Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2020-02-10
2020-08-25
Brief Summary
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Detailed Description
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\- To assess the effect of the number and spatial distribution of active electrodes on the stimulation charge required to achieve the loudness associated with C and T levels (Experiment 2).
Secondary objectives:
* To assess how loudness is affected by changes in electrical charge of individual pulses made by adjusting the pulse amplitude versus adjusting pulse duration (Experiment 1).
* To assess how loudness elicited by a train of pulses is affected by the duration of that pulse train (Experiment 3).
Experiment 1:
The test will investigate the effect of loudness on changes in electrical charge of individual pulses, made by separately adjusting pulse amplitude or pulse width. The electrical charge required to elicit different loudness ("just-audible", "soft", "medium", "comfortable", "loud but comfortable") either when increasing the amplitude or the duration of the pulses.
Experiment 2:
The test will investigate the effect of the number of stimulating electrodes and their distribution within the cochlea on the stimulation levels required to achieve T-levels and C-levels and to elicit different loudness ("just-audible", "soft", "medium", "comfortable", "loud but comfortable").
Experiment 3:
The test will investigate the effect on loudness of trains of pulses elicited by modifications to the duration of those trains, when operating around T and C levels. Stimulation durations ranging from 10 to 600 ms will be tested. Pulse trains will be presented to either one or several electrodes to elicit different loudness ("just-audible", "soft", "medium", "comfortable", "loud but comfortable").
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Experimental : experiment 1,2 and 3
One user included participates all experiments:
* Visit 1 : experiment 1
* Visit 2 : experiment 2
* Visit 3 : experiment 3
Experiment 1
Stimulation of one electrode at a time
Experiment 2:
Stimulation in groups of 4, 8 and 12 electrodes
Experiment 3
Stimulation total duration from 10 to 600 ms
Interventions
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Experiment 1
Stimulation of one electrode at a time
Experiment 2:
Stimulation in groups of 4, 8 and 12 electrodes
Experiment 3
Stimulation total duration from 10 to 600 ms
Eligibility Criteria
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Inclusion Criteria
* Unilateral or bilateral recipient
* 12 months CI experience to allow for acclimatization to the CI sound processing and pathological changes that could alter the electrode - tissue interface and therefore T- \& C-levels.
* Having at least 7 step sizes on three electrodes in their current clinical map (for experimentation 1).
* Able and willing to provide reliable threshold and comfort level judgements
Exclusion Criteria
* Unrealistic expectations from the candidate regarding the possible benefits, risks, and limitations that are inherent to the device
* Unwillingness or inability of the candidate to comply with all investigational requirements
* Vulnerable population
18 Years
ALL
No
Sponsors
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Oticon Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Christophe VINCENT
Role: PRINCIPAL_INVESTIGATOR
CHRU LILLE
Locations
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CHU Lille
Lille, , France
Countries
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Other Identifiers
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PIC-19
Identifier Type: -
Identifier Source: org_study_id