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



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.



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.



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.
University Department of Otorhinolaryngology, Head and Neck Surgery, Antwerp University Hospital, and University of Antwerp, Antwerp, Belgiu.
Paul
P
Van de Heyning
Dayse
D
Távora-Vieira
Griet
G
Mertens
Vincent
V
Van Rompaey
Gunesh P
GP
Rajan
Joachim
J
Müller
John Martin
JM
Hempel
Daniel
D
Leander
Daniel
D
Polterauer
Mathieu
M
Marx
Shin-Ichi
SI
Usami
Ryosuke
R
Kitoh
Maiko
M
Miyagawa
Hideaki
H
Moteki
Kari
K
Smilsky
Wolf-Dieter
WD
Baumgartner
Thomas Georg
TG
Keintzel
Georg Mathias
GM
Sprinzl
Astrid
A
Wolf-Magele
Susan
S
Arndt
Thomas
T
Wesarg
Stefan
S
Zirn
Uwe
U
Baumann
Tobias
T
Weissgerber
Tobias
T
Rader
Rudolf
R
Hagen
Anja
A
Kurz
Kristen
K
Rak
Robert
R
Stokroos
Erwin
E
George
Ruben
R
Polo
María Del Mar
MDM
Medina
Yael
Y
Henkin
Ohad
O
Hilly
David
D
Ulanovski
Ranjith
R
Rajeswaran
Mohan
M
Kameswaran
Maria Fernanda
MF
Di Gregorio
Mario E
ME
Zernotti
D019929:Cochlear Implantation / Q000379:methods*; D003054:Cochlear Implants; D003638:Deafness / Q000503:physiopathology / Q000534:rehabilitation*; D006310:Hearing Aids; D046088:Hearing Loss, Unilateral / Q000503:physiopathology / Q000534:rehabilitation*; D006801:Humans; D008137:Longitudinal Studies; D009622:Noise; D011446:Prospective Studies; D011788:Quality of Life; D013017:Sound Localization; D013067:Speech Perception; D011795:Surveys and Questionnaires; D014012:Tinnitus; D016896:Treatment Outcome
Asymmetric hearing loss; Bimodal stimulation; Bone conduction device; Bone-anchored hearing aid; Cochlear implant; Contralateral routing of signals hearing aid; Single-sided deafness; Testing method consensus; Unilateral hearing loss