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Evaluation of an integrated electrocochleography function for the monitoring of residual hearing

Completed
Conditions
deafness
hearing loss
10019243
Registration Number
NL-OMON46549
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Trial ended prematurely

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
13
Inclusion Criteria

Eligible for cochlear implantation, with residual hearing in the implanted ear

Exclusion Criteria

No residual hearing, co-morbidities

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main study parameters are ECoG recordings, and specifically their<br /><br>amplitudes that will be compared before, during and after surgery. These<br /><br>measures can be correlated to the standard subjective clinical measures (pure<br /><br>tone audiograms) after surgery.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Benchmark recordings of the ECoG during surgery using standard (high-quality)<br /><br>BERA equipment. Similarly, eCAP recordings will be benchmarked against the<br /><br>normal standard-of care eCAP recordings obtained via the implant electronics.<br /><br>eCAPs will be analyzed through standard methods, including amplitude-growth<br /><br>functions and threshold measurements.</p><br>
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