Study Comparing Tonotopy-Based and Default Cochlear Implant Fittings for Speech Understanding in Adults with Hearing Loss

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 cochleas 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 Gerte GesmbH.

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