Impact of Anatomy-Based Cochlear Implant Programming on Early Performance

Launched by MED-EL CORPORATION · Dec 10, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how different settings on cochlear implants can affect how well new users hear and understand sounds. Specifically, it will focus on people who have hearing loss in one ear and normal to moderately severe hearing in the other ear. The goal is to see if adjusting the cochlear implant's frequency settings can improve performance for those who are newly implanted.

To participate in the study, individuals must be at least 18 years old and qualify for a cochlear implant based on the evaluation at the participating center. They should also have a MED-EL cochlear implant in one ear and must use a hearing aid in the other ear if they have moderate hearing loss or worse. Participants will be expected to follow the study procedures, which include programming the implant to provide electric stimulation to the implanted ear. This trial is not yet recruiting participants, but it will be important for those interested to meet the eligibility criteria outlined for successful participation.

Gender

ALL

Eligibility criteria

• • At least 18 years of age
• • Is a cochlear implant candidate as deemed by the participating center
• • Implanted (or to be implanted) unilaterally with a MED-EL cochlear implant with moderately severe or better acoustic hearing in the contralateral ear.
• • For patients who are already implanted, device activation must have occurred within 2 weeks of enrollment
• • Patients with moderate contralateral hearing loss or greater must utilize a hearing aid in the contralateral ear.
• • Programmed with electric-only stimulation in the implanted ear
• • The ear to be implanted, acoustic hearing thresholds must be no better than 50 dBHL at 250 Hz and 65 dBHL at 500 Hz
• • Post-operative CT scan allows for completion of OTOPLAN analysis
• • ABF settings possible at defaults in clinical programming software
• • Minimum of 10 active electrodes at activation
• • Programmed using a Fine Structure coding strategy
• • English is the primary language
• • Willing and able to comply with all scheduled procedures as defined in the protocol
• Exclusion Criteria:
• • Subjects who do not meet one or more of the above-mentioned inclusion criteria are excluded from the study
• • Subjects required to use a hearing aid per inclusion criteria who stop use of a hearing aid in the contralateral ear will be withdrawn at the time of discontinued hearing aid use
• • Subjects who receive a cochlear implant in the contralateral ear prior to the 12-month interval