NCT04010721

Effects of Pulses on Loudness

Effects of Parameters of the Electrical Stimulation on Loudness in Oticon Medical Cochlear Implant Patients. Investigational Study for Cochlear Implant Fitting Facilitation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Oticon Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (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

• Hearing Loss, Cochlear

Interventions

Type	Name	Description
DEVICE	Experiment 1	Stimulation of one electrode at a time
DEVICE	Experiment 2:	Stimulation in groups of 4, 8 and 12 electrodes
DEVICE	Experiment 3	Stimulation total duration from 10 to 600 ms

Timeline

• Start date: 2020-02-10
• Primary completion: 2020-08-25
• Completion: 2020-08-25
• First posted: 2019-07-08
• Last updated: 2021-10-20

Locations

1 site across 1 country: France