112
Participants
Start Date
March 21, 2022
Primary Completion Date
September 6, 2022
Study Completion Date
October 25, 2022
Lenire
The sound stimulus of PS6 is comprised of sequences of tones and is spectrally modified according to the participant's hearing thresholds so that different components of the sound stimulus can be sufficiently heard by the participant irrespective of their hearing characteristics (audiological profile). The tongue stimulus of PS6 is delivered by an array of electrical signals via 32 transmucosal electrodes contacting the anterodorsal surface of the tongue. The sound and tongue stimulus parameters are presented with certain stimulus rates and timing relationships between modalities.
BRAI3N, Ghent
German Hearing Center, Hanover
The Wellcome HRB Clinical Research Facility at St. James's Hospital, Dublin
Lead Sponsor
BRAI3N (clinical site), Belgium
UNKNOWN
St James's Hospital (clinical site), Ireland
UNKNOWN
German Hearing Center Hannover (clinical site), Germany
UNKNOWN
Avania (CRO/project manager), Netherlands
UNKNOWN
Neuromod Devices Ltd.
INDUSTRY