Main objective of this study is to characterize the possible benefits of the new Phonak Marvel CI-CROS device on speech understanding in noise, including its implemented beamformers (UltraZoom and StereoZoom) using different noise setups.
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Speech Reception Threshold (SRT) in decibel.
Secondary outcome
Subject characteristics that could possibly influence the performance, for
example residual hearing, duration of deafness, type of implant, electrode
position in cochlea, duration of implantation, clinical
Consonant-Vowel-Consonant (CVC) scores, demographics, participant ratings of
sound perception with the loudness balancing feature of CROS device, and
percentage of words correct in a sentence or SRTs with the CROS feature.
Background summary
A cochlear implant (CI) is a device placed in the inner ear of deaf patients,
which can stimulate the auditory nerve. CI is the treatment of choice for
severe to profound sensorineural hearing loss. In the Netherlands and other
countries, implantation only of one side is covert by the insurance (Vickers et
al., 2016). One pressing problem for unilateral CI users is that hearing with
one ear leads to attenuated sound perception when speech is presented to the
non-implanted side due to the head shadow effect. Further, CI users in general
experience a marked reduction in speech intelligibility in noisy surroundings.
The aim of this proposal is to test the contralateral routing of signals (CROS)
system which is designed to eliminate the head shadow effect. In addition, CROS
features state-of-the-art beamformers of the Phonak Marvel Contralateral
Routing Of Signals (CROS) system and these will be tested for efficiency as
well. Beamforming efficiency depends highly on the spatial aspects of the
experimental setup.
Different setups are used by different research groups, making it harder to
compare results between groups and draw conclusions. A comparison between most
encountered setups and their effect on BF effectiveness has never been
performed. To accomplish this, we want to conduct a study in normal-hearing
(NH) and CI users to test different noise setups, to see the spatial effects of
setups on the speech understanding. In addition, we also want to test the CI
users in these setups to see the spatial benefits and effects of the new Phonak
Marvel CROS device and the added UltraZoom and StereoZoom beamformers.
Study objective
Main objective of this study is to characterize the possible benefits of the
new Phonak Marvel CI-CROS device on speech understanding in noise, including
its implemented beamformers (UltraZoom and StereoZoom) using different noise
setups.
Study design
This study is a single-centered cross-over trial. The total duration of the
study is estimated to be 3 years. Normal-hearing and CI users are included as
subjects in this study.
Intervention
-
Study burden and risks
Normal-hearing subjects will participate in 2 sessions, the CI users
participating in the CROS efficiency substudy in 2 sessions, and CI users
participating in the beamforming in different spatial noise setups substudy in
3 sessions on non-consecutive days (number of sessions depending on how quick
measurements go). Every session will take approximately 2-3 hours. Breaks can
be included at every moment. The risk is considered negligible in this study,
and the burden minimal. Attrition is accounted for in the subject calculation,
making the groups large enough for a high power for the study. Because of this,
this study is ethically justified. There will be no direct benefits for NH
listeners or CI users.
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
Patients (cochlear implant users):
o Implanted with cochlear implant of Advanced Bionics on one side
o Minimum age of 18 years old
o Minimum of 6 months experience with their CI
o Speech understanding score (CVC phenome test) in quiet of at least 50%
Healthy subjects (normal-hearing):
o Minimum of 18 years old
o Normal-hearing, meaning an average pure-tone threshold of not more than 60 dB
across a frequency of 500 - 4000 Hz
Exclusion criteria
- Disorders other than hearing impairment that could have an effect on study
results
- Not able to complete 2 hours of consecutive testing
- Not fluent in Dutch
- Prelingual deafness
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL85007.058.23 |