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NCT06734039 | NOT YET RECRUITING | Hearing Loss, Unilateral

Impact of Anatomy-Based Cochlear Implant Programming on Early Performance
Sponsor:

Med-El Corporation

Brief Summary:

The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users using electric-only stimulation in the implanted ear with normal hearing to moderately severe hearing loss in the opposite ear.

Condition or disease

Hearing Loss, Unilateral

Cochlear Implants

Hearing Loss, Sensorineural

Single-Sided Deafness (SSD)

Asymmetric Hearing Loss

Intervention/treatment

Programming of cochlear implant audio processor frequency settings

Phase

NA

Detailed Description:

Participants will be randomized into a starting frequency setting at device activation or shortly after device activation for the first three months of device use. After 3 months listening experience, participants will be randomized into different frequency settings and tested before and after a period of listening experience. Participant outcomes for each of the multiple frequency settings will be evaluated using standard clinical speech testing and through questionnaires designed to capture information about patient sound quality and quality of life.

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : SINGLE
Masking Description : Participants will be blinded to each of the frequency settings they are utilizing.
Primary Purpose : TREATMENT
Official Title : Impact of Anatomy-Based Frequency (ABF) Allocations on Early Performance Outcomes in MED-EL Cochlear Implant Recipients
Actual Study Start Date : 2025-04-30
Estimated Primary Completion Date : 2028-04
Estimated Study Completion Date : 2028-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
    Impact of Anatomy-Based Cochlear Implant Programming on Early Performance

    Location Details

    NCT06734039

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    United States, North Carolina

    MED-EL Corporation

    Durham, North Carolina, United States, 27516