Minimal Reporting Standards for Active Middle Ear Hearing Implants

Maier, Hannes; Baumann, Uwe; Baumgartner, Wolf‐Dieter; Beutner, Dirk; Caversaccio, Marco; Keintzel, Thomas; Kompis, Martin; Lenarz, Thomas; Magele, Astrid; Mewes, Torsten; Müller, Alexander; Rahne, Torsten; Schraven, Sebastian P.; Schwab, Burkard; Sprinzl, Georg Mathias; Strauchmann, Bernd; Todt, Ingo; Wesarg, Thomas; Wollenberg, Barbara; Plontke, Stefan K.

doi:10.1159/000490878

Cited by 26 publications

(17 citation statements)

References 55 publications

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“…This should be more closely monitored in clinical practice. A recent publication highlights which audiological, surgical and subjective outcome measures should ideally be collected for the investigation of active middle ear implants [ 25 ]. This would facilitate the retrospective analysis of patient data and data pooling across studies.…”

Section: Discussionmentioning

confidence: 99%

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A retrospective European multicenter analysis of the functional outcomes after active middle ear implant surgery using the third generation vibroplasty couplers

Rahne

Skarżyński

Hagen

et al. 2020

Eur Arch Otorhinolaryngol

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Purpose To evaluate the safety and performance of three novel vibroplasty couplers that allow attachment of the floating mass transducer of a transcutaneous active middle ear implant (AMEI) to the round window (RW) membrane, the long process (LP), or the incus body and the short process (SP) of the incus. Methods Retrospective multicenter cohort study of 25 AMEI users with sensorineural or mixed hearing loss that were among the first implanted with an AMEI vibrating ossicular prosthesis in combination with the third generation of vibroplasty couplers between 2014 and 2016. Main Outcome Measures were bone-conduction pure-tone and vibroplasty thresholds, postoperative aided sound field thresholds and postoperative aided word recognition score (WRS). Results Bone conduction threshold changes of more than 10 dB in 4PTA BC were observed in two subjects. A mean improvement of 57.8% in speech recognition was observed with a mean WRS at 65 dB SPL improving from 14.8% (SD 21.9%) preoperatively to a mean aided score of 72.6% (SD 18.6%). Sound field thresholds improved from an average 4PTA SF of 64.1 dB HL (SD 9.8 dB HL) to 37.0 dB HL (SD 8.9 dB HL), resulting in a mean functional gain of 27.1 dB. There was no significant difference in WRS or functional gain between the coupler types. Conclusion Initial experience shows that all three third generation vibroplasty couplers represent safe and efficient attachment options for the FMT allowing the surgeon to choose the coupling type based on the present pathology.

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Section: Discussionmentioning

confidence: 99%

“…The pure tone average (4PTA SF ) was calculated across conversational frequencies 0.5, 1, 2, and 4 kHz. The functional gain (FG) was defined as the mean difference between unaided and aided 4PTA SF [ 25 ]. The effective gain was determined by subtracting the aided 4PTA SF and the pre-operative 4PTA BC [ 26 ].…”

Section: Methodsmentioning

confidence: 99%

A retrospective European multicenter analysis of the functional outcomes after active middle ear implant surgery using the third generation vibroplasty couplers

Rahne

Skarżyński

Hagen

et al. 2020

Eur Arch Otorhinolaryngol

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“…Therefore, it would also be desirable to conduct user-oriented studies, outside large hearing centres, on the current state of hearing aid provision. To assess the comparability of results, these tests should adhere to speech-audiometric standards as proposed for clinical studies on hearing improvement [ 22 ], for example with active middle-ear implants [ 16 ]. These should also include, as far as possible, speech-intelligibility measurements in noise.…”

Section: Discussionmentioning

confidence: 99%

Speech recognition with hearing aids for 10 standard audiograms

Dörfler

Hocke²,

Hast

et al. 2020

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Background Improvement of speech perception in quiet is an important goal of hearing aid provision. In practice, results are highly variable. The aim of this study was to investigate the relationship between type and extent of hearing loss (audiogram type), maximum word recognition score, and aided speech perception. Materials and methods Pure tone and speech audiometric data of 740 ears in 370 patients were reviewed. All subjects visited our hearing center for hearing aid evaluation between 2012 and 2017. The maximum word recognition score (WRS max ) and the monosyllabic speech recognition score with hearing aids, WRS 65 (HA) were analyzed for 10 different standard audiogram types. Results The WRS 65 (HA) with hearing aids for different degrees of hearing loss is, within error boundaries, comparable to previous investigations and shows a difference of 10–20 percentage points to the WRS max . This difference tends to be larger for flat and moderately sloping audiograms compared to steep-sloping audiograms. The ratio WRS 65 (HA)/WRS max can be interpreted as an efficiency factor for hearing aid provision, since it relates speech recognition with hearing aids to the maximally achievable information carrying capacity of the hearing impaired. Conclusion The expectation regarding hearing aid provision has to be adjusted according to maximum word recognition score, the derived quality measures, degree of hearing loss, and audiogram type.

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“…These were superseded with new guidelines published in 2012 which suggested a minimum of two core outcome measures (word recognition score and average pure tone threshold) were reported for clinical trials losses (Gurgel et al 2012). Whilst these guidelines have been criticised for over simplification (Maier et al 2018), our findings suggest that only a small proportion of studies actually conform to this suggested minimum COS. Despite this, the need and appetite for the use of COS within hearing loss research is still present as shown by reports from different consensus groups (Maier et al 2018), editorial comments (Hall 2018) and registration with COS bodies such as COMET (http:// www.comet-initiative.org).…”

Section: Discussionmentioning

confidence: 71%

Hearing outcome measures for conductive and mixed hearing loss treatment in adults: a scoping review

Hill-Feltham

Johansson

Hodgetts

et al. 2020

International Journal of Audiology

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Objective: Rehabilitation options for conductive and mixed hearing loss are continually expanding, but without standard outcome measures comparison between different treatments is difficult. To meaningfully inform clinicians and patients core outcome sets (COS), determined via a recognised methodology, are needed. Following our previous work that identified hearing, physical, economic and psychosocial as core areas of a future COS, the AURONET group reviewed hearing outcome measures used in existing literature and assigned them into different domains within the hearing core area. Design: Scoping review. Study Sample: Literature including hearing outcome measurements for the treatment of conductive and/or mixed hearing loss. Results: The literature search identified 1434 studies, with 278 subsequently selected for inclusion. A total of 837 hearing outcome measures were reported and grouped into nine domains. The largest domain constituted pure-tone threshold measurements accounting for 65% of the total outcome measures extracted, followed by the domains of speech testing (20%) and questionnaires (9%). Studies of hearing implants more commonly included speech tests or hearing questionnaires compared with studies of middle ear surgery. Conclusions: A wide range of outcome measures are currently used, highlighting the importance of developing a COS to inform individual practice and reporting in trials/research.

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Minimal Reporting Standards for Active Middle Ear Hearing Implants

Cited by 26 publications

References 55 publications

A retrospective European multicenter analysis of the functional outcomes after active middle ear implant surgery using the third generation vibroplasty couplers

A retrospective European multicenter analysis of the functional outcomes after active middle ear implant surgery using the third generation vibroplasty couplers

Speech recognition with hearing aids for 10 standard audiograms

Hearing outcome measures for conductive and mixed hearing loss treatment in adults: a scoping review

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