Open AccessTowards a Unified Testing Framework for Single-Sided Deafness Studies: A Consensus Paper
Author(s) -
Paul Van de Heyning,
Dayse Távora-Vieira,
Griet Mertens,
Vincent Van Rompaey,
Gunesh Rajan,
Joachim Müller,
John Martin Hempel,
Daniel Leander,
Daniel Polterauer,
Mathieu Marx,
Shinichi Usami,
Ryosuke Kitoh,
Maiko Miyagawa,
Hideaki Moteki,
Kari Smilsky,
WolfDieter Baumgartner,
Thomas Keintzel,
Georg Mathias Sprinzl,
Astrid WolfMagele,
Susan Arndt,
Thomas Wesarg,
Stefan Zirn,
Uwe Baumann,
Tobias Weißgerber,
Tobias Rader,
Rudolf Hagen,
Anja Kurz,
Kristen Rak,
Robert J. Stokroos,
Erwin L. J. George,
Rubén Polo,
María del Mar Venegas Medina,
Yael Henkin,
Ohad Hilly,
David Ulanovski,
Ranjith Rajeswaran,
Mohan Kameswaran,
María Fernanda Di Gregorio,
Mario Zernotti
Publication year - 2016
Publication title -
audiology and neuro-otology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.106
H-Index - 78
eISSN - 1421-9700
pISSN - 1420-3030
DOI - 10.1159/000455058
Subject(s) - reimbursement , audiology , medicine , hearing loss , sound localization , protocol (science) , political science , health care , alternative medicine , pathology , law
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.