Towards a Unified Testing Framework for Single-Sided Deafness Studies: A Consensus Paper

Paul Van de Heyning; Dayse Távora-Vieira; Griet Mertens; Vincent Van Rompaey; Gunesh P Rajan; Joachim Müller; John Martin Hempel; Daniel Leander; Daniel Polterauer; Mathieu Marx; Shin-Ichi Usami; Ryosuke Kitoh; Maiko Miyagawa; Hideaki Moteki; Kari Smilsky; Wolf-Dieter Baumgartner; Thomas Georg Keintzel; Georg Mathias Sprinzl; Astrid Wolf-Magele; Susan Arndt; Thomas Wesarg; Stefan Zirn; Uwe Baumann; Tobias Weissgerber; Tobias Rader; Rudolf Hagen; Anja Kurz; Kristen Rak; Robert Stokroos; Erwin George; Ruben Polo; María Del Mar Medina; Yael Henkin; Ohad Hilly; David Ulanovski; Ranjith Rajeswaran; Mohan Kameswaran; Maria Fernanda Di Gregorio; Mario E Zernotti

doi:10.1159/000455058

Towards a Unified Testing Framework for Single-Sided Deafness Studies: A Consensus Paper

Paul Van de Heyning, Dayse Távora-Vieira^*, Griet Mertens, Vincent Van Rompaey, Gunesh P Rajan, Joachim Müller, John Martin Hempel, Daniel Leander, Daniel Polterauer, Mathieu Marx, Shin-Ichi Usami, Ryosuke Kitoh, Maiko Miyagawa, Hideaki Moteki, Kari Smilsky, Wolf-Dieter Baumgartner, Thomas Georg Keintzel, Georg Mathias Sprinzl, Astrid Wolf-Magele, Susan ArndtThomas Wesarg, Stefan Zirn, Uwe Baumann, Tobias Weissgerber, Tobias Rader, Rudolf Hagen, Anja Kurz, Kristen Rak, Robert Stokroos, Erwin George, Ruben Polo, María Del Mar Medina, Yael Henkin, Ohad Hilly, David Ulanovski, Ranjith Rajeswaran, Mohan Kameswaran, Maria Fernanda Di Gregorio, Mario E Zernotti

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUND: While hearing aids for a contralateral routing of signals (CROS-HA) and bone conduction devices have been the traditional treatment for single-sided deafness (SSD) and asymmetric hearing loss (AHL), in recent years, cochlear implants (CIs) have increasingly become a viable treatment choice, particularly in countries where regulatory approval and reimbursement schemes are in place. Part of the reason for this shift is that the CI is the only device capable of restoring bilateral input to the auditory system and hence of possibly reinstating binaural hearing. Although several studies have independently shown that the CI is a safe and effective treatment for SSD and AHL, clinical outcome measures in those studies and across CI centers vary greatly. Only with a consistent use of defined and agreed-upon outcome measures across centers can high-level evidence be generated to assess the safety and efficacy of CIs and alternative treatments in recipients with SSD and AHL.

METHODS: This paper presents a comparative study design and minimum outcome measures for the assessment of current treatment options in patients with SSD/AHL. The protocol was developed, discussed, and eventually agreed upon by expert panels that convened at the 2015 APSCI conference in Beijing, China, and at the CI 2016 conference in Toronto, Canada.

RESULTS: A longitudinal study design comparing CROS-HA, BCD, and CI treatments is proposed. The recommended outcome measures include (1) speech in noise testing, using the same set of 3 spatial configurations to compare binaural benefits such as summation, squelch, and head shadow across devices; (2) localization testing, using stimuli that rove in both level and spectral content; (3) questionnaires to collect quality of life measures and the frequency of device use; and (4) questionnaires for assessing the impact of tinnitus before and after treatment, if applicable.

CONCLUSION: A protocol for the assessment of treatment options and outcomes in recipients with SSD and AHL is presented. The proposed set of minimum outcome measures aims at harmonizing assessment methods across centers and thus at generating a growing body of high-level evidence for those treatment options.

Original language	English
Pages (from-to)	391-398
Number of pages	8
Journal	Audiology and Neurotology
Volume	21
Issue number	6
DOIs	https://doi.org/10.1159/000455058
Publication status	Published - 2016

Keywords

Cochlear Implantation
Cochlear Implants
Consensus
Deafness
Hearing Aids
Hearing Loss, Unilateral
Humans
Longitudinal Studies
Noise
Prospective Studies
Quality of Life
Sound Localization
Speech Perception
Surveys and Questionnaires
Tinnitus
Treatment Outcome
Comparative Study
Journal Article
Randomized Controlled Trial

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Cite this

Van de Heyning, P., Távora-Vieira, D., Mertens, G., Van Rompaey, V., Rajan, G. P., Müller, J., Hempel, J. M., Leander, D., Polterauer, D., Marx, M., Usami, S.-I., Kitoh, R., Miyagawa, M., Moteki, H., Smilsky, K., Baumgartner, W.-D., Keintzel, T. G., Sprinzl, G. M., Wolf-Magele, A., ... Zernotti, M. E. (2016). Towards a Unified Testing Framework for Single-Sided Deafness Studies: A Consensus Paper. Audiology and Neurotology, 21(6), 391-398. https://doi.org/10.1159/000455058

@article{e58cedaa18a7409d9871abc62664a533,

title = "Towards a Unified Testing Framework for Single-Sided Deafness Studies: A Consensus Paper",

abstract = "BACKGROUND: While hearing aids for a contralateral routing of signals (CROS-HA) and bone conduction devices have been the traditional treatment for single-sided deafness (SSD) and asymmetric hearing loss (AHL), in recent years, cochlear implants (CIs) have increasingly become a viable treatment choice, particularly in countries where regulatory approval and reimbursement schemes are in place. Part of the reason for this shift is that the CI is the only device capable of restoring bilateral input to the auditory system and hence of possibly reinstating binaural hearing. Although several studies have independently shown that the CI is a safe and effective treatment for SSD and AHL, clinical outcome measures in those studies and across CI centers vary greatly. Only with a consistent use of defined and agreed-upon outcome measures across centers can high-level evidence be generated to assess the safety and efficacy of CIs and alternative treatments in recipients with SSD and AHL.METHODS: This paper presents a comparative study design and minimum outcome measures for the assessment of current treatment options in patients with SSD/AHL. The protocol was developed, discussed, and eventually agreed upon by expert panels that convened at the 2015 APSCI conference in Beijing, China, and at the CI 2016 conference in Toronto, Canada.RESULTS: A longitudinal study design comparing CROS-HA, BCD, and CI treatments is proposed. The recommended outcome measures include (1) speech in noise testing, using the same set of 3 spatial configurations to compare binaural benefits such as summation, squelch, and head shadow across devices; (2) localization testing, using stimuli that rove in both level and spectral content; (3) questionnaires to collect quality of life measures and the frequency of device use; and (4) questionnaires for assessing the impact of tinnitus before and after treatment, if applicable.CONCLUSION: A protocol for the assessment of treatment options and outcomes in recipients with SSD and AHL is presented. The proposed set of minimum outcome measures aims at harmonizing assessment methods across centers and thus at generating a growing body of high-level evidence for those treatment options.",

keywords = "Cochlear Implantation, Cochlear Implants, Consensus, Deafness, Hearing Aids, Hearing Loss, Unilateral, Humans, Longitudinal Studies, Noise, Prospective Studies, Quality of Life, Sound Localization, Speech Perception, Surveys and Questionnaires, Tinnitus, Treatment Outcome, Comparative Study, Journal Article, Randomized Controlled Trial",

author = "{Van de Heyning}, Paul and Dayse T{\'a}vora-Vieira and Griet Mertens and {Van Rompaey}, Vincent and Rajan, {Gunesh P} and Joachim M{\"u}ller and Hempel, {John Martin} and Daniel Leander and Daniel Polterauer and Mathieu Marx and Shin-Ichi Usami and Ryosuke Kitoh and Maiko Miyagawa and Hideaki Moteki and Kari Smilsky and Wolf-Dieter Baumgartner and Keintzel, {Thomas Georg} and Sprinzl, {Georg Mathias} and Astrid Wolf-Magele and Susan Arndt and Thomas Wesarg and Stefan Zirn and Uwe Baumann and Tobias Weissgerber and Tobias Rader and Rudolf Hagen and Anja Kurz and Kristen Rak and Robert Stokroos and Erwin George and Ruben Polo and Medina, {Mar{\'i}a Del Mar} and Yael Henkin and Ohad Hilly and David Ulanovski and Ranjith Rajeswaran and Mohan Kameswaran and {Di Gregorio}, {Maria Fernanda} and Zernotti, {Mario E}",

note = "{\textcopyright} 2017 The Author(s) Published by S. Karger AG, Basel.",

year = "2016",

doi = "10.1159/000455058",

language = "English",

volume = "21",

pages = "391--398",

journal = "Audiology and Neurotology",

issn = "1420-3030",

publisher = "S. Karger AG",

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Van de Heyning, P, Távora-Vieira, D, Mertens, G, Van Rompaey, V, Rajan, GP, Müller, J, Hempel, JM, Leander, D, Polterauer, D, Marx, M, Usami, S-I, Kitoh, R, Miyagawa, M, Moteki, H, Smilsky, K, Baumgartner, W-D, Keintzel, TG, Sprinzl, GM, Wolf-Magele, A, Arndt, S, Wesarg, T, Zirn, S, Baumann, U, Weissgerber, T, Rader, T, Hagen, R, Kurz, A, Rak, K, Stokroos, R, George, E, Polo, R, Medina, MDM, Henkin, Y, Hilly, O, Ulanovski, D, Rajeswaran, R, Kameswaran, M, Di Gregorio, MF & Zernotti, ME 2016, 'Towards a Unified Testing Framework for Single-Sided Deafness Studies: A Consensus Paper', Audiology and Neurotology, vol. 21, no. 6, pp. 391-398. https://doi.org/10.1159/000455058

TY - JOUR

T1 - Towards a Unified Testing Framework for Single-Sided Deafness Studies

T2 - A Consensus Paper

AU - Van de Heyning, Paul

AU - Távora-Vieira, Dayse

AU - Mertens, Griet

AU - Van Rompaey, Vincent

AU - Rajan, Gunesh P

AU - Müller, Joachim

AU - Hempel, John Martin

AU - Leander, Daniel

AU - Polterauer, Daniel

AU - Marx, Mathieu

AU - Usami, Shin-Ichi

AU - Kitoh, Ryosuke

AU - Miyagawa, Maiko

AU - Moteki, Hideaki

AU - Smilsky, Kari

AU - Baumgartner, Wolf-Dieter

AU - Keintzel, Thomas Georg

AU - Sprinzl, Georg Mathias

AU - Wolf-Magele, Astrid

AU - Arndt, Susan

AU - Wesarg, Thomas

AU - Zirn, Stefan

AU - Baumann, Uwe

AU - Weissgerber, Tobias

AU - Rader, Tobias

AU - Hagen, Rudolf

AU - Kurz, Anja

AU - Rak, Kristen

AU - Stokroos, Robert

AU - George, Erwin

AU - Polo, Ruben

AU - Medina, María Del Mar

AU - Henkin, Yael

AU - Hilly, Ohad

AU - Ulanovski, David

AU - Rajeswaran, Ranjith

AU - Kameswaran, Mohan

AU - Di Gregorio, Maria Fernanda

AU - Zernotti, Mario E

PY - 2016

Y1 - 2016

N2 - BACKGROUND: While hearing aids for a contralateral routing of signals (CROS-HA) and bone conduction devices have been the traditional treatment for single-sided deafness (SSD) and asymmetric hearing loss (AHL), in recent years, cochlear implants (CIs) have increasingly become a viable treatment choice, particularly in countries where regulatory approval and reimbursement schemes are in place. Part of the reason for this shift is that the CI is the only device capable of restoring bilateral input to the auditory system and hence of possibly reinstating binaural hearing. Although several studies have independently shown that the CI is a safe and effective treatment for SSD and AHL, clinical outcome measures in those studies and across CI centers vary greatly. Only with a consistent use of defined and agreed-upon outcome measures across centers can high-level evidence be generated to assess the safety and efficacy of CIs and alternative treatments in recipients with SSD and AHL.METHODS: This paper presents a comparative study design and minimum outcome measures for the assessment of current treatment options in patients with SSD/AHL. The protocol was developed, discussed, and eventually agreed upon by expert panels that convened at the 2015 APSCI conference in Beijing, China, and at the CI 2016 conference in Toronto, Canada.RESULTS: A longitudinal study design comparing CROS-HA, BCD, and CI treatments is proposed. The recommended outcome measures include (1) speech in noise testing, using the same set of 3 spatial configurations to compare binaural benefits such as summation, squelch, and head shadow across devices; (2) localization testing, using stimuli that rove in both level and spectral content; (3) questionnaires to collect quality of life measures and the frequency of device use; and (4) questionnaires for assessing the impact of tinnitus before and after treatment, if applicable.CONCLUSION: A protocol for the assessment of treatment options and outcomes in recipients with SSD and AHL is presented. The proposed set of minimum outcome measures aims at harmonizing assessment methods across centers and thus at generating a growing body of high-level evidence for those treatment options.

AB - BACKGROUND: While hearing aids for a contralateral routing of signals (CROS-HA) and bone conduction devices have been the traditional treatment for single-sided deafness (SSD) and asymmetric hearing loss (AHL), in recent years, cochlear implants (CIs) have increasingly become a viable treatment choice, particularly in countries where regulatory approval and reimbursement schemes are in place. Part of the reason for this shift is that the CI is the only device capable of restoring bilateral input to the auditory system and hence of possibly reinstating binaural hearing. Although several studies have independently shown that the CI is a safe and effective treatment for SSD and AHL, clinical outcome measures in those studies and across CI centers vary greatly. Only with a consistent use of defined and agreed-upon outcome measures across centers can high-level evidence be generated to assess the safety and efficacy of CIs and alternative treatments in recipients with SSD and AHL.METHODS: This paper presents a comparative study design and minimum outcome measures for the assessment of current treatment options in patients with SSD/AHL. The protocol was developed, discussed, and eventually agreed upon by expert panels that convened at the 2015 APSCI conference in Beijing, China, and at the CI 2016 conference in Toronto, Canada.RESULTS: A longitudinal study design comparing CROS-HA, BCD, and CI treatments is proposed. The recommended outcome measures include (1) speech in noise testing, using the same set of 3 spatial configurations to compare binaural benefits such as summation, squelch, and head shadow across devices; (2) localization testing, using stimuli that rove in both level and spectral content; (3) questionnaires to collect quality of life measures and the frequency of device use; and (4) questionnaires for assessing the impact of tinnitus before and after treatment, if applicable.CONCLUSION: A protocol for the assessment of treatment options and outcomes in recipients with SSD and AHL is presented. The proposed set of minimum outcome measures aims at harmonizing assessment methods across centers and thus at generating a growing body of high-level evidence for those treatment options.

KW - Cochlear Implantation

KW - Cochlear Implants

KW - Consensus

KW - Deafness

KW - Hearing Aids

KW - Hearing Loss, Unilateral

KW - Humans

KW - Longitudinal Studies

KW - Noise

KW - Prospective Studies

KW - Quality of Life

KW - Sound Localization

KW - Speech Perception

KW - Surveys and Questionnaires

KW - Tinnitus

KW - Treatment Outcome

KW - Comparative Study

KW - Journal Article

KW - Randomized Controlled Trial

U2 - 10.1159/000455058

DO - 10.1159/000455058

M3 - Article

C2 - 28319951

SN - 1420-3030

VL - 21

SP - 391

EP - 398

JO - Audiology and Neurotology

JF - Audiology and Neurotology

IS - 6

ER -