implants from measurements in human cadaveric ears

Großöhmichen

Waldmann²,

Salcher

et al. 2017

Sci Rep

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“…Transducer placement and ossicular loading exertion are possible explanations for this threshold shift, however. 9 The transducer was placed on the stapes head for S2, whereas S3, S4 and S6 had incus placement. The limited sample size did not permit evaluation of the effect of transducer placement on the hearing threshold shift.…”

Section: Discussionmentioning

confidence: 99%

Sample Size Tables for Clinical Studies

Machin

2008

749

662

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“…45 Over the years, the surgical procedure for implanting the MET has been optimized. There is no longer a need to create a hole in the incus for positioning the transducer tip 58 and couplers have been proposed for improving sound transmission. 59 Since 2009, several studies have also evaluated the feasibility of treating MHL, primarily otosclerosis, by stimulating the round window or a third window.…”

Section: Rionmentioning

confidence: 99%

The development of active middle ear implants: A historical perspective and clinical outcomes

Kließ

Ernst

Wagner

et al. 2018

Laryngoscope Investig Oto

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Objective (s)Energy emitting, active middle ear implants (aMEI) have taken more than two decades of research to reach technological sophistication, medical safety, and regulatory approval to become a powerful tool in treating sensorineural, conductive, and mixed hearing loss. The present review covers this era.Data SourceLiterature found from searching Pubmed (MEDLINE); EMBASE, SciSearch, German Medical Science Journals and Meetings, and The Cochrane Library; and published as of February 2017. Study bibliographies were hand‐searched to find further materials.MethodsA systematic literature review was conducted to identify studies evaluating the safety, efficacy, effectiveness, and subjective outcomes of partially implantable aMEIs. Data were extracted on systems with regulatory approval and summarized narratively. Meta‐analyses were conducted for aMEIs with more than 25 publications. Study selection, data extraction, and quality appraisal for quantitative data synthesis was carried out by two reviewers.ResultsFour hundred thirty‐one studies included in narrative synthesis describe that albeit good audiological outcomes, clinical safety and (dis)investment are major barriers to continued market access. The synthesised risk of adverse events was three fold with the MET than with the VIBRANT SOUNDBRIDGE. With the latter system, audiological outcomes were stable and similar for all indications and age groups.ConclusionTo date, the majority of the literature covers the clinical application of the VIBRANT SOUNDBRIDGE system as it is applicable to a wide range of otologic and audiological conditions, particularly with the introduction of couplers to extend its clinical reach. The MAXUM and MET still have to find their way into surgical routine.Level of Evidence:

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Intraoperative adjustments to optimize active middle ear implant performance

Cited by 21 publications

References 19 publications

Validation of methods for prediction of clinical output levels of active middle ear implants from measurements in human cadaveric ears

Validation of methods for prediction of clinical output levels of active middle ear implants from measurements in human cadaveric ears

Sample Size Tables for Clinical Studies

The development of active middle ear implants: A historical perspective and clinical outcomes

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