Status:
COMPLETED
Effects of Pulses on Loudness
Lead Sponsor:
Oticon Medical
Conditions:
Hearing Loss, Cochlear
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to investigate the effect of varying additional factors on loudness summation in Neuro Zti Cochlear Implant users.
Detailed Description
Primary objective: \- 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 (Exper...
Eligibility Criteria
Inclusion
- Neuro One or Neuro 2 user
- 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
- Medical conditions that contraindicate the study tests (e.g. tinnitus, dizziness)
- 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
Key Trial Info
Start Date :
February 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04010721
Start Date
February 10 2020
End Date
August 25 2020
Last Update
October 20 2021
Active Locations (1)
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1
CHU Lille
Lille, France, 59000