The objective is to improve the understanding of intracochlear electrocochleography for objective measurement of residual hearing. ECochG responses obtained postoperatively in patients with different aetiologies will be evaluated in concordance…
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters will be the eCochG responses, more specifically, the
amplitudes and the phase of the cochlear microphonic (CM) receptor potential,
the summating potential (SP) and the compound action potential (CAP). In
addition, the audiometric thresholds, electric field imaging, and insertion
depth of electrode will be evaluated.
Secondary outcome
Clinically obtained CT-imaging scans to define the electrode location
Background summary
Cochlear Implant (CI) candidacy has broadened the past years due to the
advancements in CI technology and performance. Nowadays, many CI candidates
have useful low-frequency residual hearing in the to-be-implanted ear. Residual
hearing can aid the patients* pitch perception and speech intelligibility,
especially when electric and acoustic hearing are combined by electroacoustic
stimulation [1]. Preserving low-frequency residual hearing during surgery is
important for pitch perception and speech intelligibility. Electrocochleography
has been introduced clinically as a tool to preserve residual hearing by
minimizing the amount of cochlear trauma inflicted during implantation [2]. In
addition, intracochlear electrocochleography has the potential to objectively
measure residual hearing and tuning curves post-operatively. To this date, the
relation between eCochG thresholds and hearing thresholds is subject of debate,
and how different pathologies affect eCochG responses remains unknown. In the
LUMC a model of intracochlear electrocochleography was developed [3]. In the
current study, electrocochleography thresholds will be measured postoperatively
on multiple frequencies and will be correlated to audiograms and simulations
with different aetiologies, with the aim to improve interpretation of
post-operatively obtained eCochG responses.
In an accompanying non-WMO study we will evaluate the effectiveness of the
intra-operative tool by retrospectively comparing patients who are measured
intra-operatively with patients who were previously implanted.
Study objective
The objective is to improve the understanding of intracochlear
electrocochleography for objective measurement of residual hearing. ECochG
responses obtained postoperatively in patients with different aetiologies will
be evaluated in concordance with hearing tests and a computational model.
Study design
Observational and longitudinal study
Study burden and risks
At three different dates eCochG measurements will be done. The eCochG
measurements can be done during visits that are part of the routine protocol of
care after cochlear implantation and are expected to add 30 minutes to the
visits. Postoperative audiometric testing and imaging is part of standard
clinical routine. There are no plausible complications with either the ECochG
measurements or the audiometric testing postoperatively. There will be no
direct benefit for the patient. Ultimately, the project will improve the
accuracy and interpretation of the ECochG responses, which will benefit all
CI-users.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- Subject meets the normal clinical candidacy criteria (functional speech
perception scores below 80%) for cochlear implantation.
- Subjects are implanted with the Advanced Bionics cochlear implant system
- Subjects have 80 dB or better pure tone unaided audiometric thresholds at
125, 250 or 500 Hz in the (to-be) implanted ear.
- Subjects have agreed to participate in the study via written informed consent.
- Subjects should be able to understand the written informed consent form.
- Subjects are at least 18 years of age
Exclusion criteria
Disorders other than a hearing impairment that could affect the study results,
such as psychiatric disorders or physical disorders that would limit their
ability to undergo testing (e.g., movement disorders, blindness etc);
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL84595.058.24 |