Comparison of Speech Understanding Between a Tonotopy-based Bimodal Fitting and a Default Bimodal Fitting in Newly Cochlear-implanted Patients: a Double-blind Randomized Crossover Study.

What this Trial Is About

Researchers are evaluating a new fitting strategy for people with profound bilateral deafness who use a cochlear implant (CI) combined with a hearing aid (HA) on the other ear, called bimodal hearing. The study compares a tonotopy-based fitting approach (TFS4), which matches electrode stimulation more closely to the cochlea's natural frequency layout, with a standard fitting method (FS4). The aim is to see if this new method improves speech understanding in noisy environments, as well as speech recognition in quiet and overall auditory skills. The study is a double-blind, randomized crossover trial where participants will use each fitting method for six weeks in a different order. One group starts with the default fitting (FS4) for six weeks then switches to the tonotopy-based fitting (TFS4) for six weeks, and the other group follows the reverse order. The cochlear implant settings are adjusted according to the assigned fitting strategy during these periods. Participants will be assessed at six weeks and twelve weeks after activation of the cochlear implant. During these visits, speech recognition in noise and quiet will be measured, along with evaluations of the auditory skills experienced by the participant. The trial is conducted at a single center, and the total study duration for each participant is twelve weeks of follow-up after activation. The sponsor is MED-EL Elektromedizinische Geräte GesmbH.

Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting